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Drug Catalog - Product Detail

DICYCLOMINE HCL TB 20MG 500

NDC Mfr Size Str Form
00378-1620-05 MYLAN 500 20MG TABLET
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Description
11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula: Dicyclomine hydrochloride, USP 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 capsules, USP, for oral administration, contain 10 mg of dicyclomine hydrochloride, USP. Each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. In addition the imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, pharmaceutical glaze and propylene glycol. Dicyclomine hydrochloride tablets, USP, for oral administration, contain 20 mg of dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. Dicyclomine Hydrochloride Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine Hydrochloride Capsules, USP are available containing 10 mg of dicyclomine hydrochloride, USP. The 10 mg capsules are a hard-shell gelatin capsule with a light turquoise blue opaque cap and light turquoise blue opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 1610 in black ink on both the cap and the body. They are available as follows: NDC 0378-1610-01 bottles of 100 capsules NDC 0378-1610-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dicyclomine Hydrochloride Tablets, USP are available containing 20 mg of dicyclomine hydrochloride, USP. The 20 mg tablets are blue, round, unscored tablets debossed with M over D6 on one side of the tablet and blank on the other side. They are available as follows. NDC 0378-1620-01 bottles of 100 tablets NDC 0378-1620-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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 is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine is 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 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 4 times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg 4 times a day, unless side effects limit dosage escalation Discontinue dicyclomine if efficacy not achieved or side effects require doses less than 80 mg per day after 2 weeks of treatment 2.1 Oral Dosage and Administration in Adults The recommended initial dose is 20 mg 4 times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg 4 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.