METHADONE HYDROCHLORIDE- methadone hydrochloride powder

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)

Prieinama:

Mallinckrodt, Inc.

INN (Tarptautinis Pavadinimas):

METHADONE HYDROCHLORIDE

Sudėtis:

METHADONE HYDROCHLORIDE 1 g in 1 g

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

1.  For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 2.  For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. 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 Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requiremen

Produkto santrauka:

Methadone Hydrochloride Powder is supplied in containers of 50 gm, 100 gm, and 500 gm for prescription compounding only. 50 gm bottle NDC 0406-1510-56 100 gm bottle NDC 0406-1510-57 500 gm bottle NDC 0406-1510-59 Preserve in tight, light-resistant containers. Store at controlled room temperature (15° to 30°C) (59° to 86°F) [see USP Controlled Room Temperature]. Mallinckrodt™  MALLINCKRODT INC. St. Louis, Missouri 63134 Rev 12/2016 

Autorizacija statusas:

New Drug Application

Prekės savybės

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE POWDER
MALLINCKRODT, INC.
----------
METHADONE HYDROCHLORIDE
USP POWDER
CII
FOR ORAL USE ONLY
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
LIFE-THREATENING RESPIRATORY DEPRESSION
RESPIRATORY DEPRESSION, INCLUDING FATAL CASES, HAVE BEEN REPORTED
DURING INITIATION AND
CONVERSION OF PATIENTS TO METHADONE, AND EVEN WHEN THE DRUG HAS BEEN
USED AS
RECOMMENDED AND NOT MISUSED OR ABUSED (SEE WARNINGS). PROPER DOSING
AND TITRATION
ARE ESSENTIAL AND METHADONE HYDROCHLORIDE SHOULD ONLY BE PRESCRIBED BY
HEALTHCARE
PROFESSIONALS WHO ARE KNOWLEDGEABLE IN THE USE OF METHADONE FOR
DETOXIFICATION AND
MAINTENANCE TREATMENT OF OPIOID ADDICTION. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF METHADONE HYDROCHLORIDE OR FOLLOWING A DOSE
INCREASE. THE PEAK
RESPIRATORY DEPRESSANT EFFECT OF METHADONE OCCURS LATER, AND PERSISTS
LONGER THAN THE PEAK
PHARMACOLOGIC EFFECT, ESPECIALLY DURING THE INITIAL DOSING PERIOD (SEE
WARNINGS).
LIFE-THREATENING QT PROLONGATION
QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (TORSADES DE POINTES)
HAVE OCCURRED
DURING TREATMENT WITH METHADONE (SEE WARNINGS). MOST CASES INVOLVE
PATIENTS BEING
TREATED FOR PAIN WITH LARGE, MULTIPLE DAILY DOSES OF METHADONE,
ALTHOUGH CASES HAVE BEEN
REPORTED IN PATIENTS RECEIVING DOSES COMMONLY USED FOR MAINTENANCE
TREATMENT OF OPIOID
ADDICTION. 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 FOR CHANGES IN CARDIAC RHYTHM DURING
INITIATION AND TITRATION OF
METHADONE HYDROCHLORIDE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF METHADONE HYDROCHLORIDE, ESPECIALLY BY
CHILDREN, CAN RESULT IN FATAL
OVERDOSE OF METHADONE (SEE WARNINGS).
MISUSE, ABUSE, AND DIVERSION OF OPIOIDS
METHADONE HYDR