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MARCAINE - VIAL Index Section (bupivacaine hydrochloride injection, USP - VIAL)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

2.2 Recommended Concentrations and Dosages of MARCAINE / MARCAINE WITH EPINEPHRINE

2.3 Use in Epidural Anesthesia

2.4 Test Dose for Caudal and Lumbar Epidural Blocks

2.5 Use in Dentistry

2.6 Use in Ophthalmic Surgery

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Cardiac Arrest with Use of MARCAINE in Obstetrical Anesthesia

5.2 Dose-Related Toxicity

5.3 Methemoglobinemia

5.4 Antimicrobial Preservatives in Multiple-Dose Vials

5.5 Chondrolysis with Intra-Articular Infusion

5.6 Risk of Adverse Reactions Due to Drug Interactions with MARCAINE WITH EPINEPHRINE

5.7 Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block)

5.8 Allergic-Type Reactions to Sulfites in MARCAINE WITH EPINEPHRINE

5.9 Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection

5.10 Risk of Toxicity in Patients with Hepatic Impairment

5.11 Risk of Use in Patients with Impaired Cardiovascular Function

5.12 Risk of Ischemic Injury or Necrosis in Body Areas with Limited Blood Supply

5.13 Risk of Cardiac Arrhythmias with Concomitant Use of Potent Inhalation Anesthetics

5.14 Risk of Adverse Reactions with Use in Head and Neck Area

5.15 Risk of Respiratory Arrest with Use in Ophthalmic Surgery

5.16 Risk of Inadvertent Trauma to Tongue, Lips, and Buccal Mucosa in Dental Applications

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Local Anesthetics

7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

7.3 Ergot-Type Oxytocic Drugs

7.4 Nonselective Beta-Adrenergic Antagonists

7.5 Drugs Associated with Methemoglobinemia

7.6 Potent Inhalation Anesthetics

7.7 Phenothiazines and Butyrophenones

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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