Application Nr Approved Date Route Status External Links
NDA018304 None Perineural None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Sensorcaine (Bupivacaine Hcl) 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 Non-Obstetrical Surgical Procedures In Pregnant Patients Is Not Sufficient To Recommend Use Of The 0.75% Concentration Of Bupivacaine Hcl In These Patients. Sensorcaine Is Not Recommended For Intravenous Regional Anesthesia (Bier Block) (See Warnings). The Routes Of Administration And Indicated Sensorcaine Concentrations Are: Local Infiltration 0.25% Peripheral Nerve Block 0.25%, 0.5% Retrobulbar Block 0.75% Sympathetic Block 0.25% Lumbar Epidural 0.25%, 0.5% And 0.75% (Non-Obstetrical) Caudal 0.25%, 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 Sensorcaine. Use Only The Single Dose Ampules And Single Dose Vials For Caudal Or Epidural Anesthesia; The Multiple Dose Vials Contain A Preservative And, Therefore, Should Not Be Used For These Procedures.

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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