methadone hydrochloride 10 mg
1 INDICATIONS AND USAGE Methadone Hydrochloride Tablets are indicated for the: 1. Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use • Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve Methadone Hydrochloride Tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic. 2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. 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 )] . 4. Methadone Hydrochloride Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use • Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioids, reserve Methadone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) • Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic. ( 1 ) 5. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 6. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. ( 1 ) 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 ( 2.1 ).
Hikma Pharmaceuticals USA Inc.
ROUND WHITE 54 24
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hikma pharmaceuticals usa inc.
methadone hydrochloride 10 mg
Hikma Pharmaceuticals USA Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
METHADONE HYDROCHLORIDE Tablets USP 5 mg tablets are white, biconvex tablets, scored on one side and product identification “54 25” debossed on the other side. NDC 0054-0709-25: Bottle of 100 Tablets NDC 0054-0709-20: 10x10 Unit-Dose The 10 mg tablets are white, biconvex tablets, scored on one side and product identification “54 24” debossed on the other side. NDC 0054-0710-25: Bottle of 100 Tablets NDC 0054-0710-20: 10x10 Unit-Dose Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Store
METHADONE HYDROCHLORIDE Tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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