July 26, 2016
Recommended Topic Related To:


"The US Food and Drug Administration (FDA) has approved diclofenac sodium injection (Dyloject, Hospira Inc), a proprietary nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain, and for the management of mod"...



How Supplied


Buprenex (buprenorphine) is indicated for the relief of moderate to severe pain.


Adults: The usual dosage for persons 13 years of age and over is 1 ml Buprenex (buprenorphine) (0.3 mg buprenorphine) given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed. Repeat once (up to 0.3 mg) if required, 30 to 60 minutes after initial dosage, giving consideration to previous dose pharmacokinetics, and thereafter only as needed. In high-risk patients (e.g., elderly, debilitated, presence of respiratory disease, etc.) and/or in patients where other CNS depressants are present, such as in the immediate postoperative period, the dose should be reduced by approximately one-half. Extra caution should be exercised with the intravenous route of administration, particularly with the initial dose.

Occasionally, it may be necessary to administer single doses of up to 0.6 mg to adults depending on the severity of the pain and the response of the patient. This dose should only be given I.M. and only to adult patients who are not in a high risk category (see WARNINGS and PRECAUTIONS). At this time, there are insufficient data to recommend single doses greater than 0.6 mg for long-term use.

Children: Buprenex (buprenorphine) has been used in children 2-12 years of age at doses between 2-6 micrograms/kg of body weight given every 4-6 hours. There is insufficient experience to recommend a dose in infants below the age of two years, single doses greater than 6 micrograms/kg of body weight, or the use of a repeat or second dose at 30-60 minutes (such as is used in adults). Since there is some evidence that not all children clear buprenorphine faster than adults, fixed interval or "round-the-clock" dosing should not be undertaken until the proper inter-dose interval has been established by clinical observation of the child. Physicians should recognize that, as with adults, some pediatric patients may not need to be remedicated for 6-8 hours.

Safety and Handling: Buprenex (buprenorphine) is supplied in sealed ampules and poses no known environmental risk to health care providers. Accidental dermal exposure should be treated by removal of any contaminated clothing and rinsing the affected area with water.

Buprenex (buprenorphine) is a potent narcotic, and like all drugs of this class has been associated with abuse and dependence among health care providers. To control the risk of diversion, it is recommended that measures appropriate to the health care setting be taken to provide rigid accounting, control of wastage, and restriction of access.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.


# Name Strength Dosage Form Appearance Package Type Package Qty NDC
1 Buprenex 0.324 : 1 INJECTION, SOLUTION
1 :1 12496-0757-1

Buprenex (buprenorphine hydrochloride) is supplied in cartons containing five clear glass snap-ampules of 1 ml (0.3 mg buprenorphine).

NDC 12496-0757-1

Avoid excessive heat (over 104°F or 40°C). Protect from prolonged exposure to light.

Manufactured by: Reckitt Benckiser Healthcare (UK) Ltd., Hull, England, HU8 7DS. Distributed by: Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA 23235. Buprenex (buprenorphine) ® is a registered trademark of Reckitt Benckiser Healthcare (UK) Limited. REVISED APRIL 2005. FDA Rev date: 6/10/2003

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/22/2008

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Chronic Pain/Back Pain

Find tips and advances in treatment.

Health Resources
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations