Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Chlordiazepoxide Hydrochloride (UNII: MFM6K1XWDK) (Chlordiazepoxide - UNII:6RZ6XEZ3CR), Clidinium Bromide (UNII: 91ZQW5JF1Z) (CLIDINIUM - UNII:BO76JF850N)
Bausch Health US, LLC
Chlordiazepoxide Hydrochloride
Chlordiazepoxide Hydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
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
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
New Drug Application
Bausch Health US LLC ---------- 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 Les hele dokumentet
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 Les hele dokumentet