CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Chartwell RX, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules 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 hydrochloride and clidinium bromide capsules are 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.

Resumen del producto:

Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg are available in green opaque hard gelatin capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 120 (NDC 62135-696-12) with imprinted "696" on the cap and body of the capsule in black ink. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF. Manufactured for: Chartwell RX, LLC Congers, NY 10920 Revised: 04/2022 L70906

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Chartwell RX, LLC
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MEDICATION GUIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules
(klor dye az e pox' ide) (kli di' nee um)
•
What is the most important information I should know about
chlordiazepoxide hydrochloride and
clidinium bromide capsules?Do not stop taking chlordiazepoxide
hydrochloride and clidinium
bromide capsules without first talking to your healthcare provider.
Stopping chlordiazepoxide
hydrochloride and clidinium bromide capsules suddenly can cause
serious side effects.
•
Taking chlordiazepoxide hydrochloride and clidinium bromide capsules
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 hydrochloride and clidinium bromide capsules affects
you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
chlordiazepoxide hydrochloride and clidinium bromide capsules without
first talking to your
healthcare provider. When taken with alcohol or drugs that cause
sleepiness or dizziness,
chlordiazepoxide hydrochloride and clidinium bromide capsules may make
your sleepiness or
dizziness much worse.
•
chlordiazepoxide hydrochloride and clidinium bromide capsules can
cause abuse and dependence.
•
Do not stop taking chlordiazepoxide hydrochloride and clidinium
bromide capsules all of a
sudden. Stopping chlordiazepoxide hydrochloride and clidinium bromide
capsules 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
What are chlordiazepoxide hydrochloride and clidinium bromide
capsules?
•
Chlordiazepoxide hydrochloride and clidinium bromid

Ficha técnica

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
CHARTWELL RX, LLC
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES USP, 5
MG/2.5 MG
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).
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.
DESCRIPTION
Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5
mg/2.5 mg
combines in a single capsule formulation the antianxiety action of
chlordiazepoxide
hydrochloride and the anticholinergic/spasmolytic effects of clidinium
bromide.
Each chlordiazepoxide hydrochloride and clidinium bromide capsules
USP, 5 mg/2.5 mg
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, sodium lauryl sulfate, D&C Yellow No. 10,
FD&C Green No. 3,
titanium dioxide, and gelatin. The imprinting ink contains ammonia
solution, black iron
oxide, potassium hydroxide, propylene glycol, and shellac.
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 2-oxide monohydrochloride. A white to slightly yellow,
crystalline
powder, it is soluble in water. It is unstable in solution and the
powder must be
protected from light. The molecular weight is 336.2. The structural
formula of
chlordiazepoxide hy