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|Zyprexa IntraMuscular

OLANZAPINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Zyprexa
• Zyprexa IntraMuscular
• Zyprexa Zydis

† Not commercially available in Canada.

Category

• Antipsychotic

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 should NOT be used to treat behavioral problems in older adult patients who have dementia.

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.)

Before Using This Medicine

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. This medicine should not be used for behavioral problems in older adults with dementia.

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

Proper Use of This Medicine

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):
  • 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)
  • 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 While Using This Medicine

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 of This Medicine

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:

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:

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

Revised: 04/18/2005

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