Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
CHLORDIAZEPOXIDE (UNII: 6RZ6XEZ3CR) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)
Par Pharmaceutical Inc
CHLORDIAZEPOXIDE
CHLORDIAZEPOXIDE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL- CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET PAR PHARMACEUTICAL INC ---------- SUICIDALITY AND ANTIDEPRESSANT DRUGS ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL THINKING AND BEHAVIOR (SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES OF MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE CONSIDERING THE USE OF CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN THE RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE). DESCRIPTION Chlordiazepoxide and amitriptyline hydrochloride tablets combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. Each film coated tablet for oral administration contains 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt) or 10 mg chlordiazepoxide and 25 mg amitriptyline as the hydrochloride salt). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, hydroxypropyl cellulose, isopropyl alc Lestu allt skjalið