RVP

Drug Catalog - Product Detail

DICYCLOMINE HCL 10MG CP 1000

NDC Mfr Size Str Form
00143-3126-10 HIKMA 1000 10MG CAPSULE
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Description
11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as: Dicyclomine hydrochloride capsules, USP for oral use containing 10 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride 10 mg capsules contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Capsule shells contain FD&C Blue No.1, FD&C Red No.40, gelatin, purified water, and sodium lauryl sulfate. The white monogramming ink contains: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, simethicone, and titanium dioxide. Dicyclomine hydrochloride is [bicyclohexyl]-1­-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 •HCl and the following structural formula: 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. Dicyclomine hydrochloride structural image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine hydrochloride capsules, USP 10 mg are supplied as Blue/Blue Capsule Printed “West-ward 3126” in White Ink and are available in: Bottles of 100 capsules NDC 0143-3126-01 Bottles of 1000 capsules NDC 0143-3126-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and moisture. To prevent fading, avoid exposure to direct sunlight. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Dicyclomine hydrochloride capsules, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride capsules, USP are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride capsules must be adjusted to individual patient needs (2) . If a dose is missed, patients should continue the normal dosing schedule (2) . Oral in adults (2.1 ) : • Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation • Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment 2.1 Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.