CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR), CLIDINIUM BROMIDE (UNII: 91ZQW5JF1Z) (CLIDINIUM - UNII:BO76JF850N)

Fáanlegur frá:

Bryant Ranch Prepack

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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 63629-2146-1), 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.

Leyfisstaða:

New Drug Application Authorized Generic

Upplýsingar fylgiseðill

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- chlordiazepoxide
hydrochloride and clidinium bromide capsule
Bryant Ranch Prepack
----------
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 contains

Vara einkenni

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
BRYANT RANCH PREPACK
----------
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 antisecretory
ef