METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED- methadone hydrochloride concentrate

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Lannett Company, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Methadone Hydrochloride 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 is contraindicated in patients with: - 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)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13)] - Hypersensitivity (e.g., anaphylaxis) to methadone or any othe

Přehled produktů:

Methadone Hydrochloride Oral Concentrate, USP dye-free, sugar-free, unflavored 10 mg per mL is supplied as a dye-free, sugar-free, unflavored clear colorless liquid concentrate. 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 securely and dispose of properly [see Patient Counseling Information (17)] .

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED-
METHADONE HYDROCHLORIDE CONCENTRATE
LANNETT COMPANY, INC.
----------
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, USP, DYE-FREE, SUGAR-FREE,
UNFLAVORED, 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 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 CAN RESULT IN FATAL
OVERDOSE OF
METHADONE, ESPECIALLY IN CHILDREN. (5.4)
METHADONE HYDROCHLORIDE 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
Me