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Quetiapine 50 mg side effects: Quetiapine: MedlinePlus Drug Information

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Quetiapine: MedlinePlus Drug Information

Important warning for older adults with dementia:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as quetiapine have an increased risk of death during treatment.

Quetiapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavioral problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking quetiapine. For more information visit the FDA website: http://www.fda.gov/Drugs

Important warning for people who have depression:

A small number of children, teenagers, and young adults (up to 24 years of age) who took medications for depression during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 10 years of age should not normally take quetiapine, but in some cases, a doctor may decide that quetiapine is the best medication to treat a child’s condition.

You should know that your mental health may change in unexpected ways when you take quetiapine or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking quetiapine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with quetiapine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

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

See also Warning section.

Constipation, drowsiness, upset stomach, tiredness, weight gain, blurred vision, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor promptly.

Dizziness or lightheadedness may occur, especially when you first start or increase your dose of this drug. Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

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

Tell your doctor right away if you have any serious side effects, including: restlessness/constant need to move, shakiness (tremor), mental/mood changes (such as increased anxiety, depression, thoughts of suicide), difficulty swallowing, constipation with persistent abdominal pain, persistent nausea/vomiting, loss of appetite, yellowing eyes/skin, interrupted breathing during sleep, trouble urinating.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, severe dizziness.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

Quetiapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms or legs).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

Quetiapine may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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

In the US –

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

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

Common and Rare Side Effects for quetiapine oral

COMMON side effects

If experienced, these tend to have a Severe expression i

Sorry, we have no data available. Please contact your doctor or pharmacist.

If experienced, these tend to have a Less Severe expression i

  • orthostatic hypotension, a form of low blood pressure
  • throat irritation
  • dry mouth
  • indigestion
  • constipation
  • drowsiness
  • dizziness
  • difficulty sleeping
  • weight gain
  • headache
  • low energy and weakness
  • generalized weakness

INFREQUENT side effects

If experienced, these tend to have a Severe expression i

  • low levels of white blood cells
  • suicidal thoughts
  • a type of movement disorder called parkinsonism
  • low blood pressure
  • a feeling of restlessness with inability to sit still
  • a skin rash
  • a type of speech disorder called dysarthria
  • trouble breathing
  • high blood sugar
  • abnormal liver function tests
  • a high alanine transaminase level
  • a high aspartate transaminase level

If experienced, these tend to have a Less Severe expression i

  • a high prolactin level
  • high cholesterol
  • high amount of triglyceride in the blood
  • agitation
  • lazy eye
  • a change in vision
  • a stuffy and runny nose
  • stuffy nose
  • inflammation of the lining of the stomach and intestines
  • an abnormal increase in muscle tone
  • flu-like symptoms
  • excessive sweating
  • pain
  • muscle tremors
  • decreased appetite
  • increased hunger
  • heart throbbing or pounding
  • cough
  • vomiting
  • restless legs syndrome, an extreme discomfort in the calf muscles when sitting or lying down
  • intense abdominal pain
  • abnormal dreams
  • fast heartbeat

RARE side effects

If experienced, these tend to have a Severe expression i

  • a condition with low thyroid hormone levels
  • a complication of diabetes with high blood ketone levels called diabetic ketoacidosis
  • diabetes
  • a disorder with excess antidiuretic hormone called syndrome of inappropriate antidiuretic hormone
  • low amount of sodium in the blood
  • decreased blood platelets
  • very low levels of granulocytes, a type of white blood cell
  • low levels of a type of white blood cell called neutrophils
  • increased eosinophils in the blood
  • depression
  • tardive dyskinesia, a disorder characterized by involuntary movements of the face, mouth and tongue
  • extrapyramidal disease, a type of movement disorder
  • neuroleptic malignant syndrome, a reaction characterized by fever, muscle rigidity and confusion
  • clouding of the lens of the eye called cataracts
  • cardiomyopathy, a disease of the heart muscle
  • slow heartbeat
  • prolonged QT interval on EKG
  • inflammation of the middle tissue heart muscle
  • a stroke
  • cerebral ischemia, a lack of blood supply to the brain
  • thrombotic thrombocytopenic purpura, a type of blood disorder
  • blocked bowels with decreased peristaltic movement
  • blockage of the stomach or intestine
  • liver tissue death
  • liver failure
  • inflammation of the liver called hepatitis
  • priapism, a prolonged erection of the penis
  • breastmilk production not associated with childbirth or nursing
  • a problem with menstrual periods
  • a skin disorder with blistering and peeling skin called toxic epidermal necrolysis
  • a skin disorder with blistering and peeling skin called Stevens-Johnson syndrome
  • a condition with muscle tissue breakdown called rhabdomyolysis
  • muscle pain
  • seizures
  • sleep apnea
  • fluid retention in the legs, feet, arms or hands
  • an inability to completely empty the bladder
  • low body temperature
  • a significant type of allergic reaction called anaphylaxis
  • accidental falls
  • problems with food passing through the esophagus
  • pancreatitis
  • a type of skin disorder called acute generalized exanthematous pustulosis
  • a type of significant allergic skin reaction called DRESS syndrome

If experienced, these tend to have a Less Severe expression i

  • nightmares
  • widening of blood vessels
  • memory loss
  • fainting
  • fever
  • difficulty swallowing
  • bedwetting
  • abnormal muscle movements

Effectiveness, Ease of Use, and Satisfaction

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Effectiveness

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57 People found this comment helpful

Previously I had been treated with very limited success with: Lithium, Depacote, Triliptal, Risperdal, Lamictal, zoloft, Wellbutrin, Abilify, clonsepam, zypreza etc. My exsistance was unbearable. I went to a clinic and was taken off all the above. I spent three weeks rapid cycling with psychotic features and devestating depressions and suicidality. Within a week of starting Seroquel my sympto…

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to early to tell

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Condition: Bipolar Depression EffectivenessEase of UseSatisfaction

I started quetipine about 6 months ago it really helped me with my mood staying stable and my panic attacks. This medication dosnt make me feel like a shell of a person which has been a struggle with previous medications. I’m just over all much happier and can appreciate the little things again.

1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Schizophrenia EffectivenessEase of UseSatisfaction 1 ShapeCreated with Sketch. thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar I Disorder with Most Recent Episode Mixed EffectivenessEase of UseSatisfaction 1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar Depression EffectivenessEase of UseSatisfaction

I’m not to sure we’re to start I have been on q for about 5 years now and I hope it’s not just me that wakes up with really bad munchies, I went to bed the other night and woke up with chocolate next to my bed. it makes me so tired and I just eat. I was eating the other night falling asleep and my partner had to wake me so I didn’t choke lol. well all jokes aside I do really find this effective as I said I’ve been on this for 5 years I’ve had other medications in the past and quituipuine just sits right with me but I know we are not all the same. Read More Read Less

1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Other EffectivenessEase of UseSatisfaction 1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Schizophrenia EffectivenessEase of UseSatisfactionShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Manic-Depression EffectivenessEase of UseSatisfaction

Do not take this medication, especially if you have history of concussion associated bipolar – it will not work and create more problems than necessary. Read health literature, holistic medicine and balance your mood naturally instead.

ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar Depression EffectivenessEase of UseSatisfaction

I just started taking this and have noticed it has made me very aggressive. Idk if I’ll stay on it.

1 ShapeCreated with Sketch. 2 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Schizophrenia EffectivenessEase of UseSatisfaction

Been on it 2 years. Only helps me sleep. Nothing Else. Dont do it

1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Manic-Depression EffectivenessEase of UseSatisfaction

Start with 50 for 4 days and 100 6 days and slow increases. Go very slow. If you can not Get out of bed reduce a little. I stopped using doctors for mental health 30 years ago. At 71 I feel very good.

1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Repeated Episodes of Anxiety EffectivenessEase of UseSatisfaction

Took it for 3 weeks. Gained 15 lbs and aside from being sleepy, it did not help my anxiety at all.

2 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Manic-Depression EffectivenessEase of UseSatisfaction

Had Q x3 in 6 mo,1st ok until hives facial & joint swell at 4wks.Stopped Q tried other antipsy in 2mo,Q sensitized me to others,no luck. March restarted Q as desperate 2nd reaction face swelled,body hives.NOW,had a breakdown psych wouldnt give me anything new,got ref to senior psych,unmed for 2mo He convinced me to take both Q&lamotrigine(also sensitive to)thru desperation agreed,called them cure to severe dep&mood dis. Started at 25mg for wk 50mg after,NO improvement on mood previous good results in days on this dose,im WORSE angry,low,anxious,in bed crying.Foggy head cant do any tasks no convos.weight gain even though I cant eat so bloated I look preg.Hives needed steroids,Feet were wwollen couldnt walk Water retention on thighs,acid reflux x4 a day presc antihis. because of Q too dont help at all. 3days ago He took away only lamo&told wait a week!I cant live this way,stop todayRead More Read Less

ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar Depression EffectivenessEase of UseSatisfaction

Iâ??ve been on this for a year it started out helping me sleep and more relaxed but I had to get off it l was extremely tired and Ins fog didnâ??t want to go anywhere and I found I was having breathing problems like I couldnâ??t get enough air and extremely thirsty and was told it was drying my lungs out now I feel better

2 ShapeCreated with Sketch. thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar Depression EffectivenessEase of UseSatisfaction

This drug worked decent for about a year, but then for some reason just kind of fizzled out. It also gave me maddening RLS (Restless Leg Syndrome), which kept me awake most of the night, leaving me excruciatingly tired and stressed out every morning.

8 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Schizophrenia EffectivenessEase of UseSatisfaction

I have been on this medication for just over 1 month. It has reduced my feeling of paranoia a great deal. The arguing between the voices in my head has begun to get less and less. The voices are fading. They are now longer dominate.

1 ShapeCreated with Sketch. thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Repeated Episodes of Anxiety EffectivenessEase of UseSatisfaction

I have been on this medication for just over 1 month. It has greatly reduced my anxiety and panic attacks. It has helped me a great deal.

2 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar Depression EffectivenessEase of UseSatisfaction

I’ve been on this for 5 days now and all I want to do is sleep. Have a difficult time getting out of bed in the morning. I don’t feel depressed but I’m still agitated with everything. I feel like I’m in a fog and cant think clearly. I started out with 50mg until last night and now I’m on 100mg. Still feel groggy and I’ve noticed that I can’t talk without stumbling. I think I’m going to call my doctor and request a different drug. I just don’t feel right on this. Have a dry mouth and throat, tired, head fog, agitated feeling, dizzy and just overall not feeling well. In the past the drugs that worked the best didn’t make me feel like this at all. They worked great from the start but eventually stopped working which is why I’m on this one. Need a replacement. Read More Read Less

13 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Bipolar Disorder in Remission EffectivenessEase of UseSatisfaction

I’ve been on this drug for 10 yrs.. not a good experience I had scary side effects orthostatic hypotension.. and passing out.. rapid heart rate. But it did help in ways and helped me sleep .

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I have borderline personality disorder with complex ptsd, depression & gad. A couple of years ago I started taking this in addition to venaflaxine & it’s had a massive positive on my mood & anxiety. I feel so much calmer & can think more clearly, I don’t kno what I’d do without it now

2 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Additional Medications to Treat Depression EffectivenessEase of UseSatisfaction

I was put on this for non-bipolar depression. It made me very angry, full of rage, and plain mean beyond irritable. This was not environmentally induced, for I seldom interacted with others because of the extent of my depression.

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Side Effects of Seroquel (Quetiapine Fumarate), Warnings, Uses

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Basics, Side Effects & Reviews

Higher risk of death and stroke

  • Risk factors: Older adults with dementia-related psychosis

Older adults with dementia-related psychosis have a higher risk of death or having a stroke when treated with antipsychotic medications. Quetiapine (Seroquel) is not approved to treat dementia-related psychosis.

Suicidal thoughts or behaviors

  • Risk factors: Age 24 or younger | Use of antidepressant medications

Quetiapine (Seroquel)may raise your risk for suicidal thoughts or behaviors. Watch for worsening depression or any unusual changes in your mood or behavior, especially during the first few months of treatment or when the dose changes. Report anything concerning to your provider right away.

Serious brain and nerves reactions

Quetiapine (Seroquel) can sometimes cause high fever, muscle stiffness, confusion, sweating, and changes in pulse, heart rate, and blood pressure. This only happens in rare cases, however these symptoms can be life-threatening. If you notice any of these symptoms, get medical help right away.

Uncontrollable body movements

  • Risk factors: Older adults | Long-term use | Large doses

Quetiapine (Seroquel) can cause uncontrollable movements involving your face, tongue, and other body parts. Symptoms include shaking, muscle stiffness, or feeling like you can’t sit still. Tell your provider right away if you notice any unusual movements or restlessness since it can be hard to get rid of.

Weight gain and increased levels of blood sugar and cholesterol

  • Risk factors: Diabetes | High cholesterol | Family history of diabetes | Obesity

Quetiapine (Seroquel) can raise your blood sugar and cholesterol levels and increase your appetite, all of which can lead to weight gain. Blood tests may be done regularly by your provider to make sure that your blood sugar and cholesterol are not too high.

Low white blood cell count

  • Risk factors: History of low white blood cell count

Quetiapine (Seroquel) can lower the amount of white blood cells in your body. White blood cells help your body to fight off infections and diseases. If you notice a fever or that you’re getting sick more easily, let your provider know right away. Blood tests may be done before you start quetiapine (Seroquel) and during the first few months of being on this medication to make sure that you have a healthy amount of white blood cells.

Poor mental alertness

Quetiapine (Seroquel) weakens your ability to focus, think, and react. Be careful and avoid activities that require you to be alert, such as driving a car or operating machinery, until you know how this medication affects you.

Seizures

  • Risk factors: History of seizures | Health conditions that make it easier to get seizures

Quetiapine (Seroquel) can make you more likely to have seizures. Before starting this medication, let your provider know if you have a history of seizures or have a medical condition that puts you at risk for getting seizures.

Changes in blood pressure

  • Risk factors: History of heart disease or stroke | Dehydration | Taking medications for high blood pressure

Quetiapine (Seroquel) can cause a sudden drop in blood pressure. Dizziness and falls can happen due to a sudden drop in blood pressure when you change positions, such as going from sitting to standing. If you’re sensitive to low blood pressure, change position slowly until your body is used to the medication. In some cases, quetiapine (Seroquel) may raise the blood pressure in children (age 10 to 17). It’s recommended to monitor the blood pressure in children at the start of treatment and occasionally throughout treatment.

Eye problems

  • Risk factors: Long-term use

In some rare cases, quetiapine (Seroquel) can cause changes to your vision. Regular eye exam is recommended to rule out any serious eye damage or disease.

Trouble controlling body temperature

Quetiapine (Seroquel) can make it harder for your body to cool down once the body temperature gets high. Don’t exercise too hard, stay out of the sun, and drink lots of water to avoid getting dehydrated.

Difficulty swallowing

  • Risk factors: Older adults with Alzheimer’s dementia

Quetiapine (Seroquel) can sometimes make it hard for you to swallow food or liquids. This can be dangerous if food or liquids get into your lungs, because it can cause issues with your breathing. Make sure to chew your food completely and swallow carefully if you notice tightening of your throat or neck area.

Long-lasting painful erection

Quetiapine (Seroquel) can cause painful erection that lasts for a long time. In severe and rare cases, surgery may be required to correct this problem. If you have an erection that isn’t going away, get medical help right away.

Irregular heartbeat

  • Risk factors: History of heart problems | Taking medications for irregular heartbeat | Older adults

Quetiapine (Seroquel) can cause irregular heartbeat. If you have a heart condition or have a history of heart disease, let your provider know before starting this medication.

Low thyroid and high prolactin levels

Quetiapine (Seroquel) can cause thyroid blood levels to go down and prolactin blood levels to go up. Symptoms of low thyroid include tiredness, weight gain, gets cold easily, and brittle nails. High prolactin levels can lead to fertility problems, enlarged male breasts, sexual dysfunction, absence or irregular menstrual periods, and weak bones. Your provider may do regular blood tests to make sure that these levels are within normal range.

Withdrawal

  • Risk factors: Sudden discontinuation of medication

Don’t stop taking quetiapine (Seroquel) all of a sudden, because this can lead to withdrawal symptoms such as trouble sleeping, nausea, and vomiting. Your provider will slowly lower your dose to avoid withdrawal effects.

Muscle contraction problems

Quetiapine (Seroquel) can prevent certain muscles (even the ones that you don’t actively move like muscles in the bladder or intestine) from contracting. This can be troublesome for people who have urination, constipation, or prostate problems. Talk to your provider if you already have these problems before starting quetiapine (Seroquel).

Risk to baby during and after delivery

More research is needed on whether quetiapine (Seroquel) affects an unborn baby during pregnancy. There is some evidence that taking quetiapine (Seroquel) during the third trimester may increase the risk for withdrawal symptoms in newborns after delivery. If you are pregnant, or thinking about becoming pregnant, talk to your healthcare provider about the risks and benefits of taking quetiapine (Seroquel).

Quetiapine. Also called Seroquel. Side effects and dosage

About quetiapine

Type of medicine An antipsychotic medicine
Used for Easing the symptoms of schizophrenia; mood disorders associated with bipolar disorder
Also called Seroquel®; Atrolak® XL; Biquelle® XL; Brancico® XL; Mintreleq® XL; Seroquel® XL; Sondate® XL; Zaluron® XL
Available as Standard-release tablets, prolonged-release tablets and oral liquid medicine

Quetiapine belongs to a group of medicines called antipsychotics. It may have been prescribed for you to relieve the symptoms of schizophrenia or, alternatively, for a mood disorder such as mania or depression. In all of these conditions, quetiapine works on the balance of chemical substances in your brain.

Quetiapine is available as standard-release tablets (which are generally taken twice daily) and also as modified-release tablets (which are taken once daily). Modified-release tablets have the letters ‘XL’ after the brand name – these release quetiapine more slowly and evenly throughout the course of the day.

Before taking quetiapine

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking quetiapine it is important that your doctor knows:

  • If you are pregnant or breastfeeding.
  • If you have a heart condition or blood vessel disease.
  • If you have had a stroke, or if you have been told you have ‘thickening’ of the blood vessels to your brain.
  • If you have liver, kidney, or prostate problems.
  • If you have any problems with your breathing, or if you have any difficulties swallowing.
  • If you have breathing difficulties whilst sleeping (sleep apnoea).
  • If you have any of the following: epilepsy, Parkinson’s disease, raised pressure in your eye (glaucoma) or a condition which causes muscle weakness, called myasthenia gravis.
  • If you have ever had yellowing of your skin or of the whites of your eyes (jaundice) or a blood disorder.
  • If you have a tumour on your adrenal gland (a condition called phaeochromocytoma).
  • If you have had problems with alcohol or drug abuse.
  • If you have had an allergic reaction to a medicine.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines. 

How to take quetiapine

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about quetiapine and it will also provide you with a full list of the side-effects which you may experience from taking it.
  • Take quetiapine exactly as your doctor tells you to. It is taken once or twice a day depending upon the type of tablet prescribed. There are several different strengths of tablet available so your doctor will prescribe a dose to suit your condition. The directions for taking the tablets will be printed on the label of the pack to remind you about what the doctor said to you.
  • Try to get into the habit of taking your doses at the same times of day each day, as this will help you to remember to take them regularly. If you are taking quetiapine for depression, you should take your doses at bedtime.
  • Standard-release quetiapine tablets (these are usually taken twice daily) can be taken either before or after meals.
  • If you have been given prolonged-release tablets (these have the letters ‘XL’ after the brand name) you must swallow the tablet whole when your stomach is empty. This means that you should not chew or break the tablet before your swallow it, and that you should take each of your doses at least an hour before a meal, or wait until two hours afterwards.
  • If you have been given the oral liquid medicine, use the dosing syringe or cup to measure your dose accurately. The medicine can be taken either before or after meals.
  • Do not drink grapefruit juice while you are on quetiapine. This is because a chemical in grapefruit is likely to increase the amount of quetiapine in your bloodstream and make side-effects more likely.
  • If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose, in which case leave out the forgotten dose. Do not take two doses together to make up for a missed dose.

Getting the most from your treatment

  • Your treatment will require careful monitoring to make sure that you get the best possible benefit from quetiapine. Keep your regular doctor’s appointments so that your progress can be checked. You will need to have some tests from time to time.
  • Quetiapine tablets come in different strengths and colours. If your dose is changed, your tablets may look different. If you are unsure about your tablets at any time, please ask your pharmacist for advice.
  • Treatment with quetiapine is usually long-term unless you experience an adverse effect. Keep taking the tablets unless your doctor tells you otherwise. Stopping quetiapine suddenly can cause problems so your doctor may want you to reduce your dose gradually if this becomes necessary.
  • If you drink alcohol, ask your doctor for advice. Alcohol increases the risk of side-effects from quetiapine so it is best avoided.
  • If you have diabetes you may need to check your blood glucose more frequently, as quetiapine may affect the levels of sugar in your blood. Your doctor will advise you about this.
  • Some medicines similar to quetiapine can cause the skin to become more sensitive to sunlight than normal. It may be advisable to use a sunscreen in bright sunlight until you know how your skin reacts.
  • If you are due to have any medical or dental treatment, tell the person carrying out the treatment which medicines you are taking. This is important because quetiapine may interfere with any anaesthetic you receive.
  • If you buy or take any ‘over-the-counter’ medicines or herbal remedies, please check with a pharmacist that they are suitable for you to take with quetiapine.
  • A small number of people taking medicines for mood disorders can have thoughts about harming themselves or ending their lives, particularly when a new medicine is started. It is very important that you tell your doctor about this if it happens to you.

Can quetiapine cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with quetiapine. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Very common quetiapine side-effects (these affect more than 1 in 10 people) What can I do if I experience this?
Changes to the results of some blood tests Your doctor will check for these
Headache Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know
Feeling dizzy or light-headed when you stand up This can happen particularly when you first start taking quetiapine. Getting up more slowly until you are aware of how you react should help
Feeling sleepy or drowsy Do not drive and do not use tools or machines. Avoid alcohol
Increased weight, dry mouth Speak with your pharmacist if troublesome
Feeling restless or shaky, unusual or uncontrollable muscle movements Speak with your doctor about any of these. Your treatment may need adjusting
Common quetiapine side-effects (these affect fewer than 1 in 10 people) What can I do if I experience this?
Indigestion, feeling sick (nausea) or being sick (vomiting) Stick to simple meals – avoid rich or spicy foods
Constipation Eat a well-balanced diet and drink several glasses of water each day
Blurred vision Do not drive and do not use tools or machines
Feeling tired, increased appetite, abnormal dreams, having a feeling that your heart is pounding (palpitations), feeling short of breath, swollen feet or ankles, feeling irritable If any of these become troublesome, speak with your doctor

Important: if you experience symptoms such as muscle stiffness, a very high temperature, feeling confused, a fast heartbeat and sweating, you should contact your doctor immediately. These can be signs of a rare but serious condition known as neuroleptic malignant syndrome.

If you experience any other symptoms which you think may be due to the tablets, please speak with your doctor or pharmacist for further advice.

How to store quetiapine

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.
  • The oral liquid medicine lasts for 28 days after first opening. It is a good idea to write on the label the date you opened the bottle.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Quetiapine instructions for use: indications, contraindications, side effects – description of Quetiapine tab., Cover. film coating, 200 mg: 30 pcs. (31481)

📜 Instructions for use Quetiapine

💊 Composition of the preparation Quetiapine

✅ Application of the drug Quetiapine

📅 Storage conditions Quetiapine

⏳ Shelf life Quetiapine

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Description of the medicinal product

Quetiapine
(Quetiapine)

Based on the officially approved instructions for use of the drug and prepared for the electronic edition of the Vidal handbook 2012, updated: 2012. 09.03

Marketing Authorization Holder:

Dosage forms

Quetiapine

Tab., cover film coating, 25 mg: 30 or 60 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Tab. , Coated film coating, 100 mg: 30 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Tab., Coated film coating, 150 mg: 30 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Tab., cover film coating, 200 mg: 30 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Release form, packaging and composition
Quetiapine drug

Film-coated tablets 1 tab.
quetiapine 200 mg

10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets 1 tab.
quetiapine 100 mg

10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets 1 tab.
quetiapine 150 mg

10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets 1 tab.
quetiapine 25 mg

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.

Pharmacological action

Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin (hydroxytryptamine) receptors (5HT 2 ) than for dopamine receptors D 1 and D 2 in the brain. Quetiapine also has a more pronounced affinity for histamine and alpha 1 -adrenergic receptors and less in relation to alpha 2 -adrenergic receptors. No noticeable affinity of quetiapine for muscarinic and benzodiazepine receptors was found. In standard tests, quetiapine exhibits antipsychotic activity.

Pharmacokinetics

When administered orally, quetiapine is well absorbed from the gastrointestinal tract and is actively metabolized in the liver.The main metabolites in plasma do not have pronounced pharmacological activity.

Food intake does not significantly affect the bioavailability of quetiapine. T 1/2 is about 7 hours. Approximately 83% of quetiapine binds to plasma proteins.

Pharmacokinetics of quetiapine is linear, there are no differences in pharmacokinetic parameters in men and women.

Average clearance of quetiapine in elderly patients is 30-50% less than in patients aged 18 to 65 years.

Average plasma clearance of quetiapine is approximately 25% less in patients with severe renal impairment (creatinine clearance less than 30 ml / min / 1.73 m 2 ) and in patients with liver damage, but interindividual clearance values ​​are within the range corresponding to healthy volunteers … Approximately 73% of quetiapine is excreted in the urine and 21% in the faeces. Less than 5% of quetiapine is not metabolized and is excreted unchanged by the kidneys or faeces. It has been established that CYP3A4 is a key isoenzyme of quetiapine metabolism mediated by cytochrome P450.

In a study of the pharmacokinetics of quetiapine at various doses, the use of quetiapine before taking ketoconazole or simultaneously with ketoconazole led to an increase, on average, C max and the area under the concentration-time curve (AUC) of quetiapine by 235% and 522%, respectively , as well as to a decrease in the clearance of quetiapine, on average, by 84%. T 1/2 quetiapine increased, but T max did not change.

Quetiapine and some of its metabolites exhibit weak inhibitory activity against cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6 and ZA4, but only at a concentration 10-50 times higher than the concentration observed at a commonly used effective dose of 300-450 mg / days

Based on in vitro results, concomitant use of quetiapine with other drugs should not be expected to result in clinically significant inhibition of cytochrome P450-mediated metabolism of other drugs.

Indications of the drug

Quetiapine

  • acute and chronic psychoses, including schizophrenia;
  • manic episodes in the structure of bipolar disorder.

Dosing regimen

Adults:

Acute and chronic psychoses, including schizophrenia

The daily dose for the first 4 days of therapy is: 1st day – 50 mg, 2nd day – 100 mg, 3rd day – 200 mg, 4th day – 300 mg. Starting from the 4th day, the dose should be adjusted to the clinically effective dose, which usually ranges from 300 to 450 mg / day.Depending on the clinical effect and individual tolerance, the dose can vary from 150 to 750 mg / day.

Treatment of manic episodes in the structure of bipolar disorder

Quetiapine is used as monotherapy or as adjuvant therapy to stabilize mood.

The daily dose for the first 4 days of therapy is: 1st day – 100 mg, 2nd day – 200 mg, 3rd day – 300 mg, 4th day – 400 mg. In the future, by the 6th day of therapy, the daily dose of the drug can be increased to 800 mg.The increase in the daily dose should not exceed 200 mg per day.

Depending on the clinical effect and individual tolerance, the dose can vary from 200 to 800 mg / day. The usual effective dose is 400 to 800 mg / day.

For the treatment of schizophrenia , the maximum recommended daily dose of quetiapine is 750 mg, for the treatment of manic episodes in the structure of bipolar disorder, the maximum recommended daily dose of quetiapine is 800 mg / day.

In elderly patients , the initial dose of quetiapine is 25 mg / day. The dose should be increased daily by 25-50 mg until an effective dose is reached, which is likely to be less than in younger patients.

In patients with renal or hepatic impairment , it is recommended to start quetiapine therapy with 25 mg / day. It is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.

Side effects

The most common adverse reactions associated with taking the drug: drowsiness (17.5%), dizziness (10%), constipation (9%), dyspepsia (6%), orthostatic hypotension and tachycardia (7%), dry mouth (7%), increased activity of “liver” enzymes in the blood serum (6 %), increased concentration of cholesterol and triglycerides in blood plasma.

Reception of quetiapine may be accompanied by the development of moderate asthenia, rhinitis and dyspepsia, an increase in body weight (mainly in the first weeks of treatment). Quetiapine can cause orthostatic hypotension (accompanied by dizziness), tachycardia and, in some patients, fainting; these adverse reactions mainly occur during the initial period of dose selection (see.section “Special instructions”). Quetiapine therapy is associated with a small dose-dependent decrease in the concentration of thyroid hormones, in particular, total T4 and free T4. The maximum decrease in total and free T4 was recorded at the 2nd and 4th week of quetiapine therapy, without further decrease in hormone concentration during long-term treatment. Subsequently, there were no signs of clinically significant changes in the concentration of thyroid-stimulating hormone.

With long-term use of quetiapine, there is a potential for the development of tardive dyskinesia.If symptoms of tardive dyskinesia occur, it is necessary to reduce the dose or stop further treatment with quetiapine. With abrupt withdrawal of high doses of antipsychotic drugs, the following acute reactions (“withdrawal” syndrome) may occur: nausea, vomiting, rarely insomnia.

Cases of exacerbation of psychotic symptoms and the appearance of involuntary movement disorders (akathisia, dystonia, dyskinesia) are possible. In this connection, the withdrawal of the drug is recommended to be carried out gradually.

Below are the side reactions observed with the use of quetiapine and distributed among organs and systems:

From the nervous system : drowsiness, dizziness, headache, anxiety, asthenia, hostility, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesias, neuroleptic malignant syndrome (hyperthermia, muscle rigidity, changes in mental status, lability of the autonomic nervous system, increased creatine phosphokinase activity), restless legs syndrome.

From the cardiovascular system: orthostatic hypotension, tachycardia, prolongation of the Q-T interval.

From the digestive system: dryness of the oral mucosa, nausea, vomiting, abdominal pain, diarrhea or constipation, increased activity of liver transaminases, jaundice, hepatitis.

Respiratory system: pharyngitis, rhinitis.

Allergic reactions: to a skin rash, eosinophilia, angioedema, Stevens-Johnson syndrome, anaphylactic reactions.

Laboratory indicators: leukopenia, neutropenia, hypercholesterolemia, hypertriglyceridemia, decreased T4 concentration (first 4 weeks), hyperglycemia.

Other: back pain, chest pain, subfebrile condition, weight gain (mainly in the first weeks of treatment), myalgia, dry skin, visual impairment, incl. blurred vision, decompensation of existing diabetes mellitus, priapism, galactorrhea.

Contraindications to use

  • hypersensitivity to any component of the drug;
  • concomitant use with CYP3A4 inhibitors such as HIV protease inhibitors, azole antifungal drugs, erythromycin, clarithromycin, nefazodone;
  • children under 18 years old;
  • lactation period.

Use with caution in patients with cardiovascular and cerebrovascular diseases or other conditions predisposing to arterial hypotension; in old age; with liver failure; history of seizures; pregnancy.

Application during pregnancy and lactation

Use with caution during pregnancy.Contraindicated during lactation.

Application for violations of liver function

In patients with hepatic impairment , it is recommended to start quetiapine therapy with 25 mg / day. It is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.

Application for impaired renal function

In patients with renal impairment , it is recommended to start quetiapine therapy with 25 mg / day.It is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.

Use in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

In elderly patients , the initial dose of quetiapine is 25 mg / day.The dose should be increased daily by 25-50 mg until an effective dose is reached, which is likely to be less than in younger patients.

Special instructions

Quetiapine can cause orthostatic hypotension, especially in the initial period of dose selection (in older patients it is more common than in young people). There was no relationship between the intake of quetiapine and an increase in QT from the interval.However, when using quetiapine simultaneously with drugs that prolong the QT interval from , caution must be exercised, especially in the elderly. During the period of treatment, with a decrease in the number of neutrophils less than 1000 / μl, quetiapine should be discontinued.

With the development of orthostatic hypotension during treatment with the drug, it is necessary to reduce the dose or more slowly titrate the doses. The drug is not indicated for the treatment of psychoses associated with dementia. In the case of the development of symptoms of tardive dyskinesia, the dose of the drug should be reduced or the drug should be gradually withdrawn.The symptoms of tardive dyskinesia may worsen or even appear after the drug is stopped.

In case of development of neuroleptic malignant syndrome, the drug must be canceled.

Considering that quetiapine mainly affects the central nervous system, the drug should be used with caution in combination with other drugs that depress the central nervous system, or alcohol. In children, adolescents and young people (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior.Therefore, when prescribing Quetiapine or any other antidepressants in children, adolescents and young people (under 24 years of age), the risk of suicide and the benefits of their use should be correlated. In short-term studies, the risk of suicide was not increased in people over 24 years old, and in people over 65 years old, it decreased slightly. Any depressive disorder in itself increases the risk of suicide. Therefore, during antidepressant treatment, all patients should be monitored for early detection of behavioral disturbances or changes, as well as suicidal tendencies.

Influence on the ability to drive vehicles and mechanisms

Quetiapine can cause drowsiness, therefore, during the period of treatment, patients are advised to refrain from driving vehicles and engaging in activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Data on overdose of quetiapine are limited.Cases of taking quetiapine in a dose exceeding 20 g without fatal consequences and with full recovery have been described, however, there are reports of extremely rare cases of overdose of quetiapine, leading to death or coma.

Symptoms may result from increased known pharmacological effects of the drug, such as drowsiness and excessive sedation, tachycardia and decreased blood pressure.

Treatment: no specific antidotes to quetiapine. In cases of overdose, gastric lavage is possible (after intubation, if the patient is unconscious), intake of activated charcoal and laxatives to remove unabsorbed quetiapine, however, the effectiveness of these measures has not been studied.Symptomatic therapy and measures aimed at maintaining respiratory function, cardiovascular system, ensuring adequate oxygenation and ventilation are shown. Medical control and observation should be continued until the patient is fully recovered.

Drug interactions

With the simultaneous use of drugs that have a powerful inhibitory effect on the CYP3A4 isoenzyme (such as antifungal agents of the azole group and erythromycin, clarithromycin, nefazodone), the plasma concentration of quetiapine increases, therefore, their simultaneous administration with quetiapine is contraindicated.With the simultaneous use of quetiapine with drugs that induce the liver enzyme system, such as carbamazepine, it is possible to reduce the concentration of the drug in the plasma, which may require an increase in the dose of quetiapine, depending on the clinical effect. In a study of the pharmacokinetics of quetiapine in various doses, when used before or simultaneously with carbamazepine (an inducer of hepatic enzymes), it led to a significant increase in the clearance of quetiapine. This increase in the clearance of quetiapine reduced the AUC by an average of 13% compared with the use of quetiapine without carbamazepine.The simultaneous use of quetiapine with another inducer of liver microsomal enzymes – phenytoin, also led to an increase in the clearance of quetiapine. With the simultaneous use of quetiapine and phenytoin (or other inducers of liver enzymes, such as barbiturates, rifampicin), an increase in the dose of quetiapine may be required. You may also need to reduce the dose of quetiapine if phenytoin or carbamazepine or another inducer of the liver enzyme system is discontinued or if a drug that does not induce liver microsomal enzymes (for example, valproic acid) is replaced.

Pharmacokinetics of lithium preparations does not change with the simultaneous use of quetiapine.

Quetiapine did not induce the hepatic enzyme systems involved in the metabolism of antipyrine. Pharmacokinetics of quetiapine does not change significantly when used simultaneously with antipsychotic drugs – risperidone or haloperidol. However, the simultaneous administration of quetiapine and thioridazine led to an increase in the clearance of quetiapine. CYP3A4 is a key enzyme involved in the cytochrome P450-mediated metabolism of quetiapine.The pharmacokinetics of quetiapine does not change significantly with the simultaneous use of cimetidine, which is a P450 inhibitor.

The pharmacokinetics of quetiapine did not significantly change with the simultaneous use of imipramine (CYP2D6 inhibitor) or fluoxetine (CYP3A4 and CYP2D6 inhibitor). CNS depressants and ethanol increase the risk of side effects from quetiapine.

Storage conditions of the drug Quetiapine

Keep out of the reach of children, in a dry, dark place at a temperature not exceeding 25 ° C.

Shelf life of the drug Quetiapine

Shelf life is 2 years.

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instructions for use, dosage, composition, analogs, side effects / Pillintrip

The most common side effects of Seroquel ® Prolong are drowsiness, dizziness, dry mouth, mild asthenia, constipation, tachycardia, orthostatic hypotension and dyspepsia.

Taking Seroquel ® Prolong, like other antipsychotic drugs, may be accompanied by an increase in body weight, fainting, the development of neuroleptic malignant syndrome, leukopenia, neutropenia and peripheral edema.

The frequency of adverse reactions is given in the form of the following gradation: very often – ≥1 / 10; often – ≥1 / 100, <1/10; infrequently - ≥1 / 1000, <1/100; rarely - ≥1 / 10000, <1/1000; very rare - <1/10000, unspecified frequency.

Very often
From the side of the central nervous system dizziness 1, 4, 17 , drowsiness 2, 17 , headache
From the side of the gastrointestinal tract Dry mouth
General disorders withdrawal syndrome 1, 10
Changes in laboratory and instrumental parameters increase in triglyceride concentration 11 , total cholesterol (mainly LDL) 12 , decrease in HDL cholesterol concentration 18 , increase in body weight 9 , decrease in hemoglobin concentration
Often
On the part of the hematopoietic system leukopenia 1
On the part of the central nervous system dysarthria, unusual and nightmares, fainting 1, 4 , extrapyramidal symptoms 1, 13 , increased appetite
On the part of the cardiovascular system tachycardia 1, 4 , orthostatic hypotension 1, 4
On the part of the organ of vision blurred vision
On the part of the respiratory system rhinitis
From the gastrointestinal tract constipation, dyspepsia
General disorders mild asthenia, irritability, peripheral edema
Changes in laboratory and instrumental parameters increased activity of hepatic transaminases (AST, AL 3 , decreased neutrophil count, hyperglycemia 7 , increased serum prolactin concentration 15
Infrequently
From the side of the blood system eosinophilia
From the side of the immune system hypersensitivity reactions
From the side of the central nervous system convulsions 1 , restless legs syndrome, tardive dyskinesia
From the gastrointestinal tract dysphagia 8
Changes in laboratory parameters and instruments

increase in the activity of creatine phosphokinase, not associated with neuroleptic malignant syndrome; increased activity of GGT 3 , thrombocytopenia 14
Rarely
From the gastrointestinal tract jaundice 6
From the reproductive system General priapism, 9018 galactorrhea 9033

0 16 disorders:

6 anaphylactic reactions

neuroleptic malignant syndrome 1
Changes in laboratory and instrumental parameters increased creatine phosphokinase activity 15
Very rarely
From the immune system
Metabolic disorders diabetes mellitus 1, 5, 6
From the side of the central nervous system tardive dyskinesia 6
From the side of the gastrointestinal tract hepatitis 6 900 33
Skin and subcutaneous tissue disorders Angioedema 6 , Stevens-Johnson syndrome 6
Unspecified frequency
Hematopoietic system 9003 Neutropenia

1

0 …See “Special instructions”.

2. Drowsiness usually occurs within the first 2 weeks after the start of therapy and, as a rule, resolves on the background of continued administration of Quetiapine ® Prolong.

3. Possibly asymptomatic increase in the activity of AST, ALT and GGT in the blood serum, as a rule, reversible against the background of continued administration of Seroquel ® Prolong.

4. Like other antipsychotics and α 1 -adrenergic blockers, quetiapine ® Prolong often causes orthostatic hypotension, which is accompanied by dizziness, tachycardia, in some cases – fainting, especially at the beginning of therapy (see.”Special instructions”).

5. Very rare cases of diabetes mellitus decompensation have been reported.

6. The frequency of this side effect was estimated on the basis of the results of post-marketing observation of the use of the drug Seroquel ® Prolong.

7. Increase in fasting blood glucose concentration ≥126 mg / dL (≥7 mmol / L) or blood glucose after meals ≥200 mg / dL (≥11.1 mmol / L), at least with a single determination.

8. A higher frequency of dysphagia with quetiapine compared with placebo was observed only in patients with depression in the structure of bipolar disorder.

9. More than 7% excess of the original body weight. It mainly occurs at the beginning of therapy.

10. When studying withdrawal syndrome in short-term placebo-controlled clinical trials of Seroquel ® Prolong in monotherapy, the following symptoms were noted: insomnia, nausea, headache, diarrhea, vomiting, dizziness and irritability. Withdrawal rates were significantly reduced 1 week after discontinuation of the drug.

11.An increase in triglyceride concentration ≥200 mg / dL (≥2,258 mmol / L) in patients ≥18 years old or ≥150 mg / dL (≥1,694 mmol / L) in patients <18 years old, at least with a single determination.

12. Increase in total cholesterol concentration ≥240 mg / dL (≥6.2064 mmol / L) in patients ≥18 years old or ≥200 mg / dL (≥5.172 mmol / L) in patients <18 years old, at least with a single dose definition.

13. See the instructions below.

14. Decrease in the number of platelets ≤100 · 10 9 / l, at least with a single determination.

15. Without connection with neuroleptic malignant syndrome. According to clinical studies.

16. Increase in prolactin concentration in patients ≥18 years of age:> 20 μg / l (≥869.56 pmol / l) in men; > 30 μg / L (≥1304.34 pmol / L) in women.

17. May cause a fall.

18. Reduction of HDL cholesterol concentration <40 mg / dL in men and <50 mg / dL in women.

Prolongation of the QT interval, ventricular arrhythmias, sudden death, cardiac arrest and bidirectional ventricular tachycardia are considered side effects inherent in antipsychotics.

The frequency of EPS in short-term clinical trials in schizophrenia and mania in the structure of bipolar disorder was comparable in the quetiapine and placebo groups (patients with schizophrenia: 7.8% in the quetiapine group and 8% in the placebo group; mania in the structure of bipolar disorder: 11, 2% in the quetiapine group and 11.4% in the placebo group).

The frequency of EPS in short-term clinical studies with depression in the structure of bipolar disorder in the quetiapine group was 8.9%, in the placebo group – 3.8%.At the same time, the frequency of individual EPS symptoms (such as akathisia, extrapyramidal disorders, tremor, dyskinesia, dystonia, anxiety, involuntary muscle contractions, psychimotor agitation and muscle rigidity), as a rule, was low and did not exceed 4% in each of the therapeutic groups. In long-term clinical trials of quetiapine for schizophrenia and bipolar disorder, the frequency of EPS was comparable in the quetiapine and placebo groups.

During therapy with quetiapine, there may be a slight dose-dependent decrease in the concentration of thyroid hormones, in particular total thyroxine (T4) and free T4.The maximum decrease in total and free T4 was registered on the 2nd and 4th weeks of therapy with Quetiapel ® Prolong, without further decrease in the concentration of hormones during long-term treatment. In almost all cases, the concentration of total and free T4 returned to the initial level after cessation of therapy with Quetiroquel ® Prolong, regardless of the duration of treatment. A slight decrease in total triiodothyronine (T3) and reverse T3 was observed only with the use of high doses.The concentration of thyroxine-binding globulin (TSH) remained unchanged; there was no increase in TSH concentration.

Seroquel XR – instructions, use, analogues of the drug, composition, indications, contraindications, side effects in the reference book of medicines from UNIAN

Quetiquel XR Application

Seroquel XR – composition and release form of the drug

Seroquel XR: how to take the drug

Seroquel XR – contraindications, side effects

Seroquel XR analogs

Quetiapine is an atypical antipsychotic drug.Quetiapine and its active plasma metabolite, norkvetiapine, interact with many neurotransmitter receptors.

Application of quetiapine XR

quetiauel XR is indicated for the treatment of

Schizophrenia, including the prevention of relapse in patients with stable schizophrenia receiving maintenance therapy with quetiapine.

Bipolar disorder, in particular:

  • for the treatment of moderate to severe manic episodes in bipolar disorder;
  • for the treatment of severe depressive episodes of bipolar disorder;
  • for the prevention of recurrence of the disease in patients with bipolar disorder, in patients with manic or depressive episodes, in which quetiapine treatment is effective.

As adjunctive therapy for severe depressive episodes in patients with severe depressive disorder (TDR) in whom a suboptimal response to antidepressant monotherapy has been reported. Before starting therapy, the physician should carefully review the safety profile of Quetiroquel XR.

Seroquel XR – composition and release form of the drug

The drug is available in the form of tablets.

Active ingredient : Quetiapine.

50 mg tablets: 1 tablet contains 57.56 mg of quetiapine fumarate, which corresponds to 50 mg of quetiapine;

Tablets of 200 mg: 1 tablet contains 230.26 mg of quetiapine fumarate, which corresponds to 200 mg of quetiapine;

Tablets of 300 mg: 1 tablet contains 345.38 mg of quetiapine fumarate, which corresponds to 300 mg of quetiapine;

Tablets of 400 mg: 1 tablet contains 460.50 mg of quetiapine fumarate, which corresponds to 400 mg of quetiapine;

Excipients:

lactose, monohydrate; microcrystalline cellulose, sodium citrate, hypromellose 2208, magnesium stearate, hypromellose 2910, polyethylene glycol 400, titanium dioxide (E171),

for tablets of 50, 200 and 300 mg – iron oxide yellow (E172),

for tablets of 50 mg – iron oxide red (E172).

Quetiawel XR: How to take the drug

There are different dosing regimens for each indication. Seroquel XR should be used once a day on an empty stomach. The tablets should be swallowed whole without breaking, chewing or crushing them.

For the treatment of moderate to severe schizophrenia and manic episodes in bipolar disorder

Seroquel XR should be used at least 1 hour before meals. The daily dose at the beginning of therapy is 300 mg on the first day and 600 mg on the second day.The recommended daily dose is 600 mg, but if clinically justified, the dose can be increased to 800 mg per day. The dose should be adjusted within the effective dose range from 400 mg to 800 mg per day, depending on the clinical response and tolerability.

For the treatment of depressive episodes in bipolar disorder

Seroquel XR should be used at bedtime. The total daily dose for the first four days of treatment is 50 mg (on day 1), 100 mg (on day 2), 200 mg (on day 3), and 300 mg (on day 4).The recommended daily dose is 300 mg. The 600 mg dose may be effective in selected patients. Doses above 300 mg should be prescribed by a physician experienced in treating bipolar disorder.

For the prevention of recurrence of the disease in bipolar disorder

the prescribed dose at bedtime.The dose of quetiapine XR can be adjusted within a dose range of 300 mg to 800 mg / day, depending on the clinical response and tolerability of each individual patient.

For the concomitant treatment of severe depressive episodes in TDR.

Quetioquel XR should be taken at bedtime. The daily dose at the beginning of therapy is 50 mg on the 1st and 2nd day, and 150 mg on the 3rd and 4th day. In short-term studies of concomitant therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine), the antidepressant effect was observed at doses of 150 and 300 mg / day and at a dose of 50 mg / day as monotherapy …When using higher doses of the drug, the risk of developing adverse reactions increases. Therefore, the physician should ensure that the lowest effective dose is used for treatment, starting at 50 mg / day. The need to increase the dose from 150 to 300 mg / day should be based on an assessment of the individual patient’s condition.

Like other antipsychotics and antidepressants, quetiapine XR should be used with caution in elderly patients, especially at the beginning of treatment and dose selection. Treatment of elderly patients should be started with a dose of 50 mg / day.

Therefore, quetiapine XR should be used with caution in patients with known liver dysfunction, especially during the initial dose selection period.

Seroquel XR – contraindications, side effects

Contraindication

Hypersensitivity to the active substance or to any component of the drug.

Concomitant use of cytochrome P450 3A4 inhibitors such as HIV protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone is contraindicated.

Adverse reactions

When taking quetiapine, the following adverse reactions were most often reported: drowsiness, dizziness, dry mouth, headache, withdrawal symptoms (discontinuation), increased serum triglyceride levels, increased total cholesterol (especially cholesterol) LDL), decreased HDL cholesterol, weight gain, decreased hemoglobin, and extrapyramidal symptoms.

  • Decreased hemoglobin level
  • Leukopenia, decreased neutrophil count, increased eosinophil level
  • Thrombocytopenia, anemia,
  • Agranulocytosis
  • Neutropenia
  • Hypersensitivity
  • Hypersensitivity reactions
  • allergic reactions

  • T 4 decrease in free T 4 decrease in total T 3 , increase in TSH
  • hypothyroidism
  • Inadequate secretion of antidiuretic hormone
  • Increase in serum triglycerides , increase in total cholesterol, cholesterol lowering (especially cholesterol) , increased body weight
  • Increased appetite, increased blood glucose levels to hyperglycemic levels
  • Hyponatremia, diabetes mellitus
  • Metabolic syndrome
  • Unusual dreams and nightmares, suicide Thinking and suicidal behavior
  • Sleepwalking and related phenomena such as sleep talk and sleep eating disorders
  • Dizziness , Drowsiness, headache, extrapyramidal symptoms
  • Dysarthria
  • Seizures dyskinesia , syncope
  • Tachycardia, palpitation
  • Prolongation of QT interval, bradycardia
  • Blurred vision
  • Orthostatic hypotension
  • Venous thromboembolism
  • Urinary retention

  • Venous thromboembolism
  • Urinary retention

  • vomiting
  • Dysphagia
  • Pancreatitis, intestinal obstruction / ileus
  • Increased serum alanine aminotransferase (ALT) levels, increased gamma-HT levels
  • Increased serum aspartate transaminase (
  • , hepatic hepatitis

  • 06
  • Angioedema, Stevens-Johnson syndrome
  • Toxic epidermal necrolysis, erythema multiforme
  • Rhabdomyolysis
  • Neonatal withdrawal syndrome, neonatal withdrawal symptoms
  • Sexual dysfunction
  • Menstrual cycle disorders
  • Withdrawal (discontinuation of use)
  • Mild asthenia, peripheral edema, irritability, pyrexia
  • Malignant neuroleptic syndrome, hypothermia
  • Increased level of creatinine phosphokinase in the blood

Seroquel’s analogs XR

Source: State Register of Medicines of Ukraine.The instructions are published with abbreviations for information only. Before use, consult your doctor and read the instructions carefully. Self-medication can be harmful to your health.

instructions for use, analogs, composition, indications

Since quetiapine has several indications for prescription, its safety profile is determined depending on the disease and the dose of the drug.

Children and adolescents

Quetiapine is not recommended for use in children and adolescents under 18 years of age due to the lack of data confirming the efficacy and safety of the drug in this age group.Clinical studies have shown that in the group of children and adolescents, some side effects while taking quetiapine (increased appetite, increased serum prolactin levels and extrapyramidal symptoms) were observed more often than in the group of adults; and there was one side effect not seen in adults (increased blood pressure). Thyroid dysfunction has also been observed in children and adolescents.

The safety of long-term (more than 26 weeks) administration of quetiapine and the lack of effect on the growth and maturation of children and adolescents have not been studied.Long-term effects on cognitive and behavioral development are not known.

In placebo-controlled clinical trials in the group of children and adolescents who received quetiapine for the treatment of schizophrenia and manic episodes in bipolar disorders, there was an increase in the incidence of extrapyramidal symptoms (EPS) compared with the placebo group.

Suicide / Suicidal thoughts or clinical deterioration

Depression in bipolar disorder is associated with an increased risk of suicidal ideation, self-harm, and suicide.This risk persists until the onset of pronounced remission. Due to the fact that it may take several weeks or more before the patient’s condition improves from the start of treatment, patients should be under close medical supervision until improvement occurs. According to clinical experience, the risk of suicide may increase in the early stages of remission.

Other psychiatric disorders for which quetiapine is prescribed are also associated with an increased risk of suicidal events.In addition, such conditions can be comorbid with a major depressive episode. Thus, the precautions used in the treatment of patients with major depressive episodes should also be used in the treatment of patients with other mental disorders. Patients with a history of suicidal events, as well as patients who clearly express suicidal thoughts before starting therapy, are at increased risk of suicidal attempts and should be carefully monitored during treatment.

Patients with a history of suicidal episodes, as well as those with high levels of suicidal thoughts prior to starting treatment, are at greater risk of suicidal ideation or attempted suicide and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials on the use of antidepressants in adults with mental disorders showed an increased risk of suicidal behavior with antidepressants compared with placebo in patients younger than 25 years.

Careful monitoring of patients (especially those from the high-risk group) during treatment is necessary, especially at the beginning of treatment and when the dose is changed. Patients (and caregivers) should be aware of the need for immediate medical attention in case of symptoms of clinical deterioration, suicidal behavior or suicidal thoughts, unusual changes in behavior.

In short-term placebo-controlled clinical trials, patients with major depressive episodes of bipolar disorder who received quetiapine showed an increased risk of suicidal events in young adult patients (younger than 25 years) compared with patients who received placebo (3.0% and 0, 0% respectively).

Extrapyramidal symptoms

In placebo-controlled clinical trials in adult patients with major depressive episodes of bipolar disorder who took quetiapine, there was an increase in the incidence of extrapyramidal symptoms (EPS) compared with the group of patients taking placebo.

The use of quetiapine may be associated with the development of akathisia, characterized by a feeling of internal motor restlessness and manifested in the patient’s inability to sit or stand for a long time.

Symptoms of akathisia are most likely to develop during the first weeks of treatment.

If symptoms of akathisia develop, increasing the dose is undesirable.

Tardive dyskinesia

Tardive dyskinesia is a potentially irreversible syndrome characterized by involuntary dyskinetic movements that can develop in patients treated with antipsychotics, including quetiapine. If symptoms of tardive dyskinesia appear, it is necessary to resolve the issue of dose reduction or withdrawal of quetiapine.The symptoms of tardive dyskinesia may worsen or even occur after treatment is stopped.

Drowsiness and dizziness

Taking quetiapine has been associated with drowsiness and sedation. In clinical studies in patients with depression with bipolar disorders, drowsiness occurred during the first 3 days of treatment and was predominantly mild to moderate. Patients with depression in bipolar disorder who develop severe drowsiness require more frequent medical supervision for at least 2 weeks from the onset of drowsiness until symptoms have subsided; discontinuation of treatment may be considered if necessary.

Orthostatic hypotension

Reception of quetiapine may be associated with the occurrence of orthostatic hypotension and dizziness, which usually develop at the beginning of dose titration. This can increase the incidence of accidental injuries (falls), especially in the elderly. Therefore, patients should be warned to exercise caution until they are familiar with the potential effects of the drug.

Quetiapine should be used with caution in patients with cardiovascular disease, cerebrovascular disease and other conditions that predispose to a decrease in blood pressure.

Taking quetiapine can cause the development of orthostatic hypotension, especially at the beginning of dose titration (more often in elderly patients). In these cases, a dose reduction or more gradual titration is recommended. In patients with cardiovascular disease, a slow dose titration regimen is recommended.

Epileptic seizures

In controlled clinical trials, there was no difference in the incidence of seizures between patients receiving quetiapine and placebo.There are no reports of cases of seizures in patients with a history of seizures. However, caution should be exercised when prescribing antipsychotics (including quetiapine) in the treatment of patients with a history of epileptic seizures.

Malignant neuroleptic syndrome (NMS)

When using antipsychotics (including quetiapine), neuroleptic malignant syndrome may develop. Clinical manifestations of NMS include fever, changes in mental status, muscle stiffness, disorders of the autonomic nervous system, and an increase in creatine phosphokinase.If NMS develops, quetiapine should be discontinued and appropriate treatment prescribed.

Severe neutropenia and agranulocytosis.

In these clinical studies, there are rare reports of the development of severe neutropenia (neutrophil count <0.5 x 109 / L) with the use of quetiapine. Most cases of severe neutropenia occurred within a few months of starting quetiapine and were not dose-dependent. According to post-marketing data, leukopenia and / or neutropenia disappeared after discontinuation of quetiapine.Risk factors for the development of neutropenia: a previous decrease in the number of blood leukocytes or a history of neutropenia caused by taking medications. Patients should stop taking quetiapine (neutrophil count <1.0 x 109 / L). Patients should be monitored for possible symptoms of infection and until neutrophil levels are <1.5 x 109 / L and above.

The development of neutropenia during the use of quetiapine should be considered in patients with infection or fever, especially in the absence of obvious predisposing factors.In this case, appropriate therapeutic measures should be taken. Patients taking quetiapine should be informed to immediately inform their doctor about signs / symptoms of agranulocytosis or infection (eg, fever, weakness, drowsiness, or sore throat). In this case, it is necessary to immediately determine the number of leukocytes and the absolute number of neutrophils in the patient’s blood, especially in the absence of predisposing factors.

Interactions

Cm.See also the section “Interaction with other medicinal products”.

When used simultaneously with strong inducers of hepatic enzymes, such as carbamazepine or phenytoin, the concentration of quetiapine in the blood plasma is significantly reduced, which may affect the effectiveness of quetiapine. In patients receiving hepatic enzyme inducers, treatment with quetiapine can be started only in cases where the doctor believes that the intended benefit of using quetiapine outweighs the risk of canceling the hepatic enzyme inducer.Any change in the dose of the inducer should be gradual, and if necessary, it should be replaced with a non-inducible drug (for example, sodium valproate).

Body weight

An increase in body weight was noted in patients who took quetiapine. Patients taking quetiapine should be monitored in accordance with the basic rules for the use of antipsychotics.

G Ip Erglycemia

With the use of quetiapine, there have been rare reports of the development of hyperglycemia and / or exacerbation of preexisting diabetes mellitus, sometimes associated with the development of ketoacidosis or coma, including death.An increase in body weight in some cases may be a predisposing factor. Clinical observation is necessary in accordance with the basic rules for the use of antipsychotics. Patients taking antipsychotics, including quetiapine, should be monitored for symptoms of hyperglycemia (polydipsia, polyuria, polyphagia, and weakness). Patients with diabetes mellitus or with risk factors for the development of diabetes mellitus should regularly monitor their blood glucose levels. It is necessary to regularly monitor body weight.

Lipids

In clinical studies of quetiapine, there were cases of an increase in triglycerides, LDL and total cholesterol levels and a decrease in HDL cholesterol. If lipid metabolism is disturbed, appropriate treatment should be undertaken.

Risk of metabolic disorders

Given the changes in body weight, glucose and lipids in the blood observed in clinical trials (including in patients with normal baseline values ​​of these indicators), there may be an increase in the risk of metabolic disorders (see.(See also the Side Effects section).

Span extension QT

In the course of clinical studies and use according to the instructions, treatment with quetiapine was not associated with a permanent prolongation of the QT interval.

In the post-marketing period, with the use of therapeutic doses, as well as with an overdose, there have been reports of prolongation of the QT interval (see section “Side Effects”). As with other antipsychotics, caution should be exercised when prescribing quetiapine to patients with cardiovascular disease or a family history of QT prolongation.Caution should be exercised when prescribing quetiapine to patients taking drugs that prolong the QT interval (including other antipsychotics), especially elderly patients, patients with congenital prolongation of the QT interval, heart failure, cardiac hypertrophy, hypokalemia or hypomagnesemia (see the section “Interaction with other medicines “).

Cardiomyopathy and myocarditis

Cardiomyopathy and myocarditis have been noted in clinical studies and during post-marketing experience, but a causal relationship with quetiapine has not been established.Treatment with quetiapine should be reviewed in patients with suspected cardiomyopathy or myocarditis.

Elderly patients with psychosis associated with dementia

Quetiapine is not approved for the treatment of patients with dementia-related psychosis.

In randomized placebo-controlled clinical trials on the use of some atypical antipsychotics in the treatment of elderly patients with dementia, a 3-fold increase in the risk of developing cerebrovascular side effects was found in the group of patients receiving antipsychotics compared with the placebo group.The mechanism of this increase is not known. The increased risk cannot be excluded for other antipsychotics or other patient groups. Quetiapine should be used with caution in patients with risk factors for stroke.

A meta-analysis of studies of atypical antipsychotics demonstrates that elderly patients with psychosis associated with dementia have an increased risk of death compared to the placebo group. However, in two 10-week placebo-controlled studies in the same patient population (n = 710, mean age: 83 years, range: 56-99 years), the mortality rate in the group of patients taking quetiapine was 5.5%, and in placebo group – 3.2%.In these studies, patients died from a variety of causes that are consistent with the assumptions for this population. These data do not allow establishing a causal relationship between the use of quetiapine and death in elderly patients with dementia.

Dysphagia

Cases of dysphagia have been reported during treatment with quetiapine. Caution should be exercised when prescribing quetiapine to patients at high risk of developing aspiration pneumonia.

Constipation and intestinal obstruction

Constipation is a risk factor for bowel obstruction. There have been reports when, against the background of the use of quetiapine, there were cases of constipation and intestinal obstruction, including fatal cases in patients at high risk of developing intestinal obstruction, including those receiving concomitant medications that reduce intestinal motility, even in the absence of complaints. It is necessary to carefully monitor the condition of patients with intestinal obstruction and, if necessary, provide emergency care.

Withdrawal syndrome

Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability have been described after abrupt discontinuation of quetiapine. It is recommended to gradually discontinue quetiapine by reducing the dose for at least 1-2 weeks.

Liver

If jaundice develops while taking quetiapine, the drug should be discontinued.

Accompanying illnesses

Cases of dysphagia (see also the Side Effects section) and aspiration have been reported with quetiapine. Although a causal relationship with aspiration pneumonia has not been established, quetiapine should be used with caution in patients at risk of developing aspiration pneumonia.

Venous thromboembolism (VTE)

Cases of venous thromboembolism (VTE) have been reported in patients taking antipsychotics.Since patients receiving antipsychotics often have acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with quetiapine and preventive measures taken.

Pancreatitis

In clinical studies and during the post-marketing period, cases of pancreatitis have been reported while taking quetiapine. Among the post-marketing messages, not all patients had risk factors for pancreatitis, but many patients had risk factors (increased triglyceride levels, gallstones, alcohol).

Lactose

Kutipin tablets contain lactose. Patients with rare hereditary forms of galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.

Additional Information

There are limited data on the use of quetiapine in combination with divalproex and lithium for the treatment of moderate to severe manic episodes, but the combination therapy is well tolerated (see.(See also sections “Side effects” and “Interaction with other drugs”). The data obtained show an additive effect at the 3rd week.

Pregnancy and lactation Pregnancy

First trimester

The moderate amount of published data on pregnant women taking quetiapine (300-1000 pregnancy outcomes), including isolated reports and observational studies, do not suggest an increased risk of fetal malformations due to quetiapine treatment.However, based on all the available data, it is impossible to draw an unambiguous conclusion, since animal studies have shown reproductive toxicity. Quetiapine should only be used during pregnancy when the doctor believes the intended benefit of taking quetiapine outweighs the potential risk to the fetus.

Third trimester

Newborns whose mothers took antipsychotics (including quetiapine) in the third trimester of pregnancy are at risk of developing adverse reactions, including extrapyramidal disorders and / or withdrawal symptoms, which can be of varying severity and duration.There have been reports of the following manifestations: agitation, hypertension, hypotension, tremors, drowsiness, respiratory distress, or eating disorders. Newborns whose mothers took antipsychotics (including quetiapine) in the third trimester of pregnancy should be closely monitored.

Breastfeeding

Based on very limited data from published reports of quetiapine excretion in human breast milk, drug excretion at therapeutic doses remains uncertain.The risk to the newborn cannot be ruled out. Therefore, the decision to continue / discontinue breastfeeding or continue / discontinue quetiapine therapy should be made taking into account the benefits of breastfeeding for the baby and the benefits of the drug for the mother.

Fertility

The effect of quetiapine on human fertility has not been evaluated.

Effects associated with increased prolactin levels have been observed in rats.But this information is not directly related to people.

Quetiapine: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ® , contains all the information you need to know about the drug, including the indications, route of administration, side effects, and when you should contact your healthcare provider.

Trade names: USA

SEROquel; SEROquel XR

Trade names: Canada

ACH-Quetiapine Fumarate XR; ACT QUEtiapine; AG-Quetiapine; APO-QUEtiapine; APO-QUEtiapine XR; Auro-QUEtiapine; BIO-QUEtiapine; DOM-QUEtiapine; JAMP-QUEtiapine; Mar-QUEtiapine; MINT-QUEtiapine; NAT-QUEtiapine; NRA-Quetiapine; PMS-QUEtiapine; Priva-QUEtiapine; PRO-QUEtiapine; RAN-QUEtiapine; RIVA-QUEtiapine; SANDOZ QUEtiapine XRT; SANDOZ QUEtiapine [DSC]; SEROquel; SEROquel XR; TEVA-QUEtiapine XR; TEVA-QUEtiapine [DSC]; VAN-QUEtiapine [DSC]

Warning

  • There is an increased risk of death in older people who take this drug for mental health problems associated with dementia.Most of the known deaths were due to heart disease or infection. This drug is not approved for the treatment of mental health problems associated with dementia.
  • Drugs like this have increased the likelihood of suicidal thoughts or actions in children and young people. This risk may be higher in people who have attempted suicide or have had suicidal thoughts in the past. All people taking this drug must be closely monitored.Call your doctor right away if you have signs such as depressed mood (depression), nervousness, anxiety, grumpiness, or anxiety attacks, or if other mood or behavior changes occur or worsen. Call your doctor right away if you have suicidal thoughts or attempted suicides.
  • This drug is not approved for use in children under 10 years of age. Consult your doctor.

What is this drug used for?

  • The drug is used to treat schizophrenia.
  • This medication is used to treat bipolar disorder.
  • The drug is used to treat depression.
  • This drug can be given to children for other indications. Consult your doctor.

What do I need to tell my doctor BEFORE my child takes this drug?

  • If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
  • If your child has ever had an increase in the length of the ECG QT interval or other abnormalities in the heart rhythm.
  • If your child has any of the following health problems: Low potassium or magnesium levels.
  • If your child is taking any drugs that can cause some type of heart rhythm disorder (prolonged QT interval). There are many drugs that can have this effect.If in doubt, consult your doctor or pharmacist.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns. You need to make sure that this drug is safe for your child’s illness and in combination with other drugs he or she is already taking.You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

What do I need to know or do while my child is taking this drug?

  • Tell all health care providers for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
  • Get your child’s blood tested frequently.Check with your child’s doctor.
  • Have your child avoid tasks or activities that require attention until you see how this drug is working for your child. This includes cycling, playing sports, or using items such as scissors, lawn mowers, electric scooters, toy cars, or motorized vehicles.
  • To reduce the risk of dizziness or fainting, have your child get up slowly from a sitting or lying position.Make sure your child is careful when going up and down the stairs.
  • This drug may interfere with some lab tests. Tell all healthcare professionals and laboratory staff providing your child’s healthcare that your child is taking this drug.
  • Do not suddenly stop using this drug by your child without talking to your doctor. Your child may be at increased risk of developing withdrawal symptoms.If necessary, this drug should be discontinued gradually, as directed by your healthcare practitioner.
  • Alcohol may interact with this drug. Make sure your child does not drink alcohol.
  • Consult with your child’s doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow down your child’s actions.
  • In rare cases, cataract formation is possible.
  • Get your child’s vision checked as directed by a healthcare practitioner.
  • With the use of drugs similar to this drug, there was an increase in blood sugar or diabetes, an increased level of cholesterol and an increase in body weight. These changes can increase the likelihood of developing vascular disease of the heart and brain.
  • Monitor your child’s blood sugar as directed by your doctor.
  • Low leukocyte counts were observed while taking drugs of this kind.This can increase the likelihood of infection. In rare cases, infections have been fatal. If your child has ever had a low white blood cell count, tell the doctor. See your doctor right away if your child develops symptoms of an infection, such as high fever, chills, or sore throat.
  • Dizziness, drowsiness, or unsteadiness may happen with this drug. This can lead to a fall, which carries the risk of bone fractures or other harm.
  • Make sure your child is careful in hot weather or during vigorous activity. Make sure your child drinks plenty of fluids to stay hydrated.
  • If the patient is a child, use this medication with caution. In children, the risk of some side effects may be higher.
  • Children and adolescents have high blood pressure. Monitor your child’s blood pressure as directed by the child’s doctor.
  • Constipation is common with this drug. Bowel obstruction is sometimes observed. In rare cases, bowel obstruction has been fatal in people taking this drug with other drugs that slow the movement of food through the gastrointestinal (GI) tract. If you have any questions, please consult your doctor.
  • This drug may adversely affect a woman’s ability to get pregnant. This ability is restored after stopping treatment with this drug.If you have any questions, please consult your doctor.

If your daughter is pregnant or breastfeeding:

  • Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.
  • Use of this drug during the third trimester of pregnancy may result in uncontrolled muscle contractions and withdrawal in the newborn.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people. Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

  • Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
  • Symptoms of decreased thyroid hormone levels such as constipation, cold intolerance, memory impairment, mood swings, or unexplained burning, numbness, or tingling sensations.
  • Signs of high blood sugar, such as confusion, drowsiness, increased thirst and hunger, increased urination, facial flushing, rapid breathing, and fruity breath.
  • Severe dizziness or fainting.
  • Chest pain, angina pectoris, tachycardia or irregular heartbeat.
  • Uncontrolled body movements, convulsive movements, imbalance, difficulty swallowing or speaking.
  • Wobbly gait, difficulty walking, or muscle stiffness.
  • Drooling.
  • Convulsions.
  • Change in vision.
  • Severe constipation or abdominal pain. These may be signs of a severe bowel disorder.
  • Obstruction of the urinary tract.
  • Flu-like symptoms.
  • Breast enlargement, nipple discharge, inability to achieve and maintain an erection, changes in the menstrual cycle.
  • Patients can develop a very serious and sometimes fatal complication called neuroleptic malignant syndrome. Call your child’s doctor right away if the child has a fever, muscle cramps or stiffness in the muscles, dizziness, very bad headache, confusion, changes in thinking, tachycardia, a feeling of irregular heartbeat, and profuse sweating.
  • Some people may develop a serious muscle disorder called tardive dyskinesia.This effect may decrease or disappear after the drug is discontinued, but it may persist. People with diabetes and older people, especially older women, are at increased risk. The risk increases with long-term use or high doses, but can also occur with short-term low doses. Call your child’s doctor right away if your child has uncontrolled body movements or muscle problems in the tongue, face, mouth, or jaw, such as protruding tongue, swollen cheeks, lips compressed into a tube, or involuntary chewing movements.

What are some other side effects of this drug?

Any drug can have side effects. However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

  • Feeling dizzy, sleepy, tired, or weak.
  • Headache.
  • Nervous tension and agitation.
  • Constipation.
  • Dry mouth.
  • Increased appetite.
  • Weight gain.
  • Nausea or vomiting.
  • Pain in the intestines.
  • Back pain.
  • stuffy nose.

This list of potential side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor.Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor. Read all the information provided to you. Follow all instructions strictly.

Immediate-release tablets of active ingredient:

  • Give this drug with or without food.

Extended release tablets:

  • Have your child swallow whole. Tell your child not to chew, crush, or crush the tablet.
  • Give on an empty stomach or with a light meal.

All forms of issue:

  • Continue giving this drug as directed by your child’s doctor or other healthcare professional, even if your child is well.
  • Try to get your child to drink lots of non-caffeinated liquids every day, unless the doctor has told you to drink less liquids.

What if my child misses a dose of a drug?

  • Give the missed dose as soon as possible.
  • If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal dosage schedule.
  • Do not give a double dose at the same time or additional doses.
  • If you are unsure what to do if your child misses a dose, contact your doctor.

How do I store and / or discard this drug?

  • Store at room temperature, protected from light. Store in a dry place. Do not store in the bathroom.
  • Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
  • Dispose of unused or expired drugs.Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

  • If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
  • Do not share your child’s medication with others or give anyone else’s medication to your child.
  • Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
  • If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

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© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

instructions for use, reviews of doctors and patients, analogs, price


This information is for reference only. Do not self-diagnose and self-medicate. See a doctor .

Quetixol is a drug belonging to the group of atypical antipsychotic drugs. Able to interact with serotonin, histamine and alpha2-adrenergic receptors localized in the brain.

The main active ingredient is quetiapine. Additional substances included in the preparation include carbohydrates and mineral components.

Available in tablet form of 25, 100, 200 mg of active ingredient, capsules are covered with a specific protective shell.

Pharmacological profile

When administered into the body, Quetixol has a weak cataleptic effect, which blocks dopamine receptors in the brain.

The drug has a pronounced sedative and antipsychotic effect due to inhibition of neuro-reflex transmission. Quetiapine affects the production of pituitary and hypothalamic hormones, increases blood pressure and relieves symptoms of mental illness.

It is taken orally, actively absorbed on the gastric mucosa and enters the bloodstream.Eighty percent of the active ingredient is able to bind to the protein structures of plasma blood cells. At the end of their circulation, the waste products are filtered in the kidney tissue.

Indications and contraindications for use

As an antipsychotic drug, Quetixol is used at:

A positive effect occurs after two doses throughout the day. Quetixol is absolutely safe to use.

The only contraindications are:

  • allergic reaction to any of the components of the preparation;
  • simultaneous use of antibacterial drugs.

Treatment and dosage regimen

An adult should use the drug 2 times a day. The dosage regimen differs depending on the type of mental illness.

For schizophrenia, the dosages are as follows:

  • 1 day – 50 mg / day;
  • 2 day – 100;
  • 3 day – 200;
  • 4 day – 300.

The dosage can be adjusted depending on the individual tolerance and effectiveness of the effect on a particular patient.

In the treatment of manic-depressive syndrome and bipolar disorder:

  • 1 day – 100 mg / day;
  • 2 day – 200;
  • 3 days – 300;
  • 4 days – 400.

Quetixol should be taken with caution in the elderly and suffering from hepatic and renal insufficiency due to the increased risk of overdose.The initial dose should be no more than 25 mg per day, then the dose is gradually increased until the maximum therapeutic effect is achieved.

To date, the mechanism of action of the drug on children under the age of 18 has not been studied, which is why Quetixol is not used in pediatric practice.

How the use of the medication will affect the body of a pregnant woman and the fetus is not fully understood. That is why, in such situations, the use of a medicinal substance is carried out only in extreme and advanced forms of mental disorder.

Overdose cases and adverse reactions

Symptoms of overdose are very rare, and no deaths have been reported to date.

Signs of overdose can be directly related to insufficient functioning of the conductive system of the heart and manifest itself in the form of tachycardia, a decrease in blood pressure and “angina pectoris”.

When a dose is used above the norm, a pronounced sedative effect on the central nervous system develops, which is characterized by drowsiness and even apathy.

No specific drug has been developed as an antidote, patients must be urgently taken to the intensive care unit, where resuscitation measures and control over the general condition of the patient will be provided.

A side effect from taking a drug can develop at the level of any anatomical system of the body.

From the nervous system:

From the side of the alimentary canal:

  • feeling of dryness of the oral mucosa;
  • flatulence;
  • constipation;
  • Difficulty swallowing food.

From the side of the visual organs:

  • sharp decrease in visual acuity;
  • increased intraocular pressure;
  • a feeling of flickering before the eyes.

From the side of the cardiovascular system:

  • violation of the rhythm of heart contractions;
  • heart palpitations;
  • decrease in blood pressure indicators.

Special instructions

It is necessary to use Quetixol with extreme caution in persons who suffer from chronic cardiovascular pathologies, as there is an increased risk of developing a hypotensive state up to vascular collapse.

Epileptics need to strictly control the regimen of administration and dosing of the drug due to the fact that the drug is capable of increasing the frequency of seizures.

Taking this drug can provoke the development or progression of neuroleptic malignant syndrome, in which case it is recommended to temporarily stop taking the neuroleptic or replace it with another drug.

Withdrawal syndrome is a pathological condition that develops against the background of a sharp withdrawal of Quetixol.It manifests itself in the form of nausea, vomiting, dizziness and the sudden progression of a mental disorder. To prevent the development of such a condition, the dose of the drug must be gradually reduced until it is completely canceled.

Drug interactions

Given the fact that Quetixol has a direct effect on the functioning of the central nervous system, it should be taken with caution with other drugs of a similar mechanism of action. It must be combined with caution with drugs that lower blood pressure.

The drug interacts absolutely favorably with antipsychotics, hypnotics, and sedatives.

Practical experience of application

Reviews of doctors and patients about Quetixol, which we found on the Internet and which seemed interesting to us.

Hello! My sister has been suffering from manic-depressive syndrome for six years, when the doctor prescribed Quetixol, we noticed that the attacks of hallucinations and aggression became much less frequent.During the intake, no side effects were observed.

Galina, 47 years old

I prescribe Quetixol as a treatment for exacerbated forms of schizophrenia, my patients have a positive dynamics of the disease, the period of remission has increased in time.

During my clinical practice, when taking the drug, there were no manifestations of side effects and symptoms of overdose.

Elena Aleksandrovna, doctor of psychiatrist, 25 years of experience

Purchase and analogues

The price of a pack of Quetixol is from 500 -800 rubles, depending on the dosage, similar medicines are also available for purchase:

Store in a cool and dark place at a temperature not exceeding 25 degrees.Pharmacy dispensing only with a prescription from a psychiatrist.

Kapoten in diabetes: contraindications, composition

Patients with diabetes mellitus are accompanied by various complications, and one of them is diabetic nephropathy. In the fight against this pathology, “Kapoten” acts – a medical preparation of a wide spectrum of action, which is distinguished by the speed of the onset of the therapeutic effect. The therapeutic effect of “Kapoten” extends to another disease that is often diagnosed in diabetes mellitus – arterial hypertension.High blood pressure values ​​in people with diabetes are especially dangerous and therefore require urgent action.

Composition and form of release

Kapoten is sold in the form of tablets, packaged in blister packs of 10 or 14 pieces and placed in cardboard boxes, each of which contains 2 or 4 blisters. The drug contains an active ingredient – captopril and the following excipients:

  • corn starch;
  • MCC;
  • octadecanoic acid;
  • milk sugar.

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Indications

Pharmaceutical preparation “Kapoten” lowers blood pressure to normal levels and minimizes the load on the heart, which makes it possible to use it for the treatment of hypertension and cardiac dysfunctions accompanied by insufficient blood supply to organs and tissues. Helps “Kapoten” to cure myocardial infarction and, together with other medicines, to overcome diabetic nephropathy that occurs in type I diabetes mellitus.

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Instructions for the use of “Kapoten” in diabetes

Medical consultation before taking the drug is required.

Before starting a therapeutic course with the medication “Kapoten”, it is necessary to consult with a specialized physician, since the dosages indicated in the annotation to the medicine are generalized. The doctor will individually prescribe safe and effective doses based on the diagnosis, age and general condition of the patient.

The medicine is taken orally on an empty stomach, preferably one hour before a meal.The tablets are not crushed in any way, but are swallowed whole, washed down with purified water, at least ½ glass. Treatment is started with minimum doses, gradually increasing them every 14 days by 2 times. The maximum permissible dosage of the medication “Kapoten” is 0.6 g per day, however, doctors recommend using no more than 300 mg, since it is believed that exceeding this value can provoke undesirable consequences. Usually for the treatment of diabetic nephropathy it is recommended to drink “Kapoten” 25 mg three times a day.If this dosage is ineffective, then after two weeks it is increased to 50 mg in the morning and in the evening.

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Contraindications

It is not recommended to use “Kapoten” to eliminate complications of diabetes mellitus for patients under 18 years of age, as well as for individuals with individual intolerance to the components of the medication, pregnant and lactating mothers. “Kapoten” is capable of doing harm if taken under existing pathological conditions that impede the outflow of blood, stenosis of the arteries in patients with the 1st kidney and in case of violations of the normal functioning of the liver and kidneys.Contraindication to the use of “Kapoten” is Quincke’s edema, hyperkalemia and bilateral stenosis of the renal arteries. Patients with cerebral ischemia, the elderly, and those on a diet to control sodium intake should be taken with extreme caution.

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Side effects

Using “Kapoten”, the following negative effects may occur:

When taking the drug, sometimes pulmonary edema occurs.

  • dry cough;
  • painful palpitations;
  • narrowing of the bronchial lumen;
  • edema of the lungs, mucous walls of the larynx, extremities, mouth and face;
  • increase in the level of potassium, sodium in the blood;
  • the presence of protein in the urine;
  • violation of acid-base balance;
  • anemia;
  • decrease in the number of platelets, neutrophils;
  • violation of taste and vision, dry mouth;
  • soreness in the abdomen, frequent loose stools;
  • drowsiness, dizziness and headaches;
  • increase in body temperature;
  • Skin rashes and itching.

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Substitutes

Pharmaceutical agent “Kapoten” can be replaced by synonyms, that is, drugs that have an identical active substance in the composition, and analogs with a similar effect. Therefore, when it is not possible to use Capoten, doctors replace it with one of the following medicines:

Captopril has a similar composition and the same properties.

  • “Blockordil”;
  • “Amprilan”;
  • Captopril;
  • “Hypernik”;
  • Akcupro;
  • “Gopten”;
  • Corpril;
  • “Hypernik”;
  • Metapril;
  • Lysiprex;
  • Diroton;
  • “Lizoril”;
  • Vasolong;
  • Parnavel;
  • Renitek;
  • Sinopril;
  • Zokardis;
  • “Ramigamma”;
  • “Lisinopril”;
  • Dilaprel;
  • “Leiten”;
  • Envas;
  • Stoppress;
  • “Pyristal”;
  • Enafarm;
  • “Prenessa”;
  • Fosinap;
  • Arentopres.

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Special instructions

Before starting treatment and in the process of taking “Kapoten”, you must regularly monitor the renal performance. It may be necessary to discontinue therapy with the described medication if, against the background of its use, the concentration of creatinine has increased.

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