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Buprenorphine (Subutex®, Suboxone®)

Buprenorphine (US brand name Subutex® which has been discontinued and generic) is an opioid medication. It is a partial agonist at the mu opioid receptor (MOR) and mainly an antagonist at the kappa opioid receptor (KOR). Here is key information about this medication.

FDA-approved indications

Indicated for the treatment of opioid dependence, preferably during the induction phase of the treatment

Dosage

For induction, consideration should be given to type of opioid dependence (i.e., long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence.

1. Induction: Dose needs to be titrated till it is effective

a. Patients taking heroin or other short-acting opioids:

Administer at least 4 hours after the patient last used opioids or preferably when moderate objective signs of opioid withdrawal appear

b. Patients on methadone or other long-acting opioids:

Withdrawal symptoms are more likely to appear in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose. Therefore buprenorphine monotherapy should be initiated preferably when moderate objective signs of opioid withdrawal appear.

2. Maintenance: Suboxone® (buprenorphine plus naloxone) is preferred since it can be administered without daily supervision (see below). Buprenorphine monotherapy is given only in cases where the patient is hypersensitive to presence of naloxone in Suboxone®.

Maintenance dose (monotherapy): 4–24 mg/day (to be adjusted in increments or decrements of 2–4 mg/day )

Dosage forms and strengths

Buprenorphine for sublingual use. Available in 2 mg and 8 mg strengths.

Please refer to Prescribing Information (see link below) for complete discussion of dosage, administration, warnings and precautions, contraindications, etc.


Buprenorphine plus Naloxone (Suboxone® and generic)

Buprenorphine is an agonist on mu-opioid receptor and antagonist on kappa-opioid receptor. Naloxone is an antagonist at mu-opioid receptor.

FDA-approved indications

Treatment of opioid dependence

Dosage

1. If the patient is dependent on short-acting opioid products, at least 6 hours have passed since last use, and patient is in opioid withdrawal

Day 1: up to buprenorphine 8 mg and naloxone 2 mg in divided doses

Start with 2 mg and 0.5 mg or 4 mg and 1 mg buprenorphine and naloxone and titrate upwards in 2 or 4 mg of buprenorphine every 2 hours, up to daily maximum of 8 mg and 2 mg depending on control of withdrawal symptoms.

Day 2: up to buprenorphine 16 mg plus naloxone 4 mg in a single dose

Note: If patient is dependent on methadone or long-acting opioid products, buprenorphine monotherapy is preferred on first 2 days of the treatment.

2. For maintenance treatment

Buprenorphine 16 mg plus naloxone 4 mg as a single daily dose

Administration: Can be administered by placing under the tongue (sublingual) or inside of the cheek (buccal). Do not cut, chew, or swallow sublingual film.

Dosage forms and strengths

Buprenorphine plus naloxone as a film for sublingual use. Available in the following strengths:

  • 2 mg buprenorphine with 0.5 mg naloxone
  • 4 mg buprenorphine with 1 mg naloxone
  • 8 mg buprenorphine with 2 mg naloxone
  • 12 mg buprenorphine with 3 mg naloxone

Please refer to Prescribing Information (see link below) for complete discussion of dosage, administration, warnings and precautions, contraindications, etc.


Related Pages

Clinical pearls on prescribing buprenorphine: Part one

Clinical pearls on prescribing buprenorphine: Part two

News: July 7, 2016. Buprenorphine prescribing limit raised significantly (Free)

Tips on using naltrexone extended-release injectable (Vivitrol®)

How to order, store, and administer naltrexone extended-release injection (Vivitrol®)

Opioids in the urine drug screen

Tips for opioid dependent patients


References

Suboxone® Prescribing Information

Buprenorphine Prescribing Information


Copyright 2016, Rajnish Mago, MD. All rights reserved. May not be reproduced in any form without express written permission.

Disclaimer: The content on this website is provided as general education for medical professionals. It is not intended or recommended for patients or other laypersons, or as a substitute for medical advice, diagnosis, or treatment. Patients must always consult a qualified health care professional regarding their diagnosis and treatment. Healthcare professionals should always check this website for the most recently updated information.

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