Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
methadone (methadone hydrochloride)
SpecGx LLC
methadone (methadone hydrochloride)
5mg
tablets
Prescription
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHADONE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1947 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; AND TREATMENT FOR OPIOID ADDICTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • METHADONE HYDROCHLORIDE TABLETS EXPOSE USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS. (5.1) • SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. THE PEAK RESPIRATORY DEPRESSANT EFFECT OF METHADONE OCCURS LATER, AND PERSISTS LONGER THAN THE PEAK ANALGESIC EFFECT. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.2) • ACCIDENTAL INGESTION OF METHADONE HYDROCHLORIDE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE OF METHADONE. (5.2) • QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (_TORSADES _ _DE _ _POINTES_) HAVE OCCURRED DURING TREATMENT WITH METHADONE. CLOSELY MONITOR PATIENTS WITH RISK FACTORS FOR DEVELOPMENT OF PROLONGED QT INTERVAL, A HISTORY OF CARDIAC CONDUCTION ABNORMALITIES, AND THOSE TAKING MEDICATIONS AFFECTING CARDIAC CONDUCTION. (5.3) • NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) IS AN EXPECTED AND TREATABLE OUTCOME OF USE OF METHADONE HYDROCHLORIDE TABLETS DURING PREGNANCY. NOWS MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED IN THE NEONATE. THE BALANCE BETWEEN THE RISKS OF NOWS AND THE BENEFITS OF MATERNAL METHADONE HYDRO- CHLORIDE TABLETS USE MAY DIFFER BASED ON Soma hati kamili
Methadone Hydrochloride Tablets USP, 5mg and 10mg SpecGx LLC • 385 Marshall Avenue • Webster Groves, MO 63119 • 314.654.2000 T • www.mallinckrodt.com Appendix 1.9 Summary of Product Characteristics 1. NAME OF MEDICINAL PRODUCT: Methadone Hydrochloride Tablets USP, 5mg and 10mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (5MG): Active Ingredient: Methadone Hydrochloride, USP 5.00 mg Excipients: Microcrystalline Cellulose, NF 39.63 mg Lactose Monohydrate, NF 79.25 mg Silicon Dioxide, NF 0.50 mg Magnesium Stearate, NF 0.62 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (10MG): Active Ingredient: Methadone Hydrochloride, USP 10.00 mg Excipients: Microcrystalline Cellulose, NF 79.26 mg Lactose Monohydrate, NF 158.50 mg Silicon Dioxide, NF 1.00 mg Magnesium Stearate, NF 1.24 mg 3. PHARMACEUTICAL FORM: tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: Methadone hydrochloride tablets are an opioid agonist indicated for the: 1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve methadone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic. 2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). Methadone Hydrochloride Tablets USP, 5mg and 10mg SpecGx LLC • 385 Marshall Avenue • Webster Groves, MO 63119 • 314.654.2000 T • www.mallinckrodt.com 3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with ap Soma hati kamili