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Dronabinol

Pronunciation

Dosage Form: capsule

Dronabinol
Capsules USP

Rx only
CIII

DESCRIPTION

Dronabinol is a cannabinoid designated chemically as(6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d] pyran-1-ol. Dronabinol has the following empirical and structural formulas:

Dronabinol, the active ingredient in Dronabinol Capsules, is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol is also a naturally occurring component of Cannabis sativa L. (Marijuana).

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Dronabinol is light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.

Capsules for oral administration: Dronabinol Capsules is supplied as round, soft gelatin capsules containing 2.5 mg, 5 mg, or 10 mg Dronabinol.

Each Dronabinol Capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, FD&C red No. 40, D&C yellow No. 10, titanium dioxide, iron oxide black, shellac glaze, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and purified water; 5 mg capsule contains gelatin, glycerin, sesame oil, FD&C yellow No. 6, FD&C red No. 40, FD&C blue No. 1, titanium dioxide, shellac glaze, simethicone, isopropyl alcohol, ammonium hydroxide, n-butyl alcohol, propylene glycol and purified water; 10 mg capsule contains gelatin, glycerin, sesame oil, FD&C yellow No. 6, titanium dioxide, iron oxide black, shellac glaze, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and purified water.

CLINICAL PHARMACOLOGY

Dronabinol is an orally active cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS), including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of Dronabinol and other cannabinoids.

Pharmacodynamics

Dronabinol-induced sympathomimetic activity may result in tachycardia and/or conjunctival injection. Its effects on blood pressure are inconsistent, but occasional subjects have experienced orthostatic hypotension and/or syncope upon abrupt standing.

Dronabinol also demonstrates reversible effects on appetite, mood, cognition, memory, and perception. These phenomena appear to be dose-related, increasing in frequency with higher dosages, and subject to great interpatient variability.

After oral administration, Dronabinol has an onset of action of approximately 0.5 to 1 hours and peak effect at 2 to 4 hours. Duration of action for psychoactive effects is 4 to 6 hours, but the appetite stimulant effect of Dronabinol may continue for 24 hours or longer after administration.

Tachyphylaxis and tolerance develop to some of the pharmacologic effects of Dronabinol and other cannabinoids with chronic use, suggesting an indirect effect on sympathetic neurons. In a study of the pharmacodynamics of chronic Dronabinol exposure, healthy male volunteers (N = 12) received 210 mg/day Dronabinol, administered orally in divided doses, for 16 days. An initial tachycardia induced by Dronabinol was replaced successively by normal sinus rhythm and then bradycardia. A decrease in supine blood pressure, made worse by standing, was also observed initially. These volunteers developed tolerance to the cardiovascular and subjective adverse CNS effects of Dronabinol within 12 days of treatment initiation.

Pharmacokinetics

Absorption and Distribution: Dronabinol Capsules are almost completely absorbed (90 to 95%) after single oral doses. Due to the combined effects of first pass hepatic metabolism and high lipid solubility, only 10 to 20% of the administered dose reaches the systemic circulation. Dronabinol has a large apparent volume of distribution, approximately 10 L/kg, because of its lipid solubility. The plasma protein binding of Dronabinol and its metabolites is approximately 97%.

The elimination phase of Dronabinol can be described using a two compartment model with an initial (alpha) half-life of about 4 hours and a terminal (beta) half-life of 25 to 36 hours. Because of its large volume of distribution, Dronabinol and its metabolites may be excreted at low levels for prolonged periods of time.

The pharmacokinetics of Dronabinol after single doses (2.5, 5, and 10 mg) and multiple doses (2.5, 5, and 10 mg given twice a day; BID) have been studied in healthy women and men.

Summary of Multiple-Dose Pharmacokinetic Parameters of Dronabinol in Healthy Volunteers (n=34; 20-45 years) under Fasted Conditions
Mean (SD) PK Parameter Values
BID Dose Cmax ng/mL Median Tmax (range), hr AUC(0-12) ng•hr/mL
2.5 mg 1.32 (0.62) 1.0 (0.5 to 4.0) 2.88          (1.57)
5 mg 2.96 (1.81) 2.5 (0.5 to 4.0) 6.16          (1.85)
10 mg 7.88 (4.54) 1.5 (0.5 to 3.5) 15.2          (5.52)

A slight increase in dose proportionality on mean Cmax and AUC(0-12) of Dronabinol was observed with increasing dose over the dose range studied.

Metabolism: Dronabinol undergoes extensive first-pass hepatic metabolism, primarily by microsomal hydroxylation, yielding both active and inactive metabolites. Dronabinol and its principal active metabolite, 11-OH-delta-9-THC, are present in approximately equal concentrations in plasma. Concentrations of both parent drug and metabolite peak at approximately 0.5 to 4 hours after oral dosing and decline over several days. Values for clearance average about 0.2 L/kg-hr, but are highly variable due to the complexity of cannabinoid distribution.

Elimination: Dronabinol and its biotransformation products are excreted in both feces and urine. Biliary excretion is the major route of elimination with about half of a radio-labeled oral dose being recovered from the feces within 72 hours as contrasted with 10 to 15% recovered from urine. Less than 5% of an oral dose is recovered unchanged in the feces.

Following single dose administration, low levels of Dronabinol metabolites have been detected for more than 5 weeks in the urine and feces.

Special Populations: The pharmacokinetic profile of Dronabinol Capsules has not been investigated in either pediatric or geriatric patients.

CLINICAL TRIALS

Antiemetic: Dronabinol Capsules treatment of chemotherapy-induced emesis was evaluated in 454 patients with cancer, who received a total of 750 courses of treatment of various malignancies. The antiemetic efficacy of Dronabinol Capsules was greatest in patients receiving cytotoxic therapy with MOPP for Hodgkin's and non-Hodgkin's lymphomas. Dronabinol Capsules dosages ranged from 2.5 mg/day to 40 mg/day, administered in equally divided doses every four to six hours (four times daily). As indicated in the following table, escalating the Dronabinol Capsules dose above 7 mg/m2 increased the frequency of adverse experiences, with no additional antiemetic benefit.

Dronabinol Capsules Dose: Response Frequency and Adverse Experiences* (N = 750 treatment courses)

*Nondysphoric events consisted of drowsiness, tachycardia, etc.

Dronabinol
Capsules Dose
Response Frequency % Adverse Events
Complete Partial Poor None Nondysphoric Dysphoric
<7mg/m2 36 32 32 23 65 12
>7mg/m2 33 31 36 13 58 28

Combination antiemetic therapy with Dronabinol Capsules and a phenothiazine (prochlorperazine) may result in synergistic or additive antiemetic effects and attenuate the toxicities associated with each of the agents.

INDIVIDUALIZATION OF DOSAGES

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.

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: 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 therapy. In antiemetic studies, no difference in efficacy was apparent in patients >55 years old.

INDICATIONS AND USAGE

Dronabinol Capsules is indicated for the treatment of:

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

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.

PRECAUTIONS

General: The risk/benefit ratio of Dronabinol Capsules use should be carefully evaluated in patients with the following medical conditions because of individual variation in response and tolerance to the effects of Dronabinol Capsules.

Seizure and seizure-like activity have been reported in patients receiving Dronabinol Capsules during marketed use of the drug and in clinical trials. (See ADVERSE REACTIONS and OVERDOSAGE.)

Dronabinol Capsules should be used with caution in patients with a history of seizure disorder because Dronabinol Capsules may lower the seizure threshold. A causal relationship between Dronabinol Capsules and these events has not been established. Dronabinol Capsules should be discontinued immediately in patients who develop seizures and medical attention should be sought immediately.

Dronabinol Capsules should be used with caution in patients with cardiac disorders because of occasional hypotension, possible hypertension, syncope, or tachycardia. (See CLINICAL PHARMACOLOGY.)

Dronabinol Capsules should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence, because they may be more prone to abuse Dronabinol Capsules as well. Multiple substance abuse is common and marijuana, which contains the same active compound, is a frequently abused substance.

Dronabinol Capsules should be used with caution and careful psychiatric monitoring in patients with mania, depression, or schizophrenia because Dronabinol Capsules may exacerbate these illnesses.

Dronabinol Capsules should be used with caution in patients receiving concomitant therapy with sedatives, hypnotics or other psychoactive drugs because of the potential for additive or synergistic CNS effects.

Dronabinol Capsules should be used with caution in elderly patients because they may be more sensitive to the neurological, psychoactive, and postural hypotensive effects of the drug. (See INDIVIDUALIZATION OF DOSAGES.)

Dronabinol Capsules should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations.

Information for Patients: 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.

Drug Interactions: In studies involving patients with 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.

CONCOMITANT DRUG CLINICAL EFFECT(S)
Amphetamines, cocaine, other sympathomimetic agents Additive hypertension, tachycardia, possibly cardiotoxicity
Atropine, scopolamine, antihistamines, other anticholinergic agents Additive or super-additive tachycardia, drowsiness
Amitriptyline, amoxapine, desipramine, other tricyclic antidepressants Additive tachycardia, hypertension, drowsiness
Barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants Additive drowsiness and CNS depression
Disulfiram A reversible hypomanic reaction was reported in a 28 y/o man who smoked marijuana; confirmed by dechallenge and rechallenge
Fluoxetine A 21 y/o female with depression and bulimia receiving 20 mg/day fluoxetine X 4 wks became hypomanic after smoking marijuana; symptoms resolved after 4 days
Antipyrine, barbiturates Decreased clearance of these agents, presumably via competitive inhibition of metabolism
Theophylline Increased theophylline metabolism reported with smoking of marijuana; effect similar to that following smoking tobacco

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenicity studies in mice and rats have been conducted under the US 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, 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.

Pregnancy: 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, and in rats at 74 to 295 mg/m2 (equivalent to 0.8 to 3 times MRHD of 90 mg/m2 in cancer 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.

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.

Geriatric Use: Clinical studies of Dronabinol Capsules in cancer patients did not include the 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.

Adverse Reactions

Adverse experiences information summarized in the tables below was derived from well-controlled clinical trials conducted in the US and US territories involving 474 patients exposed to Dronabinol. 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 in the antiemetic (24%) clinical trials. (See Clinical Trials.)

PROBABLY CAUSALLY RELATED: Incidence greater than 1%.

Rates derived from clinical trials in chemotherapy-related nausea (N=317).

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Body as a whole: Asthenia.

Cardiovascular: Palpitations, tachycardia, vasodilation/facial flush.

Digestive: Abdominal pain*, nausea*, vomiting*.

Nervous system: (Amnesia), anxiety/nervousness, (ataxia), confusion, depersonalization, dizziness*, euphoria*, (hallucination), paranoid reaction*, somnolence*, thinking abnormal*.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

*Incidence of events 3% to 10%

PROBABLY CAUSALLY RELATED: Incidence less than 1%.

Event rates derived from clinical trials in chemotherapy-related nausea (N=317).

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Cardiovascular: Conjunctivitis*, hypotension*.

Digestive: Diarrhea*, fecal incontinence.

Musculoskeletal: Myalgias.

Nervous system: Depression, nightmares, speech difficulties, tinnitus.

Skin and Appendages: Flushing*.

Special senses: Vision difficulties.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

*Incidence of events 0.3% to 1%

CAUSAL RELATIONSHIP UNKNOWN: Incidence less than 1%.

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

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Body as a whole: Chills, headache, malaise.

Digestive: Anorexia, hepatic enzyme elevation.

Respiratory: Cough, rhinitis, sinusitis.

Skin and Appendages: Sweating.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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 ABUSE AND DEPENDENCE

Dronabinol Capsules is one of the psychoactive compounds present in cannabis, and is abusable and controlled [Schedule III (CIII)] under the Controlled Substances Act. Both psychological and physiological dependence have been noted in healthy individuals receiving Dronabinol, but addiction is uncommon and has only been seen after prolonged high dose administration.

Chronic abuse of cannabis has been associated with decrements in motivation, cognition, judgment, and perception. The etiology of these impairments is unknown, but may be associated with the complex process of addiction rather than an isolated effect of the drug. No such decrements in psychological, social or neurological status have been associated with the administration of Dronabinol for therapeutic purposes.

An abstinence syndrome has been reported after the abrupt discontinuation of Dronabinol in volunteers receiving dosages of 210 mg/day for 12 to 16 consecutive days. Within 12 hours after discontinuation, these volunteers manifested symptoms such as irritability, insomnia, and restlessness. By approximately 24 hours post Dronabinol discontinuation, withdrawal symptoms intensified to include “hot flashes”, sweating, rhinorrhea, loose stools, hiccoughs and anorexia.

These withdrawal symptoms gradually dissipated over the next 48 hours. Electroencephalographic changes consistent with the effects of drug withdrawal (hyperexcitation) were recorded in patients after abrupt dechallenge. Patients also complained of disturbed sleep for several weeks after discontinuing therapy with high dosages of Dronabinol.

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.

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.

DOSAGE AND ADMINISTRATION

Antiemetic: Dronabinol Capsules is 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

Dronabinol Capsules should be packaged in a well-closed container and stored in a cold environment between 2°C and 8°C (36°F and 46°F).

Store in refrigerator.

Protect from freezing.

Protect from light.

HOW SUPPLIED

Dronabinol Capsules (Dronabinol solution in sesame oil in soft gelatin capsules)

2.5 mg - beige soft gelatin, round-shape capsule printed “61” in black ink
NDC 17478-761-06 (Bottle of 60 capsules).

5 mg - brown soft gelatin, round-shape capsule printed “62” in white ink
NDC 17478-762-06 (Bottle of 60 capsules).

10 mg - orange soft gelatin, round-shape capsule printed “63” in black ink
NDC 17478-763-06 (Bottle of 60 capsules).

AKORN

Manufactured by USGP,
a division of PROCAPS for Akorn, Inc.
Lake Forest, IL 60045

Made in Colombia

200010128
DR00N
Rev. 05/14

Principal Display Panel Text for Container Label:

NDC 17478-761-06 60 Capsules

Dronabinol

Capsules USP

2.5 mg CIII

Do not use if seal around the cap imprinted

with “SEALED for YOUR PROTECTION” is

broken or missing

Rx only Akorn Logo

Principal Display Panel Text for Carton Label:

NDC 17478-761-06

Dronabinol

Capsules USP

2.5 mg CIII

Do not use if seal around the cap imprinted

with “SEALED for YOUR PROTECTION” is

broken or missing

60 Capsules

Rx only Akorn Logo

Principal Display Panel Text for Container Label:

NDC 17478-762-06 60 Capsules

Dronabinol

Capsules USP

5 mg CIII

Do not use if seal around the cap imprinted

with “SEALED for YOUR PROTECTION” is

broken or missing

Rx only Akorn Logo

Principal Display Panel Text for Carton Label:

NDC 17478-762-06

Dronabinol

Capsules USP

5 mg CIII

Do not use if seal around the cap imprinted

with “SEALED for YOUR PROTECTION” is

broken or missing

60 Capsules

Rx only Akorn Logo

Principal Display Panel Text for Container Label:

NDC 17478-763-06 60 Capsules

Dronabinol

Capsules USP

10 mg CIII

Do not use if seal around the cap imprinted

with “SEALED for YOUR PROTECTION” is

broken or missing

Rx only Akorn Logo

Principal Display Panel Text for Carton Label:

NDC 17478-763-06

Dronabinol

Capsules USP

10 mg CIII

Do not use if seal around the cap imprinted

with “SEALED for YOUR PROTECTION” is

broken or missing

60 Capsules

Rx only Akorn Logo

Dronabinol 
Dronabinol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-761
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dronabinol (Dronabinol) Dronabinol 2.5 mg
Inactive Ingredients
Ingredient Name Strength
gelatin  
glycerin  
sesame oil  
FD&C red no. 40  
D&C yellow no. 10  
titanium dioxide  
ferrosoferric oxide  
shellac  
isopropyl alcohol  
butyl alcohol  
propylene glycol  
ammonia  
water  
Product Characteristics
Color brown (beige) Score no score
Shape ROUND (ROUND) Size 3mm
Flavor Imprint Code 61
Contains         
Packaging
# Item Code Package Description
1 NDC:17478-761-06 1 BOTTLE in 1 CARTON
1 60 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079217 06/20/2014
Dronabinol 
Dronabinol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-762
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dronabinol (Dronabinol) Dronabinol 5 mg
Inactive Ingredients
Ingredient Name Strength
gelatin  
glycerin  
sesame oil  
FD&C yellow no. 6  
FD&C red no. 40  
FD&C blue no. 1  
titanium dioxide  
shellac  
dimethicone  
silicon dioxide  
isopropyl alcohol  
ammonia  
butyl alcohol  
propylene glycol  
water  
Product Characteristics
Color brown (brown) Score no score
Shape ROUND (ROUND) Size 3mm
Flavor Imprint Code 62
Contains         
Packaging
# Item Code Package Description
1 NDC:17478-762-06 1 BOTTLE in 1 CARTON
1 60 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079217 06/20/2014
Dronabinol 
Dronabinol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-763
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dronabinol (Dronabinol) Dronabinol 10 mg
Inactive Ingredients
Ingredient Name Strength
gelatin  
glycerin  
sesame oil  
FD&C yellow no. 6  
titanium dioxide  
ferrosoferric oxide  
shellac  
isopropyl alcohol  
butyl alcohol  
propylene glycol  
ammonia  
water  
Product Characteristics
Color orange (orange) Score no score
Shape ROUND (ROUND) Size 3mm
Flavor Imprint Code 63
Contains         
Packaging
# Item Code Package Description
1 NDC:17478-763-06 1 BOTTLE in 1 CARTON
1 60 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079217 06/20/2014
Labeler - Akorn, Inc. (062649876)
Revised: 06/2014
 
Akorn, Inc.
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