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Mylan-Quetiapine

Common Name

quetiapine

How does this medication work? What will it do for me?

Quetiapine belongs to a class of medications known as antipsychotics. It is used to treat symptoms of schizophrenia, manic episodes associated with bipolar disorder, and depressive episodes associated with bipolar disorder. It works by affecting the actions of certain chemicals in the brain known as neurotransmitters.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

25 mg
Each peach coloured, round, biconvex, film-coated tablet engraved "Q" on one side contains quetiapine fumarate equivalent to 25 mg. Nonmedicinal ingredients: calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate; coating: opadry pink polyethylene glycol, hypromellose, iron oxide red, and titanium dioxide.

100 mg
Each yellow, round biconvex, film-coated tablet engraved "Q" over "100" on one side contains quetiapine fumarate equivalent to 100 mg. Nonmedicinal ingredients: calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate; coating: opadry yellow polyethylene glycol, hypromellose, iron oxide yellow, talc, and titanium dioxide.

200 mg
Each white, round, biconvex, film-coated tablet engraved "Q" over "200" on one side contains quetiapine fumarate equivalent to 200 mg. Nonmedicinal ingredients: calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate; coating: opadry white polyethylene glycol, hypromellose, polysorbate, and titanium dioxide.

300 mg
Each white, capsule shaped, biconvex, film-coated tablet engraved "Q" over "300" on one side contains quetiapine fumarate equivalent to 300 mg. Nonmedicinal ingredients: calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate; coating: opadry white polyethylene glycol, hypromellose, polysorbate, and titanium dioxide.

How should I use this medication?

The usual recommended starting dose for schizophrenia is 25 mg twice daily. Quetiapine is usually started with a low dose in order to allow the body to get used to it. This dose is increased as tolerated to a target dose of 150 mg twice daily. No more than 400 mg twice daily should be taken as the safety of higher doses has not been established.

For manic episodes associated with bipolar disorder, the recommended starting dose is 50 mg twice daily. This dose is increased up to 400 mg twice daily as tolerated. Most people respond to doses between 200 mg and 400 mg twice daily.

For depressive episodes associated with bipolar disorder, the recommended starting dose is 50 mg once daily, usually at bedtime. This dose is increased to 300 mg once daily as tolerated.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Quetiapine can be taken with or without food. Do not stop taking this medication or change the time of the day you take it without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor to ensure that you are getting the maximum benefit from the medication. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Quetiapine should not be taken by anyone who is allergic to quetiapine or to any of the ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• dizziness
• drowsiness
• dry mouth
• feeling of fast or irregular heartbeat
• headache
• indigestion or upset stomach
• lightheadedness or dizziness when rising from a lying or sitting position
• stuffy or runny nose
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• abnormal dreams
• blurred vision
• confusion
• difficult or unusually fast breathing
• increased sweating
• loss of balance control
• loss of bladder control
• problems swallowing
• severe muscle stiffness
• signs of infection (such as fever, chills, muscle aches, or sore throat)
• skin rash
• slowed movements
• swelling of feet or lower legs
• trembling and shaking of hands and fingers
• unusually pale skin
• unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• fainting
• seizures (e.g., loss of consciousness with uncontrollable shaking)
• symptoms of an allergic reaction (shortness of breath or difficulty breathing; hives; swelling of the eyes, mouth, lips, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Blood cholesterol: Quetiapine has been associated with increased blood cholesterol levels. Talk to your doctor if you have any concerns. People with elevated blood cholesterol levels should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Cataracts: Changes in the lens of the eye may develop with long-term use of quetiapine. Regular eye exams are recommended before and after treatment with this medication. If you notice any change in your vision, contact your physician as soon as possible.

Diabetes: A risk of aggravating preexisting diabetes has been linked to quetiapine and other antipsychotic medications. If you have diabetes, discuss this link with your doctor. People with diabetes or people at risk for diabetes (e.g., family history of diabetes, obesity) should discuss with their doctor how this medication may affect their medical condition and whether any special monitoring is needed.

Drowsiness/reduced alertness: Quetiapine may cause dizziness and drowsiness. People taking quetiapine should avoid operating hazardous machinery (including cars) until they are certain that the medication does not impair their mental alertness, judgment, or physical coordination.

Heart conditions: People with certain heart conditions such as angina, heart failure, and irregular heartbeat, and people who have had a heart attack should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney problems: People with moderate or severe kidney failure should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: People with moderate or severe liver failure should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Quetiapine may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. Because this medication can cause dizziness or lightheadedness, do not get up too quickly after you have been sitting or lying for prolonged periods.

Movement disorders: There is a risk of developing tardive dyskinesia (TD), a condition where repetitive, uncontrollable, and purposeless movements (such as grimacing; tongue protrusion; lip smacking; puckering; rapid eye blinking; rapid movements of the arms, legs, and body trunk). If you experience any of these symptoms, contact your doctor immediately.

Neuroleptic malignant syndrome (NMS): A risk of developing this condition has been associated with antipsychotic medications, including quetiapine. If you experience increased sweating and sensations of warmth, muscle stiffness, emotional and behavioural changes, or irregular heartbeat, contact your doctor immediately. People taking this medication should take care to avoid becoming overheated or dehydrated.

Seizures: People with a history of seizures should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may cause side effects. A gradual reduction in dose over a period of time is recommended. If you are thinking of stopping the medication, check with your doctor first.

Suicidal or agitated behaviour: Adults and children taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking this medication.

Pregnancy: The safety of quetiapine use during pregnancy is not known. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if quetiapine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and efficacy of this medication have not been established for children under 18 years of age.

Seniors: There may be a higher risk of strokes, heart attacks, and deaths associated with the use of antipsychotic medications by seniors. Talk to your doctor about the risks and benefits of using this medication. If you notice the following signs and symptoms, get medical attention immediately:

• signs of a stroke: sudden weakness or numbness in the face, arms or legs (often on one side of the body); speech problems; vision problems; balance problems or dizziness; confusion; sudden severe headache with no known cause
• signs of a heart attack: discomfort or pain in the chest, back, neck, jaw, arms, or stomach; sweating; shortness of breath; nausea; lightheadedness; feeling of impending doom.

What other drugs could interact with this medication?

There may be an interaction between quetiapine and any of the following:

alcohol amantadine anti-HIV medications (e.g., delaviridine, indinabir, lopinavir, ritonavir) antihypertensives (e.g., diltiazem, verapamil) antiseizure medications (e.g., carbamazepine, divalproex, phenobarbital, phenytoin) atypical antipsychotics (e.g., risperidone, ziprasidone) "azole" antifungal medications (e.g., fluconazole, ketoconazole) bromocriptine certain antihistamines (e.g., chlorpheniramine, dimenhydrinate diphenhydramine) divalproex domperidone

dopamine agonists (e.g., pramipexole, ropinirole) fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin) levodopa lithium macrolide antibiotics (e.g.,azithromycin, clarithromycin, erythromycin) metoclopramide opioid pain relievers (e.g., codeine, morphine, oxycodone) pimozide quinine quinidine nefazodone rifampin SSRI antidepressants (e.g., citalopram, fluoxetine) thioridazine tricyclic antidepressants (e.g., amitriptyline, desipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material © 1996-2013 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.