Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)
Solco Healthcare US LLC
CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Chlordiazepoxide Hydrochloride Capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide hydrochloride capsules in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Chlordiazepoxide Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to the drug. Controlled Substance Chlordiazepoxide is a Schedule IV controlled substance. Chlordiazepoxide is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
Chlordiazepoxide Hydrochloride Capsules, USP are available in the following presentations: 5 mg hard gelatin capsules in bottles of 100 (NDC 43547-251-10), with S251 imprinted on the opaque green cap and Solco’s logo "S" imprinted on the opaque yellow body. 10 mg hard gelatin capsules in bottles of 100 (NDC 43547-252-10), with S252 imprinted on the opaque black cap and Solco’s logo "S" imprinted on the opaque green body. 25 mg hard gelatin capsules in bottles of 100 (NDC 43547-253-10), with S253 imprinted on the opaque green cap and Solco’s logo "S" imprinted on the opaque white body. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Distributed by: Solco Healthcare U.S., LLC Cranbury, NJ 08512 Rev. 01/2021 p/n
Abbreviated New Drug Application
Solco Healthcare US LLC ---------- MEDICATION GUIDE Chlordiazepoxide Hydrochloride (klor″ dye az″ e pox′ ide hye″droe klor′ ide) Capsules USP, C-IV What is the most important information I should know about chlordiazepoxide hydrochloride? • Chlordiazepoxide Hydrochloride is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (CNS) (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: o shallow or slowed breathing o breathing stops (which may lead to the heart stopping) o excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking chlordiazepoxide hydrochloride with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including chlordiazepoxide hydrochloride, which can lead to overdose and serious side effects including coma and death. o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including chlordiazepoxide hydrochloride.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. o You can develop an addiction even if you take chlordiazepoxide hydrochloride exactly as prescribed by your healthcare provider. o Take chlordiazepoxide hydrochloride exactly as your healthcare provider prescribed. o Do not share your chlordiazepoxide hydrochloride with other people. o Keep chlordiazepoxide hydrochloride in a safe place and away from children. • Physical dependence and withdrawal reactions. Chlordiazepoxide Hydrochloride can cause physical dependence and withdrawal reactions, especially if you continue to take chlordiazepoxide hyd Læs hele dokumentet
CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED SOLCO HEALTHCARE US LLC ---------- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV RX ONLY WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS • • • DESCRIPTION Chlordiazepoxide Hydrochloride, is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide Hydrochloride is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide Hydrochloride is available as capsules containing 5 mg, 10 mg or 25 CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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). THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, EXPOSES USERS TO RISK 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 CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISK OF DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITH Læs hele dokumentet