Quetiapine is an atypical antipsychotic medication used to treat various mental health conditions. Discover its effects, potential side effects, and how it interacts with other substances. Get answers to common questions about this medication.

What is Quetiapine?

Quetiapine, also known by its brand name Seroquel, is an atypical antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and major depressive disorder. It works by blocking the effects of the neurotransmitter dopamine in the brain, which can help reduce symptoms associated with these mental health conditions.

How Does Quetiapine Work?

Dopamine is a chemical messenger in the brain that plays a crucial role in regulating thinking, emotions, behavior, and perception. In certain mental illnesses, there may be an imbalance in dopamine levels, leading to unwanted symptoms. Quetiapine’s main mechanism of action is to block the effects of dopamine in the brain, which can help alleviate these symptoms. Additionally, the medication also affects other neurotransmitters, such as serotonin, which may contribute to its therapeutic benefits.

Quetiapine and Everyday Life

It is common for people to experience the full effects of quetiapine within four to six weeks of starting treatment. However, some individuals may notice improvements sooner. It is important to stay in touch with your doctor to monitor your progress and any potential side effects during the initial weeks of treatment. If you do not experience any significant benefits after two to three weeks, your doctor may decide to increase the dosage or switch to a different medication.

Potential Side Effects of Quetiapine

Quetiapine can have a range of side effects, including weight gain, sleepiness, and changes in blood sugar levels. Some studies have shown an increased risk of developing diabetes, particularly in young people with a family history of the condition. It is essential to watch for early signs of diabetes, such as excessive thirst, frequent urination, and feelings of weakness, and to discuss any concerns with your doctor.

Interactions with Other Substances

Quetiapine can interact with various other medications, as well as alcohol and street drugs. It is important to inform your doctor about any other medications, supplements, or substances you are taking. Grapefruit juice, in particular, should be avoided while taking quetiapine, as it can increase the amount of the drug absorbed into the body. Additionally, the combination of quetiapine and alcohol or certain street drugs can lead to increased drowsiness and other potentially dangerous effects.

Staying Safe and Supported

If you experience any concerning side effects or changes in your condition while taking quetiapine, it is important to speak with your doctor. They may be able to adjust the dosage or switch to a different medication. Additionally, it can be helpful to let your family and friends know that you are taking quetiapine, as they can provide valuable support and help you monitor for any potential side effects.

Frequently Asked Questions

Does quetiapine cause weight gain?

Yes, weight gain is a common side effect of quetiapine. The degree of weight gain can vary from person to person, and it is important to discuss any concerns about weight changes with your doctor.

Can I drink alcohol while taking quetiapine?

While it is possible to continue drinking alcohol while taking quetiapine, the combination can increase drowsiness and other side effects. It is generally recommended to avoid alcohol, especially during the first few days of starting the medication.

Does quetiapine affect sleep?

Yes, quetiapine can cause drowsiness and sleepiness, particularly in the first few days of treatment. In some cases, it may also lead to sleep-related behaviors, such as sleep-talking or sleepwalking. If you experience any concerning sleep-related issues, be sure to inform your doctor.

Can quetiapine be abused?

Yes, quetiapine has the potential for abuse, as it can enhance the effects of certain street drugs. It is important never to share your quetiapine medication with anyone else, as this can be dangerous and illegal.

Quetiapine | Atypical Antipsychotic Use & Side Effects

About quetiapine

Please note

Thinking about trying medication? Read our guide

How quetiapine works

Dopamine is a chemical messenger (‘neurotransmitter’) in the brain mainly involved with thinking, emotions, behaviour and perception.

In some illnesses, there may be too much dopamine, causing some unwanted symptoms. The main effect that quetiapine has is to block the effects of dopamine in the brain, resulting in a reduction of symptoms. 

Quetiapine also has effects on other neurotransmitters in the brain such as serotonin, and its beneficial effects may be related to this as well.

Read our guide to bipolar disorder

Quetiapine and everyday life

Frequently asked questions

Many people say that it takes four to six weeks for quetiapine to show its full effect. However, some people experience benefits sooner than this.

You should stay in touch with your doctor to see how it goes over the first few weeks. They might do some tests to check your symptoms.

If you have had no good effects after two to three weeks, your doctor may increase the dose or change the medicine.

Your doctor will start with a low dose, which they will increase slowly until you find a dose that is effective for you. This may take several days or weeks.

Some studies have shown a risk of developing diabetes among young people taking quetiapine who have a family history of diabetes. This could be linked to putting on weight, which can also be a side effect of taking quetiapine.

Watch out for any early signs of diabetes. These include:

• wanting to drink a lot
• going for a wee a lot
• feeling weak

If you are a young person who already has diabetes, taking quetiapine may affect your blood sugar levels.

Talk to your doctor and check your blood glucose levels regularly.

You may have to increase the dosage of the medication you use for your diabetes.

A side effect of quetiapine can be either weight loss or weight gain. Weight gain is more common than weight loss.

It is very difficult to know how it will affect each person who takes it, but if you start to have problems with your weight while taking quetiapine, talk to your doctor or pharmacist about this.

If you put on weight while taking this medication, and this bothers you, talk to your doctor about other similar medicines you could try. You could also discuss managing your weight through diet and exercise.

You may want to let your family and friends know you are taking quetiapine so they can support you and help you look out for side effects.

For guidance on this, check out our page on getting support with your medication.

In the first few days of taking quetiapine, you may feel extremely sleepy.

Taking quetiapine with alcohol or some other medicines could make this even worse.

If you have been taking quetiapine for a few weeks, and you feel very sleepy, you should go back to your doctor to see if there is something else that you can try.

Quetiapine can also cause sleep-talking, sleep-walking, and some people have done other activities while they were asleep, like eating.

You might also have strange dreams or nightmares.

Talk to your doctor if any of this worries you.

Alcohol

You can continue to drink alcohol while taking quetiapine, but having the two together might make you very sleepy.

During the first few days, it might be best to stop drinking alcohol until you see how the medicine affects you.

If you want to drink alcohol, remember that you might be sleepy and make sure you can get home safely.

Street drugs

Some street drugs can increase levels of dopamine in the brain (e.g. cocaine and ecstasy). As antipsychotics block the effects of dopamine, the ‘high’ from street drugs may not be as ‘high’ as before. You may therefore be tempted to increase the dose of your street drug to make up for it, but this could be dangerous.

Cannabis and other drugs may have their own side effects on your mental health, like anxiety or psychosis. For more information, have a look at our drugs and alcohol page.

Some street drugs can make you feel sleepy and this could be made worse with quetiapine.

Quetiapine can enhance the effects of some street drugs and has itself been abused for this purpose. Do not share your quetiapine with anyone else.

Quetiapine does not mix well with some other medicines and drugs.

Always talk to the doctor if you are taking other medicines. Tell the pharmacist you are taking quetiapine if you buy medicines (including things you put on your skin) for common illnesses.

Do not drink grapefruit juice while you are taking quetiapine, as it can increase the amount of drug absorbed from the gut.

Taking quetiapine may make you feel tired or dizzy, and may affect your eyesight when you start taking it.

This could affect you if you drive a car, ride a bike, or do anything else that needs a lot of focus. It might be best to stop doing these things for the first few days, until you know how it affects you.

Do not worry – most people drive as normal while taking quetiapine.

You must tell The DVLA (Driver and Vehicle Licensing Agency) if you have bipolar disorder, schizophrenia, schizoaffective disorder or other mental health conditions that could affect your driving.

You can be fined up to £1,000 if you do not tell DVLA about a medical condition that affects your driving.

You may be prosecuted if you are involved in an accident as a result.

Pregnancy

When deciding whether to take quetiapine during pregnancy it is important to weigh up how necessary quetiapine is to your health against the possible risks to you or your baby, some of which will depend on how many weeks pregnant you are.

Quetiapine is not seen as high risk and has a low rate of transfer across the placenta into a baby.

There does not appear to be an increased risk of malformations, miscarriages or having a baby born early.

From month four of a pregnancy onwards, an increase in dose of quetiapine may be required to keep body levels the same.

Quetiapine may slightly increase your chance of getting high blood pressure linked to pregnancy (pre-eclampsia), putting on extra weight and gestational (pregnancy-linked) diabetes.

To reduce the chance of a blood clot in your leg you may be advised to have a course of blood-thinning injections. Your doctor can advise you about this.

Post-natal

If you take quetiapine close to delivery your baby may have some side effects or discontinuation symptoms, like being irritable, crying or problems feeding and sleeping. These are usually mild and go away within a few days without treatment.

Breastfeeding

Quetiapine is passed in small amounts to the baby through breast milk. Breastfeeding may help with any discontinuation symptoms.

You should discuss the risks and benefits of breastfeeding with your midwife or doctor.

Remember that it is important for you to remain well while you are bonding with and looking after your baby. For this reason, it may be best to take medicine for your mental health when breastfeeding.

Make sure that your doctor, nurse, or health visitor checks your baby for any side effects.

If your baby was premature or has health problems, then you will need to be extra careful about taking medicines while breastfeeding. It may be best not to breastfeed if this is the case, but you should discuss this with your doctor or midwife.

Sex

Quetiapine can have side effects that might affect your sex life. These should pass within a couple of weeks. If not, go back and see your doctor as there are other medications you can try.  

Sexual side effects are rare but can include:

• not feeling like you want to have sex
• swelling of the breasts and (very rarely) some milk flow, regardless of gender
• changes to your period
• getting a painful erection that could last a long time (priapism). If this happens to you, seek medical advice immediately as it is dangerous

Fertility

There is nothing to suggest that quetiapine affects fertility.

Quetiapine is not a banned substance in sport.

It can, however, produce a false positive test for methadone or tricyclic antidepressants on a urine drug screen.

You could also feel very sleepy, have blurred vision, or feel less alert when you start taking it. This might affect your performance in sports where you need a lot of focus.

You should not participate in sports where you need to focus until you know how quetiapine affects you.

Do not worry – most people play sports as normal while taking quetiapine.

Try not to take quetiapine for the first time just before your exams.

You might feel very sleepy, have blurred vision or not feel as alert as usual.

You should talk to your doctor about any future exams if you are starting quetiapine.

You might decide together to delay starting it until you have done them.

If they are more than a month away, however, you might find that it is better to start quetiapine to improve your motivation to study.

Do not worry – most people take exams as normal while taking quetiapine.

Your doctor should know

Uses, warnings, safety and side effects of quetiapine

Taking quetiapine

How long will I need to take quetiapine for?

You and your doctor should talk about how long you need to take quetiapine before you start your treatment.

If you take quetiapine for mania, bipolar depression or schizophrenia you will probably take it for a few years, otherwise your old symptoms can come back.

If you stop the medicine, you will go back for checks to see that your old symptoms do not come back.

You should only take quetiapine as agreed with your doctor

Take your medicine at a regular time every day to get the best effect.

Make sure that you know your dose. If it is not written on the label, check with your pharmacist or doctor.

You will start with a low dose that your doctor will increase slowly to a dose that is effective for you. This may take several days or weeks.

You will usually take your dose once or twice a day.

It doesn’t matter what time you take it each day. Choose a time that you can always remember. This could be a mealtime, or when you brush your teeth.

You can take the ordinary tablets with or without food and they should be swallowed with a drink of water – the tablets have an unpleasant bitter taste if chewed.

The prolonged-release (long-acting) tablets should not be broken as they have a special system in them to deliver the medicine into your body slowly over a few hours.

You should take the prolonged-release (long-acting) tablets by swallowing them whole (do not chew or crush) with a glass of water on an empty stomach – one hour before food, or two hours after food.

What should I do if I miss a dose of quetiapine?

If you remember later during the day, take it as soon as possible.

If you forget to take it by your next dose, just take the next dose at the correct time. Do not try to catch up on missed doses.

Do not take a double dose.

What will happen if I forget to take my quetiapine?

If you forget to take your tablets for a few days, you may start getting your old symptoms back or some withdrawal symptoms. Talk to your doctor if this happens.

Stopping the use of quetiapine

Once you start taking an antipsychotic, the brain adjusts to having a new level of dopamine around.

If you stop taking the antipsychotic all at once, or reduce the dose too much all at once, the balance starts to change again. You could get your old symptoms back or experience unpleasant side effects including feeling or being sick, difficulty sleeping, headache, diarrhoea, feeling dizzy or irritable.

It is better to agree stopping with a doctor who will reduce your dose gradually over several weeks.

You will probably go for checks after you finish to see that your old symptoms have not come back.

Some people have thoughts about harming themselves or taking their own lives soon after they stop this medicine – you must go straight to a hospital if this happens to you.

Warnings and safety

Safety headlines

If you have taken more quetiapine than the dosage recommended by the doctor who prescribed it to you, you must get medical help immediately – even if you do not feel any different.

While taking quetiapine, some people may think about hurting themselves or taking their own lives. You must go straight to hospital with your tablets if you have any of these thoughts.

Quetiapine can sometimes cause serious side effects. Tell your doctor immediately if you experience unusual movements (mainly of the face or tongue).

Feeling a little dizzy or sleepy is common, particularly at the start of treatment. This usually passes, but if you feel very dizzy or excessively sleepy, contact your doctor. Go to hospital if you have a seizure (fit).

Quetiapine can in rare cases cause a long-lasting and painful erection (called priapism). If this happens, you will need to be treated in hospital.

In very rare cases, people have severe allergic reactions to quetiapine. Go to hospital if you have difficulty breathing, or swelling of your face or throat.

Quetiapine is not addictive, but stopping it suddenly can cause problems such as difficulty sleeping, feeling or being sick, headache, diarrhoea (loose poo), feeling dizzy or irritable. See you doctor if you want to stop, or if you are having these effects.

You might feel sleepy or dizzy, and not able to see properly, in the first few days after taking quetiapine. Do not drive a car, ride a bike or operate machines until you see how this affects you.

If you are pregnant, or thinking of becoming pregnant, please read the ‘pregnancy, post-natal and breastfeeding’ section under the ‘Side Effects’ tab, because quetiapine may affect the developing baby.

Side effects of quetiapine

Side effects of quetiapine

Not everyone will experience side effects with quetiapine, and most of the common side effects of this medication will go away or get better within a couple of weeks. If you think you have a side effect that has lasted longer than this, see your doctor to discuss possible alternatives to quetiapine.

Don’t stop taking quetiapine without consulting your doctor, as this can lead to withdrawal symptoms.

Very common side effects of quetiapine (affecting more than one in ten people) include:

• dizziness, which may lead to falls
• headache
• dry mouth
• feeling sleepy
• weight gain
• unusual muscle movements

Common side effects of quetiapine (affecting up to one in ten people) include:

• feeling like your heart is pounding, racing or skipping beats
• indigestion or constipation (having difficulty pooing)
• feeling weak
• swelling of the arms or legs
• high blood sugar
• blurred vision
• unusual dreams or nightmares
• increased appetite
• disturbances in speech or language
• thoughts of suicide or worsening of your depression
• shortness of breath
• being sick (mainly in older people)

Young people are more likely than adults to get the following side effects:

• having thoughts about hurting themselves or taking their own lives
• increased appetite
• higher blood pressure
• movement disorders
• higher levels of the hormone prolactin in the blood
• feeling irritable

Taking quetiapine

How long will I need to take quetiapine for?

You and your doctor should talk about how long you need to take quetiapine before you start your treatment.

If you take quetiapine for mania, bipolar depression or schizophrenia you will probably take it for a few years, otherwise your old symptoms can come back.

If you stop the medicine, you will go back for checks to see that your old symptoms do not come back.

You should only take quetiapine as agreed with your doctor

Take your medicine at a regular time every day to get the best effect.

Make sure that you know your dose. If it is not written on the label, check with your pharmacist or doctor.

You will start with a low dose that your doctor will increase slowly to a dose that is effective for you. This may take several days or weeks.

You will usually take your dose once or twice a day.

It doesn’t matter what time you take it each day. Choose a time that you can always remember. This could be a mealtime, or when you brush your teeth.

You can take the ordinary tablets with or without food and they should be swallowed with a drink of water – the tablets have an unpleasant bitter taste if chewed.

The prolonged-release (long-acting) tablets should not be broken as they have a special system in them to deliver the medicine into your body slowly over a few hours.

You should take the prolonged-release (long-acting) tablets by swallowing them whole (do not chew or crush) with a glass of water on an empty stomach – one hour before food, or two hours after food.

What should I do if I miss a dose of quetiapine?

If you remember later during the day, take it as soon as possible.

If you forget to take it by your next dose, just take the next dose at the correct time. Do not try to catch up on missed doses.

Do not take a double dose.

What will happen if I forget to take my quetiapine?

If you forget to take your tablets for a few days, you may start getting your old symptoms back or some withdrawal symptoms. Talk to your doctor if this happens.

Stopping the use of quetiapine

Once you start taking an antipsychotic, the brain adjusts to having a new level of dopamine around.

If you stop taking the antipsychotic all at once, or reduce the dose too much all at once, the balance starts to change again. You could get your old symptoms back or experience unpleasant side effects including feeling or being sick, difficulty sleeping, headache, diarrhoea, feeling dizzy or irritable.

It is better to agree stopping with a doctor who will reduce your dose gradually over several weeks.

You will probably go for checks after you finish to see that your old symptoms have not come back.

Some people have thoughts about harming themselves or taking their own lives soon after they stop this medicine – you must go straight to a hospital if this happens to you.

Warnings and safety

Safety headlines

If you have taken more quetiapine than the dosage recommended by the doctor who prescribed it to you, you must get medical help immediately – even if you do not feel any different.

While taking quetiapine, some people may think about hurting themselves or taking their own lives. You must go straight to hospital with your tablets if you have any of these thoughts.

Quetiapine can sometimes cause serious side effects. Tell your doctor immediately if you experience unusual movements (mainly of the face or tongue).

Feeling a little dizzy or sleepy is common, particularly at the start of treatment. This usually passes, but if you feel very dizzy or excessively sleepy, contact your doctor. Go to hospital if you have a seizure (fit).

Quetiapine can in rare cases cause a long-lasting and painful erection (called priapism). If this happens, you will need to be treated in hospital.

In very rare cases, people have severe allergic reactions to quetiapine. Go to hospital if you have difficulty breathing, or swelling of your face or throat.

Quetiapine is not addictive, but stopping it suddenly can cause problems such as difficulty sleeping, feeling or being sick, headache, diarrhoea (loose poo), feeling dizzy or irritable. See you doctor if you want to stop, or if you are having these effects.

You might feel sleepy or dizzy, and not able to see properly, in the first few days after taking quetiapine. Do not drive a car, ride a bike or operate machines until you see how this affects you.

If you are pregnant, or thinking of becoming pregnant, please read the ‘pregnancy, post-natal and breastfeeding’ section under the ‘Side Effects’ tab, because quetiapine may affect the developing baby.

Side effects of quetiapine

Side effects of quetiapine

Not everyone will experience side effects with quetiapine, and most of the common side effects of this medication will go away or get better within a couple of weeks. If you think you have a side effect that has lasted longer than this, see your doctor to discuss possible alternatives to quetiapine.

Don’t stop taking quetiapine without consulting your doctor, as this can lead to withdrawal symptoms.

Very common side effects of quetiapine (affecting more than one in ten people) include:

• dizziness, which may lead to falls
• headache
• dry mouth
• feeling sleepy
• weight gain
• unusual muscle movements

Common side effects of quetiapine (affecting up to one in ten people) include:

• feeling like your heart is pounding, racing or skipping beats
• indigestion or constipation (having difficulty pooing)
• feeling weak
• swelling of the arms or legs
• high blood sugar
• blurred vision
• unusual dreams or nightmares
• increased appetite
• disturbances in speech or language
• thoughts of suicide or worsening of your depression
• shortness of breath
• being sick (mainly in older people)

Young people are more likely than adults to get the following side effects:

• having thoughts about hurting themselves or taking their own lives
• increased appetite
• higher blood pressure
• movement disorders
• higher levels of the hormone prolactin in the blood
• feeling irritable

The information on this page was reviewed by the College of Mental Health Pharmacy in March 2020.

Visit the CMHP website

CMHP. College of Mental Health Pharmacy

Seroquel / Seroquel XR and associated names

Table of contents

• Overview
• Key facts
• All documents

Overview

On 22 May 2014, the European Medicines Agency completed a review of Seroquel and Seroquel XR. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).

Seroquel and Seroquel XR are antipsychotic medicines that contain the active substance quetiapine. They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). They are also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression. Seroquel XR can also be used as add-on treatment in major depression.

The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin. As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this affects signals transmitted between brain cells. Since these neurotransmitters are involved in schizophrenia, bipolar disorder and major depression, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

Seroquel is available as tablets (25, 100, 150, 200 and 300 mg) while Seroquel XR is available as prolonged-release tablets (50, 150, 200, 300 and 400 mg). Prolonged-release means that the active substance is released slowly from the tablet over a few hours. Seroquel and Seroquel XR are also marketed under other trade names. The company that markets these medicines is Astra Zeneca.

Seroquel and Seroquel XR are authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.

Seroquel and Seroquel XR were identified by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) as needing harmonisation.

On 12 June 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Seroquel and Seroquel XR in the EU.

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the use of the medicines, the CHMP agreed that Seroquel and Seroquel XR can continue to be used for the treatment of schizophrenia and treatment and prevention of bipolar disorder, but recommended harmonised wordings for these indications as follows:

• treatment of schizophrenia;
• treatment of moderate to severe manic episodes in bipolar disorder and major depressive episodes in bipolar disorder;
• prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.

Seroquel XR can also continue to be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.

4.2 Posology and method of administration

The CHMP also harmonised the dosing recommendations, particularly how to increase the dose and the recommended daily dose.

4.6 Fertility, pregnancy and lactation

Having reviewed the data available on the use of quetiapine during pregnancy, the CHMP concluded that no definite conclusion can be drawn on the risk of malformations in the unborn child when the medicine is used during early pregnancy (first trimester). Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks. Additionally, the data available show that newborns who were exposed to antipsychotics (including quetiapine) during late pregnancy (third trimester) are at risk of side effects including agitation, somnolence, breathing and feeding problems. Consequently, newborns should be monitored carefully.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use) and 4.8 (undesirable effects).

The amended information to doctors and patients is available in the ‘All documents’ tab.

The European Commission issued a decision on 6 August 2014.

Key facts

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview – lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e. g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

How useful was this page?

Add your rating

★

★

★

★

★

Average

★

★

★

★

★

Pharmacy on Minaev st.

Ò

&nbsp,

Trade name of the drug:

KETILEPTÒ

International non-proprietary name: quetiapine

Dosage form: film-coated tablets

Composition for 1 tablet.

Active ingredient: quetiapine fumarate, 28.78 mg, 115.13 mg, 172.70 mg, 230.26 mg and 345.40 mg, which corresponds to 25 mg, 100 mg, 150 mg, 200 mg , 300 mg quetiapine.

Excipients: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (type A), povidone K-90, magnesium stearate, colloidal silicon dioxide, anhydrous, film coating contains: hypromellose, titanium dioxide, lactose monohydrate, macrogol / PEG 3350, triacetin (triacetylglycerol). The shell of tablets 150 mg and 200 mg also contains iron dye yellow oxide and iron dye red oxide.

&nbsp,

Description:

&nbsp film-coated tablets 25 mg:

White or off-white, round, biconvex, film-coated tablets, debossed with the letter E on one side and the number 201 – on the other side of the tablet, odorless or almost odorless

100 mg film-coated tablets:

White or almost white, round biconvex film-coated tablets, engraved with the letter E and the number 202 on one side of the tablet , no or almost odorless

Film-coated tablets 150 mg:

Pink, round biconvex film-coated tablets, engraved with the letter E and the number 203 on one side of the tablet, odorless or almost odorless

900 59 Tablets &nbsp, film-coated 200 mg film-coated:

Dark pink, round biconvex film-coated tablets, engraved with the letter E and the number 204 on one side of the tablet, odorless or almost odorless

Tablets, film-coated 300 mg:

White or almost white, round biconvex film-coated tablets, engraved with the letter E and the number 205 on one side of the tablet, odorless or almost odorless 9 0007

&nbsp,

PHARMACOLOGICAL PROPERTIES

Mechanism of action

incidence of extrapyramidal symptoms and concomitant use of anticholinergics , drugs.

The effect of quetiapine on the 5HT receptors ₂ and D ₂ lasts up to 12 hours after taking the drug.

&nbsp,

Indications

CONTRAINDICATIONS

Pregnancy and lactation.

Pregnancy category: C. The safety and efficacy of quetiapine during pregnancy has not been established. &nbsp, Ketilept should not be used during pregnancy, unless the benefit to the mother outweighs the possible risk to the fetus.

Lactation period: It is not known whether quetiapine is excreted in human breast milk. Therefore, lactating women are advised to stop breastfeeding while taking Ketilept.

With caution – in patients with cardiovascular and cerebrovascular diseases or other conditions predisposing to arterial hypotension, advanced age, liver failure, history of seizures.

DOSAGE AND ADMINISTRATION

Adults:

Acute and chronic psychosis, including schizophrenia: the drug is prescribed 2 times a day.

The total daily dose for the first 4 days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4).

Starting on day 4, the usual effective daily dose of Ketilept is 300 to 450 mg/day.

Depending on the clinical effect and tolerability in each patient, the dose can be selected (varied) in the range from 150 mg to 750 mg per day.

The maximum recommended daily dose is 750 mg.

For the treatment of acute manic episodes in the structure of bipolar disorder: the drug is prescribed 2 times a day. The total daily dose in the first 4 days of therapy is 100 mg (day 1), 200 mg (day 2), 300 mg (day 3) and 400 mg (day 4). Further selection of the dose up to 800 mg per day by the 6th day is possible with an increase of no more than 200 mg per day. Depending on the clinical response and tolerability of each patient, the dose can be adjusted from 200 mg to 800 mg per day. The usual effective dose is in the range of 400 to 800 mg per day.

The maximum recommended daily dose is 800 mg/day.

For the treatment of depressive episodes in the structure of bipolar disorder: Ketilept is prescribed 1 time per day at night. The daily dose in the first 4 days of therapy is 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) and 300 mg (day 4). The recommended dose is 300 mg/day. The maximum recommended daily dose is 600 mg/day.

Elderly patients:

The recommended starting dose is 25 mg per day, and then the dose should be increased by 25-50 mg per day until an effective dose is reached, which is likely to be lower than in young patients.

Similarly, more careful dose titration and reduced doses are recommended for patients who are debilitated or susceptible to hypotensive reactions.

Children and adolescents:

The efficacy and safety of quetiapine in children and adolescents has not been established.

It is recommended to start therapy at 25 mg per day, then increase the dose by 25-50 mg daily until an effective dose is reached, depending on the patient’s clinical response and individual tolerance.

Maintenance therapy:

To maintain remission, it is advisable to use the lowest dose. Patients should be periodically examined to determine the need for maintenance therapy.

Resumption of an interrupted course of treatment in patients previously treated with quetiapine:

If therapy is resumed less than 1 week after discontinuation of Ketilept, the drug can be continued at a dose adequate for maintenance therapy. who have not received Ketilept for more than 1 week, you should follow the rules for the initial selection of the dose and establish the effective dose according to the clinical response of the patient.

SIDE EFFECTS

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

Based on the pooled data from clinical studies, the number of patients who discontinued the drug due to side effects is approximately the same in the placebo and quetiapine groups.

As with other antipsychotics, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, and peripheral edema have been reported with quetiapine.

Adverse events observed with the administration of quetiapine and classified by body systems are listed below in this order: very common &gt.1/10), common (&lt.1/10 and &gt.1/100), infrequent (&lt.1 /100 and &gt,1/1000), rare (&lt,1/1000), very rare (&lt,1/10,000).

Blood and lymph system

Frequent: leukopenia ³ . Uncommon: eosinophilia. Very rare: neutropenia ³ .

Immune system disorders

Uncommon: hypersensitivity.

Metabolism and nutrition

Frequent: increase in body weight ⁴ , increase in serum transaminases (ALT, AST) ⁵ . Very rare : hyperglycemia ^1.7 , diabetes mellitus ^1.7 .

Nervous system disorders

Very common: dizziness ^{1, 6} , drowsiness ² . Frequent: headache, anxiety, psychomotor agitation, tremor, syncope ^{1, 6} . Uncommon: epileptic seizures ¹ .

Cardiac dysfunction

Frequent: tachycardia ^{1, 6} .

Vascular disorders

Frequent: orthostatic hypotension ^{1, 6} .

Respiratory and thoracic and mediastinal disorders

Frequent: rhinitis, pharyngitis.

Gastrointestinal disorders

Frequent: dry mouth, constipation, diarrhoea, dyspepsia, abdominal pain.

Disorders of the reproductive organs and mammary glands

Rare: priapism.

General disorders and tissue conditions at the injection site

Frequent: slight asthenia, peripheral oedema. Rare : neuroleptic malignant syndrome ¹ .

Laboratory tests

Uncommon: increase in gamma-HT levels ⁵ , increase in postprandial triglycerides, increase in total cholesterol.

Other : back pain, chest pain, subfebrile condition, myalgia, dry skin, decreased visual acuity.

(1) See section “Special instructions and precautions for use”.

(2) Drowsiness may occur, especially during the first two weeks of treatment, which usually resolves with continued use of Ketilept.

(3) No cases of sustained severe neutropenia or agranulocytosis have been reported in controlled clinical trials with quetiapine. During the post-registration follow-up period, leukopenia and/or neutropenia resolved after discontinuation of quetiapine administration. Possible risk factors for leukopenia and/or neutropenia include a pre-existing decrease in the number of white blood cells and a history of drug-induced leukopenia and/or neutropenia.

(4) Weight gain is predominantly observed in the first weeks of treatment.

(5) Asymptomatic elevations in serum transaminases (ALT, AST) or gamma-HT have been noted in some patients during quetiapine administration. These increases usually resolved with continued administration of quetiapine.

(6) Like other antipsychotics with alpha-1-blocking activity, Ketilept can cause orthostatic hypotension with dizziness, tachycardia and (in some patients) syncope, especially during the initial period of dose selection. See section 4.4 “Special instructions and precautions for use”.

(7) In very rare cases, hyperglycemia and worsening of pre-existing diabetes have been noted while taking quetiapine.

Quetiamine has been associated with low-dose induced decreases in thyroid hormone levels (T ₄ and free T ₄ ). The maximum decrease occurred during the first two or four weeks of taking quetiapine, but with a long course of treatment, a further decrease did not occur. In almost all cases, discontinuation of quetiapine resulted in restoration of T9 levels.0106 4 and free T ₄ regardless of the duration of treatment.

A less significant decrease in T ₃ and reverse T ₃ was observed only at higher doses of quetiapine.

TSH and TSH (thyroxine-binding globulin) levels remained unchanged.

Clinically significant hypothyroidism was not detected.

As with other antipsychotics, quetiapine may cause QTc prolongation, but this effect was not consistent in clinical trials.

Reactions to abrupt discontinuation of the drug have been described (see Special Instructions).

&nbsp,

OVERDOSE

Data on quetiapine overdose are limited.

Treatment: There are no specific antidotes for quetiapine. In cases of serious intoxication, symptomatic therapy should be considered and measures aimed at maintaining respiratory function, the cardiovascular system, ensuring adequate oxygenation and ventilation are recommended.

Medical supervision should be continued until the patient has fully recovered.

& nbsp,

Interaction with other drugs

requires special care when prescribing the drug Ketilept in combination with other drugs acting on the central nerve system.

In vitro studies have shown that quetiapine and its 9 metabolites are weak in vivo inhibitors of cytochrome P450 (1A2, 2C9) mediated metabolic processes., 2C19, 2D6 and 3A4). CYP3A4 is the main enzyme involved in the P-450 mediated metabolism of quetiapine.

Effect of other drugs on Ketilept

Phenytoin: &nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, vetiapine in plasma, tk. phenytoin induces cytochrome P450 isoenzyme 3A4. The combination of quetiapine (250 mg three times a day) and phenytoin (100 mg twice a day) increased the mean clearance of quetiapine 5-fold after oral administration.

Increased doses of Ketilept or other liver enzyme inducers (eg, carbamazepine, barbiturates, rifampicin, or glucocorticoids) may be required to correct symptoms of schizophrenia in patients receiving concomitant quetiapine and phenytoin. &nbsp, In these cases, caution is required when discontinuing phenytoin and/or switching to valproate, which does not have enzyme-inducing properties.

Carbamazepine:&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, Co-administration with carbamazepine significantly increased the clearance of quetiapine, which reduced the systemic exposure of quetiapine. Due to this interaction, higher doses of Ketilept may be required.

P450 3A Inhibitors:&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,  rence quetiapine after oral administration by 84%, as a result of which the concentration of quetiapine in the blood plasma increased by an average of 235%. Therefore, caution is required when combining Ketilept with ketoconazole and other inhibitors of cytochrome P450, azole antifungals and macrolide antibiotics (for example, itraconazole, fluconazole and erythromycin), a corresponding reduction in the dose of quetiapine is necessary.

Cimetidine : &nbsp,&nbsp,&nbsp,&nbsp,&nbsp, Daily regular administration of cimetidine (400 mg three times a day for 4 days), which is a non-specific enzyme inhibitor, resulted in a 20% decrease in the mean clearance of quetiapine (150 mg three times a day) from plasma after oral administration. With the simultaneous use of Ketilept with cimetidine, there is no need to change the dose of Ketilept.

Thioridazine :&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, Thioridazine (200 mg 2 times a day) increased the clearance of quetiapine (300 mg 2 times a day) from plasma by 65% ​​after oral administration.

Risperidone and haloperidol: Combining quetiapine (300 mg twice daily) with the antipsychotic haloperidol (7.5 mg twice daily) or risperidone (3 mg twice daily) did not alter equilibrium pharmacokinetics of quetiapine.

Fluoxetine and imipramine: Combining quetiapine (300 mg twice daily) with the antidepressant and CYP3A4 and CYP2D6 inhibitor fluoxetine (60 mg once daily) or the known CYP2D6 inhibitor imipramine (75 mg twice daily) did not change equilibrium pharmacokinetics of quetiapine.

Influence of Ketilept on other medicinal products

Antipyrine: Multiple daily administration of quetiapine (up to 750 mg per day in three doses) did not cause clinically significant changes in the clearance of antipyrine or its metabolites. This indicates that quetiapine does not have a significant inhibitory effect on hepatic enzymes involved in the metabolism of antipyrine mediated by cytochrome P450.

Lithium : The combination of quetiapine (250 mg three times a day) with lithium did not affect any pharmacokinetic parameters of lithium at steady state.

Lorazepam : The mean clearance of lorazepam after oral administration (single dose of 2 mg) was reduced by 20% while taking quetiapine (250 mg 3 times a day).

Smoking did not affect plasma clearance of quetiapine.

Clinical studies have shown that quetiapine potentiates the cognitive and motor effects of alcohol in psychotic patients. Therefore, you should not drink alcohol during the course of treatment with Ketilept.

&nbsp,

Special instructions

Cardiovascular disease:

and cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. &nbsp,

Ketilept can cause orthostatic hypotension, especially in the initial period of dose adjustment, this occurs more often in elderly than in young patients.

There was no correlation between taking quetiapine and an increase in QT _from interval. However, when prescribing quetiapine concomitantly with drugs that prolong the QT interval _with , care must be taken, especially in the elderly.

Tardive dyskinesia:

Ketilept, like other antipsychotics, may cause tardive dyskinesia with prolonged use. If signs and symptoms of tardive dyskinesia occur, consider reducing the dose or discontinuing Ketilept.

Antipsychotic malignant syndrome may be associated with ongoing antipsychotic treatment. Clinical manifestations of the syndrome include hyperthermia, altered mental status, muscle rigidity, instability of the autonomic nervous system, and increased levels of creatine phosphokinase. In such cases, Quetiapine should be canceled and appropriate treatment should be carried out.

&nbsp,

Sudden withdrawal reactions:

Acute withdrawal symptoms, including nausea, vomiting, and insomnia, have been described in very rare cases after abrupt discontinuation of high doses of antipsychotics. Recurrence of symptoms of psychosis and the appearance of disorders associated with involuntary movements (akathisia, dystonia and dyskinesia) are possible. Therefore, if it is necessary to stop taking the drug, a gradual dose reduction is recommended.

Lactose intolerance:

When preparing a diet for patients with lactose intolerance, it should be taken into account that the film-coated tablets 25 mg, 100 mg, 150 mg, 200 mg and 300 mg contain lactose, respectively, 4.42 mg, 17.05 mg, 25.47 mg, 34.1 mg and 50.94 mg. This medicinal product should not be used in patients with rare hereditary problems of galactose intolerance, hereditary Saami lactose deficiency or glucose-galactose malabsorption syndrome.

Given that quetiapine mainly affects the central nervous system, quetiapine should be used with caution in combination with other drugs that have a depressant effect on the central nervous system or alcohol.

Influence on the ability to drive vehicles and mechanisms

Due to the effect on the central nervous system, Ketilept may cause drowsiness. Therefore, at the first stages of treatment, for an individually determined period of time, the patient should be prohibited from driving motor vehicles or dangerous mechanisms. In the future, the degree of restrictions should be set for each patient individually.

 

Presentation

Film-coated tablets 25, 100, 150, 200, 300 mg.

10 tablets in a PVC/PVDC/Al foil blister, 3 or 6 blisters in a carton box with instructions for use.

&nbsp,

Shelf life

5 years. Do not use after the expiry date stated on the package.

&nbsp,

Storage conditions

Store below 25°C.&nbsp, Keep out of reach of children.

&nbsp,

Holiday conditions

Available only by prescription , Moscow, st. Ivana Franko, 8, phone: (495) 363-39-66

&nbsp,

List of substances

14. Quetiapine (Quetiapine)

Sources:

– https://chembeyond.com/new/quetiapine.html

– https://bluelight.org/xf/threads/can-you-get-high-off-of-quetiapine-fumarate.893798/

– Jasdave S. Maan; Mona Ershadi; Israr Khan; Abdolreza Saadabadi, Quetiapine

– Evoy, K. E., Teng, C., Encarnacion, V. G., Frescas, B., Hakim, J., Saklad, S., & Frei, C. R. (2019). Comparison of Quetiapine Abuse and Misuse Reports to the FDA Adverse Event Reporting System With Other Second-Generation Antipsychotics. Substance Abuse: Research and Treatment, 13, 117822181984420. doi:10.1177/1178221819844205

Active ingredient: Quetiapine (Quetiapine)

Nomenclature name: 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)pi perazine -1-yl)ethoxy)ethan-1-ol

Molecular formula: C21h35N3O2S

Molecular weight: 383. 5

Russian Federation: Quetiapine traffic control has not been established.

Republic of Belarus: control over the circulation of Quetiapine has not been established.

Substance control status shown corresponds to the date the alert was created.

Quetiapine is a tetracyclic compound chemically similar to the benzodiazepine Clozapine.

Quetiapine is an antipsychotic drug for the treatment of schizophrenia, depression and bipolar disorder with sedative properties. It was developed by AstraZeneca in 1992-1996 with the improvement of first-generation antipsychotics. It was first approved by the FDA in 1997.

Quetiapine is used as an adjuvant in the treatment of Tourette’s syndrome. It is the most widely used drug for the treatment of psychosis in Parkinson’s disease due to the low likelihood of side effects. Quetiapine, like other neuroleptics, may lower the seizure threshold. When changing the drug, the dosage should be carefully and gradually reduced in order to avoid the withdrawal syndrome as much as possible, which may include symptoms such as anxiety: insomnia, increased sweating, nausea, vomiting and loss of appetite. An overdose of the drug leads to a sedative effect, arterial hypotension and tachycardia in most cases.

Quetiapine is a potent dopaminergic, serotonergic and adrenergic antagonist and a potent antihistamine with clinically insignificant anticholinergic properties. Quetiapine binds strongly to serotonin receptors; acts as a partial 5-HT1A receptor agonist. When taking quetiapine, the peak level of quetiapine is reached approximately 1.5 hours after administration, and the elimination half-life of quetiapine is 6 or 7 hours.

Quetiapine is sold by prescription in the US, Canada, UK and Austria under the trade names Quepin, Seroquel and Ketipinor.

Recreational use occurs, but not yet very widely and locally. The medical literature describes cases of abuse of quetiapine, which is due more to its sedative and anxiolytic effects (to help with sleep or “calm down”), rather than its antipsychotic properties. In addition to oral administration, the drug is sometimes taken intranasally by inhaling powdered tablets. By some estimates, up to 30% of US prisoners who sought psychiatric help feigned psychotic symptoms while trying to get Quetiapine. It is believed that this drug is more often abused in prisons than on the street.

A number of studies have indicated that in patients with a history or risk factors for substance use disorders, quetiapine may be more likely to abuse than other second-generation antipsychotics such as olanzapine, risperidone, aripiprazole.

The active recreational dose of Quetiapine ranges from 10 mg (mild) to 300 and above. Main effects: slow thinking, speech retardation, suppression of emotions, lack of anxiety, disinhibition, suppression of motivation, increased drowsiness.

In March 2023, a proposal to sell the Quetiapine compound as a new designer drug was recorded on one of the recreational products marketplaces. The compound is offered as a white powder with a purity of 98%.

The appearance of the medicinal substance Quetiapine in the illegal circulation is a recent trend – in the conditions of disturbed traffic flows, the list of recreational products is expanded due to the substances of the “gray market”.