Drug Catalog - Product Detail
CHLORDIAZEPOXIDE W/CLIDINIUM 5/25.5MG CAPS 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42494-0409-01 | CAMERON PHARMACEUTICALS | 100 | 5-2.5MG | CAPSULE |
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Description
DESCRIPTION Chlordiazepoxide HCl/Clidinium Bromide combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Each Chlordiazepoxide HCl/Clidinium Bromide capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, methylparaben, propylparaben, potassium sorbate, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin. Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows: Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is: structure1 structure2
How Supplied
HOW SUPPLIED Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, in bottles of 100 (NDC 42494-409-01), with LIBRAX ® ICN imprinted on the body of the capsule. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children. Dispense in a tight, light-resistant container as defined in USP/NF. Distributed by: Cameron Pharmaceuticals Louisville, KY 40245 USA Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada Librax is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. ©Valeant Pharmaceuticals North America LLC 9542102 20001848 Revised: 04/2017
Indications & Usage
INDICATIONS AND USAGE Chlordiazepoxide HCl/Clidinium Bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide HCl/Clidinium Bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide HCl/Clidinium Bromide varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime. Geriatric Dosing Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Chlordiazepoxide HCl/Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated.