METHADONE HYDROCHLORIDE concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SpecGx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methadone hydrochloride oral concentrate 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 oral concentrate is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.1)] 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)] Acute or severe bronchial asthma in an unmonitored setting or in

Product summary:

Methadone Hydrochloride Oral Concentrate USP, 10 mg per mL is supplied as a red, raspberry flavored liquid concentrate: 1 fl. oz. (30 mL) Bottle with an oral dropper provided in a carton .......................... NDC 0406-4123-03 1 Liter (1000 mL) Bottle .................................................................................... NDC 0406-4123-10 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 oral concentrate securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE CONCENTRATE
SPECGX LLC
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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, 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
ORAL CONCENTRATE 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 ORAL CONCENTRATE CAN
RESULT IN FATAL
OVERDOSE OF METHADONE, ESPECIALLY IN CHILDREN. (5.4)
METHADONE HYDROCHLORIDE ORAL CONCENTRATE 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
Methadone hydrochloride oral conce