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Basic Drug Info
Drug Name:Buprenorphine Hydrochloride
Manufacturer:Bedford Laboratories
Other Info:

Buprenorphine HCl is supplied in sealed vials 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.Buprenorphine HCl 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.



Clinical Trials:


Indications and Usage
Buprenorphine HCl injection is indicated for the relief of moderate to severe pain.
Contraindications
Buprenorphine HCl injection should not be administered to patients who have been shown to be hypersensitive to the drug.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

As with other potent opioids, clinically significant respiratory depression may occur within the recommended dose range in patients receiving therapeutic doses of buprenorphine.

Buprenorphine HCl should be used with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression).

Particular caution is advised if buprenorphine HCl is administered to patients taking or recently receiving drugs with CNS/respiratory depressant effects.

In patients with the physical and/or pharmacological risk factors above, the dose should be reduced by approximately one-half.NALOXONE MAY NOT BE EFFECTIVE IN REVERSING THE RESPIRATORY DEPRESSION PRODUCED BY BUPRENORPHINE HCl.

THEREFORE, AS WITH OTHER POTENT OPIOIDS, THE PRIMARY MANAGEMENT OF OVERDOSE SHOULD BE THE REESTABLISHMENT OF ADEQUATE VENTILATION WITH MECHANICAL ASSISTANCE OF RESPIRATION, IF REQUIRED.
Branded Drugs
The following US Branded drugs contain Buprenorphine Hydrochloride


BUPRENEX -- RECKITT BENCKISER PHARMACEUTICALS INC

SUBUTEX -- RECKITT BENCKISER PHARMACEUTICALS INC

SUBOXONE -- RECKITT BENCKISER PHARMACEUTICALS INC


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