Buprenorphine (injection)

Buprenorphine (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Buprenorphine (injection) is a opiod analgesic that is FDA approved for the treatment of moderate to severe pain. Common adverse reactions include pruritis, nausea, vomiting, constipation, xerostomia, headache, and dizziness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

Buprenex is indicated for the relief of moderate to severe pain

Dosage

Adults: The usual dosage for persons 13 years of age and over is 1 ml Buprenex (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 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 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 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Buprenorphine (injection) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Buprenorphine (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Buprenorphine (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Buprenorphine (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Buprenorphine (injection) in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Buprenorphine (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Buprenorphine (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Buprenorphine (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Buprenorphine (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Buprenorphine (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Buprenorphine (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Buprenorphine (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Buprenorphine (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Buprenorphine (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Buprenorphine (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Buprenorphine (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Buprenorphine (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Buprenorphine (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Buprenorphine (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Buprenorphine (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Buprenorphine (injection) in the drug label.

Pharmacology

There is limited information regarding Buprenorphine (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Buprenorphine (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Buprenorphine (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Buprenorphine (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Buprenorphine (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Buprenorphine (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Buprenorphine (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Buprenorphine (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Buprenorphine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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