Methadone Hydrochloride — 10MG/ML, Concentrate, carton of 1 × 30 mL bottle

Methadone Hydrochloride — 10MG/ML, Concentrate, carton of 1 × 30 mL bottle

Methadone Hydrochloride is a concentrate for oral use. Methadone Hydrochloride Oral Concentrate ( Intensol ™) contains methadone, an opioid agonist indicated for the: • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use o Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions ( 5.5 )] , reserve Methadone Hydrochloride Intensol ™ for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. o Methadone Hydrochloride Intensol ™ are not indicated as an as-needed (prn) analgesic. • Detoxification t

• Active ingredient or product type: METHADONE HYDROCHLORIDE
• Strength/concentration: 10MG/ML
• Dosage form and route: Concentrate, Oral
• Exact package presentation: carton of 1 × 30 mL bottle
• NDC/item number: 0054-3553-44
• Manufacturer: HIKMA PHARMACEUTICALS USA INC
• Storage/handling: 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 Intensol ™ securely and dispose of properly [see Patient Counseling Information ( 17 )] .
• Status: Rx only

Important safety information: • Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. ( 5.6 ) • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. ( 5.8 ) • Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administrat

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