CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Chlordiazepoxide Hydrochloride (UNII: MFM6K1XWDK) (Chlordiazepoxide - UNII:6RZ6XEZ3CR), Clidinium Bromide (UNII: 91ZQW5JF1Z) (Clidinium - UNII:BO76JF850N)

Available from:

Bi-Coastal Pharmaceutical Corporation

INN (International Name):

Chlordiazepoxide Hydrochloride

Composition:

Chlordiazepoxide Hydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Chlordiazepoxide HCl and Clidinium Bromide Capsules are available in light green capsules, imprinted with "607", each containing 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg Clidinium Bromide. Bottle of 100 NDC 42582-300-10 Bottle of 250 NDC 42582-300-16 Bottle of 1000 NDC 42582-300-20 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.

Authorization status:

unapproved drug other

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
BI-COASTAL PHARMACEUTICAL CORPORATION
_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 recent evidence indicat