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:

Cameron Pharmaceuticals, LLC

INN (International Name):

Chlordiazepoxide Hydrochloride

Composition:

Chlordiazepoxide Hydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide HCl/Clidinium Bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide HCl/Clidinium Bromide may also be used 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. 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 discontinuance of chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to tho

Product summary:

Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, in bottles of 100 (NDC 42494-409-01), with LIBRAX® ICN imprinted on the body of the capsule. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children. Dispense in a tight, light-resistant container as defined in USP/NF. Distributed by: Cameron Pharmaceuticals Louisville, KY 40245 USA Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada Librax is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. ©Valeant Pharmaceuticals North America LLC 9542102 20001848 Revised: 04/2017

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Cameron Pharmaceuticals, LLC
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MEDICATION GUIDE
Chlordiazepoxide HCl/Clidinium Bromide
capsules
What is the most important information I should know about
Chlordiazepoxide HCl/Clidinium Bromide?
•
Do not stop taking Chlordiazepoxide HCl/Clidinium Bromide without
first talking to your
healthcare provider. Stopping Chlordiazepoxide HCl/Clidinium Bromide
suddenly can cause
serious side effects.
•
Taking Chlordiazepoxide HCl/Clidinium Bromide 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
Chlordiazepoxide HCl/Clidinium Bromide affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
Chlordiazepoxide HCl/Clidinium Bromide without first talking to your
healthcare provider.
When taken with alcohol or drugs that cause sleepiness or dizziness,
Chlordiazepoxide
HCl/Clidinium Bromide may make your sleepiness or dizziness much
worse.
•
Chlordiazepoxide HCl/Clidinium Bromide can cause abuse and dependence.
•
Do not stop taking Chlordiazepoxide HCl/Clidinium Bromide all of a
sudden. Stopping
Chlordiazepoxide HCl/Clidinium Bromide 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 Chlordiazepoxide HCl/Clidinium Bromide?
•
Chlordiazepoxide HCl/Clidinium Bromide 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
•
Chlordiazepoxide HCl/Clidinium Bromide

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
CAMERON PHARMACEUTICALS, LLC
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CHLORDIAZEPOXIDE HCL/CLIDINIUM BROMIDE
CAPSULES
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death (see WARNINGS and PRECAUTIONS).
•
•
•
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.
Each Chlordiazepoxide HCl/Clidinium Bromide capsule contains the
active ingredients 5 mg
chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each
capsule also contains the inactive
ingredients corn starch, lactose monohydrate, talc, methylparaben,
propylparaben, potassium sorbate,
D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, 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:
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
Clidinium bromide is a synthetic anticholinergic agent which has been
shown in experimental and
clinical studies to have a pronounced antispasmodic and antisecre