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|Marinol

DRONABINOL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Marinol

In Canada—

• Marinol

Another commonly used name is delta-9-tetrahydrocannabinol (THC) .

Category

• Antiemetic
• appetite stimulant

Description

Dronabinol (droe-NAB-i-nol)is used to prevent the nausea and vomiting that may occur after treatment with cancer medicines. It is used only when other kinds of medicine for nausea and vomiting do not work. Dronabinol is also used to increase appetite in patients with acquired immunodeficiency syndrome (AIDS).

Dronabinol is available only with your doctor"s prescription. Prescriptions cannot be refilled, and you must obtain a new prescription from your doctor each time you need this medicine. It is available in the following dosage form:

• Oral
• Capsules (U.S. and Canada)

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 dronabinol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dronabinol, marijuana products, or sesame oil. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. However, studies in animals have shown that dronabinol, given in doses many times the usual human dose, increases the risk of death of the fetus and decreases the number of live babies born.

Breast-feeding—Dronabinol passes into human breast milk. There is a possibility that serious unwanted effects may occur in the nursing infant.

Children—Although there is no specific information comparing use of dronabinol in children with use in other age groups, the effects that this medicine may have on the mind may be of special concern in children. Children should be watched closely while they are taking this medicine.

Older adults—This medicine has been tested in a limited number of patients up to 82 years of age and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, the effects this medicine may have on the mind may be of special concern in the elderly. Therefore, older people should be watched closely while they are taking 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. When you are taking dronabinol, it is especially important that your health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with dronabinol may increase the CNS depressant effects

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

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on dronabinol may develop

• Bipolar disorder (manic or depressive states) or
• Heart disease or
• High blood pressure (hypertension) or
• Severe mental illness—Dronabinol may make the condition worse

Proper Use of This Medicine

Take this medicine only as directed by your physician . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may lead to medical problems because of an overdose.

Dosing—The dose of dronabinol 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 dronabinol. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking dronabinol .

• For oral dosage form (capsules):
  • For nausea and vomiting caused by cancer medicines:
    • Adults and teenagers—Dose is based on body surface area. Your doctor will tell you how much medicine to take and when to take it.
    • Children—Dose is based on body surface area and must be determined by your doctor.
  • For increasing appetite in patients with AIDS:
    • Adults and teenagers—To start, 2.5 milligrams (mg) two times a day, taken before lunch and supper. Your doctor may change your dose depending on your condition. However, the dose is usually not more than 20 mg a day.
    • 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 you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses .

Storage—To store this medicine:

• Keep out of the reach of children. Overdose is very dangerous in young children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep this medicine in the refrigerator but keep it from freezing.
• 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

Dronabinol will add to the effects of alcohol and other 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 medicines including other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine .

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded .

Dizziness, lightheadedness, or fainting may occur , especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

If you think you or someone else may have taken an overdose of dronabinol, get emergency help at once . Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to severe mental effects. Signs of overdose include changes in mood, confusion, hallucinations, mental depression, nervousness or anxiety, and fast or pounding heartbeat.

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: 01/06/2003

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