buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Warning

Addiction, abuse, and misuse may lead to overdose and death

Contraindications

• Hypersensitivity to buprenorphine or naloxone

Adverse Reactions

• Respiratory depression
• CNS depression
• Neonatal opioid withdrawal syndrome

General Guidance

Dosage adjustments may be necessary in patients with hepatic impairment or those taking CYP3A4 inhibitors or inducers

Pregnancy

• Use during pregnancy may lead to neonatal opioid withdrawal syndrome
• Dose adjustments may be necessary during pregnancy

Nursing Mothers

• Caution is advised when administering the drug to nursing mothers

Pediatric Use

• The safety and effectiveness of the drug have not been established in pediatric patients

Geriatric Use

• Caution is advised when administering the drug to geriatric patients due to possible decreased hepatic, renal, or cardiac function