Pronunciation:

droe-NAB-i-nol

Brand Names:

• Marinol
• Syndros

Dosage Forms:

• Solution
• Capsule, Liquid Filled

Classifications:

Therapeutic—

Antiemetic

Chemical—

Cannabinoid

Uses of This Medicine:

Dronabinol is used to prevent or treat nausea and vomiting that may occur after treatment with cancer medicines. It is used only when other kinds of medicine for nausea and vomiting did not work. This medicine is also used to increase appetite in patients with acquired immunodeficiency syndrome (AIDS).

This medicine is available only with your doctor's prescription.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of dronabinol have not been performed in children with AIDS-related anorexia (loss of appetite). Safety and efficacy have not been established.

Appropriate studies on the relationship of age to the effects of Syndros™ have not been performed in children with nausea and vomiting caused by cancer medicines. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Marinol® in children with nausea and vomiting caused by cancer medicines. However, because of this medicine's effects on brain function, it should be used with caution.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dronabinol in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving dronabinol.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Disulfiram
• Metronidazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Itraconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Alcohol abuse or dependence, history of or
• Drug abuse or dependence, history of—Dependence on dronabinol may develop.

• Allergy to alcohol, history of—Should not be used in patients with this condition.

• Bipolar disorder (manic or depressive illness), or history of or
• Heart disease or
• Hypertension (high blood pressure) or
• Schizophrenia (mental illness), or history of or
• Seizures, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. 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.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, or chew it.

If you are using the oral liquid:

• Measure the oral liquid with the marked oral dosing syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid.
• Take each dose with a full glass of water.
• If you are taking this medicine for treatment of nausea and vomiting caused by cancer medicines, take the first dose on an empty stomach, at least 30 minutes before a meal. After your first dose, you can take it with or without food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

• For oral dosage form (capsules):
  • For increasing appetite in patients with AIDS:
    • Adults and teenagers—At first, 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 per day.
    • Children—Use and dose must be determined by your doctor.
  • For nausea and vomiting caused by cancer medicines:
    • Adults and teenagers—Dose is based on body surface area and must be determined by your doctor. 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 oral dosage form (solution):
  • For increasing appetite in patients with AIDS:
    • Adults—At first, 2.1 milligrams (mg) two times a day, taken 1 hour before lunch and 1 hour before dinner. Your doctor may gradually increase your dose as needed and tolerated. However, the dose is usually not more than 8.4 mg two times a day.
    • Older adults—At first, 2.1 mg once a day, taken 1 hour before dinner or at bedtime. Your doctor may gradually increase your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of nausea and vomiting caused by cancer medicines:
    • Adults—Dose is based on body surface area and must be determined by your doctor. The dose is usually 4.2 milligrams (mg) per square meter (m[2]) taken 1 to 3 hours before chemotherapy and then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day. Your doctor may gradually increase your dose as needed and tolerated. However, the dose is usually not more than 12.6 mg/m[2] per dose for 4 to 6 doses per day.
    • Older adults—Dose is based on body surface area and must be determined by your doctor. The dose is usually 2.1 milligrams (mg) per square meter (m[2]) taken 1 to 3 hours before chemotherapy.
    • 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. 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—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may keep the opened bottle of oral liquid at room temperature. Throw away any unused medicine 28 days after opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Do not take this medicine if you are also using disulfiram (Antabuse®) or metronidazole (Flagyl®) within the past 14 days. Do not use disulfiram or metronidazole within 7 days after treatment with Syndros™.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant 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 allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), 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, 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 develop any unusual or strange thoughts and behavior while using dronabinol, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol.

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.

Tell your doctor right away if you have a new or worsening nausea, vomiting, or stomach pain after taking Syndros™.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

Less common

Changes in mood

confusion

delusions

fast or pounding heartbeat

feelings of unreality

loss of memory

mental depression

nervousness or anxiety

problems with memory

seeing, hearing, or feeling things that are not there

Rare

Blurred vision

chills

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

unusual tiredness or weakness

Incidence not known

Fainting

feeling of warmth

hives or rash

redness of the face, neck, arms, and occasionally, upper chest

seizures

sores in the mouth

swelling of the lips

tightness in the throat

trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Being forgetful

change in how fast you think time is passing

change in your sense of smell, taste, sight, sound, or touch

constipation

decrease in motor coordination

drowsiness (severe)

dryness of the mouth (severe)

false sense of well-being

feeling sluggish

panic reaction

problems in urinating

redness of the eyes

seizures

slurred speech

unusual drowsiness or dullness

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Clumsiness or unsteadiness

dizziness

drowsiness

false sense of well-being

nausea

trouble with thinking

vomiting

Less common or rare

Abdominal or stomach pain

flushing of the face

lack or loss of strength

restlessness

Rare

Burning, dry, or itching eyes

continuing ringing or buzzing or other unexplained noise in the ears

cough

diarrhea

discharge, excessive tearing

headache

hearing loss

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

runny nose

sneezing

stuffy nose

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.