DRONABINOL- dronabinol capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Actavis Pharma, Inc.

INN (nemzetközi neve):

DRONABINOL

Összetétel:

DRONABINOL 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 capsules or any of their ingredients. Dronabinol capsules contain 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, judgement, and perception. The etiology of thes

Termék összefoglaló:

Dronabinol Capsules, USP 2.5 mg white capsules (Identified UM). NDC 0591-3591-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM). NDC 0591-3592-60 (Bottle of 60 capsules). 10 mg orange capsules (Identified UM). NDC 0591-3593-60 (Bottle of 60 capsules). Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 1248B00 06/16 June, 2016

Engedélyezési státusz:

New Drug Application

Termékjellemzők

DRONABINOL- DRONABINOL CAPSULE
ACTAVIS PHARMA, INC.
----------
DRONABINOL CAPSULES, USP
2.5 MG, 5 MG, 10 MG
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 empirical and structural
formulas:
Dronabinol, the active ingredient in dronabinol capsules, USP, 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
round, soft gelatin capsules
containing either 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, and
titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide
black, gelatin, glycerin, sesame
oil, and titanium dioxide; 10 mg capsule contains iron oxide red and
iron oxide yellow, gelatin, glycerin,
sesame oil, and titanium dioxide.
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 app