Trazodone Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

See also the Warning section.

Nausea, vomiting, diarrhea, drowsiness, dizziness, tiredness, blurred vision, changes in weight, headache, muscle ache/pain, dry mouth, bad taste in the mouth, stuffy nose, constipation, or change in sexual interest/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: shaking (tremors), nightmares, ringing in the ears, problems urinating, blood in urine, signs of infection (e. g., fever, persistent sore throat), shortness of breath, stomach/abdominal pain.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, fainting, fast/irregular heartbeat, seizures, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

For males, in the very unlikely event you have a painful or prolonged erection (priapism) lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Side Effects of Desyrel (Trazodone Hydrochloride), Warnings, Uses

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Trazodone (Oral Route) Side Effects

Side Effects

Drug information provided by: IBM Micromedex

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

1. 
   Blurred vision
2. 
   confusion
3. 
   dizziness
4. 
   dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
5. 
   lightheadedness
6. 
   sweating
7. 
   unusual tiredness or weakness

Less common

1. 
   Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
2. 
   confusion about identity, place, and time
3. 
   decreased concentration
4. 
   fainting
5. 
   general feeling of discomfort or illness
6. 
   headache
7. 
   lack of coordination
8. 
   muscle tremors
9. 
   nervousness
10. 
    pounding in the ears
11. 
    shortness of breath
12. 
    slow or fast heartbeat
13. 
    swelling

Rare

1. 
   Skin rash
2. 
   unusual excitement

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. 
   Dry mouth (usually mild)
2. 
   muscle or bone pain
3. 
   trouble sleeping
4. 
   trouble with remembering
5. 
   unpleasant taste

Less common

1. 
   Constipation
2. 
   continuing ringing or buzzing or other unexplained noise in the ears
3. 
   diarrhea
4. 
   hearing loss
5. 
   muscle aches or pains
6. 
   weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: Aug. 01, 2021

Copyright © 2021 IBM Watson Health. All rights reserved. Information is for End User’s use only and may not be sold, redistributed or otherwise used for commercial purposes.

.

Side Effects Of Taking Trazodone For Sleep

While primarily an antidepressant, more doctors are now prescribing trazodone for sleep issues.

We’ll look today at whether or not trazodone is an effective agent for insomnia and other sleep disorders and, more importantly, whether it’s safe to use in this capacity.

Before anything else, though, what is trazodone?

What Is Trazodone

Trazodone is an antidepressant drug mainly prescribed to treat the symptoms of depression. Doctors also commonly prescribe trazodone for the treatment of anxiety, schizophrenia, and uncontrollable movements that crop up as a side effect of other meds.

First approved by the FDA in 1981 (under the brand name Desyrel), trazodone is now available as a generic medication produced by several leading drug companies. Oleptro is the only remaining brand name for trazodone.

Trazodone belongs to a class of medications called serotonin modulators. These drugs work by moderating levels of serotonin – a neurotransmitter – in the brain and increasing its availability in the CNS (central nervous system).

Categorized as a SARI (serotonin antagonist reuptake inhibitor), trazodone stops neurons from reabsorbing serotonin once the neurotransmitter has been released into the CNS. It’s through this mechanism that trazodone can help with some cases of depression.

Unfortunately, many other antidepressants are much more effective for treating depression while the chemical composition of trazodone gives it mild sedating properties, often unwanted if being used to treat depression.

So, although not designed as a sedative or hypnotic to address sleep disorders, doctors are now prescribing trazodone off-label to mitigate insomnia.

Before we move on to examine the side effects of using trazodone for sleep, what is insomnia? We’ll briefly highlight that right now.

What Is Insomnia?

There are many different types of insomnia, and the word is used to describe a range of sleep problems from difficulty falling asleep to waking up in the night and being unable to sleep again.

There are 2 broad categories of insomnia, primary and secondary:

• Primary insomnia: With primary insomnia, you have standalone problems with sleep not brought about by other physical or psychological disorders.
• Secondary insomnia: Difficulties sleeping caused by either a medical condition or a mental health disorder is known as secondary insomnia.

Treatment of primary insomnia involves addressing and attacking the sleep problem itself.

With secondary insomnia, the condition causing the insomnia needs to be dealt with alongside medical or behavioral treatment of the insomnia itself.

There are multiple sub-types of insomnia.

• Acute insomnia: Typically triggered by a stressful life event, acute insomnia is a brief, fleeting episode of sleep disturbance that often resolves with no need for treatment.
• Chronic insomnia: Insomnia is normally labelled chronic if you have problems falling asleep or staying asleep for at least 3 nights weekly over 3 months or more. There are many causes and treatment varies accordingly.
• Comorbid insomnia: If insomnia occurs alongside another condition, it’s termed comorbid insomnia. Conditions like anxiety and depression often precipitate sleeping problems. Debilitating back pain or conditions like arthritis can also make it hard to sleep.
• Late insomnia: Waking extremely early in the morning and being unable to sleep again.
• Maintenance insomnia: An inability to stay asleep is known as maintenance insomnia and it’s characterized by waking during the night then finding it tough to get back to sleep.
• Sleep onset insomnia: You’re suffering from onset insomnia if you find it tough to fall asleep when you climb into bed.

Many medications are used to address the issues that come with insomnia including Ambien and trazodone.

So, does taking an antidepressant really work if you’ve got insomnia?

Does This Help You Sleep

In 2017, a systematic review of trazodone for insomnia yielded 45 studies into the safety and efficacy of off-label use of this medication. The study concluded that trazodone is useful for treating both primary and secondary insomnia. Trazodone was also shown to be effective for treating symptoms caused by depression and dementia.

That said, physicians and sleep scientists often baulk at the idea of using antidepressants like trazodone for the treatment of insomnia. Popular alternatives like Lunesta and Ambien better deal with the neurological upset often associated with insomnia. CBT (cognitive behavioral therapy) is also promoted as an effective non-pharmacologic solution.

A key advantage of using trazodone to counter sleep issues is that it can be safely used for much longer than most common sleep aids. Normally, prescription sleeping pills are used for no more than 2 weeks. Trazodone can be safely used for longer than this.

The 3 to 6 hour half-life of trazodone makes it most suitable for treating sleep onset insomnia or maintenance insomnia.

Trazodone as a sleep aid has several core benefits:

• Scientifically proven to effectively treat both primary insomnia and secondary insomnia
• Trazodone can be used to treat sleep issues at low doses
• This medication is safely than the alternative medications for elderly patients
• You can find generic trazodone much more cheaply than Ambien
• Trazodone has fewer side effects than most common sleep aids
• Unlike benzodiazepines, trazodone is not addictive
• Trazodone can be used to treat sleep apnea

Sleep scientists recommend CBT along with other appropriate behavioral modifications as a first line of attack against insomnia. If these modalities are not suitable for you or don’t work, the sedative effects of trazodone can be beneficial.

So, how much do you need?

Dosage for Sleep

Trazodone tablets come in multiple doses:

When used as a sleep aid, start off with 25 to 50mg and increase the dose if necessary up to 100mg. Studies have also shown that trazodone has utility even in lower doses.

So, you can see that trazodone works well for combatting insomnia and that you don’t need to take this non-addictive medication in high doses either.

What about the downside of trazodone for sleep, though?

We’ll look now at what side effects you can expect if trazodone is prescribed for insomnia.

Side Effects of Trazodone

If you use trazodone to alleviate insomnia and suddenly discontinue use, you might experience symptoms like anxiety, irritability, depression and mild flu-like symptoms. These side effects can be largely eliminated by slowly tapering off and using less trazodone over time.

When compared to Ambien, withdrawal symptoms are pretty mild.

How about more general side effects, then?

Experiencing any of the following is commonplace:

• Blurred vision
• Confusion
• Constipation
• Diarrhea
• Difficulties with walking or coordination
• Dizziness
• Dry mouth
• Fatigue
• Headache
• Lightheadedness
• Low blood pressure
• Muscle pain
• Nausea or vomiting
• Nervousness
• Palpitations
• Rapid heart rate
• Sleepiness
• Skin reactions, such as a rash
• Tremors
• Weight changes

While much less common, you might also experience the following serious side effects:

• Abnormal heart rhythms
• Anemia
• Extrapyramidal symptoms
• Fainting
• Hallucinations
• Heart attack
• Hepatitis (liver inflammation)
• Hypertension (high blood pressure)
• Hypomania
• Mania
• Neutropenia (low white blood cell count)
• Orthostatic hypotension (low blood pressure when standing)
• Priapism (persistent painful erection)
• Psychosis exacerbation
• Seizures
• SIADH (Syndrome of Inappropriate Anti-Diuretic Hormone secretion)
• Stroke
• Suicidal thoughts
• Tardive dyskinesia
• Worsening depression

In rare instances, trazodone can provoke serious reactions. If you find difficulty breathing or experience any other severe reaction, call 911 immediately.

According to the Food and Drug Administration, trazodone poses the following serious risks:

• Cardiac arrhythmias: Changed in heart rhythm can occur. The risk is heightened if you have existing heart problems.
• Serotonin syndrome: Too much serotonin accumulating in the body can trigger negative reactions. If you’re taking migraine medication or other supplements, the risk of this is magnified. Symptoms include dizziness, seizures, agitation, and hallucinations.
• Suicidal thoughts: There’s a risk of suicidal thoughts when using trazodone. This is most prevalent in young adults.
• Hypotension: When you stand up, hypotension is an abrupt drop in blood pressure. This happens more frequently when some people use trazodone.
• Heightened danger of bleeding: If you’re taking blood-thinning drugs like Warfarin or Heparin along with trazodone, you should be aware that your risk of bleeding increases.
• Mania: Trazodone can induce feelings of hyperactivity, euphoria, and excessive excitement.
• Priapism: In very rare cases, trazodone can cause priapism, an erection that lasts a long time and causes pain.

We reiterate, you are highly unlikely to experience most of the above side effects if you use trazodone for insomnia. You should nevertheless be aware of everything that could happen.

How about overdose, then? Is this a danger with trazodone?

Trazodone Overdose

Although uncommon, there have been a handful of reports of trazodone overdose.

The risk of overdose is heightened if you’re drinking alcohol. You should also avoid taking benzodiazepines or any other CNS depressant drugs. All of these can arrest your breathing and slow your reactions.

Symptoms of a trazodone overdose include:

• Drowsiness
• Heart rhythm changes
• Respiratory arrest (breathing stops)
• Seizures
• Vomiting

Any drug overdose can be fatal so call 911 immediately if you think you might have taken too many trazodone tablets.

If you or someone you know is struggling with an addiction to Trazodone or other antidepressants and is searching for an inpatient rehab facility, call us at 888-448-0302 to chat with a recovery specialist. We are available 24/7 to answer your questions and get you the information you need to make the best recovery decision for you. Your call is 100% confidential, and we are ready to help you get started whenever you decide that it’s the right time

Trazodone: FDA Warning

Just like a number of antidepressants, this medication has been issued with an FDA Black Box Warning.

This concerns the increased risk of suicidal thoughts or behaviors in children and young adults. The FDA states that anyone taking trazodone should be “closely monitored” and add that this medication “is not approved for use in pediatric patients”.

The Bottom Line

Despite generally positive results with trazodone for both primary insomnia and secondary insomnia, the American Academy of Sleep Medicine suggests that the potential damage and risk of using trazodone for insomnia outweigh the advantages.

Studies have shown that you might only shave off 10 minutes from the time it takes you to fall asleep, and you only reduce the amount of time you’re awake by 8 minutes. Admittedly, these are not impressive stats.

While not recommended the first line of treatment against insomnia, trazodone can be a highly effective sleep aid. If you haven’t had much luck with behavioral therapy or other types of medication from Ambien to Valium, you could find some benefit from trying trazodone.

Final Word

If you’d like advice about any aspect of medication, don’t hesitate to get in touch. Since trazodone is non-addictive and you won’t experience severe withdrawal symptoms, you won’t need residential rehab to stop taking it.

You may, however, like the idea of exploring cognitive behavioral therapy as an alternative to medication for sleep. If so, call us on 888-448-0302 and we can help you out.

Your Path to Recovery Starts Here

Recovery starts here. Talk to a Recovery Specialist now.

888-448-0302

Your Path to Recovery Starts Here

Recovery starts here. Talk to a Recovery Specialist now.

888-448-0302

About the Author

Landmark Recovery Staff

This post was written by a Landmark Recovery staff member. If you have any questions, please contact us at 888-448-0302.

Nov 26, 2019

Posted in: Drug

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Trazodone Hydrochloride 50mg and 100mg Capsules – Patient Information Leaflet (PIL)

What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet.
The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on 0800 198 5000.
The product code(s) for this leaflet are: PL04425/0609, PL17780/0617, PL17780/0618, PL04425/0180.

TRAZODONE HYDROCHLORIDE 50MG AND 100MG CAPSULES

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What trazodone is and what it is used for

2. Before you take trazodone

3. How to take trazodone

4. Possible side effects

5. How to store trazodone

6. Further information

The name of your medicine is Trazodone Hydrochloride 50mg or 100mg Capsules (called trazodone in this leaflet). This belongs to a group of medicines called antidepressants.

Trazodone can be used to treat anxiety and depression.

Do not take this medicine and tell your doctor if you:

• are allergic to trazodone or any of the other ingredients of these capsules (listed in section 6).
  
  Signs of an allergic reaction can include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• have recently had a heart attack.
• are a heavy drinker or are taking sleeping tablets.
• are under 18 years of age.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking trazodone.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this if you:

• have previously had thoughts about killing or harming yourself.
• are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Trazodone should not be used in children and adolescents under 18 years of age.

If you are elderly, you may be more prone to side effects, increased caution is necessary especially when taking other medicines at the same time as trazodone or if you have some other diseases.

• have or have ever had fits or seizures (epilepsy)
• have severe liver, kidney or heart problems
• are pregnant, trying to become pregnant or are breast-feeding
• have an overactive thyroid gland (hyperthyroidism)
• have problems passing water or need to pass water (urine) frequently
• have narrow angle glaucoma (an eye disorder)
• have schizophrenia or other type of mental disorder
• are elderly, as you may be more prone to side effects
• are taking buprenorphine (a strong pain killer). The use of buprenorphine with trazodone can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and trazodone”).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking trazodone.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you buy without a prescription, including herbal medicines.

This is because trazodone can affect the way some other medicines work. Also some medicines can affect the way trazodone work.

• MAOI (MonoAmine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease), or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or fluoxetine)
• Buprenorphine/opioids. These medicines may interact with trazodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as carbamazepine and phenytoin
• Medicines used to treat high blood pressure, for example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as ketoconozole and itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin, an antibiotic used to treat infections
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting)

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trazodone.

You should avoid drinking alcohol while taking trazodone.

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Trazodone should only be taken during pregnancy if your doctor tells you that treatment with trazodone is essential for you and tells you to take this medicine.

Taking trazodone in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Trazodone may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.

Trazodone Capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this this medicine.

Always take trazodone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food. This can help lower the chances of side effects
• If you have been told to take trazodone only once each day then you should take it before going to bed
• If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor

Adults:

Depression

• Adults usually start by taking 150mg each day
• Your doctor may increase the dose to 300mg each day depending on your condition
• For adults in hospital the dose may be as high as 600mg each day

Anxiety

• Adults usually start by taking 75mg each day
• Your doctor may increase the dose to 300mg each day

Elderly

• Older people or those who are frail will usually be given a starting dose of 100mg each day

Children

Children and adolescents under 18 years should not take trazodone.

If you take more trazodone than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen: feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures), confusion, breathing or heart problems.

If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

Keep taking trazodone until your doctor tells you to stop. Do not stop taking trazodone just because you feel better. When your doctor tells you to stop taking these capsules he/she will help you to stop taking them gradually.

Like all medicines, trazodone can cause side effects, although not everybody gets them.

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to trazodone.
• Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
• Getting infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be because of a blood disorder (thrombocytopenia)
• You have severe abdominal pain and bloating, are being sick (vomiting) and have constipation.
  
  These may be signs that your intestine is not working properly (paralytic ilius)

• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (parasthesia)
• Feeling confused, restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat, you may have something called Serotonin syndrome.
• Feeling very unwell, possibly with shortness of breath (dyspnoea), difficulty in walking or walking with a shuffling gait, shaking, uncontrolled muscle twitching and a high temperature (above 38°C).
  
  This could be a rare condition known as Neuroleptic Malignant Syndrome.
• Rapid, slow or irregular heartbeat.

• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting), indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva, blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor (shaking)
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or sitting up quickly (postural hypotension), fainting (syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain in your joints
• Jerking movements that you can not control, mainly in the arms and legs, uncontrolled muscle movements or twitches
• Frequent infections with high temperature, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia.
• Feeling anxious or more nervous than usual, feeling agitated
• Overactive behaviour or thoughts (mania), believing things that are not true (delusions), memory disturbance
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a “spinning” feeling (vertigo)
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells (seen by a blood test)
• High levels of liver enzymes in your blood (shown by a blood test)
• Severe liver disorders such as hepatitis
• Liver failure with potentially fatal outcome
• Feeling tired, weak and confused, having muscles that ache, are stiff or do not work well. There may also be headache, loss of appetite, nausea or vomiting, convulsion. This may be due to low sodium levels in your blood.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine in a safe place where children cannot see or reach it.

Do not use trazodone after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Store below 30°C in a dry place.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• Each trazodone hydrochloride 50mg capsule contains 50mg of the active substance, trazodone hydrochloride.
• Each trazodone hydrochloride 100mg capsule contains 100mg of the active substance, trazodone hydrochloride.
• Other ingredients include lactose, magnesium stearate, gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132), yellow iron oxide (E172) and ink (black iron oxide E172, shellac, propylene glycol and ammonium hydroxide (pH adjustment) or black iron oxide E172, shellac, propylene glycol, strong ammonia solution (pH adjustment) and potassium hydroxide (pH adjustment). The 100mg capsules also contain red iron oxide (E172).

Trazodone hydrochloride 50mg capsules are violet and green, printed with the Roussel logo on one half and R365B on the other.

Trazodone hydrochloride 100mg capsules are violet and fawn coloured, printed with the Roussel logo on one half and R365C on the other.

Trazodone 50mg Capsules are supplied in blister packs of 84 and 100 capsules.

Trazodone 100mg Capsules are supplied in blister packs of 56 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom

Manufacturer

Sanofi-Aventis Sp. z.0.0
Drug Production and Distribution Plant
Ul. Lubelska 52 35-233
Rzeszow
Poland

or

Zentiva, k. s.
U Kabelovny 130
102 37 Prague 10
Dolni Mecholupy
Czech Republic

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in February 2021

© Zentiva, 2021

ZV/650 76

Side Effects, Withdrawal, Dosage & Interactions

What is Desyrel? Desyrel is known by the trade name trazodone and is used to treat depression. It is in a class of antidepressants known as serotonin modulators. Desyrel comes in the form of a tablet that you take by mouth. When a person starts taking this medication, their doctor will slowly adjust their dosage until their condition is under control. Desyrel does not begin working immediately; it may take several weeks before the effects of the drug are noticeable. As with any prescription medication, one should listen to and follow the instructions of their doctor and pharmacist very carefully.

Important Information Before Use:

• Tell your doctor about every prescription or nonprescription medication you are taking or have recently taken, including herbal supplements and over-the-counter remedies. Depending on your medication history, your doctor may need to adjust your dosage of Desyrel or watch you closely for potential side effects.
• Talk to your doctor about any medication allergies you might have.
• If you are pregnant or plan to become pregnant, tell your doctor. Also, tell your doctor if you are currently breastfeeding.
• Certain health conditions can complicate the use of Desyrel. Tell your doctor if you’re currently undergoing electroshock therapy or if you have or ever have had cancer. In addition, tell your doctor about any personal history of HIV, AIDS, high blood pressure, irregular heartbeat, heart disease, or heart attack.

Important Information During Use:

• If your depression symptoms suddenly get worse or you have thoughts of harming yourself, talk to your doctor immediately. Your doctor will likely want to quickly transition you to another medication or refer you to an inpatient care facility.
• Before any surgery, even dental surgery, tell the attending physician that you are taking Desyrel.
• Be careful when driving or operating machinery until you know how the medication will affect you. If you feel overpowering drowsiness, then you should not drive.
• Only consume alcohol in small quantities. Alcohol makes the side effects of Desyrel more pronounced.
• Get out of bed slowly to avoid the lightheaded feeling that is a common side effect of Desyrel. Try resting your feet on the floor for a few minutes until you feel completely awake and ready to stand up.

Desyrel Side Effects

Comparing Trazodone

Sources and Links for Fact Checking:

Trazodone Potential Side Effects

Trazodone is an antidepressant sometimes used in treating depressive symptoms in bipolar disorder. It is also often prescribed to treat insomnia across a broad variety of psychiatric illnesses.

It is also used off-label to treat aggressive behavior in dementia. Trazodone was originally solid under the brand name is Desyrel; there is also an extended-release form sold under the brand name Oleptro.

Common Side Effects

These common side effects of trazodone may lessen or stop altogether once your body gets used to the medication.  Check with your doctor if any of the following side effects don’t go away or are bothersome:

• Back pain
• Blurred vision
• Constipation
• Diarrhea
• Dizziness or lightheadedness
• Drowsiness
• Dry mouth
• Fatigue
• Headache
• Nausea

Trazodone’s sedating effect is so common that the drug is prescribed for sleep problems. Consequently, do not engage in potentially hazardous activities, including driving, until you know how this drug affects you.

Less Common Side Effects

Always notify your doctor as soon as possible if you experience any of these less common side effects.

• Abdominal pain
• Abnormal gait
• Agitation
• Amnesia
• Bladder pain or incontinence
• Confusion
• Disorientation
• Fainting (syncope)
• Fast or slow heartbeat
• Flushing (skin becoming red and warm)
• Hearing problems
• Migraine
• Muscle aches
• Muscle tremors
• Muscle twitching
• Night sweats
• Problems with coordination or memory
• Sensitivity to light
• Shortness of breath
• Skin rash
• Speech problems
• Tingling
• Tinnitus
• Unusual excitement
• Urgent need to urinate
• Visual disturbance
• Vomiting

When to Seek Medical Attention

In addition to the above unusual side effects requiring a medical evaluation, painful, prolonged erection of the penis can occur after taking trazodone. Stop taking this medicine and seek emergency medical attention if this happens. This condition, called priapism, can result in permanent damage to erectile tissues if not treated promptly.

Other Rare But Serious Side Effects

Seek medical help immediately if you or a loved one experiences symptoms of these conditions:

• Serotonin syndrome, a serious, potentially life-threatening illness caused by too much serotonin in the body
• Hyponatremia, a low concentration of sodium in the blood

Black Box Warning

Like all antidepressants, trazodone is required to carry a warning regarding the increased possibility of suicidal thinking or behavior in young adults (24 and under), adolescents, and children. Talk to your doctor right away if you or a family member is experiencing suicidal thoughts.

Signs of Overdose

Call your doctor or a poison control center immediately if you or a loved one have potentially overdosed on trazodone. Symptoms of overdose can include:

• Drowsiness
• Loss of muscle coordination
• Nausea and vomiting
• Painful erection that does not go away
• Respiratory arrest
• Seizures
• Slower or faster heartbeat

Withdrawal Symptoms

As with other antidepressants, it’s important to not discontinue trazodone without your doctor’s approval and guidance. You will likely be put on a tapering schedule so that the medication has a chance to gradually work its way out of your system, decreasing your risk for unpleasant effects. Withdrawal symptoms that may occur, especially if you stop using trazodone suddenly, include:

• Anxiety
• Agitation
• Sleep disturbances

Description TRAZODONE indications, dosages, contraindications of the active substance TRAZODONE

Trittico instructions for use, price in pharmacies in Ukraine, analogues, composition, indications | Trittico of Aziende Chimiche Riunite Angelini Francesco

pharmacodynamics. Trazodone is a triazolepyridine derivative.Trittico is effective for the treatment of depressive conditions, including depression associated with anxiety and sleep disturbances, and has a rapid onset of action (about 1 week).

Trazodone is a serotonin reuptake inhibitor and antagonist of 5-HT ₂ receptors, the activation of which is usually associated with the appearance of insomnia, anxiety, psychomotor agitation and changes in sexual function.

Unlike other psychotropic drugs, trazodone is not contraindicated in glaucoma and disorders of the urinary system, it does not have extrapyramidal effects and does not potentiate adrenergic transmission.Trazodone is devoid of anticholinergic activity, therefore it does not have the effects typical of tricyclic antidepressants on heart function.

Pharmacokinetics. After a single oral administration of trazodone with prolonged release at a dose of 75 mg, its C _max in blood plasma is about 0. 7 μg / ml and is achieved for T _max 4 hours; AUC is about 8 μg / ml / h. After a single oral administration of trazodone with prolonged release at a dose of 150 mg, C _max is about 1.2 μg / ml and is achieved in T _max 4 hours.T1 / 2 – about 12 hours, and AUC – about 18 μg / ml / h.

In the course of studies in vitro on human liver microsomes, it was found that trazodone is metabolized mainly by cytochrome P450 3A4 (CYP 3A4).

Trazodone is excreted mainly in the urine as metabolites.

depressive disorders with or without anxiety.

the drug is used only in adults.

Therapy should begin with evening appointments with daily dose increases as recommended by a physician.Treatment should continue for at least 1 month.

To minimize side effects (increase in resorption and decrease in C _max in blood plasma), the drug is best taken after meals. The tablet with two parallel notches on the surface can be divided into three parts for the possibility of a gradual increase in dose depending on the severity of the disease, body weight, age and general condition of the patient.

Adults : 75–150 mg / day taken once in the evening before bedtime.The dose can be increased to 300 mg / day, which should be divided into 2 doses. For patients in hospital, the dose can be increased to 600 mg / day, which should be divided into several doses.

Elderly patients : An initial dose of 100 mg / day is taken in the evening. The dose may be increased depending on the clinical response. In general, single doses of more than 100 mg should be avoided in these patients. Rarely, there is a need to take a dose of more than 300 mg / day.

Children . The drug is not used in children.

known hypersensitivity to the drug or its components. Alcohol intoxication and intoxication with hypnotics. Acute myocardial infarction.

reported cases of suicidal ideation and suicidal behavior during trazodone therapy or shortly after its termination. Also, the following symptoms have been reported in patients receiving trazodone therapy, some of which are often noted in cases of untreated depression.

¹ In patients with appropriate symptoms, fluid levels and electrolyte balance in the body should be monitored.

² See also SPECIAL INSTRUCTIONS section.

³ Trazodone is a sedative antidepressant, and the drowsiness that patients sometimes experience during the first days of therapy usually disappears as the therapy is continued.

⁴ Trazodone has been shown to be less cardiotoxic than tricyclic antidepressants in animal studies, and clinical studies indicate that trazodone is less likely to cause cardiac arrhythmias in humans.Data from clinical trials involving patients with heart disease indicate that trazodone may exhibit arrhythmogenic effects in some patients in this population.

⁵ Rare cases of side effects, sometimes severe, on liver function have been reported.

⁶ See also SPECIAL INSTRUCTIONS section.

use in children and adolescents . Trazodone should not be used in children and adolescents. In a clinical study in children and adolescents, suicidal behavior (attempted suicide and his planning for suicide) and hostility (mainly aggressiveness, protest behavior and anger) were more often observed in the antidepressant group than in the placebo group.In addition, there are no data on the long-term safety of the drug in children and adolescents, given its effects on growth, puberty, and cognitive and behavioral development.

Suicide / suicidal ideation or clinical worsening . Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide (manifestations of suicidal behavior) by the patient. This risk persists until significant remission occurs. There may be no improvement in the condition during the first few weeks of therapy or longer.Patients should be carefully monitored until such improvement occurs. General clinical experience indicates a possible increased risk of suicide in the early stages of recovery.

It is known that patients with a history of suicidal behavior or patients who had a significant degree of suicidal ideation before starting therapy have a higher risk of developing suicidal thoughts or suicidal attempts, therefore, they must be closely monitored during treatment.In a meta-analysis of placebo-controlled clinical trials of antidepressants for mental disorders, it was found that among patients under the age of 25 years, a higher risk of suicidal behavior is characteristic of people in the antidepressant group compared to the placebo group.

Therapy with this drug should be accompanied by careful observation of patients, in particular those from the high-risk group, especially at the beginning of treatment and after changing the dose of the drug. Patients (and their caregivers) should be advised to monitor any clinical signs of deterioration, suicidal behavior or thoughts, and unusual behavioral changes, and if identified, seek medical advice immediately.

To minimize the potential risk of suicidal attempts, especially at the beginning of therapy, the physician should only prescribe a limited amount of trazodone to the patient at each visit.

It is recommended to carefully select the dosing regimen and carry out regular monitoring of patients with the following conditions:

• epilepsy, in particular in such patients, do not sharply increase or decrease the dose;

• liver or kidney dysfunction, especially severe;

• heart diseases such as angina pectoris, cardiac conduction disorders or varying degrees of atrioventricular block; recent myocardial infarction;

• hyperthyroidism;

• Violation of urination, for example with prostatic hypertrophy, although such problems are not expected, since the anticholinergic effect of trazodone is negligible;

• acute angle-closure glaucoma, increased intraocular pressure, although significant changes in the condition are not expected, since the anticholinergic effect of trazodone is insignificant.

If the patient develops jaundice, trazodone therapy should be discontinued.

With the use of antidepressants in patients with schizophrenia or other psychotic disorders, psychotic symptoms may increase. Paranoid thoughts may become more pronounced. With trazodone therapy, the depressive phase in manic-depressive psychosis may change to a manic phase. In this case, the use of trazodone should be discontinued.

Against the background of simultaneous use with other serotonergic drugs, such as other antidepressants (for example, tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors and MAO inhibitors) and antipsychotics, drug interactions of neurol / serotoninic syndrome / malignant neuroleptics have been reported syndrome.Cases of fatal neuroleptic malignant syndrome have been reported with the simultaneous use of the drug with antipsychotics, for which this syndrome is a known possible adverse reaction. For more information, see the INTERACTIONS and SIDE EFFECTS sections.

Since agranulocytosis can clinically present as a flu-like condition, sore throat and fever, laboratory blood counts should be checked if these symptoms occur.

The occurrence of arterial hypotension, including orthostatic arterial hypotension and syncope, has been reported in patients treated with trazodone. With the simultaneous use of antihypertensive drugs and trazodone, it may be necessary to reduce the dose of the antihypertensive drug. Elderly patients are often more susceptible to the unwanted effects of antidepressants, especially orthostatic hypotension, and other anticholinergic effects.

At the end of the course of trazodone therapy, especially if this course was long, it is recommended to gradually reduce the dose until the drug is completely discontinued in order to minimize the likelihood of withdrawal symptoms, which include nausea, headache and general malaise.

Nothing indicates that trazodone hydrochloride is addictive.

On the background of the use of trazodone, very rare cases of lengthening of the interval Q – T have been reported – an effect characteristic of other antidepressants. It is necessary to use trazodone with caution simultaneously with drugs with a known ability to lengthen the interval Q – T . Trazodone should be used with caution in patients with diagnosed cardiovascular diseases, including those accompanied by an extension of the Q – T interval.

Against the background of the use of powerful inhibitors of cytochrome CYP 3A4, the level of trazodone in the blood plasma may increase. See the INTERACTIONS section for more details.

Like other drugs with alpha-adrenergic blocking activity, trazodone in very rare cases causes priapism. If it occurs, an intracavernous injection of an alpha-adrenergic agent such as epinephrine or metaraminol should be given. However, cases of trazodone-induced priapism have been reported when surgery was necessary or when permanent sexual dysfunction resulted.In patients with suspicion of this adverse reaction, trazodone should be discontinued immediately.

Trittico sustained release tablets contain sucrose. This drug should not be used in patients with rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltose deficiency.

Use during pregnancy or lactation

Pregnancy. Data from a limited number (<200) of pregnant women exposed to trazodone indicate no adverse effects on pregnancy or fetal / newborn health. There are currently no other sufficient epidemiological data available. Data from animal studies does not indicate the presence of any direct or indirect harmful effects of this substance, used in therapeutic doses, on the course of pregnancy, embryo / fetal development, childbirth or postnatal development of offspring.

Pregnant women should use this drug with caution. If trazodone is administered to the mother before delivery, the baby should be monitored after birth to identify possible withdrawal symptoms, taking into account the maternal benefit / fetal risk ratio.

Breastfeeding. Limited data indicate that trazodone passes into breast milk in small quantities. Due to insufficient data, the decision to prolong / discontinue breastfeeding or to continue / discontinue trazodone therapy should be made taking into account the benefits of breastfeeding for the child and the benefits of trazodone therapy for the mother.

The ability to influence the reaction rate when driving or operating other mechanisms . Trazodone slightly or moderately affects the ability to drive vehicles and mechanisms. Patients should be warned that before driving and operating machinery, it is necessary to make sure that there is no drowsiness, sedation, dizziness, confusion or blurred vision while taking trazodone.

general . The sedative effects of antipsychotics, hypnotics, anxiolytics, and antihistamines may be enhanced. A dose reduction of these agents is recommended.

Oral contraceptives, phenytoin, carbamazepine and barbiturates, as a result of their action on the liver, accelerate the metabolism of antidepressants. Cimetidine and some other antipsychotics slow down the metabolism of antidepressants.

CYP 3A4 inhibitors . Data from studies on the metabolism of drug in vitro indicate the potential for drug interactions when trazodone is used concomitantly with cytochrome CYP 3A4 inhibitors such as erythromycin, ketoconazole, itraconazole, ritonavir, indinavir and nefazodone.The use of CYP 3A4 inhibitors is likely to lead to a significant increase in plasma trazodone concentration. In the course of studies in vivo with the participation of healthy volunteers, it was confirmed that after the use of ritonavir at a dose of 200 mg 2 times a day, the level of trazodone in the blood plasma more than doubled, resulting in nausea, syncope and arterial hypotension. In this regard, when using trazodone simultaneously with a potent inhibitor of CYP 3A4, it will be advisable to reduce the dose of trazodone.

However, if possible, concomitant use of trazodone and potent CYP 3A4 inhibitors should be avoided altogether.

Carbamazepine . With the simultaneous use of trazodone with carbamazepine, plasma concentrations of trazodone decrease. With simultaneous use with carbamazepine at a dose of 400 mg / day, plasma concentrations of trazodone and its active metabolite m-chlorophenylpiperazine decreased by 76% and 60%, respectively. It is necessary to carefully monitor the patient’s condition in order to find out whether he needs an increase in the dose of trazodone.

Tricyclic antidepressants . There is a risk of drug interactions, therefore, simultaneous use with trazodone should be avoided. In the case of simultaneous use, the development of serotonin syndrome and side effects from the cardiovascular system should be expected.

Fluoxetine . Against the background of the simultaneous use of trazodone with fluoxetine (a CYP 1A2 / 2D6 inhibitor), rare cases of an increase in the level of trazodone in the blood plasma and the occurrence of undesirable effects have been reported.The mechanism underlying this pharmacokinetic interaction has not yet been fully elucidated. Pharmacodynamic interaction (serotonin syndrome) cannot be ruled out.

MAO inhibitors . Isolated cases of possible interactions between trazodone and MAO inhibitors have been reported. Although some doctors practice the simultaneous use of these drugs, nevertheless, it is not recommended to use trazodone simultaneously with MAO inhibitors or within 2 weeks after their cancellation.It is also not recommended to start therapy with MAO inhibitors within 1 week after discontinuation of trazodone.

Phenothiazines . With simultaneous use with phenothiazines, for example, such as chlorpromazine, fluphenazine, levomepromazine, perphenazine, cases of severe orthostatic arterial hypotension have been reported.

Anesthetics / muscle relaxants . Trazodone hydrochloride may enhance the effects of muscle relaxants and volatile anesthetics. These combinations should be used with caution.

Alcohol . The sedative effects of alcohol under the influence of trazodone become more pronounced. During the period of therapy with trazodone, the patient should avoid drinking alcohol.

Levodopa . Antidepressants can speed up the metabolism of levodopa.

Other means . When using trazodone simultaneously with drugs with a known ability to lengthen the interval Q – T , the risk of ventricular arrhythmias, including polymorphic ventricular tachycardia (torsade de pointes), may increase.Caution should be exercised when using these agents concomitantly with trazodone.

Trazodone is only a very weak inhibitor of norepinephrine reuptake and does not affect the blood pressure response to tyramine therapy, therefore, the effect of trazodone on the hypotensive effect of guanethidine-like compounds should not be expected. However, studies in laboratory animals have shown that trazodone can inhibit most of the rapid effects of clonidine.

Although drug interactions have not been reported with other types of antihypertensive drugs concomitantly with trazodone, the potential for potentiation of the effects should be taken into account.

The incidence of undesirable effects increases when trazodone is used simultaneously with preparations containing St. John’s wort (Hypericum perforatum).

Cases of changes in the values ​​of prothrombin time have been reported in patients who were simultaneously used trazodone and warfarin.

Plasma levels of digoxin or phenytoin may increase with concomitant use of these drugs with trazodone. In patients in whom such therapy is used, the plasma levels of the above agents should be monitored.

most often in case of an overdose, drowsiness, dizziness, nausea and vomiting are observed. In complex cases, coma, tachycardia, arterial hypotension, hyponatremia, convulsions and respiratory failure occurred. Cardiac symptoms may include bradycardia, lengthening of the Q – T interval, and polymorphic ventricular tachycardia (torsade de pointes). Symptoms may appear within 24 hours of an overdose or later.

Simultaneous overdose of trazodone and other antidepressants can cause serotonin syndrome.

Treatment of overdose . There is no specific antidote. Adults who have taken more than 1 g of trazodone, or children who have taken more than 150 mg of trazodone, should be given activated charcoal within 1 hour after an overdose is detected. In other cases, in adults, it may be advisable to perform gastric lavage within 1 hour after taking potentially life-threatening doses.

It is necessary to monitor the patient’s condition for at least 6 hours after taking the drug (or 12 hours in the case of taking a sustained-release drug).Blood pressure, heart rate and Glasgow Coma Scale (GCS) data should be monitored. In the case of a decrease in the number of GCS points, blood oxygen saturation should be monitored.

Cardiac monitoring is necessary in symptomatic patients.

No treatment is required when individual short-term seizures appear. For frequent or prolonged convulsions, intravenous diazepam (0.1–0.3 mg / kg body weight) or lorazepam (4 mg for adults and 0.05 mg / kg for children) should be prescribed.

If these measures do not control seizures, an IV infusion of phenytoin may be appropriate.If necessary, the patient needs to be given oxygen and to correct the acid-base balance and metabolic disorders.

In case of arterial hypotension and excessive sedation, apply symptomatic and supportive therapy. If severe arterial hypotension persists, the appropriateness of the use of inotropic agents, such as dopamine or dobutamine, should be evaluated.

at a temperature not exceeding 25 ° C, out of the reach of children.

Date Added: 12.06.2021

Preparations and medicines with active ingredient Trazodone

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Indications for use

Depressive states of various etiologies (endogenous, psychotic, neurotic, somatogenic, etc.)) with severe anxiety, tension.

Pharmacological action

Antidepressant Mechanism of action is not fully understood. Preclinical studies have shown that trazodone selectively inhibits the reuptake of serotonin by synaptosomes in the brain and acts as a 5-HT2A / 2C serotonin receptor antagonist. Does not inhibit MAO, does not stimulate the central nervous system. It is an antagonist of alpha1-adrenergic receptors.It relieves mental (affective tension, fear, insomnia) and somatic (palpitations, headache, myalgia, frequent urination, increased sweating) manifestations of anxiety. It increases the depth and duration of sleep in depressed patients, restores the physiological structure of sleep. It is well absorbed from the gastrointestinal tract. Taking trazodone during or immediately after a meal slows down the rate of absorption, reduces the Cmax of trazodone in the blood and increases the Tmax (Tmax is 0.5–2 hours). Plasma protein binding 89–95%.Passes through histohematogenous barriers, including the BBB. It is metabolized in the liver, mainly with the participation of the isoenzyme CYP3A4 of cytochrome P450, the active metabolite is m-chlorophenylpiperazine. T1 / 2 is biphasic: the duration of the early phase is 3–6 hours, the late 5–9 hours. In some patients, cumulation is possible. It is excreted in the bile (20%) and in the urine (75%, including 70% in the form of inactive metabolites) within 98 hours after administration. There is evidence of the effectiveness of trazodone in bulimia, kleptomania, pain syndrome in diabetic neuropathy and others. types of chronic pain, phobias, incl.including agoraphobia, panic attacks, acute withdrawal symptoms in alcoholism and for the prevention of migraine.

Overdose

Symptoms: nausea, vomiting, drowsiness, dizziness, decreased blood pressure, impaired coordination, priapism, epileptiform seizures, ECG changes, respiratory arrest, aggravation of adverse reactions. Treatment: gastric lavage, forced diuresis, intake of activated charcoal, maintenance of vital functions, symptomatic therapy.There is no specific antidote.

Contraindications

Hypersensitivity, alcohol intoxication and intoxication with hypnotic drugs, age up to 6 years.

Application during pregnancy and lactation

Should not be used by pregnant women. In animal experiments, it was shown that trazodone in doses 30-50 times higher than the MRDC, causes congenital malformations and increases the frequency of fetal resorption.The FDA category of action on the fetus is C. Breastfeeding should be discontinued during treatment. Trazodone and its metabolites are found in the milk of lactating rats. It is not known whether trazodone is secreted into human breast milk.

Desirel (trazodone hydrochloride): use, dosage, side effects, interactions, warning

• Generic name: trazodone hydrochloride
• Brand name: Desyrel

Product description

What is Desirel and how is it used?

Desyrel is a prescription drug used by adults to treat major depressive disorder (MDD).Desyrel belongs to a class of medications known as SSRIs (or selective serotonin reuptake inhibitors).

What are the possible side effects of Desyrel?

Desyrel can cause serious side effects or death, including:

• Serotonin syndrome. Symptoms of serotonin syndrome include agitation, hallucinations, coordination problems, heart palpitations, tense muscles, difficulty walking, sweating, fever, nausea, vomiting, and diarrhea.
• Irregular or rapid heartbeat or fainting (lengthening of the QT interval)
• Low blood pressure. You feel dizzy or faint when you change your posture (going from sitting to standing).
• Unusual bruising or bleeding
• Erections last more than 6 hours (priapism)
• Feeling high or very good, then irritable or too much energy, feeling like you need to keep talking or stay awake (mania ).
• Withdrawal symptoms. Withdrawal symptoms may include anxiety, agitation, and trouble sleeping. Do not stop taking Desyrel without talking to your doctor.
• Vision problems.
  • eye pain
  • changes in vision
  • swelling or redness around the eyes

Only a few people are at risk of these problems. You can have an eye exam to see if you are at risk and get preventive treatment if so.

• Low blood sodium (hyponatremia). Symptoms of hyponatremia include headache, feeling weak, confusion, trouble concentrating, memory problems, and feeling unsteady when walking.

Get immediate medical attention if you have any of the symptoms listed above.

The most common side effects of Desyrel include:

• swelling
• blurred vision
• dizziness
• drowsiness
• fatigue
• diarrhea
• Desyrel
• weight loss
• Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088.

  WARNING

  SUICIDAL THOUGHTS AND BEHAVIORS

  In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children and young adults. Monitor all patients taking antidepressants closely for clinical deterioration and development of suicidal thoughts and behavior.WARNINGS AND PRECAUTIONS]. DESYREL is not approved for use in pediatric patients. Use in Specific Populations].

  DESCRIPTION

  DESIREL (trazodone hydrochloride) oral tablets contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. DESYREL is a triazolopyridine derivative designated as 2- [3- [4- (3-chlorophenyl) -1-piperazinyl] propyl] -1,2,4-triazolo [4,3-a] pyridine-3 (2H) – he.hydrochloride. It is a white crystalline powder, odorless, easily soluble in water. The structural formula is as follows:

  Molecular Formula : C ₁₉ HOUR ₂₂ CHINA ₅ O & bull; HCl
  Molecular Weight : 408.33

  Each oral tablet contains 50 mg, 100 mg, 150 mg, or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients:

  50 mg and 100 mg: corn starch, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and triacetin.

  150 mg: magnesium stearate, microcrystalline cellulose, pregelatinized starch and stearic acid.

  300 mg: magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid.

  Indications and dosage

  INDICATIONS

  DESYREL is indicated for the treatment of major depressive disorder (MDD) in adults.

  DOSAGE AND ADMINISTRATION

  Dose selection

  An initial dose of 150 mg / day in divided doses is recommended.The dosage should be started at a low dose and gradually increased according to the clinical response and any signs of intolerance. The onset of drowsiness may require the administration of most of the daily dose at bedtime or a dose reduction.

  The dose can be increased by 50 mg / day every 3-4 days. The maximum dose for outpatients should usually not exceed 400 mg / day in divided doses. Inpatients (i.e., patients with more severe depression) may be prescribed up to, but not more than, 600 mg / day in divided doses.

  antibiotic for pink eye in a child

  After an adequate response is achieved, the dosage can be gradually reduced with subsequent adjustment depending on the therapeutic response.

  Important Administration Instructions

  DESYREL can be swallowed whole or taken as a half tablet by breaking the tablet along the incision line.

  DESYREL should be taken shortly after a meal or light snack.

  Screen for bipolar disorder before starting DESYREL

  Before starting treatment with DESYREL or another antidepressant, check patients for a personal or family history of bipolar disorder, mania, or hypomania [see p. WARNINGS AND PRECAUTIONS ].

  Switching to or from an antidepressant monoamine oxidase inhibitor

  At least 14 days must elapse between discontinuing the antidepressant monoamine oxidase inhibitor (MAOI) and starting DESYREL. In addition, after stopping DESYREL, at least 14 days must elapse before starting the antidepressant MAOI [see. CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ].

  Dosage recommendations when used concomitantly with potent CYP3A4 inhibitors or inducers

  Coadministered with potent CYP3A4 inhibitors

  DRUG INTERACTIONS ].

  Co-administration with potent inducers of CYP3A4

  Consider increasing the dose of DESYREL depending on the therapeutic response when DESYREL is administered concomitantly with a potent inducer of CYP3A4 [cf. DRUG INTERACTIONS ].

  Discontinuation of treatment with Desirel

  Adverse reactions may occur after discontinuation of DESYREL [see. WARNINGS AND PRECAUTIONS ].Reduce dosage gradually if possible, rather than abruptly stopping.

  HOW SUPPLIED

  Dosage Forms and Strengths

  • 50 mg: white, round, scored film-coated tablets; embossed “50” and “P 005” on one side and smooth on the other.
  • 100 mg: white, round, scored film-coated tablets; divided in half, embossed “100” and “P 006” on one side and smooth on the other.
  • 150 mg: scored white rectangular tablets; cut on both sides, embossed with “P” and “007” on one side and “50”, “50”, “50” on the other, with a cut in half at each edge.
  • 300 mg: scored white rectangular tablets; cut on one side with “100”, “100”, “100” embossed and cut in half with “P” and “008” embossed on the other side.

  Storage and handling

  50 mg : White, round, corrugated film-coated tablets; embossed “50” and “P 005” on one side and smooth on the other. Bottles of 100 NDC 58463-005-01

  100 mg : White round, corrugated, film-coated tablets; divided in half, embossed “100” and “P 006” on one side and smooth on the other.Bottles of 100 NDC 58463-006-01

  150 mg : White rectangular scored tablets; cut on both sides, embossed with “P” and “007” on one side and “50”, “50”, “50” on the other, with a cut in half at each edge. Bottles of 100 NDC 58463-007-01

  300 mg : White rectangular scored tablets; cut on one side with “100”, “100”, “100” embossed and cut in half with “P” and “008” embossed on the other side.Bottles of 100 NDC 58463-008-01

  Store at 20 ° C to 25 ° C (68 ° F to 77 ° F). Guided tours are permitted in temperatures between 15 ° C and 30 ° C (59 ° F to 86 ° F) [ref. Room temperature controlled by USP ].

  Dispense in a tight, lightfast container as defined in the USP.

  Manufactured in Canada for: Pragma Pharmaceuticals, LLC. Distributed by: Fera, Pharmaceuticals, LLC., Locust Valley, N.Y. 11560.Revised October: 2018

  Side effects

  SIDE EFFECTS

  The following serious adverse reactions are described elsewhere in the labeling:

  Clinical trial experience

  drugs, cannot be directly compared with the frequency in clinical trials of another drug and may not reflect the rates observed in practice.

  Table 2: Common Adverse Reactions Occurring at? 2% of DESYREL patients and more than placebo patients in controlled clinical trials

  =

  9000 95

  9043% 9043 1%

  9043 1 4%

  908 9010

  9 0843 41%

  % stomach 4 6%

  	Inpatients		Outpatients
  	Desyrel N = 142	Desyrel N = 142	Desyrel N = 157	Placebo N = 158
  Allergic
  Skin condition / swelling	3%	1%	743 1%	735 1 Standalone
  Blurred vision	6%	4%	fifteen%	4%
  Constipation	7%	4%	8000 Dry mouth	fifteen%	8%	3.4%	20%
  Cardiovascular
  Hypertension	20%	1%	1%	*
  0
  Fainting	3%	two%	5%	1%
  CNS
  Confusion	8%
  Reduced concentration	3%	two%	1%	0
  Disorientation	two%	0	*		20%	5%	28%	fifteen%
  Sleepiness	24%	6%	20%
  Fatigue	11%	4%	6%	3%
  Headache	10%	5%	2043 1643
  Nervousness	fifteen%	11%	6%	8%
  Gastrointestinal tract
  Diseases	4%
  Diarrhea	0	1%	5%	1%
  Nausea / vomiting	10%	1%	1043 1313
  Musculoskeletal
  Pain / Pain	6%	3%	5%	3%
  Neurologist dynamic
  Inconsistency	5%	0	two%	*
  Tremor	3%	1%	5%	4%	4%	4
  Eyes red / tired / itchy	3%	0	0	0
  Head full-heavy	3%	0	0	0	0	0 3%	0	0	0
  Nasal / sinus congestion	3%	0	6%	3%
  Weight gain	1%	1% %	two%
  Weight loss	*	3%	6%	3%

  D Other Adverse Reactions Arising from the Occurrence

  Post-Marketing Experience

  The following adverse reactions have been identified during the use of DESYREL after approval.Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to assess their frequency or establish a causal relationship with drug exposure:

  Diseases of the blood and lymphatic system : hemolytic anemia, leukocytosis.

  Cardiac disorders : cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ectopic activity of the ventricles, lengthening of the interval QT.Prolongation of the QT interval, tachycardia and ventricular tachycardia have been reported at doses of 100 mg per day or less [see. WARNINGS AND PRECAUTIONS ].

  Endocrine disorders : inadequate ADH syndrome

  Eye diseases : diplopia

  Gastrointestinal disorders : increased salivation, nausea / vomiting, lack of clarification from the state

  and death, weakness

  Hepatobiliary disorders : cholestasis, jaundice, hyperbilirubinemia, liver enzyme disorders

  Investigations : increased amylase

  Metabolic and nutritional disorders : methemoglobinemia side effects

  treats osteohemoglobinemia

  Disorders of the nervous system : aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, large seizures, paresthesia, tardive dyskinesia, dizziness.

  Psychiatric disorders : abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor.

  On the part of the kidneys and urinary tract : urinary incontinence, urinary retention

  Reproductive system and breast diseases : breast enlargement or engorgement, clitoris, lactation, priapism [see. WARNINGS AND PRECAUTIONS ]

  Respiratory, thoracic and mediastinal disorders.: apnea

  Diseases of the skin and subcutaneous tissue : alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria.

  Vascular disorders : vasodilatation

  Drug interactions

  DRUG INTERACTIONS

  Medicines with clinically important interactions with DESYREL

  Table 3: Clinically important drug interactions with DESYREL

  Clinical exposure: Concomitant use of MAOIs and serotonergic drugs, including DESYREL, increases the risk of serotonin syndrome. Intervention: DESYREL is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or methylene blue intravenously. CONTRAINDICATIONS , DOSAGE AND ADMINISTRATION , and WARNINGS AND PRECAUTIONS ]. Examples: isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine Other serotonergic drugs s other serotonergic drugs, increases the risk of serotonin syndrome. Intervention: Observe patients for signs and symptoms of serotonin syndrome, especially when starting DESYREL treatment. If serotonin syndrome occurs, consider discontinuing DESYREL and / or concomitant serotonergic drugs [see WARNINGS AND PRECAUTIONS ]. Examples: triptans, antidepressants (tricyclic inhibitors and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s wort8 anticoagulants8 Anticoagulants The release of serotonin by platelets plays an important role in hemostasis.Concomitant use of antiplatelet agents or anticoagulants with DESYREL may increase the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding when DESYREL is used concomitantly with antiplatelet and anticoagulants. For patients taking warfarin, closely monitor the International Normalized Ratio (INR) when starting or stopping Desirel [see section 4.4. WARNINGS AND PRECAUTIONS ]. Examples: Warfarin, Rivaroxaban, Dabigatran, Clopidogrel Strong CYP3A4 Inhibitors Clinical Effects of CYP3A4 Inhibitors using one DESYREL. Intervention: If DESYREL is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower DESYREL dose should be considered [see. DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS ]. Examples: itraconazole, ketoconazole, clarithromycin, indinavir Potent inducers CYP3A4 Clinical exposure to CYP3 strong simultaneous exposure to DESYp3 9000R 9010 using one DESYREL. Intervention: DOSAGE AND ADMINISTRATION ]. Examples: rifampin, carbamazepine, phenytoin, St. John’s wort Digoxin and phenytoin Clinical effect: .Concomitant use of DESYREL may increase the concentration of digoxin or phenytoin. Intervention: Measure the serum digoxin or phenytoin concentration before using DESYREL concomitantly. Continue monitoring and reduce digoxin or phenytoin as needed. Examples: digoxin, phenytoin Central nervous system (CNS) depressants Clinical effects: Desyrel may increase the CNS response. Intervention: Patients should be advised that DESYREL may increase reactions to alcohol, barbiturates and other CNS depressants. Examples: alcohol, barbiturates Prolongation of the QT interval Clinical effects: Concomitant use of drugs that can increase the QTRYEL risk of increasing the QTR risk cardiac arrhythmias. Intervention: Avoid using DESYREL in combination with other drugs known to prolong QTc [see WARNINGS AND PRECAUTIONS ]. Examples: Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: Gatifloxacin.

  Drug Abuse and Dependence

  Controlled Substance

  DESYREL is not a Controlled Substance.

  Abuse

  Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for potential abuse, no evidence of drug seeking behavior has been found in clinical studies with trazodone hydrochloride.

  Warnings and Precautions

  WARNINGS

  Included in PRECAUTIONS Section.

  PRECAUTIONS

  Suicidal thoughts and behavior in children and adults

  behavior in children and young adult patients was higher in patients treated with antidepressants. than in patients receiving placebo.The differences between drugs and placebo in the incidence of suicidal thoughts and behavior per 1000 patients treated are presented in Table 1.

  No pediatric study reported suicides. In adult studies, there have been cases of suicide, but they were not enough to draw any conclusion about the effect of antidepressants on suicide.

  Table 1: Differences in risk of suicidal thoughts or behavior in pooled placebo-controlled trials of antidepressants in pediatric and adult patients

  Age range (years)	suicidal thoughts or behavior per 1000 patients treated
  Increases compared to placebo
  	14 additional patients
  18-24	5 additional patients
  25-64	Less than 1 patient
  & ge; 65	6 fewer patients

  It is not known if the risk of suicidal thoughts and behavior in pediatric patients and young adult patients extends to longer use, that is, more than four months.However, there is strong evidence that antidepressants slow the relapse of depression in placebo-controlled supportive studies in adults with MDD.

  Observe all patients taking antidepressants for clinical deterioration and the appearance of suicidal thoughts and behavior, especially during the first few months of drug therapy and during dosage changes. Advise family members or caregivers to watch for behavioral changes and alert health care provider.Consider changing the therapeutic regimen, including possible discontinuation of DESYREL, in patients whose depression is constantly worsening or who have emerging suicidal thoughts or behavior.

  Serotonin Syndrome

  Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including DESIREL, can cause serotonin syndrome, a potentially life-threatening condition. The risk of increases with the concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s wort) and drugs that disrupt serotonin metabolism, that is, MAOI [see INDICATIONS 9055 … Serotonin syndrome can also occur when these drugs are used alone.

  Signs and symptoms of serotonin syndrome may include changes in mental status (eg, agitation, hallucinations, delusions, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, sweating, hot flushes, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, impaired motor coordination), seizures, and gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).

  The simultaneous use of Desirel with MAOIs is contraindicated. Also, do not give Desirel to patients receiving an MAOI such as linezolid or IV methylene blue. There are no reports of methylene blue being used by other routes (such as oral tablets or local tissue injection). If a patient taking DESYREL needs to start treatment with an MAOI, such as linezolid or IV methylene blue, stop DESYREL before starting MAOI treatment [see CONTRAINDICATIONS , DRUG INTERACTIONS ].

  Monitor all patients taking Desirel for serotonin syndrome. Discontinue treatment with DESYREL and any concomitant serotonergic agents immediately if the above symptoms appear and begin supportive therapy. symptomatic treatment. If concomitant use of DESYREL with other serotonergic drugs is clinically justified, inform patients of the increased risk of serotonin syndrome and monitor for symptoms.

  Cardiac arrhythmias

  Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting heart disease.Identified arrhythmias include isolated PVCs, ventricular couplets, tachycardia with syncope, and pointe shoes. Post-marketing events, including torsade de pointes, have been reported at doses of 100 mg or less with the DESYREL immediate release formulation. Desirel should also be avoided in patients with a history of cardiac arrhythmias, as well as in other circumstances that may increase the risk of pointes and / or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.DESYREL is not recommended for the initial recovery phase of myocardial infarction. Caution should be exercised when prescribing DESYREL to patients with heart disease, and such patients should be closely monitored because antidepressants (including DESYREL) can cause cardiac arrhythmias [see. ADVERSE REACTIONS ].

  DESYREL prolongs the QT / QTc interval. The use of DESYREL should be avoided in patients with a known prolongation of the QT interval or in combination with other drugs that are inhibitors of CYP3A4 (eg, itraconazole, clarithromycin, voriconazole) or known to prolong the QT interval, including class 1A antiarrhythmics (eg, quinidine, procainamide).) or class 3 antiarrhythmics (eg amiodarone, sotalol), some antipsychotics (eg ziprasidone, chlorpromazine, thioridazine), and some antibiotics (eg gatifloxacin). Taking medications at the same time may increase your risk of heart disease. arrhythmia [see DRUG INTERACTIONS ].

  Orthostatic hypotension and syncope

  Hypotension, including orthostatic hypotension and syncope have been reported in patients receiving trazodone hydrochloride.Simultaneous use with antihypertensive drugs may require a reduction in the dose of antihypertensive drugs.

  Increased risk of bleeding

  Medicines that interfere with the reuptake of serotonin, including DESYREL, increase the risk of bleeding. Concomitant use of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. Case reports and epidemiological studies (case-control and cohort design) have shown an association between the use of drugs that inhibit serotonin reuptake and the occurrence of gastrointestinal bleeding.Bleeding associated with medications that interfere with serotonin reuptake have ranged from ecchymosis, bruising, epistaxis, and petechiae to life-threatening hemorrhages.

  Inform patients about the risk of bleeding associated with the simultaneous use of DESYREL and antiplatelet or anticoagulants. Patients taking warfarin should be closely monitored for coagulation indices when prescribing, titrating, or discontinuing DESYREL.

  Priapism

  Cases of priapism (painful erection lasting more than 6 hours) have been reported in men receiving DESYREL.Priapism, if not treated promptly, can cause permanent damage to erectile tissue. Men who have an erection for more than 4 hours, whether painful or not, should immediately stop taking the drug and seek emergency medical attention [see. ADVERSE REACTIONS , OVERDOSE ].

  DESYREL should be used with caution in men who have conditions that may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia) or in men with anatomical deformity of the penis (eg, curvature, cavernous fibrosis, or Peyronie’s disease ).

  Activation of mania or hypomania

  In patients with bipolar disorder, treatment of a depressive episode with DESYREL or another antidepressant may cause a mixed / manic episode. Activation of mania / hypomania has been reported in a small proportion of patients with major mood disorder receiving antidepressants. Before starting treatment with DESYREL, check patients for a personal or family history of bipolar disorder, mania, or hypomania [see DOSAGE AND ADMINISTRATION ].

  Withdrawal syndrome

  Adverse reactions after discontinuation of serotonergic antidepressants, especially after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesia, eg, electrical shock sensation), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures.If possible, a gradual reduction in dosage is recommended, rather than an abrupt cessation of use [See. DOSAGE AND ADMINISTRATION ].

  Potential for cognitive and motor impairment

  DESYREL may cause drowsiness or sedation and may impair the mental and / or physical abilities required to perform potentially hazardous tasks. Patients should be warned about the use of hazardous equipment, including cars, until they are sufficiently confident that drug treatment is not adversely affecting them.

  Angle-closure glaucoma

  Pupil dilation that occurs after the use of many antidepressants, including DESYREL, can cause an angle-closure attack in a patient with anatomically narrow angles who does not have an open iridectomy. Avoid the use of antidepressants, including DESYREL, in patients with untreated anatomically narrow angles.

  Hyponatremia

  Hyponatremia may result from treatment with SSRIs and SSRIs, including Desirel.Cases of serum sodium below 110 mmol / L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness that can lead to a fall. Signs and symptoms associated with more severe and / or acute cases included hallucinations, fainting, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia is the result of inappropriate antidiuretic hormone (SIADH) secretion syndrome.

  In patients with symptomatic hyponatremia, discontinue DESYREL and initiate appropriate medical intervention. Elderly patients, patients taking diuretics, and patients with volume limited may be at greater risk of developing hyponatremia with SSRIs and SNRIs [see section 4.4. Use in certain populations ].

  Patient Information

  Advise the patient to read the FDA Approved Patient Label ( Medication Guide ).

  Suicidal thoughts and behavior

  Advise patients and caregivers to watch for suicidal behavior, especially during the early stages of treatment and when increasing or decreasing dosage, and instruct them to report such symptoms to their doctor [see p. BOX WARNING and WARNINGS AND PRECAUTIONS ].

  Dosage and Administration

  Advise patients to take DESYREL shortly after a meal or light snack.Inform patients of the importance of the following dosage titration instructions [see. DOSAGE AND ADMINISTRATION ].

  Serotonin syndrome

  Warn patients about the risk of serotonin syndrome, especially when Desirel is used concomitantly with other serotonergic drugs, including triptans. tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s wort, as well as drugs that disrupt serotonin metabolism (in particular, MAOIs, such as those intended for the treatment of mental disorders, and others, such as linezolid).Patients should contact their healthcare professional or go to the emergency department if they develop signs or symptoms of serotonin syndrome [see section 4.4. WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS ].

  Mania / Hypomania Activation

  Advise patients and their caregivers to watch for signs of mania / hypomania activation and instruct them to report such symptoms to their doctor [see p. WARNINGS AND PRECAUTIONS ].

  Increased risk of bleeding

  Inform patients about the combined use of DESYREL with aspirin, NSAIDs, other antiplatelet drugs, warfarin or other anticoagulants, since the combined use of drugs that prevent serotonin reuptake and these drugs have been associated with an increased risk of bleeding. Advise them to tell their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see. WARNINGS AND PRECAUTIONS ].

  Withdrawal Syndrome

  Advise patients not to suddenly stop DESYREL and discuss any gradual reduction regimen with their healthcare provider. Adverse reactions may occur when DESYREL is discontinued [see. WARNINGS AND PRECAUTIONS ].

  Concomitant Medicines

  Advise patients to tell their health care providers if they are taking or planning to take any prescription or over-the-counter medications as there is potential for interactions [see DRUG INTERACTIONS ].

  What are the dosages of Xanax

  Pregnancy

  Advise patients to notify their healthcare professional if they become pregnant or intend to become pregnant during DESYREL therapy. Inform patients that there is a pregnancy register that tracks pregnancy outcomes for women exposed to DESYREL during pregnancy [see Use in special populations ].

  Preclinical toxicology

  Carcinogenesis, mutagenesis, impaired fertility

  Carcinogenesis

  The occurrence of drug- or dose-related carcinogenesis was not observed in rats receiving trazodone in daily oral doses exceeding the maximum recommended daily human dose of 7.3 times (MRHD) 400 mg / day for adults in mg / m².

  Mutagenesis

  Trazodone genotoxicity studies have not been performed.

  Impairment of fertility

  Trazodone does not affect fertility in rats at doses 7.3 times the adult MRHD on a mg / m² basis.

  Use in specific populations

  Pregnancy

  Pregnancy register

  There is a pregnancy register that tracks pregnancy outcomes for women who have taken antidepressants during pregnancy.Healthcare professionals are encouraged to register patients by calling the National Antidepressant Registry of Pregnancy at 1-844-405-6185 or by visiting https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

  Risk Summary

  Published prospective cohort studies, case series, and case reports over several decades using DESYREL in pregnant women have not identified any drug-related risks of serious birth defects, miscarriage, or adverse maternal or fetal outcomes (see below). Data ). Trazodone hydrochloride has been shown to induce increased fetal resorption and other adverse effects on the fetus in rats at doses approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg / day for adults per mg / m². base. There was also an increase in congenital anomalies in rabbits of about 7.3-22 times compared to MRHD on a mg / m² basis (see Data ).

  The estimated background risk of serious birth defects and miscarriage for this population is unknown.All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general US population, the estimated background risk of serious birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

  Clinical considerations

  Disease-related maternal and / or fetal risk

  A prospective longitudinal study enrolled 201 pregnant women with a history of major depressive disorder who were euthymic and were taking antidepressants early in pregnancy.Women who stopped taking antidepressants during pregnancy were more likely to relapse with major depression than women who continued taking antidepressants. Consider the risk of untreated depression when stopping or changing antidepressant medication during pregnancy and the puerperium.

  Data

  Human data

  Although available studies cannot conclusively establish the absence of risk, published prospective cohort studies, case series and case reports over several decades have not shown an association with trazodone use during pregnancy and serious birth defects. miscarriage or other adverse effects on the mother or fetus.results. All available studies have methodological limitations, including small sample sizes and incompatible comparison groups.

  Animal data

  When trazodone was administered to pregnant rats and rabbits during organogenesis in oral doses up to 450 mg / kg / day, no teratogenic effects were observed. This dose is 11 and 22 times for rats and rabbits, respectively, of the maximum recommended human dose (MRHD) of 400 mg / day for adults on a mg / m² basis.There was an increase in fetal resorption and other adverse effects on the fetus in rats 7.3–11 times the MRHD and an increase in congenital anomalies in rabbits 7.3–22 times the MRHD on a mg / m² basis. There is no further information about these studies.

  Breastfeeding

  Summary of Risks

  Data from the published literature report the transfer of trazodone into breast milk. There is no evidence of the effect of trazodone on milk production. Limited data from post-marketing reports did not and did not identify adverse effects on a breastfed baby.Consideration should be given to the developmental and health benefits of breastfeeding, as well as the mother’s clinical need for DESYREL and any potential adverse effects on the breastfed baby from DESYREL or the mother’s underlying condition.

  Pediatric use

  Safety and efficacy in the pediatric population have not been established. Antidepressants increase the risk of suicidal thoughts and behavior in pediatric patients [see. WARNING IN BOX , WARNINGS AND PRECAUTIONS ].

  Geriatric use

  Published clinical literature and experience with trazodone did not show differences in the responses of elderly and younger patients. However, since experience with trazodone hydrochloride in the elderly is limited, it should be used with caution in geriatric patients.

  Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients who may be at greater risk for this adverse reaction [see section 4.4. WARNINGS AND PRECAUTIONS ].

  Renal impairment

  Trazodone has not been studied in patients with renal impairment. In this population, trazodone should be used with caution.

  Liver failure

  Trazodone has not been studied in patients with impaired liver function. In this population, trazodone should be used with caution.

  Overdose and contraindications

  OVERDOSE

  Death from an overdose occurred in patients taking Desirel and other CNS depressants at the same time (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).

  The most severe reactions reported to have occurred with an overdose of Desirel alone were priapism, respiratory arrest, seizures, and ECG changes, including prolongation of the QT interval. The most common reactions were drowsiness and vomiting. Overdose may cause an increase in the frequency or severity of any reported adverse reactions.

  Side Effects of Child Aspirin for Adults

  There is no specific antidote for trazodone hydrochloride overdose.When managing overdose, consider the possibility of simultaneous use of several drugs. For up-to-date information on treatment for poisoning or overdose, contact the Poison Control Center (1-800-222-1222 or www.poison.org).

  CONTRAINDICATIONS

  DESYREL contraindicated:

  • Patients taking or within 14 days of discontinuing monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or IV methylene blue, due to an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS , DRUG INTERACTIONS ].

  Clinical Pharmacology

  CLINICAL PHARMACOLOGY

  Mechanism of Action

  The mechanism of antidepressant action of trazodone is not fully understood, but it is believed that it is associated with increased serotonergic activity in the central nervous system. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist, and the end result of this action on serotonergic transmission and its role in the antidepressant effect of trazodone is unknown.

  Pharmacodynamics

  Preclinical studies have shown that trazodone selectively inhibits serotonin reuptake by neurons (Ki = 367 nM) and acts as an antagonist of serotonin 5-HT-2A receptors (Ki = 35.6 nM). Trazodone is also an antagonist of several other monoaminergic receptors, including 5-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors, and it is a partial agonist of the 5-HT1A receptor (Ki = 118 nM).

  Trazodone antagonizes alpha-1-adrenergic receptors, a property that may be associated with postural hypotension.

  Pharmacokinetics.

  Absorption

  In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissues. When trazodone hydrochloride is taken shortly after a meal, there may be an increase in the amount of drug absorbed, a decrease in the maximum concentration, and an increase in the time to reach the maximum concentration. Peak plasma levels are reached about an hour after ingestion if trazodone hydrochloride is taken on an empty stomach, or 2 hours after ingestion if taken with food.

  Metabolism

  In vitro studies on human liver microsomes show that trazodone is metabolized by oxidative degradation to the active metabolite mchlorophenylpiperazine (mCPP) by CYP3A4. Other metabolic pathways that may be involved in trazodone metabolism are not well understood. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted in the urine unchanged.

  Elimination

  Trazodone may accumulate in plasma in some patients.

  Protein binding

  Trazodone binds 89-95% to protein in vitro at concentrations achieved at therapeutic doses in humans.

  Clinical Studies

  The efficacy and safety of trazodone hydrochloride has been established in inpatient and outpatient studies of an immediate-release formulation of trazodone in the treatment of major depressive disorder.

  Medication Guide

  PATIENT INFORMATION

  DESYREL
  (DEZ ur)
  (trazodone hydrochloride) oral tablets

  What is the most important information I should know about DESYREL?

  Antidepressants, depression or other serious mental illness, suicidal thoughts or actions: Talk to your doctor about:

  Ceftin is good for strep throat

  • All risks and benefits of antidepressant treatment
  • All treatment options for depression or other serious mental illness

  1. Antidepressants may increase suicidal thoughts or actions in some children, adolescents, and young adults during the first few months of treatment.
  2. Depression and other serious mental illness are the most important causes of suicidal thoughts and actions.
     Some people may have a higher risk of suicidal thoughts or actions. This includes people with a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I observe and prevent suicidal thoughts and actions?
     • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings.This is very important when starting antidepressant medications or when changing doses.
     • Call your doctor right away to report any new or sudden changes in mood, behavior, thoughts, or feelings.
     • Perform all follow-up visits with your healthcare professional as scheduled. Call your doctor between visits as needed, especially if you are concerned about symptoms.

  Call your doctor immediately if you have any of the following symptoms, especially if they are new, worse, or bother you:

  • Suicidal thoughts or death
  • Attempted suicide
  • New or Worst depression
  • New or worse anxiety
  • Feelings of intense excitement or anxiety
  • Panic attacks
  • Sleep problems (insomnia)
  • New or worse irritability
  • Aggressive behavior, anger or violence
  • Acting on dangerous impulses

  Extreme increase in activity and talking (mania)

  • Other unusual changes in behavior or mood

  What else do I need to know about antidepressants?

  • Never stop taking antidepressants without first talking to your doctor. Sudden cessation of antidepressant medication may cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression, as well as the risks of refusing treatment. You should discuss all treatment options with your doctor, not just the use of antidepressants.
  • Antidepressants have other side effects. Talk to your doctor about the side effects of your medications.
  • Antidepressants may interact with other medicines. Know all the medicines you are taking. List all medications to show to your doctor. Do not start new medications without first talking to your healthcare professional.

  It is not known if Desirel is safe and effective in children.

  What is DESYREL?

  DESYREL is a prescription drug used in adults to treat major depressive disorder (MDD).DESYREL belongs to a class of drugs known as SSRIs (or selective serotonin reuptake inhibitors).

  Do not take DECIREL:

  • If you are taking a monoamine oxidase inhibitor (MAOI). Ask your healthcare professional or pharmacist if you are unsure if you are taking an MAOI, including the antibiotic linezolid, and IV methylene blue.
  • Do not take an MAOI within 2 weeks of stopping DESYREL unless advised by your healthcare professional.
  • Do not start DESYREL if you have stopped taking an MAOI in the past 2 weeks, unless directed by your healthcare professional.

  Before taking DESYREL, tell your doctor about all of your medical conditions, including if you:

  • have heart problems, including a prolonged QT interval or a family history
  • have ever had acute heart disease. vascular disease
  • have bipolar disorder
  • have liver or kidney problems
  • have other serious medical conditions
  • are pregnant or planning to become pregnant.It is not known if DESYREL will harm your unborn child. Talk to your doctor about the risks to your unborn child if you are taking DESYREL.
    • If you become pregnant while being treated with DESYREL, talk to your doctor about registering with the National Pregnancy Registry for antidepressant medications. You can register by calling 1-844-405-6185.
  • are breast-feeding or planning to breast-feed. DESYREL passes into breast milk. Talk with your doctor about the best way to feed your baby if you are taking DESYREL.
  • you have taken a monoamine oxidase inhibitor (MAOI) or if you have stopped taking an MAOI within the past 2 weeks.

  Tell your doctor about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The use of DESYREL with some other medicines can interfere with each other, causing serious side effects.

  Especially tell your doctor if you are taking:

  • triptans used to treat migraines
  • medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclic drugs, lithium, SSRIs, SSRIs, buspirone, or antipsychotics
  • tramadol
  • over-the-counter supplements such as tryptophan or St. accept.List them and show them to your healthcare professional and pharmacist when you receive a new medicine.

    How should I take DESYREL?

    • Take DESYREL exactly as advised by your healthcare professional.
    • DESYREL should be taken shortly after a meal or light snack.
    • If you feel drowsy after taking DESYREL, talk to your doctor. Your healthcare professional may change your dose or the time of day at which you are taking DESYREL.
    • Do not stop taking DESYREL without talking to your healthcare professional.
    • DESYREL should be swallowed whole or broken in half along the incision line. Do not chew or crush DESYREL. Tell your doctor if you are unable to swallow trazodone whole or half a tablet.
    • If you have taken too much DESYREL, call your healthcare provider, your poison control center at 1-800-222-1222, or go to the nearest emergency room right away.

    What should I avoid while taking DESYREL?

    • Do not drive, operate heavy machinery or engage in other hazardous activities until you know how DESYREL affects you. DESYREL can slow down your thinking and motor skills.
    • Do not drink alcohol or take other medicines that make you drowsy or dizzy while you are taking DESYREL until you talk to your doctor. DESYREL may make your drowsiness or dizziness worse if you take it with alcohol or other drugs that make you drowsy or dizzy.

    What are the possible side effects of DESYREL?

    DESYREL can cause serious side effects or death, including:

    • See “What is the most important information I should know about DESYREL?”
    • Serotonin syndrome. Symptoms of serotonin syndrome include agitation, hallucinations, coordination problems, heart palpitations, tense muscles, difficulty walking, sweating, fever, nausea, vomiting, and diarrhea.
    • Irregular or rapid heartbeat or fainting (lengthening of the QT interval)
    • Low blood pressure. You feel dizzy or faint when you change your posture (going from sitting to standing).
    • Unusual bruising or bleeding
    • Erections last more than 6 hours (priapism)
    • Feeling high or very good, then irritable or too much energy, feeling like you need to keep talking or stay awake (mania ).
    • Withdrawal symptoms. Withdrawal symptoms may include anxiety, agitation, and trouble sleeping. Do not stop taking DESYREL without talking to your healthcare professional.
    • Vision problems.
      • eye pain
      • changes in vision
      • swelling or redness around the eyes

    Only a few people are at risk of these problems. You can have an eye exam to see if you are at risk and get preventive treatment if so.

    • Low blood sodium (hyponatremia). Symptoms of hyponatremia include headache, feeling weak, confusion, trouble concentrating, memory problems, and feeling unsteady when walking.

    Get immediate medical attention if you have any of the symptoms listed above.

    The most common DESYREL side effects include:

    • swelling
    • blurred vision
    • dizziness
    • drowsiness
    • fatigue
    • diarrhea
    • not all weight loss REL
    • Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088.

      How do I store DESYREL?

      • Store DESYREL at room temperature between 68 ° F to 77 ° F (20 ° C to 25 ° C).
      • Store in tight container
      • Keep away from light
      • Thoroughly discard old or no longer needed medicine.

      Keep DESYREL and all medicines out of the reach of children.

      General information on the safe and effective use of DESYREL.

      Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use DESYREL in a state for which it has not been assigned. Do not give DESYREL to other people, even if they have the same symptoms as you. It could hurt them. You can ask your pharmacist or healthcare provider for information about DESYREL for healthcare professionals.

      Which ingredients are included in DESYREL?

      Active Ingredient: Impact Made by Hydrochloride, USP

      Inactive Ingredients: 50 mg and 100 mg: Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellular Cellulose starch and triacetin 150 mg: magnesium stearate, microcrystalline cellulose, pregelatinized starch 300 and pregelatinized starch.mg: Magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, and stearic acid

      This medication guide is approved by the FDA.

      26 reviews, instructions for use

      Application during pregnancy and breastfeeding

      The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

      Application for violations of liver function

      The drug should be prescribed with caution in patients with hepatic insufficiency.

      Application for impaired renal function

      The drug should be prescribed with caution in patients with renal insufficiency.

      Use in children

      The use of the drug in children and adolescents under 18 years of age is contraindicated (the safety of trazodone for children has not been established).

      Use in elderly patients

      For elderly and debilitated patients, the initial dose is up to 100 mg / day in divided doses or 1 time / day at bedtime. The dose can be increased under the supervision of a physician, depending on the effectiveness and tolerability of the drug.Usually, a dose exceeding 300 mg / day is not required.

      Special instructions

      In case of depressive conditions, the risk of manifestations of suicidal thoughts, self-harm or suicide is increased. The risk may last until significant remission occurs. Since improvement may not occur within the first few weeks of treatment or more, patients should be closely monitored until such improvement occurs. According to general clinical experience, the risk of suicide may increase in the early stages of recovery.It is known that patients with a history of suicidal events, or patients who exhibit a significant degree of suicidal ideation even before starting treatment, have a higher risk of suicidal ideation or attempted suicide and should be closely monitored during treatment. The results of a meta-analysis of placebo-controlled clinical trials of antidepressants, which are used in adults with mental disorders, showed an increased risk of suicidal behavior in patients under the age of 24 years while taking antidepressants compared with placebo.Close monitoring of patients, especially those at high risk, should accompany drug therapy, especially in the early stages and after dose changes. Patients (and their carers) should be warned to monitor for any clinical deterioration, suicidal behavior or suicidal thoughts, unusual changes in behavior, and immediately seek professional advice if such symptoms appear.

      Since the drug has some adrenergic blocking activity, the development of bradycardia and a decrease in blood pressure is possible.Therefore, caution should be exercised when prescribing the drug to patients with a tendency to lengthen the QT interval, AV block of varying severity, patients with recent myocardial infarction.

      In trazodone therapy in patients with bipolar disorder, depressive attacks can range from manic-depressive to manic psychosis. In these cases, it is necessary to interrupt the treatment.

      With epilepsy, trazodone should be taken with caution, in particular avoiding sudden increases or decreases in dose.

      With the concomitant use of trazodone with drugs with serotonergic activity (tricyclic antidepressants, selective serotonin reuptake inhibitors, norepinephrine and serotonin reuptake inhibitors and MAO inhibitors), and neuroleptics, serotonin syndrome may occur.

      With the simultaneous use of trazodone with preparations containing St. John’s wort, side effects may be more frequent.

      With the use of trazodone, agranulocytosis may develop, therefore it is recommended to conduct peripheral blood tests, especially in the presence of sore throat when swallowing and the appearance of fever.

      Trazodone is effective for sleep disorders in patients with depression, increases the depth and duration of sleep, restores its physiological structure and quality.

      The use of the drug does not affect body weight.

      The drug is not addictive.

      Influence on the ability to drive vehicles and control mechanisms

      During the period of application of the drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

      Trittico: instructions, reviews, analogues, price in pharmacies

      ---

      Trittico is an antidepressant.

      Pharmacological properties

      Trazodone is a triazolpyridine derivative. It is effective for the treatment of depressive conditions, including depression associated with anxiety and sleep disturbance, and has a rapid onset of action (about 1 week).

      Trazodone is a serotonin reuptake inhibitor and 5-HT 2 receptor antagonist, the activation of which is usually associated with the appearance of insomnia, anxiety, psychomotor agitation and changes in sexual function.

      Unlike other psychotropic drugs, trazodone is not contraindicated in glaucoma and disorders of the urinary system, it has no extrapyramidal effects, but does not potentiate adrenergic transmission. Trazodone is devoid of anticholinergic activity, therefore it does not have the effects typical of tricyclic antidepressants on heart function.

      Pharmacokinetics.

      After a single oral administration of trazodone with prolonged release in a dose of 75 mg, the maximum plasma concentration C max is about 0.7 μg / ml and T max is 4:00; the area under the pharmacokinetic curve AUC is approximately 8 μg / ml / h.After a single oral administration of trazodone with prolonged release at a dose of 150 mg, C max is about 1.2 μg / ml and a T max of 4:00 is achieved. The half-life is about 12:00, and the AUC is about 18 μg / ml / h.

      In vitro studies on human liver microsomes have shown that trazodone is metabolized by cytochrome P4503A4 (CYP3A4).

      Trazodone is excreted mainly in the urine in the form of its metabolites.

      Indications for use

      Depressive disorders with / without anxiety.

      Method of application

      Use the drug only for adults.

      Therapy should be started in the evening with daily dose increases, as recommended by your doctor. Treatment should continue for at least 1 month.

      To minimize side effects (increase in resorption and decrease in maximum plasma concentration), the drug is best taken after meals. A tablet with two parallel risks on the surface can be divided into three parts for the possibility of a gradual increase in the dose depending on the severity of the disease, body weight, age and general condition of the patient.

      Adults 75-150 mg / day taken once in the evening before bedtime.

      The dose may be increased to 300 mg / day, which should be divided into two doses.

      For inpatients, the dose can be increased to

      600 mg / day, which should be divided into several doses.

      Elderly patients, an initial dose of 100 mg / day should be taken in the evening. The dose may be increased depending on the clinical response. In general, single doses of more than 100 mg should be avoided in these patients.Rarely, there is a need to take a dose of more than 300 mg / day.

      Children. Do not use for children.

      Contraindications

      Hypersensitivity to the drug or to its components.

      Alcohol intoxication and intoxication with hypnotics.

      Acute myocardial infarction.

      Interaction with other medicinal products

      Sedative effects of antipsychotics, hypnotics, anxiolytics and antihistamines may be enhanced.A dose reduction of these agents is recommended.

      Oral contraceptives, phenytoin, carbamazepine and barbiturates, due to their effect on the liver, accelerate the metabolism of antidepressants. Cimetidine and some other antipsychotics slow down the metabolism of antidepressants.

      CYP3A4 inhibitors

      Data from studies on drug metabolism in vitro indicate the potential for drug interactions when trazodone is used concurrently with cytochrome CYP3A4 inhibitors such as erythromycin, ketoconazole, itraconazole, ritonavir, indinavir and nefazodone.The use of CYP3A4 inhibitors is likely to lead to a significant increase in plasma concentrations of trazodone. In vivo studies with healthy volunteers, it was confirmed that after the use of ritonavir at a dose of 200 mg twice daily, the level of trazodone in the blood plasma more than doubled, resulting in nausea, fainting and arterial hypotension. In this regard, when using trazodone simultaneously with a potent inhibitor of CYP3A4, it will be advisable to reduce the dose of trazodone.

      However, if possible, concomitant use of trazodone and potent CYP3A4 inhibitors should be avoided altogether.

      carbamazepine

      With the simultaneous use of trazodone with carbamazepine, plasma concentrations of trazodone decrease. With simultaneous use with carbamazepine at a dose of 400 mg per day, plasma concentrations of trazodone and its active metabolite m-chlorophenylpiperazine decreased by 76% and 60%, respectively. It is necessary to carefully monitor the patient’s condition in order to find out if he needs to increase the dose of trazodone.

      tricyclic antidepressants

      There is a risk of drug interactions, therefore, simultaneous use with trazodone should be avoided.

      In the case of simultaneous use, the development of serotonin syndrome and side effects on the cardiovascular system should be expected.

      fluoxetine

      Against the background of the simultaneous use of trazodone with fluoxetine (a CYP1A2 / 2D6 inhibitor), rare cases of an increase in the level of trazodone in the blood plasma and the occurrence of side effects have been reported.The mechanism underlying this pharmacokinetic interaction has not yet been fully elucidated. Pharmacodynamic interaction (serotonin syndrome) cannot be ruled out.

      Monoamine oxidase (MAO) inhibitors

      There have been isolated cases of possible interactions between trazodone and MAO inhibitors. Although some doctors practice the simultaneous use of these drugs, nevertheless, it is not recommended to use trazodone simultaneously with MAO inhibitors or within 2 weeks after their cancellation.It is also not recommended to start therapy with MAO inhibitors within 1 week after discontinuation of trazodone.

      phenothiazines

      With simultaneous use with phenothiazines, such as chlorpromazine, fluphenazine, levomepromazine, perphenazine, cases of severe orthostatic hypotension have been observed.

      Anesthetics / muscle relaxants

      Trazodone hydrochloride may enhance the effects of muscle relaxants and volatile anesthetics. These combinations should be used with caution.

      alcohol

      The sedative effects of alcohol under the influence of trazodone become more pronounced. During the period of trazodone therapy, the patient should avoid alcohol consumption.

      levodopa

      Antidepressants may accelerate the metabolism of levodopa.

      means

      When trazodone is used simultaneously with drugs with a known ability to prolong the QT interval, the risk of ventricular arrhythmias, including polymorphic ventricular tachycardia (torsade de pointes), may increase.Caution should be exercised when using these agents concomitantly with trazodone.

      Trazodone is only a very weak inhibitor of norepinephrine reuptake and does not affect the blood pressure response to tyramine therapy, so trazodone should not be expected to influence the hypotensive effect of guanethidine-like compounds. However, studies in laboratory animals have shown that trazodone can inhibit most of the rapid effects of clonidine.

      Although drug interactions have not been reported with other types of antihypertensive drugs concomitantly with trazodone, the potential for potentiation of the effects should be considered.

      The incidence of side effects may increase when trazodone is used concurrently with drugs containing St. John’s wort (Hypericum perforatum).

      Cases of changes in PT values ​​have been reported in patients who were simultaneously used trazodone and warfarin.

      Serum digoxin or phenytoin levels may increase with concomitant use of these drugs with trazodone.

      Serum levels of the aforementioned agents should be monitored in patients undergoing such therapy.

      Use during pregnancy and lactation

      pregnancy

      Data obtained from a study of a limited number (<200) pregnant women exposed to trazodone indicate no adverse effects on pregnancy or on fetal / newborn health. There is currently no other adequate epidemiological data available. Data from animal studies does not indicate the presence of any direct or indirect harmful effects of this substance, used in therapeutic doses, during pregnancy, embryonic / fetal development, childbirth or postnatal development of offspring.

      Pregnant women should use this drug with caution. If trazodone is administered to the mother before delivery, the infant should be monitored after birth to identify possible withdrawal symptoms, taking into account the benefit to the mother / risk to the fetus ratio.

      Breastfeeding

      Limited data indicate that trazodone passes into breast milk Due to insufficient data, the decision to prolong / discontinue breastfeeding or to continue / discontinue trazodone therapy should be made considering the benefits of breastfeeding for the baby and the benefits of trazodone therapy for the mother.

      Overdose

      Most often, overdose causes drowsiness, dizziness, nausea and vomiting. In complex cases, coma, tachycardia, arterial hypotension, hyponatremia, convulsions and respiratory failure occurred.

      Cardiac symptoms may include bradycardia, prolongation of the QT interval, and polymorphic ventricular tachycardia (torsade de pointes).

      Symptoms may appear within 24 hours of an overdose or later.

      Simultaneous overdose of trazodone and other antidepressants can cause serotonin syndrome.

      overdose treatment

      There is no specific antidote. Adults who have taken more than 1 g of trazodone, or children who have taken more than 150 mg of trazodone, should be given activated charcoal within 1:00 of the discovery of an overdose. In other cases, in adults, it may be advisable to perform gastric lavage within 1:00 after taking potentially life-threatening doses.

      It is necessary to monitor the patient’s condition for at least 6:00 after taking the drug (or 12:00 when taking a sustained-release drug).

      Blood pressure, pulse, and Glasgow Coma Scale (GCS) data should be monitored. In case of a decrease in the number of points on the GCS scale, blood oxygen saturation should be monitored.

      Cardiac monitoring is necessary in symptomatic patients.

      When a single short-term trial appears, no treatment is required. For frequent or prolonged seizures, administer intravenous diazepam (0.1-0.3 mg / kg body weight) or lorazepam

      (4 mg for adults and 0.05 mg / kg for children).

      If these measures do not provide court control, intravenous infusion of phenytoin may be appropriate. If necessary, give the patient oxygen and correct the acid-base balance and metabolic disorders.

      In case of arterial hypotension and excessive sedation, apply symptomatic and supportive therapy. If severe arterial hypotension persists, the advisability of using inotropic drugs, such as dopamine or dobutamine, should be weighed.

      Adverse reactions

      Cases of suicidal thinking and suicidal behavior have been reported during the period of trazodone therapy or shortly after its termination.

      The following symptoms have also been reported in patients treated with trazodone, some of which are common in cases of untreated depression.

      Blood and lymphatic system disorders: blood dyscrasias (including agranulocytosis, thrombocytopenia, eosinophilia, leukopenia and anemia).

      From the immune system: allergic reactions.

      From the endocrine system: syndrome of inappropriate secretion of ADH.

      Metabolic and nutritional disorders: hyponatremia, weight loss, lack of appetite, increased appetite

      From the psyche: suicidal thinking or suicidal behavior, confusion, insomnia, disorientation, mania, anxiety, nervousness, agitation (which is very rare develops into delirium), delirium, aggressive reaction, hallucinations, nightmares, decreased libido, drug withdrawal.

      From the nervous system: serotonin syndrome, convulsions, neuroleptic malignant syndrome, dizziness, headache, drowsiness, anxiety, decreased concentration, tremor, blurred vision, memory impairment, myoclonus, expressive aphasia, paresthesia, dystonia, taste disturbance.

      From the heart: cardiac arrhythmias (including polymorphic ventricular tachycardia (torsade de pointes), increased heartbeat, ventricular extrasystoles, paired ventricular extrasystoles, ventricular tachycardia), bradycardia, tachycardia, deviation from the norm on the part of the ECG data ).

      From the side of the vessels: orthostatic arterial hypotension, arterial hypertension, syncope.

      From the respiratory system, chest and mediastinum: nasal congestion, shortness of breath.

      From the gastrointestinal tract: nausea, vomiting, dry mouth, constipation, diarrhea, dyspepsia, stomach pain, gastroenteritis, increased salivation, paralytic intestinal obstruction, hepatobiliary system, liver dysfunction (including jaundice and hepatocellular lesions ), intrahepatic cholestasis.

      Skin and subcutaneous tissue disorders: skin rash, itching, hyperhidrosis.

      From the musculoskeletal system and connective tissue: pain in the limbs, back pain, myalgia, arthralgia.

      On the part of the kidneys and urinary tract: urinary disorders

      On the part of the reproductive system and mammary glands: priapism.

      General disorders and general disorders and reactions at the injection site: weakness, edema, flu-like symptoms, fatigue, chest pain, fever.

      Storage conditions

      Store at a temperature not exceeding 25 ° out of the reach of children.

      Shelf life 3 years.

      Release form

      Trittico 75 mg 30 tablets in three PVC / aluminum blisters, 10 tablets each, in a cardboard box.

      Trittico 150 mg 20 tablets in two PVC / aluminum blisters, 10 tablets each, in a carton box.

      Prescription category.

      Composition

      Active ingredient: trazodone hydrochloride

      1 tablet contains trazodone hydrochloride 75 mg or 150 mg

      Excipients: sucrose, carnauba wax, povidone, magnesium stearate.

      Additionally

      Use in children and adolescents

      Trazodone should not be used in children and adolescents. In a clinical study in children and adolescents, suicidal behavior (attempted suicide and planning suicide) and hostility (mainly aggressiveness, protest behavior, and anger) were more common in the antidepressant group than in the placebo group. In addition, there are currently no data on the long-term safety of the drug in children and adolescents, given its effects on growth, puberty, and cognitive and behavioral development.

      Suicide / suicidal ideation or clinical deterioration

      Depression is associated with an increased risk of suicidal ideation, self-harm and suicide (manifestations of suicidal behavior) by the patient. This risk persists until significant remission occurs. There may be no improvement in the condition during the first few weeks of therapy or longer. Patients should be carefully monitored until such improvement occurs. General clinical experience indicates a possible increased risk of suicide in the early stages of recovery.

      It is known that patients with a history of suicidal behavior or patients who had a significant degree of suicidal ideation before starting therapy have a higher risk of developing suicidal thoughts or suicidal attempts, therefore, during treatment, they need careful supervision. In a meta-analysis of placebo-controlled clinical trials of antidepressants for mental disorders, it was shown that among patients under 25 years of age, individuals in the antidepressant group had a higher risk of suicidal behavior than in the placebo group.

      Drug therapy should be accompanied by careful monitoring of patients, including those from a high-risk group, especially at the beginning of treatment and after changing the dose of the drug. Patients (and their caregivers) should be warned to watch for any clinical signs of deterioration, suicidal behavior or thoughts, and unusual changes in behavior, and if they are identified, seek medical advice immediately.

      To minimize the potential risk of suicidal attempts, especially at the start of therapy, the physician should only prescribe a limited amount of trazodone to the patient at each visit.

      It is recommended to carefully select the dosage regimen and to carry out regular monitoring of patients with the following conditions:

      • epilepsy, in particular in such patients, the dose should not be sharply increased or decreased;
      • impaired liver or kidney function, especially severe;
      • heart diseases such as angina pectoris, cardiac conduction disorders or various degrees of blockade; recent myocardial infarction;
      • hyperthyroidism
      • urinary disorders, for example with prostatic hypertrophy, although such problems are not expected since the anticholinergic effect of trazodone is negligible;
      • Acute glaucoma, increased intraocular pressure, although significant changes in position are not expected since the anticholinergic effect of trazodone is negligible.

      If the patient develops jaundice, trazodone therapy should be discontinued.

      With the use of antidepressants in patients with schizophrenia or other psychotic disorders, psychotic symptoms may increase.

      Paranoid thoughts may become more pronounced. Against the background of trazodone therapy, the depressive phase in manic-depressive psychosis can change into the manic phase. In this case, the use of trazodone should be discontinued.

      Against the background of concomitant use with other serotonergic drugs, such as other antidepressants (for example, tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors and MAO inhibitors) and antipsychotics, drug interactions have been reported with the development of serotonignant syndrome.Cases of fatal neuroleptic malignant syndrome have been reported with concomitant use with neuroleptics, for which this syndrome is a known possible adverse reaction.

      Since agranulocytosis can clinically present as a flu-like condition, sore throat and fever, laboratory blood counts should be checked if these symptoms appear.

      The occurrence of arterial hypotension, including orthostatic hypotension and syncope, has been reported in patients treated with trazodone.With the simultaneous use of antihypertensive drugs and trazodone, it may be necessary to reduce the dose of the antihypertensive drug. Elderly patients are often more susceptible to the unwanted effects of antidepressants, especially orthostatic hypotension and other anticholinergic effects.

      At the end of the course of trazodone therapy, especially if this course was long, it is recommended to gradually reduce the dose until the drug is completely discontinued in order to minimize the likelihood of withdrawal symptoms, which include nausea, headache and general malaise.

      There is currently no indication that trazodone hydrochloride is addictive.

      While using trazodone, very rare cases of prolongation of the QT interval – an effect that is characteristic of other antidepressants, have been reported. It is necessary to use trazodone with caution simultaneously with drugs with a known ability to prolong the QT interval. Trazodone should be used with caution in patients with diagnosed cardiovascular diseases, including those accompanied by prolongation of the QT interval.

      Against the background of the use of powerful inhibitors of cytochrome CYP3A4, the level of trazodone in the serum may increase.

      Like other drugs with alpha-adrenergic blocking activity, trazodone in very rare cases causes priapism. If it occurs, an intracavernous injection of an alpha-adrenergic agent such as epinephrine or metaraminol should be administered. However, cases of trazodone-induced priapism have been reported when surgery was necessary or when permanent sexual dysfunction resulted.In patients with suspicion of this adverse reaction, trazodone should be discontinued immediately.

      Trittico extended release tablets contain sucrose. This drug should not be used in patients with rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltose deficiency.

      The ability to influence the reaction rate when driving motor transport or other mechanisms

      Trazodone insignificantly or moderately affects the ability to drive vehicles and mechanisms.Patients should be warned that before driving and operating machinery, it is necessary to make sure that there is no drowsiness, sedation, dizziness, states of confusion or blurred vision while taking trazodone.

      Trittico: description, recipe, instruction

      Trittico

      Analogues (generics, synonyms)

      Velaksin, Alventa, Vimax, Medofaxin, DeprexorVen Lift

      Active ingredient

      Trazodonum

      Pharmacological group

      Antidepressants

      Recipe

      International:

      Rp.: Tab. “Trittico” 150mg No. 20
      D.S. 1 tablet 1 time per day

      Russia:

      Prescription form 107-1 / y

      Pharmacological action

      An antidepressant, a thiazolopyridine derivative. It also has thymoleptic, anxiolytic, sedative and muscle relaxant effects. Has a high affinity for some subtypes of serotonin receptors, inhibits the reuptake of serotonin; the neuronal seizure of norepinephrine and dopamine has little effect.
      Has no anticholinergic effect, does not inhibit MAO, does not change body weight.Eliminates both mental (affective tension, irritability, fear, insomnia) and somatic manifestations of anxiety (palpitations, headache, myalgia, frequent urination, increased sweating). Increases the depth and duration of sleep in depressed patients, restores its physiological structure.
      Reduces the pathological craving for ethanol. It is effective for withdrawal symptoms in patients with drug dependence to anxiolytic drugs derivatives of benzodiazepine, eliminates anxiety-depressive state and sleep disorders (during remission, benzodiazepines can be completely replaced with trazodone).Not addictive. Promotes the restoration of libido and potency.
      The therapeutic effect in 50% of patients is observed after 3-7 days, in 25% – after 2-4 weeks.
      After oral administration, absorption from the gastrointestinal tract is high. The time to reach Cmax in blood plasma is 1-2 hours. Taking trazodone during or immediately after a meal increases absorption, reduces Cmax and increases the time to reach it.
      Penetrates through histohematogenous barriers, including the BBB. Penetrates into tissues and fluids (bile, saliva, breast milk).Plasma protein binding – 89-95%.
      Metabolized in the liver by hydroxylation. The isoenzymes CYP3A4, CYP3A5 and CYP3A7 are involved in the metabolism of the drug.
      T1 / 2 in the α-phase 3-6 hours, in the β-phase – 5-9 hours. Excreted by the kidneys – 75% in the form of inactive metabolites within 98 hours after administration; 20% – with bile.

      Pharmacodynamics

      There is no data for this section. We are currently processing information, please come back later.

      Pharmacokinetics

      There is no data for this section.We are currently processing information, please come back later.

      Method of application

      For adults:

      The initial daily dose is 150-200 mg (in 3 divided doses). In mild forms of depression, the average maintenance dose is 150 mg / day; with moderate and severe forms – 300 mg / day. If necessary, the dose can be increased to 600 mg / day. The main part of the daily dose is recommended to be taken at bedtime.

      Readings

      – Various forms of depression (endogenous, psychotic, neurotic, somatogenic), incl.h /thoughts; bulimia, kleptomania, anxiety, phobias.
      – Benzodiazepine drug dependence; acute alcohol withdrawal syndrome.
      – Decreased libido, impotence.
      – Prevention of migraine attacks.

      Contraindications

      – Ventricular arrhythmia, tachycardia, myocardial infarction (early recovery period), history of priapism
      – Pregnancy, lactation
      – Hypersensitivity to trazodone.

      Special instructions

      There is no data for this section. We are currently processing information, please come back later.

      Side effects

      – From the side of the central nervous system and peripheral nervous system: drowsiness, increased fatigue, dizziness, insomnia, headache, agitation, myalgia, impaired coordination of movements, paresthesia, disorientation, darkening of consciousness, tremor.
      – From the side of the cardiovascular system: arrhythmia, conduction disturbance, bradycardia, ventricular fibrillation, decreased blood pressure, orthostatic hypotension, fainting.
      – From the digestive system: nausea, vomiting, diarrhea, dryness and bitterness in the mouth.
      – From the side of the organ of vision: visual impairment, eye irritation.
      – From the hematopoietic system: leukopenia, neutropenia (usually insignificant).
      – Other: nasal congestion, priapism followed by impotence, allergic reactions.

      Overdose

      There is no data for this section. We are currently processing information, please come back later.

      Drug interactions

      There is no data for this section. We are currently processing information, please come back later.

      Form of issue

      Sustained-release tablets, white or white with a yellowish tinge, oval, biconvex, with two parallel lines on both sides.

      1 tab. trazodone hydrochloride 150 mg.
      Excipients: sucrose – 84 mg, carnauba wax – 24 mg, povidone – 24 mg, magnesium stearate – 6 mg.

      10 pcs. – blisters (2) – cardboard packs.
      10 Pcs. – blisters (6) – cardboard packs.

      .