LIBRAX- chlordiazepoxide hydrochloride and clidinium bromide capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Bausch Health US, LLC

INN (International Name):

Chlordiazepoxide Hydrochloride

Sammensætning:

Chlordiazepoxide Hydrochloride 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Librax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax 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. Librax 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. Controlled Substance Librax contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Librax is exempted from Schedule IV and is not controlled under the Controlled Substances Act. Abuse Chlordiazepoxide hydrochloride, a component of Librax, is a CNS depressant with a potential for abuse and addiction. Abuse is the

Produkt oversigt:

Librax is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 (NDC 0187-4100-10), with “LIBRAX® ICN” imprinted on the body of the capsule. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada LIBRAX is a trademark of Bausch Health Companies Inc. or its affiliates. © 2023 Bausch Health Companies Inc. or its affiliates Revised: 01/2023 9548904 2005280

Autorisation status:

New Drug Application

Indlægsseddel

Bausch Health US LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Librax® (lee braks)
(chlordiazepoxide hydrochloride and clidinium bromide) Capsules
for oral use
What is the most important information I should know about Librax?
•
Librax contains a benzodiazepine medicine. Taking Librax with opioid
medicines, alcohol, or other
central nervous system (CNS) depressants (including street drugs) can
cause severe drowsiness,
breathing problems (respiratory depression), coma, and death. Get
emergency help right away if any of
the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
Librax with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including Librax, which can lead to overdose or
death.
•
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including Librax. These serious side effects
may also include
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty breathing. Call your
healthcare provider or go to the nearest hospital emergency room right
away if you get any of
these serious side effects.
•
You can develop an addiction even if you take Librax as prescribed by
your healthcare provider.
•
Take Librax exactly as your healthcare provider prescribed.
•
Do not share your Librax with other people.
•
Keep Librax in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Librax can cause
physical dependence and withdrawal
reactions.
•
Do not suddenly stop using Librax. Stopping Librax suddenly can cause
serious and life-
threatening side effects, including unusual movements, responses, or
expressions, seizures,
sudden and severe mental or nervous system changes, depression, seeing
or hearing things that
others do not see or hear, an extreme increas

Produktets egenskaber

LIBRAX- CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
BAUSCH HEALTH US LLC
----------
LIBRAX®
(CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE)
CAPSULES FOR ORAL USE
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION:
Librax capsules is a fixed-combination of chlordiazepoxide
hydrochloride, a
benzodiazepine, and clidinium bromide, an anticholinergic.
Each Librax 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.
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS 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 (SEE
WARNINGS AND PRECAUTIONS AND PRECAUTIONS, DRUG
INTERACTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE
HYDROCHLORIDE, A COMPONENT OF LIBRAX, EXPOSES USERS TO RISKS OF
ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH.
ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING LIBRAX AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS)_._
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING LIBRAX, MAY LEAD TO
CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE
AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER
DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF
LIBRAX AFTER CONTINUED USE MAY PR