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.
|offLabelAdultGuideSupport======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.
|offLabelAdultNoGuideSupport======Condition1=====
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Buprenorphine (injection) in adult patients.
|fdaLIADPed======Condition1=====
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Buprenorphine (injection) in pediatric patients.
|offLabelPedGuideSupport======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.
|offLabelPedNoGuideSupport======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
|clinicalTrials=The following adverse reactions, with a causal relationship to Zemplar, occurred in <2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set. In addition, the following also includes adverse reactions reported in Zemplar-treated patients who participated in other studies, including double-blind, active-controlled and open-label studies:
|postmarketing=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
|drugInteractions=* Drug
Description
|useInPregnancyFDA=* Pregnancy Category
|useInPregnancyAUS=* 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.
|useInLaborDelivery=There is no FDA guidance on use of Buprenorphine (injection) during labor and delivery.
|useInNursing=There is no FDA guidance on the use of Buprenorphine (injection) with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of Buprenorphine (injection) with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of Buprenorphine (injection) with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of Buprenorphine (injection) with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of Buprenorphine (injection) with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of Buprenorphine (injection) in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of Buprenorphine (injection) in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of Buprenorphine (injection) in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of Buprenorphine (injection) in patients who are immunocompromised.
|administration=* Oral
Intravenous
|monitoring=There is limited information regarding Monitoring of Buprenorphine (injection) in the drug label.
Description
|IVCompat=There is limited information regarding IV Compatibility of Buprenorphine (injection) in the drug label.
|overdose====Acute Overdose===
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Buprenorphine (injection) in the drug label.
|PD=There is limited information regarding Pharmacodynamics of Buprenorphine (injection) in the drug label.
|PK=There is limited information regarding Pharmacokinetics of Buprenorphine (injection) in the drug label.
|nonClinToxic=There is limited information regarding Nonclinical Toxicology of Buprenorphine (injection) in the drug label.
|clinicalStudies=There is limited information regarding Clinical Studies of Buprenorphine (injection) in the drug label.
|howSupplied=*
|packLabel=
|fdaPatientInfo=There is limited information regarding Patient Counseling Information of Buprenorphine (injection) in the drug label.
|alcohol=* Alcohol-Buprenorphine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
01.png){kind=link}