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Zubsolv

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Manufacturer: Orexo US, Inc.

Score: 141.0

Quick Summary

Zubsolv is a sublingual tablet formulation of buprenorphine and naloxone used for the treatment of opioid dependence. It is indicated for use as part of a complete treatment plan that includes counseling and psychosocial support. The medication works by reducing withdrawal symptoms and cravings for opioids, allowing patients to manage their addiction. Key clinical findings indicate that Zubsolv is effective in reducing opioid use and improving treatment outcomes. Important safety information includes the risk of addiction, abuse, and misuse, as well as potential interactions with other medications. Contraindications include hypersensitivity to buprenorphine or naloxone, and the medication should be used with caution in patients with certain medical conditions. The recommended initial dose is up to 5.7 mg/1.4 mg on the first day, with adjustments made as needed to achieve a target dose of 11.4 mg/2.9 mg. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of opioid dependence
  • Reduces withdrawal symptoms and cravings for opioids
  • Effective in reducing opioid use and improving treatment outcomes

Important Safety Information

Warning

Risk of addiction, abuse, and misuse

Contraindications

  • Hypersensitivity to buprenorphine or naloxone

Adverse Reactions

  • Headache
  • Nausea
  • Vomiting
  • Constipation
  • Insomnia

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with hepatic impairment or those taking other medications that interact with Zubsolv

Opioid dependence

Adult Dose

Up to 5.7 mg/1.4 mg on the first day, with adjustments made as needed to achieve a target dose of 11.4 mg/2.9 mg

Pediatric Dose

Special Population Considerations

Pregnancy

  • Use during pregnancy should be carefully considered, as the effects of Zubsolv on the fetus are not well understood

Nursing Mothers

  • Caution should be exercised when using Zubsolv in nursing mothers, as the medication may be excreted in breast milk

Pediatric Use

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

Geriatric Use

  • Caution should be exercised when using Zubsolv in geriatric patients, as they may be more sensitive to the effects of the medication