FDA Approved Low Dose ZUBSOLV® for Opioid Dependence

FDA Approved Low Dose ZUBSOLV® (Buprenorphine and Naloxone) for Opioid Dependence Treatment



Contents: 0.7 mg of buprenorphine and 0.18 mg of naloxone.


Available Dose Strengths for Zubsolv: 11.4mg/2.9mg, 8.6mg/2.1mg, 5.7mg/1.4mg, 2.9mg/0.71mg, 1.4mg/0.36mg, and 0.7mg/0.18mg.


Reason for this low dose preparation: This will allow physicians for more dosing flexibility.


Mechanism: Zubsolv (CIII agent) is a partial opioid antagonist indicated for the treatment of opioid dependence.


When will this be available in market: Early 2017.


For Pregnant and Nursing Mothers:

  • Based on animal data, buprenorphine may cause fetal harm. Use of ZUBSOLV sublingual tablet in pregnant women or during breastfeeding should only be considered if the potential benefit justifies the potential risk.
  • Caution should be exercised when buprenorphine-containing products are administered to a nursing woman. The safety of buprenorphine/naloxone in breastfeeding has not been established.

For Hepatic Impairment:

  • Not recommended in patients with severe hepatic impairment.
  • May not be appropriate for patients with moderate hepatic impairment.

Source: https://www.zubsolv.com/healthcareprofessionals/


 

Please do post your questions or comments below. 


Dr. Harvinder Singh, M.D. (Admin)


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