Skip to main content

Buprenorphine Dosage

Medically reviewed by Drugs.com. Last updated on Jan 19, 2024.

Applies to the following strengths: 0.3 mg/mL; 2 mg; 8 mg; 7.5 mcg/hr; 5 mcg/hr; 10 mcg/hr; 15 mcg/hr; 20 mcg/hr; 100 mg/0.5 mL; 300 mg/1.5 mL; 74.2 mg; 8 mg/0.16 mL; 16 mg/0.32 mL; 24 mg/0.48 mL; 128 mg/0.36 mL; 32 mg/0.64 mL; 64 mg/0.18 mL; 96 mg/0.27 mL; 75 mcg; 150 mcg; 300 mcg; 450 mcg; 600 mcg; 750 mcg; 900 mcg

Usual Adult Dose for Opiate Dependence - Maintenance

SUBLINGUAL Tablets: Following a 2-day induction:


Comments:

EXTENDED-RELEASE SUBCUTANEOUS Injection (Sublocade): Following a minimum of 7-days of treatment with a transmucosal product delivering the equivalent of 8 to 24 mg buprenorphine per day:

Comments:

SUBDERMAL IMPLANT (Probuphine): For use in opioid-tolerant patients who meet ALL of the following criteria:

Insert 1 dose subdermally in the inner side of the upper arm

Comments:

Uses: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. There is no maximum recommended duration for maintenance therapy as indefinite treatment may be required; when the decision is made to discontinue, doses should be tapered.

Usual Adult Dose for Pain

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed

Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Comments:

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Usual Adult Dose for Chronic Pain

BUCCAL Film:
Opioid-Naive and Opioid Non-Tolerant:
As Initial Opioid Analgesic: 75 mcg buccally once a day, or if tolerated every 12 hours for at least 4 days; then increase to 150 mcg every 12 hours

Maximum dose: 900 mcg every 12 hours due to potential for QTc interval prolongation
CONVERSION from Other Opioids to BUCCAL Film: To reduce the risk of opioid withdrawal, taper patients to no more than 30 mg/day oral morphine mg equivalents (MME) before beginning therapy
Discontinue all around-the-clock opioid drugs when initiating buccal film
For opioid dose of less than 30 MME/day prior to taper:
For opioid dose between 30 and 89 MME/day prior to taper:
For opioid dose between 90 and 160 MME/day prior to taper:
Buccal Film NOTES:

TRANSDERMAL System:
Opioid-Naive and Opioid Non-Tolerant:
As Initial Opioid Analgesic: Apply 5 mcg/hr patch transdermally; change every 7 days
Maximum dose: 20 mcg/hr
CONVERSION from Other Opioids to TRANSDERMAL System:
Discontinue all other around-the-clock opioid drugs when initiating therapy
Transdermal NOTES:

Comments:

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Usual Adult Dose for Opiate Dependence - Induction

Treatment should be initiated when objective and clear signs of moderate opioid withdrawal appear, and


INDUCTION:
Day 1: 8 mg sublingually once a day (may give in 2 to 4 mg increments, if preferred)
Day 2: 16 mg sublingually once a day

Comments:

Uses: For the treatment of opioid dependence and is preferred for induction.

Usual Pediatric Dose for Pain

2 to 12 years:
Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours


Over 12 years:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
Maximum single dose: 0.3 mg

Comments:

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Transdermal:


Buccal Film:

Sublingual Tablets:

Extended-release subcutaneous injection:

Implant:

Dose Adjustments

Elderly: Initiate therapy at the low end of the dosing range and titrate slowly to account for increased sensitivity to drug

Oral Mucositis (buccal film): Reduce starting dose and dose titration by one-half in patients with known or suspected oral mucositis

Parenteral:


CYP450 Inhibitors or Inducers:

Unstable Patients undergoing Treatment for Opioid Dependence:

DISCONTINUATION:

Precautions

The US FDA requires Risk Evaluation and Mitigation Strategy (REMS) for buprenorphine:

For additional information: www.fda.gov/REMS

US BOXED WARNINGS: Transdermal Patch, Buccal Film, IV/IM Injection
ADDICTION, ABUSE, AND MISUSE:
RISK EVALUATION AND MITIGATION STRATEGY (REMS):
LIFE-THREATENING RESPIRATORY DEPRESSION:
ACCIDENTAL EXPOSURE:
NEONATAL OPIOID WITHDRAWAL SYNDROME:
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS:

US BOXED WARNING: Extended-Release Injection for Subcutaneous Use:
RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE(R) RISK EVALUATION AND MITIGATION STRATEGY:

US BOXED WARNING: Implant for Subdermal Administration
IMPLANT MIGRATION, PROTRUSION, EXPULSION, and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL:

Drug Addiction 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 qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe or dispense this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

CONTRAINDICATIONS:
All Products:

Additional US CONTRAINDICATIONS when buprenorphine is used for pain management:

Safety and efficacy of the IM/IV parenteral product have not been established in patients younger than 2 years.

Safety and efficacy of implant for subdermal administration have not been established in patients younger than 16 years.

Safety and efficacy of buccal film, sublingual tablets, transdermal patch, or extended-release subcutaneous injection have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Dialysis

Data not available

Other Comments

Administration advice:
SUBLINGUAL TABLETS:

EXTENDED-RELEASE SUBCUTANEOUS INJECTION:
IMPLANT for subdermal administration:
BUCCAL FILM:
PARENTERAL:
TRANSDERMAL:

General:
Opiate dependence:

Pain:

Monitoring:

Patient advice:

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.