BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

Manufacturer: REMEDYREPACK INC.

Score: 141.0

Quick Summary

Buprenorphine and Naloxone Sublingual Tablets are used for the maintenance treatment of opioid dependence. The drug contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. Key clinical findings indicate that the drug is effective in suppressing opioid withdrawal signs and symptoms. Important safety information includes warnings about addiction, abuse, and misuse, as well as contraindications for patients with hypersensitivity to buprenorphine or naloxone. The main dosing recommendation is to administer the drug sublingually as a single daily dose, with a recommended target dosage of 16 mg/4 mg buprenorphine/naloxone per day. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Maintenance treatment of opioid dependence
Suppression of opioid withdrawal signs and symptoms
Effective in reducing illicit opioid use

Important Safety Information

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

Dosing Recommendations

General Guidance

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

Opioid dependence

Adult Dose

16 mg/4 mg buprenorphine/naloxone per day

Pediatric Dose

Not established

Special Population Considerations

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

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