DICYCLOMINE HYDROCHLORIDE capsule DICYCLOMINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

DICYCLOMINE HYDROCHLORIDE

Composition:

DICYCLOMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of functional bowel/irritable bowel syndrome. - Obstructive uropathy Obstructive uropathy - Obstructive disease of the gastrointestinal tract Obstructive disease of the gastrointestinal tract - Severe ulcerative colitis (See PRECAUTIONS) Severe ulcerative colitis (See PRECAUTIONS) - Reflux esophagitis Reflux esophagitis - Unstable cardiovascular status in acute hemorrhage Unstable cardiovascular status in acute hemorrhage - Glaucoma Glaucoma - Myasthenia gravis Myasthenia gravis - Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations - Infants less than 6 months of age (See WARNINGS and PRECAUTIONS: Information for Patients.) Infants less than 6 months of age (See WARNINGS and PRECAUTIONS: Information for Patients.) - Nursing Mothers (See WARNINGS and PRECAUTIONS: Information for Patients). Nursing Mothers (See WAR

Product summary:

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. 20 mg tablets: Blue, round, unscored, flat-faced, beveled-edge tablets, debossed WATSON and 795 on the periphery on one side and plain on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICYCLOMINE HYDROCHLORIDE - DICYCLOMINE HYDROCHLORIDE CAPSULE
DICYCLOMINE HYDROCHLORIDE - DICYCLOMINE HYDROCHLORIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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DICYCLOMINE HCL
CAPSULES USP
DICYCLOMINE HCL
TABLETS USP
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
34 5.95
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 show