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:

A-S Medication Solutions

INN (International Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composition:

CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Product: 50090-1528 NDC: 50090-1528-0 30 CAPSULE in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
A-S Medication Solutions
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MEDICATION GUIDE
LIBRAX (lee braks)
(chlordiazepoxide HCl and clidinium bromide) capsules
What is the most important information I should know about Librax?
•
Do not stop taking Librax without first talking to your healthcare
provider. Stopping Librax
suddenly can cause serious side effects.
•
Taking Librax with opioid medicines, alcohol, or other central nervous
system depressants
(including street drugs) can cause severe drowsiness, breathing
problems (respiratory depression),
coma and death.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how Librax
affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking Librax
without first talking to your healthcare provider. When taken with
alcohol or drugs that cause
sleepiness or dizziness, Librax may make your sleepiness or dizziness
much worse.
•
Librax can cause abuse and dependence.
•
Do not stop taking Librax all of a sudden. Stopping Librax suddenly
can cause seizures, shaking,
stomach and muscle cramps, vomiting and sweating.
•
Physical dependence is not the same as drug addiction. Your healthcare
provider can tell you more
about the differences between physical dependence and drug addiction.
What is Librax?
•
Librax is a prescription medicine that is used with other therapies
for the treatment of:
•
stomach (peptic) ulcers
•
irritable bowel syndrome (IBS)
•
inflammation of the colon called acute enterocolitis
•
Librax contains the medicines chlordiazepoxide HCl and clidinium
bromide.
•
Librax can be abused or lead to dependence. Keep Librax in a safe
place to prevent misuse and
abuse. Selling or giving away Librax may harm others. Tell your
healthcare provider if you have
abused or been dependent on alcohol, prescription medicines or street
drugs.
•
It is not known if Librax is safe and effective in ch

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
A-S MEDICATION SOLUTIONS
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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.
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