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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Dronabinol is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

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

• Dronabinol Capsules is contraindicated in any patient who has a known sensitivity to Dronabinol Capsules or any of its ingredients. It contains cannabinoid and sesame oil and should never be used by patients allergic to these substances.

Warnings

• Patients receiving treatment with Dronabinol Capsules should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and to perform such tasks safely.

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).

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).

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.

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.Reports of fatigue have also been received. A causal relationship between Dronabinol Capsules and these events has not been established.

Drug Interactions

• In studies involving patients with AIDS and/or cancer, Dronabinol Capsules has been co-administered with a variety of medications (e.g., cytotoxic agents, anti-infective agents, sedatives, or opioid analgesics) without resulting in any clinically significant drug/drug interactions. Although no drug/drug interactions were discovered during the clinical trials of Dronabinol Capsules, cannabinoids may interact with other medications through both metabolic and pharmacodynamic mechanisms. Dronabinol is highly protein bound to plasma proteins, and therefore, might displace other protein-bound drugs. Although this displacement has not been confirmed in vivo, practitioners should monitor patients for a change in dosage requirements when administering dronabinol to patients receiving other highly protein-bound drugs. Published reports of drug/drug interactions involving cannabinoids are summarized in the following table.

This image is provided by the National Library of Medicine.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Pregnancy Category C

• Reproduction studies with dronabinol have been performed in mice at 15 to 450 mg/m2, equivalent to 0.2 to 5 times maximum recommended human dose (MRHD) of 90 mg/m2/day in cancer patients or 1 to 30 times MRHD of 15 mg/m2/day in AIDS patients, and in rats at 74 to 295 mg/m2 (equivalent to 0.8 to 3 times MRHD of 90 mg/m2 in cancer patients or 5 to 20 times MRHD of 15 mg/ m2/day in AIDS patients). These studies have revealed no evidence of teratogenicity due to dronabinol. At these dosages in mice and rats, dronabinol decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions. Such effects were dose dependent and less apparent at lower doses which produced less maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Dronabinol should be used only if the potential benefit justifies the potential risk to the fetus.

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

• Use of Dronabinol Capsules is not recommended in nursing mothers since, in addition to the secretion of HIV virus in breast milk, dronabinol is concentrated in and secreted in human breast milk and is absorbed by the nursing baby.

Pediatric Use

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

Geriatic Use

• Clinical studies of Dronabinol Capsules in AIDS and cancer patients did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of falls, decreased hepatic, renal, or cardiac function, increased sensitivity to psychoactive effects and of concomitant disease or other drug therapy.

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

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

• Carcinogenicity studies in mice and rats have been conducted under the U.S. National Toxicology Program (NTP). In the 2-year carcinogenicity study in rats, there was no evidence of carcinogenicity at doses up to 50 mg/kg/day, about 20 times the maximum recommended human dose on a body surface area basis. In the 2-year carcinogenicity study in mice, treatment with dronabinol at 125 mg/kg/day, about 25 times the maximum recommended human dose on a body surface area basis, produced thyroid follicular cell adenoma in both male and female mice but not at 250 or 500 mg/kg/day.

• Dronabinol was not genotoxic in the Ames tests, the in vitro chromosomal aberration test in Chinese hamster ovary cells, and the in vivo mouse micronucleus test. It, however, produced a weak positive response in a sister chromatid exchange test in Chinese hamster ovary cells.

• In a long-term study (77 days) in rats, oral administration of dronabinol at doses of 30 to 150 mg/m2, equivalent to 0.3 to 1.5 times maximum recommended human dose (MRHD) of 90 mg/m2/day in cancer patients or 2 to 10 times MRHD of 15 mg/m2/day in AIDS patients, reduced ventral prostate, seminal vesicle and epididymal weights and caused a decrease in seminal fluid volume. Decreases in spermatogenesis, number of developing germ cells, and number of Leydig cells in the testis were also observed. However, sperm count, mating success and testosterone levels were not affected. The significance of these animal findings in humans is not known.

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

{{#ask: Page Name::Dronabinol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Dronabinol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

• Patients receiving treatment with dronabinol capsules should be alerted to the potential for additive central nervous system depression if Dronabinol Capsules is used concomitantly with alcohol or other CNS depressants such as benzodiazepines and barbiturates.

• Patients receiving treatment with dronabinol capsules should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and to perform such tasks safely.

• Patients using dronabinol Capsules should be advised of possible changes in mood and other adverse behavioral effects of the drug so as to avoid panic in the event of such manifestations. Patients should remain under the supervision of a responsible adult during initial use of dronabinol capsules and following dosage adjustments.

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.

{{#subobject:

 |Page Name=Dronabinol
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Dronabinol
 |Label Name=Dronabinol11.png

}}

{{#subobject:

 |Label Page=Dronabinol
 |Label Name=Dronabinol11.png

}}