CHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE- chlordiazepoxide hydrochloride and clidinium bromide capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Chlordiazepoxide Hydrochloride (UNII: MFM6K1XWDK) (Chlordiazepoxide - UNII:6RZ6XEZ3CR), Clidinium Bromide (UNII: 91ZQW5JF1Z) (Clidinium - UNII:BO76JF850N)

Disponible depuis:

Virtus Pharmaceuticals

DCI (Dénomination commune internationale):

Chlordiazepoxide Hydrochloride

Composition:

Chlordiazepoxide Hydrochloride 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Chlordiazepoxide Hydrochloride/Clidinium Bromide is indicated to control the emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride/Clidinium Bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Chlordiazepoxide Hydrochloride/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

Descriptif du produit:

Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules are light green opaque capsules with "VP302" imprinted on the cap of capsule, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Bottle of 100 capsules (NDC 76439-302-10). Rx only Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Statut de autorisation:

unapproved drug other

Notice patient

AND CLIDINIUM BROMIDE CAPSULE
Virtus Pharmaceuticals
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
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Issued: 03/2019
MEDICATION GUIDE
Chlordiazepoxide Hydrochloride/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/Clidinium
Bromide Capsules?
•
Do not stop taking Chlordiazepoxide Hydrochloride/Clidinium Bromide
without first talking to your
healthcare provider . Stopping Chlordiazepoxide
Hydrochloride/Clidinium Bromide suddenly can
cause serious side effects.
•
Taking Chlordiazepoxide Hydrochloride/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.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
Chlordiazepoxide Hydrochloride/Clidinium Bromide affects you.
o
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
Chlordiazepoxide Hydrochloride/Clidinium Bromide without first talking
to your healthcare provider.
When taken with alcohol or drugs that cause sleepiness or dizziness,
Chlordiazepoxide Hydrochloride/
Clidinium Bromide may make your sleepiness or dizziness much worse.
•
Chlordiazepoxide Hydrochloride/Clidinium Bromide can cause abuse and
dependence .
o
Do not stop taking Chlordiazepoxide Hydrochloride/Clidinium Bromide
all of a sudden. Stopping
Chlordiazepoxide Hydrochloride/Clidinium Bromide suddenly can cause
seizures, shaking, stomach
and muscle cramps, vomiting and sweating.
o
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 Hydrochloride/Clidinium Bromide?
•
Chlordiazepo

Résumé des caractéristiques du produit

CHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
VIRTUS PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE/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 Hydrochloride/Clidinium Bromide combines in a single
capsule formulation the
antianxiety action of chlordiazepoxide hydrochloride and the
anticholinergic/spasmolytic effects of
clidinium bromide.
Each Chlordiazepoxide Hydrochloride/Clidinium Bromide capsule contains
active ingredients 5 mg
chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each
capsule also contains inactive
ingredients lactose monohydrate, pregelatinized starch, talc. Gelatin
capsule shells may contain titanium
dioxide with the following dye systems: 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:
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 SI