Burapren 0.75%

Product manufactured by It3 Medical Llc

Application Nr Approved Date Route Status External Links
ANDA203895 None Retrobulbar None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Bupivacaine Hydrochloride Injection, Usp Is Indicated For The Production Of Local Or Regional Anesthesia Or Analgesia For Surgery, Oral Surgery Procedures, Diagnostic And Therapeutic Procedures, And For Obstetrical Procedures. Only The 0.25% And 0.5% Concentrations Are Indicated For Obstetrical Anesthesia. (See Warnings .) Experience With Nonobstetrical Surgical Procedures In Pregnant Patients Is Not Sufficient To Recommend Use Of 0.75% Concentration Of Bupivacaine Hydrochloride Injection, Usp In These Patients. Bupivacaine Hydrochloride Injection, Usp Is Not Recommended For Intravenous Regional Anesthesia (Bier Block). See Warnings . The Routes Of Administration And Indicated Bupivacaine Hydrochloride Injection, Usp Concentrations Are: Local Infiltration 0.25% Peripheral Nerve Block 0.25% And 0.5% Retrobulbar Block 0.75% Sympathetic Block 0.25% Lumbar Epidural 0.25%, 0.5%, And 0.75% (0.75% Not For Obstetrical Anesthesia) Caudal 0.25% And 0.5% Epidural Test Dose (See Precautions ) (See Dosage And Administration For Additional Information.) Standard Textbooks Should Be Consulted To Determine The Accepted Procedures And Techniques For The Administration Of Bupivacaine Hydrochloride Injection, Usp.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE ZINC1530812

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