Trazodone hydrochloride 150 mg Tablets – 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.

TRAZODONE HYDROCHLORIDE 150MG TABLETS

• 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 150mg Tablets (called trazodone throughout 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 in these tablets (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.

Take special care with trazodone

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 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 breastfeed, 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.

This medicine contains Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

• Take this medicine by mouth
• Swallow the tablets 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 tablets 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 in 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 label and carton after EXP. The expiry date refers to the last day of that month.

Store below 30°C. Store in the original packaging 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 150mg Tablet contains 150mg of the active substance, trazodone hydrochloride
• Other ingredients include lactose, calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium starch glycollate, povidone and magnesium stearate, hydroxypropyl methyl cellulose, propylene glycol, red iron oxide (E172) and titanium dioxide (E171).

A salmon pink film-coated tablet with “MOLIPAXIN” and “150” on one face and a breakline on the other.

The tablets are available in blister packs of 28.

Marketing Authorisation Holder

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

Manufacturer

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 75

Side effects, dosages and benefits

Trazodone is an antidepressant that drug manufacturers developed to treat depression. Trazodone may also help treat sleep disorders, such as insomnia.

A person who has trouble sleeping may decide to talk to their doctor about the possibility of taking trazodone. However, trazodone may not be good for everyone and can have unwanted side effects.

Keep reading for more information on using trazodone to aid sleep.

Trazodone is an antidepressant that the Food and Drug Administration (FDA) approved to treat depression in the United States.

It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs). These drugs act by blocking the absorption of serotonin in the brain.

SSRIs are the most common antidepressants that doctors prescribe.

However, according to a review of studies, some researchers suggest that the off-label use of trazodone to treat sleep disorders now surpasses its use as an antidepressant.

Trazodone can help certain people to fall asleep. However, similarly to other medications, it may work better for some people than for others.

According to the 2017 review mentioned above,trazodone in low doses is generally safe and effective for treating insomnia, although, currently, the FDA only approve trazodone for treating depression.

Doctors generally consider trazodone safe in small doses for sleep disorders, such as insomnia. But it may not be as effective as medications such as Ambien for these sleep disorders.

If a person is having trouble sleeping due to depression, they may require a higher dose of trazodone. If this is the case, a person increases their risk of developing side effects from the medication due to the higher dose.

Doctors do not consider trazodone to be habit forming, meaning a person is not likely to become addicted to it. However, trazodone and other SSRIs may still cause physical dependence when people use them long term.

This type of dependence occurs when a person becomes used to the drug being in their system. As a result, they may experience withdrawal when the drug is no longer there.

Physical dependence is a normal process that happens with many medications.

Trazodone treats depression and may help a person fall asleep. Some additional benefits include:

• It has fewer side effects than many sleep aids, such as Ambien.
• It is not habit forming, but a person will need to gradually reduce higher doses on their doctor’s recommendations.
• Generic forms are available, so it can be cheaper than some other medications doctors may prescribe for sleep.

Trazodone can cause a variety of side effects in certain individuals. Some potential side effects include:

If a person notices side effects, they should talk to their doctor who may adjust their dose or recommend a different medication.

In addition, a person may experience more serious or life threatening side effects. If these occur, a person should seek emergency medical attention and discuss discontinuing the medication with their doctor.

Some serious side effects include:

• cardiac arrhythmia
• cognitive and motor impairment
• serotonin syndrome
• activation of mania, particularly in people with bipolar disorder
• orthostatic hypotension and fainting
• increased risk of bleeding
• seizures
• thoughts of self-harming
• prolonged and painful erections
• allergic reactions to the drug

It is also worth noting that the FDA have given trazodone a black box warning. This is the most severe warning the FDA can issue for a drug, regarding the risk for depression and suicidal behaviors.

Suicide prevention

• If you know someone at immediate risk of self-harm, suicide, or hurting another person:
• Call 911 or the local emergency number.
• Stay with the person until professional help arrives.
• Remove any weapons, medications, or other potentially harmful objects.
• Listen to the person without judgment.
• If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours a day at 1-800-273-8255.

Doses will vary between brands and a person’s prescriptions. For example, the FDA indicate the following doses for Desyrel, for treating depression:

• starting dose 150 milligrams (mg) divided into 2 doses daily
• may increase by 50 mg per day every 3–4 days
• maximum dose 400 mg per day in divided daily dose

A person should take tablets or pills whole or cut in half. They should also take trazodone with a light meal or snack.

If a person is going to discontinue using trazodone, they should gradually reduce their dosage. They should follow their doctor’s recommendation of how to wean themselves off the medication.

Since the FDA has not approved trazodone for treating sleep disorders, there is no official guidance from the manufacturer or the FDA on dosage trazodone for these conditions.

The 2017 review of studies, however, shows the doses of trazodone that people commonly use for treating sleep disorders in clinical studies were between 25–150 mg taken once at bedtime.

Certain supplements that affect serotonin levels may increase the chances that a person will develop serotonin syndrome.

Potential drug interactions with trazodone that the FDA list includes:

• benzodiazepines
• clarithromycin
• carbamazepine
• digoxin
• phenytoin
• warfarin

A person should talk to their doctor about all supplements and medications they are taking prior to starting trazodone.

They should also let their doctor know if they start taking additional medications or supplements when they are using trazodone.

The original use of trazodone was to treat depression. However, in addition to treating sleep disorders, doctors have also used trazodone to treat conditions such as unipolar depression or anxiety disorders.

There are other potential steps a person can take to help improve their sleep quality.

For those looking for alternate medication, doctors may prescribe Ambien. In addition, there are several over-the-counter (OTC) sleep aids, such as melatonin that a person may try to fall asleep.

Some people may find success with supplements to help them relax. Before taking any OTC sleep aids, including supplements, a person should talk to their doctor about their sleeping issues.

A doctor may be able to recommend additional treatments or help address any underlying condition that may exist. They will also be able to identify any potential interactions that may occur with existing medication usage.

A person may find that adequate exercise, a healthful diet, and reducing stress can all help improve sleep quality.

Click here to find out more about improving sleep quality.

For some people, trazodone may be a safe and effective sleep aid. However, drug regulators have not approved it for treating sleep disorders.

Typically, lower doses do not cause side effects, but the risk of these rises as the dosage increases.

A person should talk to their doctor about their sleeping issues and discuss all the options to make sure they are taking the best medication for their needs.

Trazodone Addiction and Abuse – Addiction Center

What Is Trazodone?

Trazodone is an antidepressant also known by the brand names Desyrel, Desyrel, Dividose, and Oleptro.  It is most commonly used to treat major depressive disorder with or without anxiety. Doctors will sometimes prescribe Trazodone off-label to treat alcohol dependence and insomnia as well. Trazodone can definitely cause dependence, although whether Trazodone addiction is possible is debated.

Trazodone falls under the category of drugs called selective serotonin re-uptake inhibitors (SSRIs), which affect chemical balance in the brain. Serotonin is a neurotransmitter that regulates emotions and, low levels of it results in depression and other mental disorders. SSRIs such as Trazodone block the brain’s neurons from using serotonin, leaving more available to facilitate connections between neurons. More serotonin leads to a healthier and more balanced brain, relieving disorders that cause depression, anxiety and trouble sleeping. Health practitioners will sometimes prescribe Trazodone over a sleeping barbiturate because it is less likely to lead to addiction or cause severe side effects.

Trazodone is  available in the form of 25 mg, 50 mg, 100 mg, 150 mg, and 300 mg tablets for oral ingestion. Dosage typically starts at 150 mg daily and can be increased in 50 mg increments based on a patient’s response to the medication. This prescription should be taken with food and avoided if a MAO inhibitor has been used within the past 14 days. Trazodone is generally safe, and research has shown that it is effective in treating depression and insomnia. However, like any substance, it carries risk for misuse, dependence, withdrawal, and overdose. Anyone who is taking Trazodone is at risk for addiction, and should only use it as prescribed by health professionals.

Trazodone Dependence and Addiction

Trazodone is a long-term medication and, although it is not inherently dangerous to take for months or years, it can still cause dependence. If a person needs to take Trazodone in order to feel normal or, if they feel withdrawal symptoms without it, they have become dependent. Whether or not antidepressants are addictive is up for debate since people do not typically crave these drugs. Regardless, people who stop taking Trazodone suddenly may experience uncomfortable withdrawal symptoms. Patients who no longer want to take this medication should talk to a healthcare provider about tapering off until it is safe to completely end treatment.

In order to avoid the experience of withdrawal symptoms, a person may continue to use Trazodone even if it is no longer needed. In extreme cases, those with a dependency or addiction will visit different doctors for more prescriptions or purchase it illegally. The cycle between withdrawal and relapse is characteristic of an addiction disorder but fortunately, prescription drug addiction can be treated with detox and combination therapy at a rehab facility.

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Symptoms of Trazodone Withdrawal

Trazodone withdrawal is a form of SSRI Discontinuation Syndrome (SSRIDS). Symptoms are similar to those of depression and anxiety and begin to manifest when medication has been stopped abruptly. Withdrawal symptoms are a result of changes in the brain that cause alterations to serotonin receptors. While taking Trazodone, the brain “down-regulates” the number of receptors in response to the increased levels of serotonin. When a person stops taking the drug, the decreased volume of receptors creates a short-term deficiency of serotonin activity. The body will typically correct this on its own, but one may experience uncomfortable symptoms during an adjustment period. Experiencing withdrawals from Trazodone does not always mean a person is addicted but it does indicate a physical dependency to the medication. Symptoms of Trazodone withdrawals may include:

• Dizziness or lightheadedness
• Nausea/Vomiting
• Shock-like sensations
• Suicidal Thoughts
• Vertigo or difficulty walking
• Trouble concentrating
• Headaches
• Irritability
• Chills
• Depersonalization

To avoid withdrawal symptoms, a person should always take Trazodone as prescribed without skipping doses. If one wishes to stop or switch their medication, they should consult a medical professional and discuss options. The best way to end treatment is by using the “tapering strategy” under medical supervision, which gradually reduces the prescribed dose until it reaches zero. Symptoms of SSRIDS can start as soon as one day after last dosage and remain for two to three weeks.

Side Effects and Risks of Trazodone

As is with all medications, Trazodone may cause side-effects. The most common side-effects are not long-lasting or life-threatening, but there can be cases where the medication may cause serious side-effects that require medical attention. Common side-effects of Trazodone include:

• blurred vision
• drowsiness, dizziness, or tiredness
• sweating
• swelling
• weight loss
• stuffy nose

Less common side effects include:

• dry mouth
• diarrhea or constipation
• sexual dysfunction
• priapism (painful and persistent erection of the penis or the clitoris)
• cardiac arrhythmia

Call your healthcare provider if you experience:

• skin rashes
• fast or pounding heartbeats, shortness of breath, and sudden dizziness (feeling like passing out)
• slow heartbeats
• easy bruising or unusual bleeding
• low sodium levels in the body

A “black box warning” has been issued by the FDA for Trazodone. A black box warning is used to inform consumers about dangerous potential effects of a prescription drug. According to the label, Trazodone can produce or increase suicidal thoughts in children and young adults. Women who are pregnant or breast-feeding should ask their doctors about the risks involved in taking this medication. Drug interactions can also be dangerous when mixing different substances. People who have used an MAO inhibitor (MAOI) such as isocarboxazid, linezolid, phenelzine, rasagiline, or others, must wait at least 14 days before taking Trazodone. Likewise, those who wish to stop taking Trazodone should wait 14 days before taking an MAOI.

Although it is not very common, it is still possible for someone to suffer an allergic reaction to Trazodone. Symptoms of an allergic reaction include hives, difficulty breathing, and swelling. One should never use Trazodone if they are allergic, or being treated with methylene blue injections. Allergic reactions can be life-threatening and require emergency medical attention.

Symptoms of Overdose

It is possible to overdose on Trazodone. Overdosing on Trazodone is usually not life-threatening but can occur if someone takes too much of the medication. When serotonin accumulates in the body it is referred to as serotonin syndrome and can result in mild to severe symptoms that include:

• Agitation or restlessness
• Twitching muscles
• Confusion
• Rapid heart rate and high blood pressure
• Diarrhea
• Shivering and goosebumps

One should have immediate medical attention if they experience:

• High fever
• Seizures
• Irregular heartbeat
• Unconsciousness

Trazodone overdose can be fatal when mixed with alcohol, barbiturates, or sedatives such as valium. One should avoid drinking alcohol while taking this medication.

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Get Help Today for a Trazodone Addiction

If you or someone you know has become addicted to Trazodone, seeking help early on can help prevent complications in the future. Contact a treatment provider today to learn more about centers which can help safely detox from Trazodone and recover from SSRI dependency.

Trazodone Overdose: Can You Overdose on Trazodone?

Trazodone is commonly used as a prescription antidepressant. Its brand names include medications like Oleptro and Desyrel. In addition to treating depression, trazodone can be used to treat anxiety disorders and even insomnia. The drug is sometimes used as an alternative to traditional sedatives, such as benzodiazepines.

When taken in excess and in ways not directed by a licensed physician, trazodone and other antidepressants can lead to negative side effects. In serious instances, an overdose may occur.

Can You Overdose on Trazodone?

Trazodone overdoses are uncommon, but they are still possible. However, an overdose of this drug is different from what many would expect. Almost every single overdose that originates from trazodone use has occurred in patients who were prescribed the drug. This is because trazodone has no perceived recreational value for a person looking to achieve a high. Using excess amounts of trazodone simply speeds up and boosts the medication’s drowsiness effect. This separates it from many other drugs, including opioids or hallucinogens, with overdoses frequently or solely caused by recreational use.

The danger of a trazodone overdose lies in taking more than one’s prescribed dose. Like many antidepressants, a patient may take more of the drug than they should to rid themselves of depressive symptoms and thoughts. Many of these types of overdoses are unintentional in nature. However, some may be premeditated attempts by patients who overuse the prescription for self-harm purposes.

How Much Trazodone to Overdose?

Doctors often recommend a daily dose of 150 mg of trazodone for depression treatment. This amount can be increased to upward of 600 mg if necessary. Much lower doses are used to treat insomnia. As such, any amount exceeding 600 mg in 24 hours is considered an overdose.

The actual dosage needed to fatally overdose on trazodone is not readily available. A large proportion of deaths linked to the antidepressant were due to mixing other substances with trazodone. Alcohol seems to be a particularly dangerous combination and should be avoided entirely.

Trazodone Overdose Symptoms

An overdose on trazodone is characterized by any number of life-threatening symptoms. Each indicator is linked to a specific region of the body:

• Respiratory system: Respiratory depression is a common side effect exhibited during trazodone overdoses. It occurs when the lungs do not properly expand and contract. Breathing may cease momentarily or stop completely during such an episode.
• Central nervous system: Trazodone acts upon the central nervous system directly for its medical benefits. Therefore, a majority of symptoms tie directly to the brain. These symptoms include drowsiness, headache, uncoordinated behavior, dizziness, seizures and coma.
• Cardiovascular system: Irregular heartbeat, low blood pressure, faint pulse and chest pain are additional side effects caused by antidepressant overdoses.

Trazodone Overdose Treatment

Like overdoses for most drugs, treatment related to trazodone begins at the site of the incident. If you, a loved one or a stranger is showing onset symptoms of an overdose, the best course of action is to contact poison control and 911.

Be prepared to give an accurate account of the scenario. This includes information about the victim’s age, weight and height. Additionally, it is helpful to know how much of the trazodone was ingested and in what specific time period.

At the hospital, victims can expect mostly preventative and symptom-specific care. There is no antidote for a trazodone overdose — time is the only treatment. Physicians may choose to administer intubation to promote proper breathing or a dose of activated charcoal to decontaminate the patient’s stomach contents. Nearly all trazodone overdoses are manageable with immediate treatment efforts.

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Medical Disclaimer: The Recovery Village aims to improve the quality of life for people struggling with a substance use or mental health disorder with fact-based content about the nature of behavioral health conditions, treatment options and their related outcomes. We publish material that is researched, cited, edited and reviewed by licensed medical professionals. The information we provide is not intended to be a substitute for professional medical advice, diagnosis or treatment. It should not be used in place of the advice of your physician or other qualified healthcare provider.

Uses, Side Effects, Dosages, Precautions

Trazodone is an antidepressant in the serotonin modulators class of drugs. It is used to treat depression and works by increasing the action of serotonin in your brain. In addition to being used for managing depression, it can be used to treat insomnia and anxiety. 

Trazodone comes in a tablet and an extended-release tablet. Common brand names include Desyrel, Desyrel Dividose, and Oleptro.

Robin Gentry / EyeEm / Getty Images

Uses

Trazodone is used to control symptoms of depression, but it cannot cure depression. Your doctor may start you at a low dose and gradually increase it. 

Trazodone increases serotonin activity in your brain. Serotonin is a chemical that normally promotes a feeling of mental wellbeing. Trazodone is also indicated for the treatment of insomnia and anxiety symptoms.  

Before Taking

Before you are prescribed this drug for the treatment of your depression, your doctor will consider whether the possible benefits outweigh the risks. Trazodone may interact with many other medications. Talk to your doctor about all medications, supplements, and vitamins that you currently take.

While some drugs pose minor interaction risks, others may outright contraindicate use or prompt careful consideration and/or monitoring for interactions.

If you are pregnant or breastfeeding, your doctor may explore other treatment options for you besides trazodone. 

Precautions and Contraindications

Trazodone should be used with caution in teenagers and young adults. Studies have shown that a small percentage of young people under the age of 24 who take trazodone may develop suicidal ideation or thoughts of harming themselves.

Your doctor will talk with you about a plan for how to contact the appropriate resources should you or your child experience thoughts of self-harm while taking trazodone.

Trazodone should not be used in patients with a history of heart disease or a recent heart attack. This drug can cause or worsen QT prolongation which can cause an irregular heart rhythm that can lead to fainting, seizures, or even death.

This heart rhythm problem is affected by the levels of potassium, sodium, and magnesium in your blood, so your doctor may check those levels before prescribing trazodone. 

If you have a history of glaucoma, trazodone could worsen it. Your doctor may ask you to have an eye exam before prescribing it. 

Other Antidepressants 

In addition to trazodone, the most common antidepressants include:

Dosage

Trazodone is available as a regular release tablet and an extended-release tablet. It is available in a generic form. According to the Food and Drug Administration (FDA), dosing should be as follows:

• For the treatment of depression, a normal starting dose is 150 milligrams (mg) per day. When the regular tablets are taken, this would most likely be scheduled as 75 mg in the morning and 75 mg at night.
• For the treatment of insomnia, the dose is usually started with 25 to 50 mg at night.

Your doctor will then work with you to find the right dose and may increase your dose every few days. You may go up by 50 mg every few days, with a maximum dose of 400 mg.

According to the journal Pharmacy and Therapeutics, dosing for extended-release tablets also starts at 150 mg per day.  These tablets are taken around bedtime because they can cause drowsiness.

Your doctor may increase your dose by 75 mg every three days until you find the right dose for you. The maximum daily dose for extended-release tablets is 375 mg per day. 

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.

How to Take and Store

• Regular release trazodone tablets should be taken with a meal or snack to prevent stomach upset.
• If you are prescribed the extended-release tablet it should be taken on an empty stomach, and it should never be chewed or crushed.

Aim to take your prescription at the same time each day.

If you miss a dose, take it as soon as you remember. If your next dose is coming up, skip the missed dose, and never double your prescription. Because trazodone can cause drowsiness, you may need to wait until the evening to take your dose. 

It is safest to keep this medication in its original bottle with the lid tightly sealed. Make sure it is out of reach of children and kept in a cool, dry place. Rooms with heat and moisture, such as the bathroom after a shower, are not the best storage place for trazodone. 

Side Effects

Common

The most common side effects of Trazodone are mild and do not usually require a change in dosing or prescription.

Common side effects include:

• Mild dry mouth
• Unpleasant taste
• Muscle soreness
• Nausea 
• Constipation 

Severe

Because of Trazodone’s effect on your mood and heart function, certain side effects must be addressed right away.

Call your doctor right away if you experience any of the following side effects:

• Suicidal thoughts
• Dizziness or lightheadedness
• Shortness of breath
• Fast or slow heartbeat 
• Confusion
• Unusual excitement or nervousness 
• Seizures

Overdose Warning

A trazodone overdose can cause serious side effects—and could be life-threatening.

Symptoms of an overdose may include:

• Loss of consciousness
• Seizures
• Shortness of breath
• Vomiting 
• Long-lasting, painful erection in men

If you or your child experience any overdose symptoms, call the Poison Center immediately.

Warnings and Interactions

Trazodone should be used with caution in patients who:

• Are adolescents with a history of suicidal thoughts
• Are pregnant
• Have a history of heart disease
• Have had a recent heart attack
• Have a history of irregular heart rhythms
• Have glaucoma
• Have certain kinds of cancer
• Have high blood pressure
• Have sickle cell anemia  
• Have liver or kidney disease

Warnings 

When used in adolescents and young adults, Trazodone comes with a black box warning because it may cause suicidal thoughts. This side effect is rare, but it’s best to have a plan in place in the event that it does happen. Talk with your doctor about changes in mood or thoughts that you should look for.

Have a list of emergency phone numbers to call for help if you notice yourself thinking of self-harm. If you are the parent of a patient taking trazodone, have honest discussions about this possibility and develop a family plan together.

When taken with other antidepressants, trazodone could cause serotonin syndrome. This happens when there is too much serotonin activity in your body. You could experience shivering, diarrhea, fever, seizures, and loss of consciousness. If you notice any of these symptoms while taking trazodone, talk with your doctor right away. 

If you and your doctor determine that trazodone is not a fit for you, do not stop it cold turkey, because you could experience withdrawal symptoms. Your doctor will most likely give you a schedule for gradually reducing your dosage. 

Trazodone Hcl Tabs | CT Weather

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Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents.. DESYREL is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride Trazodone hydrochloride ( Desyrel ®) is a prescription drug that is used for treating depression in adults. It comes in the form of tablets and is taken by mouth, usually one to three times a day Trazodone Oral tablet 100mg Drug Medication Dosage information. Learn about. Trazodone HCL 100mg tabs 2 tablets at night. Population in that year. Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle. Brand names- Desyrel, Oleptro, Trittico, Molipaxin, Trazorel (among others) Before Taking Trazodone. Hydroxyzine is used to treat itching caused by allergies. The lowest. Lightheadedness. This is an off-label use of this antidepressant. Trazodone ( Desyrel, Trialodine) is an inexpensive drug used to treat depression. Trazodone Drug 150 Mg & 500 Mg Dosage. Trazodone 50 Mg And Trazodone HCL 100 Mg Tablets. This drug is more popular than comparable drugs. Currently, trazodone is the second most commonly prescribed treatment for insomnia 5 because of its effectiveness, proven sedative properties, perceived lack of hazards and serious problems. The tablets have a score line, or indentation down the middle. Take the extended-release tablet at the same time each day, preferably at bedtime, without food. One medication used to treat depression is a serotonin modulator named trazedone, available starting at a dose of 50 mg pms-Trazodone: Trazodone belongs to the class of medications called antidepressants. It is used to treat major depressive disorder, anxiety disorders, and, with other medications, alcohol dependence. 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Trazodone has minor interactions with at least 137 different drugs. Therefore, before using this product, tell your doctor, health care professional or pharmacist of all the products you use. In practice it is widely used off-label to treat insomnia. The National Library of Medicine (NLM), on the NIH campus in Bethesda, Maryland, is the world’s largest biomedical library and the developer of electronic information services that delivers data to millions of scientists, health professionals and members of the public around the globe, every day Trazalon containing the active ingredient trazodone hydrochloride is considered a serotonin modulator type of medication. Trazodone HCl Behavioral Calming Trazodone is an atypical antidepressant commonly used in dogs for chronic anxiety-related problems in dogs, including thunderstorms or fireworks, and activity restrictions (cage rest) after surgery. Trazodone is available as a generic drug only. Bupropion HCL 200mg tabs 2 tablets twice a day. 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Trazodone in Veterinary Medicine | Today’s Veterinary Nurse

May/June 2017, Toxicology

How trazodone is used in veterinary medicine, and what to do if an animal is accidentally exposed to toxic amounts.

Tamara FossCVT | ASPCA Animal Poison Control Center | Urbana, Illinois

Tamara has been with the ASPCA Animal Poison Control Center since 2000. She earned her bachelor’s degree in agriculture with an emphasis in animal health technology from Murray State University in Kentucky. Tamara especially enjoys the toxicology-, research-, and information technology–related aspects of her position at the ASPCA. She has a passion for greyhounds and is an active volunteer and foster for American Greyhound. Outside of work, she loves spending time with her greyhounds, especially helping her greyhound Callen have fun playing running games like lure coursing and straight racing.

Though trazodone has generally been shown to be beneficial and relatively safe for dogs, being aware of signs associated with serotonin syndrome is important as this can be a serious and potentially life-threatening condition to manage. Treatment of trazodone overdose generally consists of symptomatic and supportive care. Trazodone is a serotonin 2A antagonist and reuptake inhibitor that has been used in human medicine as a prescription therapy for depression, aggression, sleeplessness, and anxiety since 1981.^1–3 It is available in 50-, 100-, 150-, and 300-mg tablets as well as 150- and 300-mg extended-release tablets.¹ No products are labeled for veterinary use.

Trazodone selectively blocks serotonin reuptake, which enhances serotonin’s effects.⁴ It is an antagonist of 5-HT_2A, h2-histaminic, and α1-adrenergic receptors at low to moderate doses, resulting in various levels of sedation.^3–6 It can have hypotensive effects.⁴ At higher doses, trazodone acts as a serotonin agonist, and serotonin syndrome can develop.^4,6 Trazodone also has anxiolytic properties, but the exact mechanism of action is unknown.⁴

Editor’s Note: This article was originally published in May 2017. Please use this content for reference or educational purposes, but note that it is not being actively vetted after publication. For the most recent peer-reviewed content, see our issue archive.

Trazodone Use in Veterinary Medicine

In 2008, Gruen and Sherman studied 56 dogs prescribed trazodone in combination with other primary behavior therapies and discovered that trazodone seemed to offer therapeutic benefit with relatively minimal adverse effects.⁷ Since then, studies have investigated the benefit of trazodone in postorthopedic surgery treatment plans involving confinement to enhance calm behavior and reduce anxiety in hospitalized dogs. Trazodone has generally been shown to be beneficial and relatively safe. Adverse events associated with trazodone can be divided into behavioral and systemic signs. Adverse events previously reported in the literature include drugged or “spacy” behavior, drowsiness, panting, anxiety/restlessness/agitation, vomiting/gagging, behavioral change (counter surfing and trash raiding), excitation, sedation, increased hunger, colitis, and aggression (growling).^5,7,8

In veterinary medicine, trazodone is generally dosed at 1.7 to 19.5 mg/kg/d on a daily or as-needed basis with immediate action (not extended-release) tablets and can be given with food.¹ When administered in combination with tricyclic antidepressants or selective serotonin reuptake inhibitors, it is recommended to begin dosing trazodone at 2 to 5 mg/kg and increase as needed to a maximum dose of 14 mg/kg/d.¹ Trazodone should be administered about an hour before potential anxiety-inducing stimuli, as its onset of action is approximately 30 to 60 minutes.^1,5 Gruen and colleagues reported owner-observed duration of effect lasting 4 hours or more.⁵ The parent compound has an elimination half-life of approximately 7 hours in immediate-release tablets.¹ Trazodone undergoes extensive metabolism in the liver and is predominantly excreted via the kidneys.^1,4

Exposure

Incidence and Clinical Signs

The ASPCA Animal Poison Control Center reported 417 incidences involving single-agent trazodone exposures in 379 dogs from 2009 to 2013.¹ In 104 dogs experiencing adverse effects, sedation and lethargy were reported in 43% of the dogs. Ataxia was reported in 16% and vomiting in 14%. Overall, lethargy, sedation, depression, somnolence, and subdued behavior are considered common signs of trazodone exposure.⁹ Additional information on signs reportedly exhibited by dogs exposed to trazodone alone from January 2003 to November 2016 and the lowest dose at which each sign was seen is provided in TABLE 1.

TABLE 1 Signs Associated With Trazodone Exposure in Dogs¹⁰

Management

Decontamination measures are an important component of exposure management. Induction of emesis within 1 hour of exposure is recommended in asymptomatic patients if no contraindications to emesis exist.⁹ Activated charcoal with sorbitol may be recommended in large exposures only.⁹

Treatment of trazodone overdose generally consists of symptomatic and supportive care. Although adverse effects are often reported, relatively few cases have involved serious signs and no deaths are attributed to trazodone exposure to date.⁹ Special attention should be given to ensuring maintenance of cardiac output and being attentive to signs of hyperthermia or hypothermia and correcting as needed.^9,11 IV fluid therapy may be needed to maintain blood pressure.^6,9 Diazepam is the drug of choice for managing tremors or seizures, and atropine is suggested for treatment of bradycardia.^6,9

Being aware of signs associated with serotonin syndrome is important as this can be a serious and potentially life-threatening condition to manage. Serotonin syndrome develops as a result of an overabundance of serotonin in the central nervous system.⁶ It can be a risk in cases of exposure to high doses of trazodone.^1,4 Clinical signs of serotonin syndrome in dogs, in order of most to least common, include vomiting, diarrhea, seizures, hyperthermia, hyperesthesia, depression, mydriasis, vocalization, death, blindness, hypersalivation, dyspnea, ataxia/paresis, disorientation, hyperreflexia, and coma.¹ Cyproheptadine, a serotonin antagonist, helps combat serotonin syndrome signs.^6,11 Phenothiazines should be used cautiously because of potential hypotensive effects.⁶

Interaction With Other Drugs

Trazodone interacts with numerous drugs, and some of these interactions may have clinically significant effects. Of special interest are medications that may be strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) isoenzyme, which is involved in trazodone metabolism.⁴ Azole antifungals (eg, ketoconazole, itraconazole, fluconazole) and macrolide antibiotics (eg, erythromycin, telithromycin, clarithromycin) are CYP3A4 inhibitors and thus may enhance the effect of trazodone.^1,4 Carbamazepine, phenobarbital, phenytoin, rifampicin, and modafinil, which are CYP3A4 inducers, may decrease the effect of trazodone.^1,4,9

Extreme caution should be used with concomitant trazodone and fluoxetine use and/or exposure as it is believed that fluoxetine may inhibit metabolism of trazodone.^1,4 Additionally, fluoxetine and other serotonergic medications (eg, paroxetine, sertraline, amitriptyline, clomipramine, amphetamines, dextromethorphan) as well as monoamine oxidase inhibitors (eg, phenelzine, amitraz, selegiline), metoclopramide, and tramadol, could heighten the risk of serotonin syndrome when combined with trazodone.^1,4,6,8

Serotonin syndrome patients with severe cardiac disease or renal and/or hepatic function deficits should be monitored very closely and may merit additional treatment measures.¹

Prognosis

The prognosis for patients exposed to trazodone is generally good, especially when serotonin syndrome has not developed. Signs generally resolve in 12 to 24 hours.⁶

About Toxicology Talk

Toxicology Talk is written and reviewed by members of the American Society for the Prevention of Cruelty to Animals (ASPCA) Animal Poison Control Center (APCC). The mission of the APCC is to help animals exposed to potentially hazardous substances, which it does by providing 24-hour veterinary and diagnostic treatment recommendations from specially trained veterinary toxicologists. It also protects and improves animal lives by providing clinical toxicology training to veterinary toxicology residents, consulting services, and case data review.

The ASPCA APCC includes a full staff of veterinarians, including board-certified toxicologists, certified veterinary technicians, and veterinary assistants, and its state-of-the-art emergency call center routinely fields requests for help from all over the world, including South America, Europe, Asia, and the Pacific Islands.

References

1. Plumb DC. Trazodone HCl. In: Veterinary Drug Handbook. 8th ed. Ames: John Wiley and Sons; 2016.
2. Trazodone (Poisindex Managements). In: POISINDEX® System (electronic version). Greenwood Village, CO: Truven Health Analytics. Available at: micromedexsolutions.com. Accessed December 2016.
3. Gruen ME. Beyond the front line: trazodone and other ancillary treatments for anxiety. Vet Med Forum May 2012 cvm.ncsu.edu/wp-content/uploads/2015/06/Gruen_VetMedForum_May2012.pdf. Accessed December 2016.
4. McEvoy GK, ed. Trazodone. In: AHFS Drug Information 2014. Bethesda, MD: American Society of Health-System Pharmacists; 2014:2450-2454.
5. Gruen ME, Roe SC, Griffith E, et al. Use of trazodone to facilitate postsurgical confinement in dogs. JAVMA 2014;245:296-301.
6. Wismer TA. Antidepressant drug overdoses in dogs. Vet Med 2000;95(7):520-525.
7. Gruen ME, Sherman BL. Use of trazodone as an adjunctive agent in the treatment of canine anxiety disorders: 56 cases (1995-2007). JAVMA 2008;233:1902-1907.
8. Gilbert-Gregory SE, Stull JW, Rice MR, et al. Effects of trazodone on behavioral signs of stress in hospitalized dogs. JAVMA 2016;249:1281-1291.
9. ASPCA Animal Poison Control Center. Trazodone vet protocol. Unpublished data.
10. ASPCA Animal Poison Control Center. AnTox database. Unpublished data.
11. Wismer TA. Antidepressant drug overdoses. Vet Tech 2006;27(5):278-281.

Trittico instructions for use: indications, contraindications, side effects – description of Trittico tab. prolonged release 150 mg: 20 or 60 pcs. (45130)

Trittico 150mg 20 pcs.tablets aziende chimiche riunite angelini france

Use in children and adolescents (under 18 years of age)

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

Suicide / suicidal thoughts or worsening clinical symptoms

Depressive conditions increase the risk of suicidal thoughts, self-harm or suicide. This risk persists until severe remission occurs. Since improvement may not occur within the first few weeks of treatment or more, patients should be closely monitored until 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. Results from a meta-analysis of placebo-controlled clinical trials of antidepressants used in adults with mental disorders have shown an increased risk of suicidal behavior in patients under 25 years of age with antidepressants compared with placebo.

Careful observation 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. To minimize the potential risk of suicide attempts, especially at the beginning of treatment, the minimum necessary dose should be prescribed in each case.

If jaundice develops, trazodone therapy should be discontinued.

The use of antidepressants in patients with schizophrenia or other mental disorders can lead to a possible worsening of mental symptoms. Paranoid thoughts can be amplified. With trazodone treatment, depressive attacks can range from manic-depressive to manic psychosis. In this case, trazodone should be canceled.

When trazodone is used concomitantly with drugs that have serotonergic activity, such as other antidepressants (for example, tricyclic antidepressants, selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors and MAO inhibitors, serone interactions with the development of serone and neuroleptics have been described) syndrome or neuroleptic malignant syndrome.Fatal neuroleptic malignant syndrome has been reported in cases of joint use with antipsychotics, for which this syndrome was a known possible adverse drug reaction.

Since agranulocytosis can manifest itself as a flu-like syndrome, sore throat and fever, it is recommended to monitor the blood picture when these symptoms appear.

Cases of hypotension, including orthostatic hypotension and syncope have been reported in patients taking trazodone.Concomitant use with antihypertensive drugs may require a reduction in the dose of the antihypertensive drug.

Elderly patients

Elderly patients are often more susceptible to antidepressants, in particular, cases of orthostatic hypotension, drowsiness and other anticholinergic effects of trazodone are more often reported.

Particular attention should be paid to the potential additive effects in connection with the concomitant use of other psychotropic or antihypertensive drugs or in the presence of risk factors, such as concomitant diseases, which may aggravate these reactions.

It is recommended that the patient or caregiver be informed of the possible occurrence of such effects. It is necessary to carefully monitor their manifestation in the patient after the initiation of therapy, before and after titration in an increasing dose.

With long-term trazodone therapy, a gradual dose reduction is recommended before discontinuation of the drug to minimize withdrawal symptoms such as nausea, headache, and malaise.

There is no evidence that trazodone hydrochloride has any addictive properties.

As with other antidepressants, QT prolongation has been reported very rarely with trazodone. Caution should be exercised when prescribing trazodone with drugs that prolong the QT interval.

Trazodone should be used with caution in patients with known cardiovascular diseases, including prolongation of the QT interval. Strong inhibitors of CYP3A4 can lead to an increase in serum trazodone levels.

As with other drugs with alpha-adrenolytic activity, trazodone is very rarely associated with priapism.This can be corrected by intracavernous injection of an alpha-adrenergic agent such as epinephrine or metaraminol. However, there have been reports of trazodone-induced priapism that required surgery or resulted in permanent sexual dysfunction. Patients who develop this suspected adverse reaction should stop taking trazodone immediately.

Influence on urinalysis results

When using immunoassays to control drugs in urine, the reactivity of the trazodone metabolite meta-chlorophenylpiperazine (m-CPP), which is structurally similar to methylenedioxymethamphetamine (MDMA, ecstasy), can cause a false positive reaction to amphetamine.In these cases, a confirmatory analysis using mass spectrometry is recommended.

Influence on the ability to drive vehicles and use mechanisms

Trazodone has little or no effect on the ability to drive vehicles or mechanisms. The patient should be warned about the risk when driving or operating machinery until he is sure that he is not experiencing drowsiness, lethargy, dizziness, confusion or blurred vision.

Trittico instructions for use, price in pharmacies in Ukraine, analogues, composition, indications | Trittico by 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 5-HT antagonist 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. T _½ is about 12 hours, and AUC is 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 your doctor. 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 the period of 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 have less cardiotoxicity 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 of 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 thinking before starting therapy have a higher risk of developing suicidal thoughts or suicidal attempts, therefore, during treatment, they must be closely monitored.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 a 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 for 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 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 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 dysfunctions, especially severe;

• heart disease 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 have been reported with the development of serotonin 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 appear.

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.

There is no indication that trazodone hydrochloride is addictive.

During the use of trazodone, very rare cases of prolongation of the interval Q – T were reported – an effect characteristic of other antidepressants. It is necessary to use trazodone with caution simultaneously with drugs with a known ability to prolong 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 information.

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 used in 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 the concentration of trazodone in the blood plasma. 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 norepinephrine reuptake inhibitor and does not affect the blood pressure response to tyramine therapy; therefore, 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 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, prolongation of the interval Q – T , 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 case of a decrease in the number of GCS points, the oxygen saturation of the blood should be monitored.

Cardiac monitoring is necessary in symptomatic patients.

Treatment is not 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, IV phenytoin may be appropriate.If necessary, the patient should be given oxygen and corrected 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 drugs, such as dopamine or dobutamine, should be evaluated.

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

Date Added: 08.04.2021

Trazodone (Trittico)

Pharmacological action
Antidepressant, 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; it has little effect on the neuronal seizure of norepinephrine and dopamine.
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 in patients with 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.

Pharmacokinetics
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.

Dosage
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.

Drug interaction
A case of the development of arrhythmia of the “pirouette” type with the simultaneous use of trazodone with amiodarone is described.
A case of a moderately pronounced decrease in the anticoagulant effect of warfarin while being used with trazodone is described.
With simultaneous use, it is possible to increase the concentration of digoxin in the blood plasma and develop symptoms of intoxication.
With simultaneous use with carbamazepine, a case of an increase in the concentration of carbamazepine in the blood plasma has been described.
With simultaneous use with lithium salts, tremors are possible, reversible symptoms of neurotoxic action.
When taking pseudoephedrine against the background of trazodone therapy, a case of the development of anxiety, panic, darkening of consciousness, depersonalization was described.
With simultaneous use with thioridazine, an increase in the concentration of trazodone in blood plasma is possible; with tryptophan – a case of the development of anorexia, psychosis, hypomania is described; with phenytoin – a case of increased side effects of phenytoin has been described; with fluoxetine – side effects may increase; with chlorpromazine, trifluoperazine – the development of arterial hypotension is possible.
When used simultaneously with ethanol, the inhibitory effect on the central nervous system is enhanced.

Pregnancy and lactation
Use during pregnancy and lactation is contraindicated.

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

Indications
Various forms of depression (endogenous, psychotic, neurotic, somatogenic) incl. with severe anxiety, including at least 4 of the following: disturbances in sleep, appetite, psychomotor agitation or lethargy, decreased interest in the environment, decreased sexual activity, guilt, increased fatigue, slow thinking, decreased ability to concentrate, suicidal attempts / 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
Use with caution in heart disease, arterial hypotension, arterial hypertension, renal and / or hepatic failure, in children and adolescents under the age of 18 years.
Should not be used concomitantly with MAO inhibitors.

Application for impaired renal function
Use with caution in renal failure.

Application for impaired liver function
Use with caution in liver failure.

Overdose
Most often with an overdose, drowsiness, dizziness and vomiting are noted. In case of acute overdose, it is necessary to immediately artificially induce vomiting or gastric lavage.At the same time, symptomatic treatment and therapy are carried out under the supervision of a physician, while maintaining an adequate fluid balance.

Terms of dispensing from pharmacies
The drug is dispensed with a prescription.

Trittico tab prol / action 150 mg No. 20 【Internet Pharmacy】 AGP

Composition

active ingredient: trazodone hydrochloride

1 tablet contains 75 mg or 150 mg trazodone hydrochloride

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

Dosage form

Tablets of prolonged action.

Basic physical and chemical properties:

tablets 75 mg: oblong tablets from white to yellowish-white color, have two risks on both sides;

tablets 150 mg: oblong tablets from white to yellowish-white color, have two marks on both sides.

Pharmacological group

Antidepressants. ATX code N06A X05.

Pharmacological properties

Pharmacodynamics.

Trazodone is a triazolpyridine derivative. It 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 an 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 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 as its metabolites.

Indications

Depressive disorders with / without anxiety.

Contraindications

Hypersensitivity to the drug or to its components.

Alcohol intoxication and intoxication with hypnotics.

Acute myocardial infarction.

Interaction with other medicinal products and other types of interactions.

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, 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 a day, the level of trazodone in blood plasma more than doubled, resulting in nausea, fainting and arterial hypotension.In this regard, when trazodone is used simultaneously with a potent CYP3A4 inhibitor, it is 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 interaction, 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; therefore, 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. In patients undergoing such therapy, serum levels of the aforementioned agents should be monitored.

Application features

Application for 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 thinking before starting therapy have a higher risk of developing suicidal thoughts or suicidal attempts, therefore, they need careful supervision during treatment. 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 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 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 increased or decreased sharply;

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.

Concomitant use with other serotonergic drugs, such as other antidepressants (eg tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors and MAO inhibitors) and neuroleptics, serotonin drug interactions with the development of a malignant syndrome have been reported neuroleptic 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. For more information, see the sections “Interaction with other medicinal products and other forms of interaction” and “Adverse reactions”.

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.

Very rare cases of prolongation of the QT interval, an effect characteristic of other antidepressants, have been reported against the background of the use of trazodone. 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 lengthening 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. For more information, see the section “Interaction with other medicinal products and other forms of interaction”.

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.

Use during pregnancy and lactation

pregnancy

Data from 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, 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 infant should be monitored after birth to detect 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.

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.

Method of administration and dosage

The drug should be used only for adults.

Therapy should begin with evening appointments 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 course 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 doses greater than 300 mg / day.

Children

Do not use in children.

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 hour 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 the case of a decrease in the number of points on the GCS scale, blood oxygen saturation should be monitored.

In symptomatic patients, cardiac monitoring is necessary.

When a separate 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 or shortly after trazodone therapy.

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

Syndrome

4 9005

73 9000

Liver dysfunction (including jaundice and hepatocellular lesions) 5, intrahepatic cholestasis

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

2 See also section “Peculiarities of use”

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

4 Trazodone has been shown to have less cardiotoxicity 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 pre-existing 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 section “Peculiarities of application”

Shelf life

3 years.

Storage conditions

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

Package

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

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

Vacation category

Prescription.

TRITTICO 0.15 N20 TABLE PROLONG RELEASE

mental disorders

suicidal behavior2, confusion, insomnia, disorientation, mania, anxiety, nervousness, agitation (very rarely aggravated to bouts of delirium), delirium, aggressive reaction, hallucinations, nightmares, decreased libido, withdrawal syndrome

Trittico retard tablets 150mg No. 20

Trittico retard instruction

Trittico retard instructions for use
medicinal product for medical use
Trittico retard tablets 150mg No. 20

Trittico tablets 150 mg

Latin name Trittico retard

TRITTICO

Dosage form Trittico retard

Controlled release tablets

Composition of Trittico retard

1 tablet, controlled release 150 mg hydrochloride.
Excipients: sucrose, carnauba wax, povidone (polyvinylpyrrolidone), magnesium stearate.

Packing Trittico retard

There are 10 tablets in a blister. In a pack of cardboard 2 blisters.

Pharmacological action Trittico retard

Trittico is an antidepressant. Trazodone, being a triazolopyridine derivative, has a predominantly antidepressant effect, with some sedative and anxiolytic effects. Trazodone has no effect on MAO, which distinguishes it from MAO inhibitors, tricyclic antidepressants.The mechanism of action of trazodone is associated with the high affinity of the drug for some subtypes of serotonin receptors, with which trazodone enters into antagonistic or agonistic interactions, depending on the subtype, as well as with the specific ability to cause inhibition of serotonin reuptake.
Quickly affects mental (affective tension, irritability, fear, insomnia) and somatic symptoms of anxiety (palpitations, headache, muscle pain, increased urination, sweating, hyperventilation).Trazodone is effective for sleep disorders in patients with depression, increases the depth and duration of sleep, restores its physiological structure and quality. Trittico stabilizes the emotional state, improves mood, reduces the pathological craving for alcohol in patients suffering from chronic alcoholism during the period of alcohol withdrawal syndrome, also in remission. With withdrawal symptoms in patients with dependence on benzodiazepine derivatives, trazodone is effective in the treatment of anxiety-depressive states and sleep disorders.During remission, benzodiazepines can be completely replaced with trazodone. Promotes the restoration of libido and potency, both in patients with depression and in persons without depression. The drug is not addictive. It has little effect on the neutral uptake of norepinephrine and dopamine. Does not affect body weight.

Indications Trittico retard

– Anxiety-depressive states of endogenous nature (including involutional depressions).
– Psychogenic depression (including reactive and neurotic depression).
– Anxiety-depressive states against the background of organic diseases of the central nervous system (dementia, Alzheimer’s disease, cerebral atherosclerosis).
– Depressive states with prolonged pain syndrome.
– Alcoholic depression.
– Benzodiazepine dependence.
– Disorders of libido and potency.

Contraindications Trittico retard

– Pregnancy.
– Lactation period.
– Children under 6 years old.
– Hypersensitivity to drug components.
The drug should be prescribed with caution to patients with:
– AV block.
– Myocardial infarction (early recovery period).
– Arterial hypertension (dose adjustment of antihypertensive drugs may be required).
– Ventricular arrhythmia.
– History of priapism.
– Renal and / or hepatic failure.
– As well as for patients under the age of 18.

Application during pregnancy and lactation Trittico retard

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

Dosage and administration Trittico retard

The drug is taken orally 30 minutes before meals or 2-4 hours after meals. The prescribed dose of the tablet should be taken whole, without chewing and drinking plenty of water.
Adults are prescribed at an initial dose of 100 mg 1 time / day after meals at bedtime. On the 4th day, the dose can be increased to 150 mg. In the future, in order to achieve the optimal therapeutic effect, the dose is increased by 50 mg / day every 3-4 days until the optimal dose is reached.A daily dose of more than 150 mg should be divided into 2 doses, with the lower dose taken in the afternoon, and the main dose at bedtime. The maximum daily dose for outpatients is 450 mg. The maximum daily dose for inpatients is 600 mg.
In the treatment of libido disorders the recommended daily dose is 50 mg.
In the treatment of impotence , in the case of monotherapy with the drug, the recommended daily dose is more than 200 mg, with combined therapy – 50 mg.
In the treatment of benzodiazepine dependence , the recommended treatment regimen is based on a gradual, sometimes over several months, dose reduction of the benzodiazepine.Each time, reducing the dose of benzodiazepine by 1/4 or 1/2 tablet, 50 mg of trazodone is added at the same time. This ratio is left unchanged for 3 weeks, then a further gradual decrease in the dose of benzodiazepines is started until they are completely canceled. Thereafter, the daily dose of trazodone is reduced by 50 mg every 3 weeks.
For elderly and debilitated patients the initial dose is up to 100 mg / day in divided doses or 1 time / day before 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.
Children aged 6-18 years: initial daily dose of 1.5-2 mg / kg / day, divided into several doses. If necessary, the dose is gradually increased to 6 mg / kg / day with an interval of 3-4 days.

Side effects Trittico retard

From the side of the central nervous system and peripheral nervous system: increased fatigue, drowsiness, agitation, headache, dizziness, weakness, myalgia, discoordination, paresthesia, disorientation, tremor.
On the part of the cardiovascular system: decrease in blood pressure, orthostatic hypotension (especially in persons with vasomotor lability) is due to the adrenolytic effect of the drug, arrhythmia, conduction disturbances, bradycardia, leukopenia and neutropenia (usually minor).
From the digestive system: dry and bitter mouth, nausea, vomiting, diarrhea, loss of appetite.
Other: allergic reactions, eye irritation, priapism (patients who experience this side effect should immediately stop taking the drug and consult a doctor).

Special instructions Trittico retard

Since the drug has some adrenolytic activity, bradycardia and a decrease in blood pressure may develop. Therefore, the drug should be prescribed with caution to patients with impaired cardiac conduction, AV block of varying severity, patients with recent myocardial infarction. With the use of trazodone, a slight decrease in the number of leukocytes is possible, which does not require specific treatment, except in cases of severe leukopenia.Therefore, during the period of treatment, it is recommended to conduct studies of peripheral blood, especially in the presence of sore throat when swallowing and the appearance of fever. The drug does not have an anticholinergic effect, therefore it can be prescribed to elderly patients suffering from prostatic hypertrophy, angle-closure glaucoma, and impaired cognitive functions.
If prolonged and inadequate erections appear, the patient should consult a doctor. During the period of treatment, the patient should refrain from drinking alcohol.
Use in pediatrics: There have been no relevant studies on the effectiveness of the drug in pediatrics, so the drug should be used with caution in children and adolescents under the age of 18 years. Doses for children under 6 years of age have not been established.
Influence on the ability to drive vehicles and control mechanisms: since the drug has anxiolytic and sedative activity, the ability to concentrate and the speed of psychomotor reactions may decrease.During treatment, the patient should avoid engaging in potentially hazardous activities, incl. driving vehicles and controlling mechanisms.

Interaction Trittico retard

Trazodone may enhance the effect of some antihypertensive drugs and usually requires a reduction in their doses. Simultaneous administration with drugs that depress the central nervous system (including clonidine, methyldopa) enhances the effect of the latter. Antihistamines and drugs with anticholinergic activity enhance the anticholinergic effect of trazodone.

Overdose of Trittico retard

Symptoms: nausea, drowsiness, arterial hypotension, increased frequency and severity of side effects.
Treatment: there is no specific antidote for the drug. In cases of overdose, symptomatic treatment is carried out (including gastric lavage, forced diuresis).

Storage conditions Trittico retard

Store at a temperature not exceeding 25 ° C

Shelf life Trittico retard

3 years.

Trittico retard

Trittico retard is a good choice.
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