DESCRIPTION

SUBOXONE sublingual tablet is an uncoated hexagonal orange tablet, debossed with an alphanumeric word identifying the product and strength. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium stearate, acesulfame K sweetener and a lemon / lime flavor. Buy Suboxone Online

 

DOSAGE AND ADMINISTRATION

Drug Addiction And Treatment Act

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Important Dosage And Administration Information

SUBOXONE sublingual tablet is administered sublingually as a single daily dose. SUBOXONE sublingual tablets should be used in patients who have been initially inducted using SUBUTEX® (buprenorphine) sublingual tablets. Buy Suboxone Online

 

Method Of Administration

SUBOXONE sublingual tablets must be administered whole. Do not cut, chew, or swallow SUBOXONE sublingual tablets. Advise patients not to eat or drink anything until the tablet is completely dissolved. SUBOXONE sublingual tablet should be placed under the tongue until it is dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

 

HOW SUPPLIED

Dosage Forms And Strengths

SUBOXONE sublingual tablet is supplied as an uncoated hexagonal orange tablet in two dosage strengths: 

  • Buprenorphine 2 mg/naloxone 0.5 mg
  • Buprenorphine 4 mg/naloxone 1 mg
  • Buprenorphine 8 mg/naloxone 2 mg
  • Buprenorphine 12 mg/naloxone 3 mg

 

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Addiction, Abuse, and Misuse 
  • Respiratory and CNS Depression 
  • Neonatal Opioid Withdrawal Syndrome 
  • Adrenal Insufficiency 
  • Opioid Withdrawal 
  • Hepatitis, Hepatic Events 
  • Hypersensitivity Reactions 
  • Orthostatic Hypotension
  • Elevation of Cerebrospinal Fluid Pressure
  • Elevation of Intracholedochal Pressure

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