Chlordiazepoxide Hydrochloride And Clidinium Bromide Recall
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Questions & Answers
Side Effects & Adverse Reactions
As in the case of other preparations containing CNS-acting drugs, patients receiving Chlordiazepoxide HCl and Clidinium Bromide Capsules should be cautioned about possible combined effects with alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle.
An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
As with all anticholinergic drugs, an inhibiting effect on lactation may occur (see Animal Pharmacology).
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
|INDICATIONS AND USAGE: 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 classiffcation of the less-than-effective indications requires further investigation.|
There is currently no drug history available for this drug.
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 contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains lactose, starch, talc, titanium dioxide, D&C Yellow #10, FD&C Green #3 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:
Chlordiazepoxide Hydrochloride And Clidinium Bromide Manufacturers
Eci Pharmaceuticals Llc
Bi-coastal Pharmaceutical Corporation
Acella Pharmaceuticals, Llc
Golden State Medical Supply, Inc.
A-s Medication Solutions Llc
Carilion Materials Management
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