METHADONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

METHADONE HYDROCHLORIDE

Composition:

METHADONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. - For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). - For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Note – Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone. Methadone is contr

Product summary:

Each 5 mg Methadone Hydrochloride Tablet USP contains 5 mg methadone hydrochloride USP.  It is available as a white to off-white, modified rectangle shaped convex tablet, one side debossed with a score between "57" and "55"; on the other side.     Bottles of 28   -  NDC 42549-577-28     Bottles of 112 -  NDC 42549-577-02 Each 10 mg Methadone Hydrochloride Tablet USP contains 10 mg methadone hydrochloride USP.  It is available as a white to off-white, modified rectangle shaped convex tablet, one side debossed with a score between "57" and "71"; on the other side.     Bottles of 28   -  NDC 42549-578-28     Bottles of 30   -  NDC 42549-578-30     Bottles of 56   -  NDC 42549-578-56     Bottles of 60   -  NDC 42549-578-60     Bottles of 112 -  NDC 42549-578-02     Bottles of 168 -  NDC 42549-578-08 Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Store at 20 to 25 degrees C (68 to 77 degrees F) [see USP Controlled Room Temperature]. is a trademark of Mallinckrodt Inc. COVIDIEN™ Mallinckrodt Mallinckrodt Inc., Hazelwood, MO 63042 USA. Rev 011309 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHADONE HYDROCHLORIDE - METHADONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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METHADONE HYDROCHLORIDE TABLETS USP
5 MG, 10 MG
CII
RX ONLY
DEATHS, CARDIAC AND RESPIRATORY, HAVE BEEN REPORTED DURING INITIATION
AND CONVERSION OF
PAIN PATIENTS TO METHADONE TREATMENT FROM TREATMENT WITH OTHER OPIOID
AGONISTS. IT IS CRITICAL
TO UNDERSTAND THE PHARMACOKINETICS OF METHADONE WHEN CONVERTING
PATIENTS FROM OTHER
OPIOIDS (_SEE_ DOSAGE AND ADMINISTRATION). PARTICULAR VIGILANCE IS
NECESSARY DURING
TREATMENT INITIATION, DURING CONVERSION FROM ONE OPIOID TO ANOTHER,
AND DURING DOSE
TITRATION.
RESPIRATORY DEPRESSION IS THE CHIEF HAZARD ASSOCIATED WITH METHADONE
HYDROCHLORIDE
ADMINISTRATION. METHADONE'S PEAK RESPIRATORY DEPRESSANT EFFECTS
TYPICALLY OCCUR LATER, AND
PERSIST LONGER THAN ITS PEAK ANALGESIC EFFECTS, PARTICULARLY IN THE
EARLY DOSING PERIOD. THESE
CHARACTERISTICS CAN CONTRIBUTE TO CASES OF IATROGENIC OVERDOSE,
PARTICULARLY DURING TREATMENT
INITIATION AND DOSE TITRATION.
IN ADDITION, CASES OF QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA
(TORSADES DE POINTES)
HAVE BEEN OBSERVED DURING TREATMENT WITH METHADONE. 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.
METHADONE TREATMENT FOR ANALGESIC THERAPY IN PATIENTS WITH ACUTE OR
CHRONIC PAIN SHOULD
ONLY BE INITIATED IF THE POTENTIAL ANALGESIC OR PALLIATIVE CARE
BENEFIT OF TREATMENT WITH
METHADONE IS CONSIDERED AND OUTWEIGHS THE RISKS.
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 an