• Seroquel Full Prescribing Information
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Patient Information Overview

Pronounced: SER-oh-kwell
Generic name: Quetiapine fumarate
Category: Antipsychotic Medication

Why is this drug prescribed?

Seroquel combats the symptoms of schizophrenia, a mental disorder marked by delusions, hallucinations, disrupted thinking, and loss of contact with reality. It is the first in a new class of antipsychotic medications. Researchers believe that it works by diminishing the action of dopamine and serotonin, two of the brain's chief chemical messengers.

Most important fact about this drug

Seroquel may cause tardive dyskinesia--a condition characterized by uncontrollable muscle spasms and twitches in the face and body. This problem can be permanent, and appears to be most common among older adults, especially women.

How should you take this medication?

Your doctor will increase your dose gradually until the drug takes effect. If you stop Seroquel for more than 1 week, you'll need to build up to your ideal dosage once again.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...

Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Seroquel.

• More common side effects may include: Abdominal pain, constipation, diminished movement, dizziness, drowsiness, dry mouth, excessive muscle tone, headache, indigestion, low blood pressure, nasal inflammation, neck rigidity, rapid heartbeat, rash, tremor, uncontrollable movements, weakness
• Less common side effects may include: Back pain, cough, difficulty breathing, difficulty speaking, ear pain, fever, flu, loss of appetite, palpitations, sore throat, sweating, swelling, weight gain
• Rare side effects may include: Abnormal dreams, abnormal ejaculation, abnormal vision, abnormal gait, abnormal thinking, acne, alcohol intolerance, amnesia, arthritis, asthma, bleeding gums, bone pain, bruising, chills, confusion, conjunctivitis (pinkeye), dehydration, delusions, diabetes, difficulty swallowing, dry eyes, ear ringing, eczema, eye pain, face swelling, fungal infection, gas, gum inflammation, hallucinations, heavy menstruation, hemorrhoids, impotence, increased appetite, increased sex drive, increased salivation, irregular pulse, itching, jerky or irregular movement, joint pain, lack of emotion, lack of coordination, leg cramps, loss of menstruation, low blood sugar, manic reaction, migraine, mouth sores, muscle weakness, neck pain, nosebleeds, painful menstruation, painful urination, paralysis, paranoia, pelvic pain, pneumonia, rash, rectal bleeding, seborrhea, sensitivity to light, skin inflammation or ulcer, slow heart rate, stomach and intestinal inflammation, stupor, swollen testicles, taste disturbances, teeth grinding, thirst, tongue swelling, twitching, uncontrollable bowel movements, underactive thyroid, urinary frequency or incontinence, urinary retention, urinary tract infection, vaginal bleeding, vaginal inflammation, vaginal yeast infection, vertigo, weight loss

Why should this drug not be prescribed?

If Seroquel gives you an allergic reaction, you will not be able to use this drug.

Special warnings about this medication

If you develop muscle stiffness, confusion, irregular or rapid heartbeat, excessive sweating, and high fever call your doctor immediately. These are signs of a serious--and potentially fatal--reaction to the drug. Be especially wary if you have a history of heart attack, heart disease, heart failure, circulation problems, or irregular heartbeat.

Particularly during the first few days of therapy, Seroquel can cause low blood pressure, with accompanying dizziness, fainting, and rapid heartbeat. To minimize these effects, your doctor will increase your dose gradually. If you are prone to low blood pressure, take blood pressure medication, or become dehydrated, use Seroquel with caution.

Seroquel also tends to cause drowsiness, especially at the start of therapy, and can impair your judgment, thinking, and motor skills. Until you are certain of the drug's effect, use caution when operating machinery or driving a car.

If you are having problems with your vision, tell your doctor. There is a chance that Seroquel may cause cataracts, and you may be asked to see an eye doctor when you start Seroquel therapy, and every 6 months thereafter.

Seroquel poses a very slight risk of seizures, especially if you are over 65, or have epilepsy or Alzheimer's disease. The drug can also suppress an underactive thyroid, and generally causes a minor increase in cholesterol levels. There is also a remote chance that it will trigger a prolonged and painful erection.

Other antipsychotic medications have been known to interfere with the body's temperature-regulating mechanism, causing patients to overheat. Although this problem has not occurred with Seroquel, caution is still advisable. Avoid exposure to extreme heat, strenuous exercise, and dehydration.

Possible food and drug interactions when taking this medication

Seroquel increases the effects of alcohol. Avoid alcoholic beverages while on Seroquel therapy.

If Seroquel is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Seroquel with the following:

• Barbiturates such as phenobarbital
• Carbamazepine (Tegretol)
• Cimetidine (Tagamet)
• Erythromycin (Eryc, Ery-Tab)
• Fluconazole (Diflucan)
• Itraconazole (Sporanox)
• Ketoconazole (Nizoral)
• Levodopa (Laradopa, Sinemet)
• Lorazepam (Ativan)
• Phenytoin (Dilantin)
• Rifampin (Rifadin, Rifamate, Rimactane)
• Steroid medications such as hydrocortisone and prednisone
• Thioridazine (Mellaril)

Special information if you are pregnant or breastfeeding

The possibility of harm to a developing baby has not been ruled out. You should take Seroquel during pregnancy only if the benefits outweigh this potential risk. Notify your doctor as soon as you become pregnant or decide to become pregnant.

It is not known whether Seroquel appears in breast milk, and breastfeeding is not recommended.

Recommended dosage

ADULTS

On the first day of therapy, you'll take 2 doses of 25 milligrams each. On the second and third day, doses are usually increased by 25 to 50 milligrams apiece. Frequency may be increased to 3 times daily. Long-term, the usual dosage is 300 to 400 milligrams a day, taken as 2 or 3 smaller doses. Doses as low as 150 milligrams a day sometimes prove effective, and daily dosage rarely exceeds 750 milligrams. Doses of 800 milligrams or more per day have not been tested for safety.

Dosage is increased more gradually--and is maintained at a lower level--for older adults, those with liver disease, those prone to low blood pressure reactions, and the debilitated.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical help immediately.

• Symptoms of Seroquel overdose may include: Dizziness, drowsiness, fainting, rapid heartbeat

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Reviewed: 01/2006