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

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

- 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. 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 ). Methadone Hydrochloride is contraindicated in patients with: - Significant respiratory depression Significant respiratory depression - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - Known or suspected gastrointestinal obstruction, including paralytic ileus Known or suspected gastrointestinal obstruction, including paralytic ileus - Hypersensitivity (e.g., anaph

Dettagli prodotto:

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. NDC 63629-2098-1 30 mL bottle in a carton with a calibrated dropper [graduations of 0.25 mL (2.5 mg), 0.5 mL (5 mg), 0.75 mL (7.5 mg), and 1 mL (10 mg) on the dropper]. 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) ]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED-
METHADONE HYDROCHLORIDE CONCENTRATE
BRYANT RANCH PREPACK
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METHADONE HYDROCHLORIDE ORAL CONCENTRATE, USP
DYE-FREE, SUGAR-FREE, UNFLAVORED
CII
RX ONLY
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).
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, IS A RISK FACTOR FOR RESPIRATORY
DEPRESSION AND DEATH (_SEE _WARNINGS_AND _PRECAUTIONS).
RESERVE CONCOMITANT PRESCRIBING OF BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS IN PATIENTS IN METHADONE TREATMENT TO THOSE FOR WHOM
ALTERNATIVES TO BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ARE
INADEQUATE.
FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND
SEDATION. IF THE PATIENT IS VISIBLY SEDATED, EVALUATE THE CAUSE OF
SEDATION AND CONSIDER DELAYING OR OMITTING DAILY METHADONE DOSING.
LIFE-THREATENING QT PROLONGATION
QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (TORSADES DE POINTES)
HAVE OCCURRED D