Chlordiazepoxide Hydrochloride/clidinium Bromide
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Questions & Answers
Side Effects & Adverse Reactions
As in the case of other preparations containing CNS-acting drugs, patients receiving chlordiazepoxide hydrochloride and clidinium bromide 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, 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).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Chlordiazepoxide Hydrochloride/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 Hydrochloride/Clidinium Bromide capsule contains 5 mg chlordiazepoxide hydrochloride, USP and 2.5 mg clidinium bromide, USP. Each capsule also contains lactose monohydrate, pregelatinized 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:
Sources
Chlordiazepoxide Hydrochloride/clidinium Bromide Manufacturers
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A-s Medication Solutions Llc
![Chlordiazepoxide Hydrochloride/clidinium Bromide (Chlordiazepoxide Hydrochloride And Clidinium Bromide) Capsule [A-s Medication Solutions Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Chlordiazepoxide Hydrochloride/clidinium Bromide | A-s Medication Solutions Llc
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride/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 Use Geriatric DosingDosage 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 Hydrochloride/Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated.
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Virtus Pharmaceuticals
Chlordiazepoxide Hydrochloride/clidinium Bromide | Virtus Pharmaceuticals
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride/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 Use Geriatric DosingDosage 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 Hydrochloride/Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated.
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Avkare, Inc.
Chlordiazepoxide Hydrochloride/clidinium Bromide | Avkare, Inc.
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride/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 Use Geriatric DosingDosage 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 Hydrochloride/Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated.
![Chlordiazepoxide Hydrochloride/clidinium Bromide (Chlordiazepoxide Hydrochloride And Clidinium Bromide) Capsule [Virtus Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=171404f0-d87a-4fc5-9551-e5139cf80988&name=chlordiazepoxide-03.jpg)
![Chlordiazepoxide Hydrochloride/clidinium Bromide (Chlordiazepoxide Hydrochloride And Clidinium Bromide) Capsule [Avkare, Inc.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
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