DRONABINOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DRONABINOL (UNII: 7J8897W37S) (DRONABINOL - UNII:7J8897W37S)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

DRONABINOL

Composition:

DRONABINOL 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Dronabinol Capsules (dronabinol solution in sesame oil in soft gelatin capsules) 2.5 mg - cream, oblong softgel capsules printed “PAR 867” in black ink. NDC 49884-867-15   Bottle of 25 capsules NDC 49884-867-02   Bottle of 60 capsules NDC 49884-867-01   Bottle of 100 capsules NDC 49884-867-05   Bottle of 500 capsules 5 mg - opaque brown, oblong softgel capsules printed “PAR 868” in black ink. NDC 49884-868-15   Bottle of 25 capsules NDC 49884-868-02   Bottle of 60 capsules NDC 49884-868-01   Bottle of 100 capsules NDC 49884-868-05   Bottle of 500 capsules 10 mg - orange, oblong softgel capsules printed “PAR 869” in black ink. NDC 49884-869-15   Bottle of 25 capsules NDC 49884-869-02   Bottle of 60 capsules NDC 49884-869-01   Bottle of 100 capsules NDC 49884-869-05   Bottle of 500 capsules Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Manufactured for: Par Pharmaceutical Companies, Inc. Spring Valley, NY  10977 Revised: 11/2011 OS867-15-17-02 302850-0B

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DRONABINOL- DRONABINOL CAPSULE
PAR PHARMACEUTICAL, INC.
----------
DRONABINOL CAPSULES, USP
CIII
RX ONLY
DESCRIPTION
Dronabinol is a cannabinoid designated chemically as
(6_aR-trans_)-6a,7,8,10a-tetrahydro-6,6,9-
trimethyl-3-pentyl-6_H_-dibenzo[_b,d_]pyran-1-ol. Dronabinol has the
following molecular 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).
Dronabinol is a 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 are supplied as
oblong, soft gelatin capsules
containing 2.5 mg, 5 mg or 10 mg dronabinol. Each dronabinol capsule
strength is formulated with the
following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin,
purified water, sesame oil,
titanium dioxide, iron oxide black, shellac glaze, isopropyl alcohol,
n-butyl alcohol, propylene glycol,
and ammonium hydroxide. The 2.5 mg and 5 mg also contain FD&C Blue No.
1 and FD&C Red No. 40.
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