Drug Notebook

FDA Alerts

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.

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quetiapine
(kwe TYE a peen)

What is quetiapine?
Quetiapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain. Quetiapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). Quetiapine may also be used for purposes other than those listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Seroquel 100MG Tablets ASTRAZENECA60/$228.46 or 180/$664.76
Seroquel 200MG Tablets ASTRAZENECA60/$428.65 or 180/$1243.55
Seroquel 25MG Tablets ASTRAZENECA60/$137.08 or 180/$392.71
Seroquel 300MG Tablets ASTRAZENECA60/$594 or 180/$1718.95
Seroquel 400MG Tablets ASTRAZENECA30/$363.26 or 90/$983.23
Seroquel 50MG Tablets ASTRAZENECA100/$365.55 or 300/$1090.05

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What are the possible side effects of quetiapine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Other serious side effects include:

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

  • jerky muscle movements you cannot control;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • increased thirst, frequent urination, excessive hunger, or weakness;

  • feeling like you might pass out; or

  • urinating less than usual or not at all.

Less serious side effects may include:

  • dizziness, drowsiness, or weakness;

  • dry mouth, runny nose, sore throat;

  • nausea, vomiting, stomach pain, constipation;

  • blurred vision, headache, anxiety, agitation;

  • breast swelling or discharge;

  • missed menstrual periods; or

  • weight gain.

This is not a complete list side effects and others may occur. Tell your doctor about unusual or bothersome side effect.

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How should I take quetiapine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Take each dose with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time. To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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What is the most important information I should know about quetiapine?
Quetiapine is not for use in psychotic conditions that are related to dementia. Quetiapine has caused fatal pneumonia or heart failure in older adults with dementia-related conditions. Stop using quetiapine and call your doctor at once if you have the following symptoms: fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, uncontrolled muscle movements, symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect quetiapine?
Before taking quetiapine, tell your doctor if you are taking any of the following medicines: cimetidine (Tagamet); lorazepam (Ativan); rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater); steroids (prednisone and others); thioridazine (Mellaril); an antibiotic such as erythromycin (E-Mycin, E.E.S, Ery-Tab), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox); medicine for depression or mental illness, such as fluoxetine (Prozac), haloperidol (Haldol), imipramine (Tofranil), or risperidone (Risperdal);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Quetiapine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryo, fetal, and maternal toxicity. There are no controlled data in human pregnancy. The drug should only be given during pregnancy when benefit outweighs risk.

There have been several case reports of women giving normal birth to healthy infants following exposure to quetiapine throughout pregnancy.

Quetiapine is excreted into human milk. The manufacturer has recommended that women receiving this drug should not breast-feed.

In 1 case report, the mean milk quetiapine concentration was 41 mcg/L and the milk:plasma ratio was 0.29 in a mother receiving 400 mg of quetiapine daily. The relative infant dose was 0.09% of the maternal weight- adjusted dose. The infant plasma quetiapine concentration was 1.4 mcg/L which was equivalent to 6% of the maternal plasma level. No adverse effects were observed in the infant. Results of a small case series suggest that at quetiapine dosing levels of 75 mg daily or less, the amount of drug excreted into breast milk may be below detectable levels. Assuming an average infant ingests 150 mL/kg/day of breast milk and using an average milk concentration of quetiapine over 6 hours an exclusively breastfed infant ingests approximately 0.09% of the weight- adjusted maternal dose. Based on these calculations, the maximum dose an infant would ingest is approximately 0.43% of the weigh- adjusted maternal dose. The average milk concentration of quetiapine over 6 hours was approximately 14 mcg/L and the maximum concentration was approximately 62 mcg/L at 1 hours. Levels of quetiapine rapidly decreased to predose levels within approximately 2 hours. There are 2 case reports of healthy infants of breastfed mothers receiving quetiapine.

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Who should NOT use this medication?

  • Known hypersensitivity to quetiapine or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include extreme drowsiness, fast heart rate, feeling light-headed, or fainting.

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What should I discuss with my healthcare provider before taking quetiapine?
Quetiapine is not for use in psychotic conditions that are related to dementia. Quetiapine has caused fatal pneumonia or heart failure in older adults with dementia-related conditions. Before you take quetiapine, tell your doctor if you have: liver or kidney disease; heart disease, high blood pressure, heart rhythm problems; a history of heart attack or stroke; a thyroid disorder; seizures or epilepsy; high cholesterol or triglycerides; a personal or family history of diabetes; or trouble swallowing.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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