METHADONE HYDROCHLORIDE concentrate

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

ATLANTIC BIOLOGICALS CORP.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

- 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.  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 - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - Known or suspected gastrointestinal obstruction, including paralytic ileus - Hypersensitivity (e.g., anaphylaxis) to methadone or any other ingredient in methadone hydrochloride oral concentrate   Methadone hydrochloride oral concentrate contains methadone, a Schedule II opioid agonist. Schedule II opioid substances, which also include hydromor

Produkt oppsummering:

Methadone hydrochloride oral concentrate USP 10 mg/mL is supplied as a red, cherry flavored liquid concentrate, as follows: 1 fl. oz. Bottle (30 mL) ………………NDC 66689-694-30 (Supplied with calibrated dropper); 1 Liter Bottle (1000 mL) ……………..NDC 66689-694-79 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL, is supplied as a dye-free, sugar-free, unflavored liquid concentrate, as follows: 1 fl. oz. Bottle (30 mL) ………………NDC 66689-695-30  (Supplied with calibrated dropper); 1 Liter Bottle (1000 mL) ……………..NDC 66689-695-79 Dispense in tight containers, protected from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE CONCENTRATE
ATLANTIC BIOLOGICALS CORP.
----------
METHADONE HCL ORAL CONCENTRATE
METHADONE HYDROCHLORIDE ORAL CONCENTRATE, USP
_AND_
METHADONE HYDROCHLORIDE ORAL CONCENTRATE, USP
(DYE-FREE, SUGAR-FREE, UNFLAVORED)
10 MG/ML
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 ORAL CONCENTRATE 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 ORAL
CONCENTRATE 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 ALTERNATES 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