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bupivacaine hydrochloride injection, USP

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

bupivacaine hydrochloride injection, USP Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA

There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride...

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1 INDICATIONS AND USAGE

Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

  • Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine...
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3 DOSAGE FORMS AND STRENGTHS

Bupivacaine Hydrochloride Injection, USP is a clear, colorless solution available as:

  • 0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose teartop vials.
  • 0.25% (75 mg/30...
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4 CONTRAINDICATIONS

Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is contraindicated in:

  • obstetrical paracervical block anesthesia. Its use in this technique has resulted...
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5 WARNINGS AND PRECAUTIONS

5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride Injection in Obstetrical Anesthesia

There have been reports of cardiac...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling:

  • Cardiac Arrest in Obstetrical...
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7 DRUG INTERACTIONS

7.1 Local Anesthetics

The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with Bupivacaine...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Bupivacaine...

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10 OVERDOSAGE

Clinical Presentation

Acute emergencies from use of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and...

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11 DESCRIPTION

Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room...

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17 PATIENT COUNSELING INFORMATION

Allergic-Type Reactions

Assess if the patient has had allergic-type reactions to amide-type local...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Distributed by Hospira, Inc., Lake Forest, IL...

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