METHADONE HYDROCHLORIDE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Akorn

INN (שם בינלאומי):

METHADONE HYDROCHLORIDE

הרכב:

METHADONE HYDROCHLORIDE 10 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

- For the management of pain severe enough to require an opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS: Addiction, Abuse, and Misuse) reserve Methadone Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. - For use in temporary treatment of opioid dependence in patients unable to take oral medication. Limitations of Use Injectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral

leaflet_short:

Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) is a clear, colorless solution and is available in: NDC 17478-380-20              20 mL Multi-dose Vials: One vial per carton Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store in carton until contents have been used. AKORN Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 MH00N            Rev. 10/22

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METHADONE HYDROCHLORIDE - METHADONE HYDROCHLORIDE INJECTION, SOLUTION
AKORN
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METHADONE HYDROCHLORIDE INJECTION, USP CII
200 MG/20 ML (10 MG/ML)
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; LIFE-THREATENING QT PROLONGATION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH
DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS; AND TREATMENT OF OPIOID ADDICTION
ADDICTION, ABUSE, AND MISUSE
METHADONE HYDROCHLORIDE INJECTION EXPOSES PATIENTS AND OTHER USERS TO
THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO
OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING
METHADONE HYDROCHLORIDE INJECTION, AND MONITOR ALL PATIENTS REGULARLY
FOR
THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS (SEE WARNINGS).
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF METHADONE HYDROCHLORIDE INJECTION. THE PEAK RESPIRATORY
DEPRESSANT EFFECT OF METHADONE OCCURS LATER, AND PERSISTS LONGER THAN
THE PEAK ANALGESIC EFFECT, ESPECIALLY DURING THE INITIAL DOSING
PERIOD.
MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
METHADONE HYDROCHLORIDE INJECTION OR FOLLOWING A DOSE INCREASE (SEE
WARNINGS).
LIFE-THREATENING QT PROLONGATION
QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (TORSADES DE POINTES)
HAVE OCCURRED 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.
CLOSELY MONITOR PATIENTS WITH RISK FACTORS FOR DEVELOPMENT OF
PROLONGED
QT INTERVAL, A HISTORY OF CARDIAC CONDUCTION ABNORMALITIES, AND THOSE
TAKING MEDICATIONS AFFECTING CARDIAC CONDUCTION FOR CHANGES IN CARDIAC
RHYTHM DURING INITIATION AND TITRATION OF METHADONE HYDROCHLORIDE
INJECTION (SEE WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
NEONATAL OPI