DICYCLOMINE HYDROCHLORIDE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

DICYCLOMINE HYDROCHLORIDE (UNII: CQ903KQA31) (DICYCLOMINE - UNII:4KV4X8IF6V)

متاح من:

Rebel Distributors Corp

INN (الاسم الدولي):

DICYCLOMINE HYDROCHLORIDE

تركيب:

DICYCLOMINE HYDROCHLORIDE 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

For the treatment of functional bowel/irritable bowel syndrome. Abuse of and/or dependence on dicyclomine for anticholinergic effects have been rarely reported.

ملخص المنتج:

Dicyclomine Hydrochloride Capsules USP and Dicyclomine Hydrochloride Tablets USP are supplied as follows: 10 mg capsules: Clear Dark Blue cap/Clear Dark Blue body hard gelatin capsules, imprinted with white ink WATSON over 794 on cap and 10 mg on the body, in bottles of 30 and 90. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a well-closed container as defined in USP/NF. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP
----------
70010341
DICYCLOMINE HCL
CAPSULES USP
DICYCLOMINE HCL
TABLETS USP
REVISED: MAY 2003
RX ONLY
DESCRIPTION
Dicyclomine hydrochloride is an antispasmodic and anticholinergic
(antimuscarinic) agent. Dicyclomine
hydrochloride occurs as a fine, white, crystalline, practically
odorless powder with a bitter taste. It is
soluble in water, freely soluble in alcohol and chloroform, and very
slightly soluble in ether.
Chemically, it is [Bicyclohexyl]-1-carboxylic acid, 2-(diethyl-amino)
ethyl ester, hydrochloride with
the following structural formula:
C
H NO •HCI
345.95
Each capsule, for oral administration, contains 10 mg of dicyclomine
hydrochloride.
Each tablet, for oral administration, contains 20 mg of dicyclomine
hydrochloride.
This product contains the following inactive ingredients: colloidal
silicon dioxide (tablets only), corn
starch (tablets only), D&C red #28 (capsules only), FD&C blue #1
(capsules only), FD&C blue #1 lake
(tablets only), FD&C red #40 (capsules only), gelatin (capsules only),
hypromellose (tablets only),
lactose monohydrate (tablets only), magnesium stearate (capsules
only), pregelatinized starch, silicon
dioxide (capsules only), sodium lauryl sulfate (capsules only), sodium
starch glycolate (tablets only),
and stearic acid (tablets only).
CLINICAL PHARMACOLOGY
Dicyclomine relieves smooth muscle spasm of the gastrointestinal
tract. Animal studies indicate that this
action is achieved via a dual mechanism: (1) a specific
anticholinergic effect (antimuscarinic) at the
acetylcholine- receptor sites with approximately 1/8 the milligram
potency of atropine (_in vitro_, guinea
pig ileum); and (2) a direct effect upon smooth muscle (musculotropic)
as evidenced by dicyclomine's
antagonism of bradykinin- and histamine-induced spasms of the isolated
guinea pig ileum. Atropine did
not affect responses to these two agonists. _In vivo_ studies in cats
and dogs showed dicyclomine to be
equally potent against acetyl