Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
Chlordiazepoxide Hydrochloride (UNII: MFM6K1XWDK) (Chlordiazepoxide - UNII:6RZ6XEZ3CR), Clidinium Bromide (UNII: 91ZQW5JF1Z) (Clidinium - UNII:BO76JF850N)
BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY
Chlordiazepoxide Hydrochloride
Chlordiazepoxide Hydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
Chlordiazepoxide HCl and Clidinium Bromide Capsules are 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 discontinuance of Chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should general
Chlordiazepoxide HCl and Clidinium Bromide Capsules are available in white opaque capsules, imprinted with "200", each containing 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide. Bottle of 100 NDC 42582-301-10 Bottle of 250 NDC 42582-301-16 Bottle of 1000 NDC 42582-301-20 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. Keep this and all medication out of the reach of children.
unapproved drug other
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE CAPSULES R ONLY DESCRIPTION Chlordiazepoxide HCl and 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 and Clidinium Bromide Capsule for oral administration contains 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide. Each capsule also contains D&C Yellow #10, FD&C Green #3, gelatin, lactose, starch, talc, and titanium dioxide. 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 3-hydroxy-1-methylquinuclidinium bromide benzilate, 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: X 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 rec Lees het volledige document