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Methadone Hydrochloride — 2MG/ML, Solution, 1 × 500 mL bottle

NDC/Item Number: 00054355663
Manufacturer:
HIKMA PHARMACEUTICALS USA INC
Form
SOLUTION
Unit size
500ML
Strength
2MG/ML

Details

Details

Methadone Hydrochloride — 2MG/ML, Solution, 1 × 500 mL bottle

Methadone Hydrochloride is a solution for oral use. Methadone Hydrochloride Oral Solution is indicated for the: • Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.2 )] , reserve opioid analgesics, including Methadone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic. • Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). • Maintenance treatment of op

  • Active ingredient or product type: METHADONE HYDROCHLORIDE
  • Strength/concentration: 2MG/ML
  • Dosage form and route: Solution, Oral
  • Exact package presentation: 1 × 500 mL bottle
  • NDC/item number: 0054-3556-63
  • Manufacturer: HIKMA PHARMACEUTICALS USA INC
  • Storage/handling: Store at 20° to 25ºC (68º to 77°F), with excursions permitted between 15° to 30°C (59° to 86° F). [See USP Controlled Room Temperature.] Store Methadone Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information ( 17 )].
  • Status: Rx only

Important safety information: • Opioid Induced Hyperalgesia (OIH) and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.