METHADOSE DISPERSIBLE- methadone hydrochloride tablet METHADONE HYDROCHLORIDE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

SpecGx LLC

INN (আন্তর্জাতিক নাম):

METHADONE HYDROCHLORIDE

রচনা:

METHADONE HYDROCHLORIDE 40 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methadone hydrochloride tablets for oral suspension contain 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 42 CFR 8.12 [see Dosage and Administration (2.1)] . Methadone hydrochloride tablets for oral suspension are 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 s

পণ্য সারাংশ:

METHADOSE™ Dispersible Tablets, 40 mg: Available as a white, round tablet, debossed with “METHADOSE 40” on one side, a quadrisect on the other. Bottles of 100……NDC 0406-0540-34 Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg: Available as a speckled orange colored, rounded rectangular tablet, debossed with “M” over “2540” on one side, a quadrisect on the other with an orange odor. Bottles of 100……NDC 0406-2540-01 Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store methadone hydrochloride tablets for oral suspension securely and dispose of properly [see Patient Counseling Information ( 17)] .

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

METHADOSE DISPERSIBLE- METHADONE HYDROCHLORIDE TABLET
METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
SPECGX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHADOSE
DISPERSIBLE TABLETS AND METHADONE HYDROCHLORIDE TABLETS FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR METHADOSE
DISPERSIBLE TABLETS AND METHADONE HYDROCHLORIDE TABLETS FOR ORAL
SUSPENSION.
METHADOSE (METHADONE HYDROCHLORIDE), DISPERSIBLE TABLETS, FOR ORAL
SUSPENSION, CII
METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION, 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
TABLETS FOR ORAL SUSPENSION 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 TABLETS FOR ORAL
SUSPENSION CAN
RESULT IN FATAL OVERDOSE OF METHADONE, ESPECIALLY IN CHILDREN. (5.4)
METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION CONTAIN 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 PROGR