Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)
ATLANTIC BIOLOGICALS CORP.
ORAL
PRESCRIPTION DRUG
- 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
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].
Abbreviated New Drug Application
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 Přečtěte si celý dokument