Dronabinol

What Is a Typical Dose of Marinol?

Marinol comes in the form of soft gelatin capsules that you take by mouth. The capsules come in three different strengths: 2.5 milligrams (mg), 5 mg, and 10 mg.

The right dose for you depends on your condition and how you respond to the medication. Your doctor will likely start you on a low dose and may gradually increase it. If you develop side effects that do not go away in a few days, your doctor may reduce your dose.

When you take Marinol to treat nausea and vomiting caused by chemotherapy, you'll usually take a dose one to three hours before chemotherapy. You can also take it two to four hours after chemotherapy. The maximum doesn't typically exceed six daily doses.

If you use Marinol to boost your appetite, you'll usually take it twice a day before lunch and dinner or once before bedtime. Swallow capsules whole. Don't crush them in any way or chew them.

What Happens If I Take Too Much Marinol and Overdose?

It's important to take Marinol exactly as your doctor prescribed. Taking too much can cause a number of side effects. Symptoms of a Marinol overdose may include:

• Drowsiness
• Inappropriate happiness
• Sharper senses than usual
• Changed awareness of time
• Red eyes
• Fast heartbeat
• Memory problems
• Feeling that you are outside of your body
• Mood changes
• Trouble urinating
• Constipation
• Loss of coordination
• Extreme tiredness
• Difficulty speaking clearly
• Dizziness or fainting when standing up too fast

If you or someone else has symptoms of an overdose, call your local poison control center at 1-800-222-1222. If someone collapses or isn't breathing, call 911.

What Happens If I Miss a Dose of Marinol or Don't Take It as Prescribed?

Don't stop taking Marinol without talking with your doctor first. If you accidentally miss a dose, take it as soon as you remember it. If it's almost time for your next regular dose, however, skip the missed dose. Don't take twice as much at one time to make up for a missed dose.

Dronabinol is part of the drug class:

• Other antiemetics

• Dronabinol comes in a capsule form. It is taken by mouth. 
• It is usually taken later in the day. 
• Swallow dronabinol capsules whole. Do not crush, chew, or break the capsules.
• This medication may be given 1 to 3 hours before cancer chemotherapy and then every 2 to 4 hours after chemotherapy, for a total of 4 to 6 doses a day.
• For appetite stimulation in people with AIDS, dronabinol is usually taken before lunch and dinner.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

The standard initial dronabinol dose for appetite stimulation in people with AIDS is 2.5 mg twice daily: before lunch and before dinner.

Your doctor will determine your dronabinol dosage based on your body surface area, which is usually calculated using your height and weight.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not use marijuana while taking dronabinol.

Do not drink alcohol while taking dronabinol.

Taking dronabinol with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with dronabinol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

The pharmacologic effects of Dronabinol capsules are dose-related and subject to considerable interpatient variability. Therefore, dosage individualization is critical in achieving the maximum benefit of Dronabinol capsules treatment.

Appetite Stimulation: In the clinical trials, the majority of patients were treated with 5 mg/day Dronabinol capsules, although the dosages ranged from 2.5 to 20 mg/day. For an adult:

1. Begin with 2.5 mg before lunch and 2.5 mg before supper. If CNS symptoms (feeling high, dizziness, confusion, somnolence) do occur, they usually resolve in 1 to 3 days with continued dosage.
2. If CNS symptoms are severe or persistent, reduce the dose to 2.5 mg before supper. If symptoms continue to be a problem, taking the single dose in the evening or at bedtime may reduce their severity.
3. When adverse effects are absent or minimal and further therapeutic effect is desired, increase the dose to 2.5 mg before lunch and 5 mg before supper or 5 and 5 mg. Although most patients respond to 2.5 mg twice daily, 10 mg twice daily has been tolerated in about half of the patients in appetite stimulation studies.

The pharmacologic effects of Dronabinol capsules are reversible upon treatment cessation.

Antiemetic: Most patients respond to 5 mg three or four times daily. Dosage may be escalated during a chemotherapy cycle or at subsequent cycles, based upon initial results. Therapy should be initiated at the lowest recommended dosage and titrated to clinical response. Administration of Dronabinol capsules with phenothiazines, such as prochlorperazine, has resulted in improved efficacy as compared to either drug alone, without additional toxicity.

Pediatrics: Dronabinol capsules are not recommended for AIDS-related anorexia in pediatric patients because it has not been studied in this population. The pediatric dosage for the treatment of chemotherapy-induced emesis is the same as in adults. Caution is recommended in prescribing Dronabinol capsules for children because of the psychoactive effects.

Geriatrics: Caution is advised in prescribing Dronabinol capsules in elderly patients because they may be more sensitive to the neurological, psychoactive and postural hypotensive effects of the drug. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. (See PRECAUTIONS.)

Dronabinol capsules should be used with caution when administered to elderly patients with dementia, who are at increased risk for falls as a result of their underlying disease state which may be exacerbated by the central nervous system effects of somnolence and dizziness associated with Dronabinol capsules. These patients should be monitored closely and placed on fall precautions prior to initiating Dronabinol capsule therapy. In antiemetic studies, no difference in efficacy was apparent in patients >55 years old.

Dronabinol capsules are contraindicated in any patient who has a known sensitivity to Dronabinol capsules or any of their ingredients. Dronabinol capsules contain cannabinoid and sesame oil and should never be used by patients allergic to these substances.

Appetite Stimulation: Initially, 2.5 mg Dronabinol capsules should be administered orally twice daily (b.i.d.), before lunch and supper. For patients unable to tolerate this 5 mg/day dosage of Dronabinol capsules, the dosage can be reduced to 2.5 mg/day, administered as a single dose in the evening or at bedtime. If clinically indicated and in the absence of significant adverse effects, the dosage may be gradually increased to a maximum of 20 mg/day Dronabinol capsules, administered in divided oral doses. Caution should be exercised in escalating the dosage of Dronabinol capsules because of the increased frequency of dose-related adverse experiences at higher dosages. (See PRECAUTIONS.)

Antiemetic: Dronabinol capsules are best administered at an initial dose of 5 mg/m2, given 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Should the 5 mg/m2 dose prove to be ineffective, and in the absence of significant side effects, the dose may be escalated by 2.5 mg/m2 increments to a maximum of 15 mg/m2 per dose. Caution should be exercised in dose escalation, however, as the incidence of disturbing psychiatric symptoms increases significantly at maximum dose. (See PRECAUTIONS.)

Storage Conditions
Dronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.

• Marinol
• Syndros

4 to 6 hours (psychoactive effects); ≥24 hours (appetite stimulation)

Half-Life Elimination

Biphasic: Alpha: 4 to 5 hours; Terminal: 25 to 36 hours

Protein Binding

~97%

Appetite stimulation in AIDS patients: Treatment of anorexia associated with weight loss in patients with AIDS.

Chemotherapy-induced nausea and vomiting: Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Capsules: Store in a cool environment between 8°C and 15°C (46°F and 59°F) or refrigerated; protect from freezing. Capsules should be stored in a well-closed container.

Oral solution: Store in a refrigerator between 2°C and 8°C (36°F and 46°F); excursions permitted to 15°C and 25°C (59°F and 77°F). The opened bottle may be stored at 25°C (77°F). Discard unused portion 28 days after first opening. Keep in original carton (keep calibrated dosing syringe in original carton, too).

Monitor heart rate and blood pressure. Monitor for CNS adverse effects, seizures, and substance abuse behavioral profile.

Adverse events have been observed in animal reproduction studies. Although information related to the use of synthetic cannabinoids during pregnancy is limited, cannabinoids cross the placenta. Maternal use may increase the risk of adverse fetal/neonatal outcomes including growth restriction, low birth weight, preterm birth, and stillbirth. Some dosage forms also contain a significant amount of alcohol.

Oral solution:
-Initial dose: 2.1 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.1 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 4.2 mg/day.
-Maintenance dose: May increase dose to 2.1 mg/day or 4.2 mg/day orally (2.1 mg 1 hour before lunch and 4.2 mg 1 hour before dinner OR 4.2 mg 1 hour before lunch and 4.2 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired.
-Maximum dose: 16.8 mg/day (8.4 mg orally 2 times a day)

Oral tablets:
-Initial dose: 2.5 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.5 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 5 mg/day.
-Maintenance dose: May increase dose to 7.5 mg/day or 10 mg/day orally (2.5 mg before 1 hour before lunch and 5 mg 1 hour before dinner OR 5 mg 1 hour before lunch and 5 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired.
-Maximum dose: 20 mg/day (10 mg orally 2 times a day)

Comments:
-The majority of patients in clinical trials were treated with oral tablet formulations of 5 mg/day, although the dosages ranged from 2.5 to 20 mg/day.
-If CNS symptoms (e.g., feeling high, dizziness, confusion, somnolence) occur, they usually resolve in 1 to 3 days with continued dosage.
-Early morning administration has been associated with an increased frequency of adverse reactions as compared to dosing later in the day.

Use: Appetite stimulant for anorexia associated with weight loss in AIDS patients

Oral tablets:
-Initial Dose: 5 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day.
-Maintenance Dose: May escalate dose by 2.5 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects.
-Maximum Dose: 15 mg/m2 per dose

Comments:
-This drug should be used with caution in children because of its psychoactive effects.
-Most patients respond to 5 mg given 3 or 4 times daily.
-Clinical trial data indicate escalating the dose above 7 mg/m2 increased the frequency of adverse effects with no additional antiemetic benefit.

Use: Treatment for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments

Nausea/Vomiting-Chemotherapy Induced:
-Oral solution: Healthcare providers should consider initial doses of 2.1 mg/m2 orally once a day 1 to 3 hours before chemotherapy in geriatric patients to reduce the risk of CNS reactions.

Severe or Persistent CNS Symptoms (when treating anorexia in AIDS patients):
-Oral solution: 2.1 mg orally once a day 1 hour before dinner
-Oral tablets: 2.5 mg orally once a day 1 hour before dinner
-Doses should be given in the evening or at bedtime if symptoms continue to be a problem.