METHADONE HYDROCHLORIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PD-Rx Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

METHADONE HYDROCHLORIDE

Samenstelling:

METHADONE HYDROCHLORIDE 5 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application

Productkenmerken

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
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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; AND TREATMENT FOR OPIOID ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Methadone hydrochloride tablets exposes 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 or conditions. ( 5.1, 9)
Serious, life-threatening, or fatal respiratory depression may occur.
Monitor closely, especially upon initiation or
following a dose increase. ( 5.2)
Accidental ingestion of methadone hydrochloride tablets, especially in
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. ( 5.3)
Prolonged use of methadone hydrochloride tablets during pregnancy can
result in neonatal opioid withdrawal
syndrome, which may be life-threatening if not recognized and treated.
If opioid use is required for a prolonged
period in a pregnant woman, advise the patient of the risk of neonatal
opioid withdrawal syndrome and ensure that
appropriate treatment will be available ( 5.4).
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. ( 1)
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 04/2015
INDICATIONS AND USAGE
Methadone hydrochloride tablets are a