Drug Catalog - Product Detail
DICYCLOMINE HCL ORAL SOLUTION, USP SOL 10MG/5ML 473ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00603-1161-58 | PAR PHARMACEUTICALS | 473 | 10MG/5ML | SOLUTION |
PACKAGE FILES
Generic Name
DICYCLOMINE HYDROCHLORIDE
Substance Name
DICYCLOMINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA040169
Description
11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful). Dicyclomine hydrochloride oral solution also contains inactive ingredients glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucrose with D&C Red #33, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6 as coloring and natural and articial tropical fruit punch flavoring. 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: Molecular weight: 345.95 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 chemcial structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine hydrochloride oral solution is supplied as a pinkish orange, tropical fruit punch-flavored syrup in bottles of 473 mL (16 fl. oz.). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in a tight container with 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 hydrochloride 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 hydrochloride 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.