Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
chlordiazepoxide hydrochloride (UNII: MFM6K1XWDK) (chlordiazepoxide - UNII:6RZ6XEZ3CR), clidinium bromide (UNII: 91ZQW5JF1Z) (clidinium - UNII:BO76JF850N)
Avera McKennan Hospital
chlordiazepoxide hydrochloride
chlordiazepoxide hydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
Based on a review of this drug by the National Academy of Sciences — National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: 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. Final classification of the less-than-effective indications requires further investigation. Chlordiazepoxide HCl/Clidinium Bromide is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt disc
Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 68682-409-10), with OPI imprinted on the cap of the capsule and 409 imprinted on the body of the capsule. NDC 69189-0489-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).
New Drug Application Authorized Generic
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE AVERA MCKENNAN HOSPITAL ---------- CHLORDIAZEPOXIDE HCL/ CLIDINIUM BROMIDE CAPSULES _to control emotional_ _and somatic factors_ _in gastrointestinal disorders_ 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, both exclusive developments of Roche research. Each Chlordiazepoxide HCl/Clidinium Bromide capsule contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and either FD&C Blue No. 1 or FD&C Green No. 3. 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: ANIMAL PHARMACOLOGY Chlordiazepoxide hydrochloride has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses. Hostile Przeczytaj cały dokument