Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)
SpecGx LLC
ORAL
PRESCRIPTION DRUG
Methadone hydrochloride oral concentrate contains methadone, an opioid agonist indicated for the: - detoxification treatment of opioid addiction (heroin or other morphine-like drugs). - maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 [see Dosage and Administration (2.1)] . Methadone hydrochloride oral concentrate is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.1)] Significant respiratory depression [see Warnings and Precautions (5.1)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] Acute or severe bronchial asthma in an unmonitored setting or in
Methadone Hydrochloride Oral Concentrate USP, 10 mg per mL is supplied as a red, raspberry flavored liquid concentrate: 1 fl. oz. (30 mL) Bottle with an oral dropper provided in a carton .......................... NDC 0406-4123-03 1 Liter (1000 mL) Bottle .................................................................................... NDC 0406-4123-10 Dispense in tight containers, protected from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store methadone hydrochloride oral concentrate securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE CONCENTRATE SPECGX LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHADONE HYDROCHLORIDE ORAL CONCENTRATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE ORAL CONCENTRATE, CII INITIAL U.S. APPROVAL: 1947 WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL, INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES AND TREATMENT FOR OPIOID ADDICTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FATAL RESPIRATORY DEPRESSION MAY OCCUR, WITH HIGHEST RISK AT INITIATION AND WITH DOSE INCREASES. INSTRUCT PATIENTS ON PROPER ADMINISTRATION OF METHADONE HYDROCHLORIDE ORAL CONCENTRATE TO REDUCE THE RISK. (5.1) CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, AND DEATH. (5.2, 7) QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (TORSADES DE POINTES) HAVE OCCURRED WITH TREATMENT WITH METHADONE. (5.3) ACCIDENTAL INGESTION OF METHADONE HYDROCHLORIDE ORAL CONCENTRATE CAN RESULT IN FATAL OVERDOSE OF METHADONE, ESPECIALLY IN CHILDREN. (5.4) METHADONE HYDROCHLORIDE ORAL CONCENTRATE CONTAINS METHADONE, A SCHEDULE II CONTROLLED SUBSTANCE AND CAN BE ABUSED AND CRIMINALLY DIVERTED. (5.5) CONCOMITANT USE WITH CYP3A4, 2B6, 2C19, 2C9 OR 2D6 INHIBITORS OR DISCONTINUATION OF CONCOMITANTLY USED CYP3A4, 2B6, 2C19, OR 2C9 INDUCERS CAN RESULT IN A FATAL OVERDOSE OF METHADONE. (5.7, 7) METHADONE PRODUCTS, WHEN USED FOR THE TREATMENT OF OPIOID ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY CERTIFIED OPIOID TREATMENT PROGRAMS AS STIPULATED IN 42 CFR 8.12. (2.1) RECENT MAJOR CHANGES Dosage and Administration (2.3) 06/2021 Warnings and Precautions (5.1, 5.2) 06/2021 INDICATIONS AND USAGE Methadone hydrochloride oral conce Прочитајте комплетан документ