Dronabinol

Dronabinol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dronabinol Capsules is indicated for the treatment of:

• Anorexia associated with weight loss in patients with AIDS; and

• Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Dosage

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.

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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Dronabinol in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dronabinol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Dronabinol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Dronabinol in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dronabinol in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

• Adverse experiences information summarized in the tables below was derived from well-controlled clinical trials conducted in the U.S. and U.S. territories involving 474 patients exposed to Dronabinol Capsules. Studies of AIDS-related weight loss included 157 patients receiving dronabinol at a dose of 2.5 mg twice daily and 67 receiving placebo. Studies of different durations were combined by considering the first occurrence of events during the first 28 days. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving dronabinol and 68 receiving placebo.

• A cannabinoid dose-related "high" (easy laughing, elation and heightened awareness) has been reported by patients receiving Dronabinol Capsules in the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%).

• The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving Dronabinol Capsules. About 25% of patients reported a minor CNS adverse event during the first 2 weeks and about 4% reported such an event each week for the next 6 weeks thereafter.

PROBABLY CAUSALLY RELATED

Incidence greater than 1%

Rates derived from clinical trials in AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317). Rates were generally higher in the anti-emetic use (given in parentheses).

File:XXXXX.png

This image is provided by the National Library of Medicine.

PROBABLY CAUSALLY RELATED Incidence greater than 1%

Rates derived from clinical trials in AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317). Rates were generally higher in the anti-emetic use (given in parentheses).

File:XXXXX.png

This image is provided by the National Library of Medicine.

CAUSAL RELATIONSHIP UNKNOWN

Incidence less than 1%

The clinical significance of the association of these events with Dronabinol Capsules treatment is unknown, but they are reported as alerting information for the clinician.

File:XXXXX.png

This image is provided by the National Library of Medicine.

Postmarketing Experience

• Seizure and seizure-like activity have been reported in patients receiving Dronabinol Capsules during marketed use of the drug and in clinical trials. (See PRECAUTIONS and OVERDOSAGE.) Reports of fatigue have also been received. A causal relationship between Dronabinol Capsules and these events has not been established.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dronabinol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dronabinol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dronabinol with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dronabinol with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dronabinol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dronabinol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dronabinol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dronabinol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dronabinol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dronabinol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dronabinol in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Dronabinol in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Dronabinol in the drug label.

Overdosage

• Signs and symptoms following MILD Dronabinol Capsules intoxication include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth and tachycardia; following MODERATE intoxication include memory impairment, depersonalization, mood alteration, urinary retention, and reduced bowel motility; and following SEVERE intoxication include decreased motor coordination, lethargy, slurred speech, and postural hypotension. Apprehensive patients may experience panic reactions and seizures may occur in patients with existing seizure disorders.

• The estimated lethal human dose of intravenous dronabinol is 30 mg/kg (2100 mg/ 70 kg). Significant CNS symptoms in antiemetic studies followed oral doses of 0.4 mg/kg (28 mg/70 kg) of Dronabinol Capsules.

Management

• A potentially serious oral ingestion, if recent, should be managed with gut decontamination. In unconscious patients with a secure airway, instill activated charcoal (30 to 100 g in adults, 1 to 2 g/kg in infants) via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal. Patients experiencing depressive, hallucinatory or psychotic reactions should be placed in a quiet area and offered reassurance. Benzodiazepines (5 to 10 mg diazepam po) may be used for treatment of extreme agitation. Hypotension usually responds to Trendelenburg position and IV fluids. Pressors are rarely required.

Pharmacology

There is limited information regarding Dronabinol Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dronabinol01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dronabinol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dronabinol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dronabinol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dronabinol in the drug label.

How Supplied

• Dronabinol Capsules are available containing 2.5 mg, 5 mg or 10 mg of dronabinol.

• The 2.5 mg capsule is an opaque off-white soft gelatin capsule printed with INS in black ink. They are available as follows:

NDC 0378-8170-91 bottles of 60 capsules

• The 5 mg capsule is an opaque maroon or brown soft gelatin capsule printed with INS in white ink. They are available as follows:

NDC 0378-8171-91 bottles of 60 capsules

• The 10 mg capsule is an opaque tan to tan-orange soft gelatin capsule printed with INS in black ink. They are available as follows:

NDC 0378-8172-91 bottles of 60 capsules

Storage

• Dronabinol Capsules should be packaged in a well-closed container and stored in a refrigerator between 2° and 8°C (36° and 46°F). Protect from freezing and light.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dronabinol in the drug label.

Precautions with Alcohol

• Alcohol-Dronabinol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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