Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
methadone (methadone hydrochloride)
SpecGx LLC
methadone (methadone hydrochloride)
40mg
tablets for oral suspension
Prescription
Page 1 of 37 022018-2 HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHADOSE ™ DISPERSIBLE TABLETS AND METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHADOSE DISPERSIBLE TABLETS AND METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION. METHADOSE ™ DISPERSIBLE TABLETS, 40 MG (METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION) AND METHADONE HYDROCHLORIDE TABLETS, 40 MG (DISPERSIBLE, ORANGE FLAVORED) (METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION), CII INITIAL U.S. APPROVAL: 1947 ----------------------------RECENT MAJOR CHANGES-------------------------- Boxed Warning 02/2018 Warnings and Precautions (5.2, 5.6) 02/2018 ----------------------------INDICATIONS AND USAGE ---------------------------- Methadone hydrochloride tablets for oral suspension are an opioid agonist indicated for the: • Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). (1) • Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1) _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. (1, 2.1) _ _ ------------------------DOSAGE AND ADMINISTRATION ----------------------- • Initiation of Detoxification and Maintenance Treatment: A single dose of 20 to 30 mg may be sufficient to suppress withdrawal syndrome. (2.4) • Do not abruptly discontinue methadone hydrochloride tablets for oral suspension in a physically dependent patient. (2.6, 5.15) • Maintenance Treatment: Clinical stability is most commonly achieved at doses between 80 to 120 mg/day. (2.5) -----------------------DOSAGE FORMS AND STRENGTHS -------------------- Tablets intended for dispersion in a liquid immediately prior to oral administration: 40 mg. (3) --- Lees het volledige document
Methadose™ Dispersible Tablets USP, 40mg 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: Methadose™ Dispersible Tablets USP, 40mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Active Ingredient: Methadone Hydrochloride, USP 40.00 mg Excipients: Microcrystalline Cellulose, NF 1,243.14 mg Colloidal Silicon Dioxide, NP 4.000mg Pregelatinized Starch, NF 262.87 mg Stearic Acid, NF 12.000 mg Magnesium Stearate, NF 5.090 mg Dibasic Calcium Phosphate, USP 82.90 mg 3. PHARMACEUTICAL FORM: tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: Methadone hydrochloride tablets for oral suspension contain 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 42 CFR 8.12. 4.2 METHOD OF ADMINISTRATION: CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS FOR THE TREATMENT OF OPIOID ADDICTION Code of Federal Regulations, Title 42, Sec 8: Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Methadose™ Dispersible Tablets USP, 40mg SpecGx LLC • 385 Marshall Avenue • Webster Gr Lees het volledige document