Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)
PD-Rx Pharmaceuticals, Inc.
CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
Chlordiazepoxide HCl 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 HCl 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 HCl capsules are contraindicated in patients with known hypersensitivity to the drug. 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. Misuse is the intentional use, for therapeutic pur
Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink “stylized barr” 159, available in bottles of: (NDC 43063-046-03) Bottles of 3 (NDC 43063-046-06) Bottles of 6 (NDC 43063-046-12) Bottles of 12 (NDC 43063-046-15) Bottles of 15 (NDC 43063-046-19) Bottles of 19 (NDC 43063-046-24) Bottles of 24 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
PD-Rx Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Chlordiazepoxide Hydrochloride ( klorʺ dye azʺ e poxʹ ide hyeʺ droe klorʹ ide) Capsules, C-IV What is the most important information I should know about Chlordiazepoxide HCl? • Chlordiazepoxide HCl 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: • 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 Chlordiazepoxide HCl with opioids affects you. • Risk of abuse, misuse, and addiction.There is a risk of abuse, misuse, and addiction with benzodiazepines, including Chlordiazepoxide HCl, which can lead to overdose and serious side effects including coma and death. • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Chlordiazepoxide HCl.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 Chlordiazepoxide HCl exactly as prescribed by your healthcare provider. • Take Chlordiazepoxide HCl exactly as your healthcare provider prescribed. • Do not share your Chlordiazepoxide HCl with other people. • Keep Chlordiazepoxide HCl in a safe place and away from children. • Physical dependence and withdrawal reactions. Chlordiazepoxide HCl can cause physical dependence and withdrawal reactions, especially if you continue to take Chlordiazepoxide HCl for several days to several weeks. • Do not suddenly stop taking Chlordiazepoxide HCl Lees het volledige document
CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE PD-RX PHARMACEUTICALS, INC. ---------- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP CIV RX ONLY WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS 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 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 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 RISKS 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 WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES OR REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION AND WARNINGS). DESCRIPTION Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochl Lees het volledige document