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Olanzapine (Systemic)


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Olanzapine (Systemic)

US Brand Names

• Zyprexa

• Zyprexa IntraMuscular

• Zyprexa Zydis

Description

Olanzapine (oh-LAN-za-peen) is used to treat psychotic mental disorders, such as schizophrenia, bipolar disorder, and agitation that occurs with schizophrenia and bipolar mania.

This medicine is available only with your doctor's prescription, in the following dosage form:

    Oral

    • Oral disintegrating tablets (U.S.)

    • Tablets (U.S.)

    Parenteral

    • Injection (U.S.)

Special Considerations

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For olanzapine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to olanzapine. Tell your doctor if you are phenylketonuric and can not take phenylalanine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy

Olanzapine has not been studied in pregnant women. A few women have become pregnant during treatment with this medicine; some pregnancies were normal and some resulted in miscarriages. Olanzapine crosses the placenta in animals and has been shown to cause a decrease in the number of successful births. You should tell your doctor if you become pregnant or intend to become pregnant during treatment with olanzapine.

Breast-feeding

It is not known whether olanzapine passes into human breast milk. However, it does pass into the milk of animals. In general, breast-feeding is not recommended during treatment with olanzapine.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of olanzapine in children up to 18 years of age with use in other age groups.

Older adults

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, it is removed from the body more slowly in older people and they may need a lower dose of this medicine.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Many different medicines can increase the chance that you will develop unwanted effects while taking olanzapine. These effects include liver problems, heat stroke, drowsiness, constipation, and dizziness or fainting when getting up from a lying or sitting position . When you are taking olanzapine, it is especially important that your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems

The presence of other medical problems may affect the use of olanzapine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Alzheimer's disease-Risk of aspiration pneumonia and convulsions (seizures) may be increased

    • Aspiration pneumonia, risk or history of-may increase risk of adverse events

    • Breast cancer (or history of)-Certain types of breast cancer may be worsened

    • Convulsions (seizures) (existing or history of)-Olanzapine has been reported to cause seizures rarely

    • Dehydration or

    • Exposure to extreme heat or

    • Strenuous exercise-Increased risk of heat stroke because olanzapine affects the body's ability to cool itself

    • Diabetes or family history of diabetes-May make condition worse and cause serious side effects

    • Enlarged prostate or

    • Glaucoma, narrow-angle or

    • Paralytic ileus (severe intestinal problem) (history of)-May be worsened

    • Heart or blood vessel disease, including previous heart attack or

    • Poor circulation to the brain-Low blood pressure may be worsened or may make these conditions worse

    • Liver disease-Olanzapine can cause liver problems

Administration

Take this medicine only as directed by your doctor in order to improve your condition as much as possible. Do not take more of it and do not take it more often than your doctor ordered.

Olanzapine may be taken with or without food, on a full or an empty stomach. If your doctor tells you to take it a certain way, follow your doctor's instructions.

Dosing

The dose of olanzapine will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of olanzapine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

    • For oral dosage form (orally disintegrating tablets and tablets):

      o For treatment of psychotic disorders, including bipolar disorder and schizophrenia:

        Adults-At first, 5 to 10 milligrams (mg) once a day. This dose may be changed to a higher or lower dose by your doctor as needed.

        Children up to 18 years of age-Use and dose must be determined by your doctor.

    • For parenteral dosage form (intramuscular injection)

      o For treatment of agitation that occurs with schizophrenia or bipolar mania:

        Adults-At first, 10 mg per dose. This dose may be changed to a higher or lower dose by your doctor as needed.

        Children-Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible if you remember it the same day. However, if you don't remember until the next day, skip the missed dose and return to your regular dosing schedule. Do not double doses.

Storage

To store this medicine:

    • Keep out of the reach of children.

    • Store away from heat and direct light.

    • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

    • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions

It is important that your doctor check your progress at regular visits , to allow for changes in your dose and help reduce any side effects.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Olanzapine may cause drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke.

Olanzapine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth feels dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

Agitation; behavior problems; difficulty in speaking or swallowing; restlessness or need to keep moving; stiffness of arms or legs; trembling or shaking of hands and fingers.

Less common

Blurred vision; chest pain; fever; flu-like symptoms; headache; inability to move eyes; itching of the vagina or genital area; lip smacking or puckering; mood or mental changes, such as anger, anxiety, giddiness, loss of memory, or nervousness; muscle spasms of face, neck, and back; muscle twitching or jerking; nervousness; pain during sexual intercourse; pounding in the ears; puffing of cheeks; rapid or worm-like movements of tongue; rhythmic movement of muscles; slow or fast heartbeat; swelling of feet or ankles; thick, white vaginal discharge with no odor or with a mild odor; twitching movements; twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs; uncontrolled chewing movements; uncontrolled jerking or twisting movements of hands, arms and legs; uncontrolled movements of lips, tongue, or cheeks; unusual or incomplete body or facial movements.

Rare

Changes in menstrual period; confusion; extra heartbeat; mental or physical sluggishness; skin rash; swelling of face; trouble in breathing.

Incidence not known

Bloating; cough; constipation; darkened urine; diabetic coma; difficulty swallowing; hives; indigestion; itching skin; itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of appetite; nausea; pain in stomach, side, or abdomen, possibly radiating to the back; painful or prolonged erection of the penis; redness of skin; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; vomiting; wheezing; yellow eyes or skin.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Acid or sour stomach; belching; change in walking and balance; clumsiness; constipation; difficulty in speaking; dizziness; dizziness or fainting when getting up suddenly from a lying or sitting position; drowsiness; dryness of mouth; headache; heartburn; runny nose; sleepiness or unusual drowsiness; stomach discomfort, upset, or pain; unsteadiness; vision problems; weakness; weight gain.

Less common or rare

Abdominal pain; awareness of heartbeat; blemishes on the skin; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; changes in vision; cramps; decrease in sexual desire; double vision; fast heartbeat; heavy bleeding; increased appetite; increased cough; increased sensitivity of skin to sunlight; joint pain; lack of feeling or emotion; low blood pressure; nausea; pain in arms or legs; pimples; sore throat; stuttering; sweating; thirst; tightness of muscles; trouble in controlling urine; trouble in sleeping; uncaring; vomiting; watering of mouth; weight loss.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

June 17, 2004

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