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ropivacaine hydrochloride injection, USP Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Dosage Recommendations

2.3 Other Administration Considerations

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 General Warnings and Precautions

5.2 Unintended Intravenous Injection

5.3 Intra-Articular Infusions and Risk of Chondrolysis

5.4 Risk of Methemoglobinemia

5.5 Central Nervous System Toxicity

5.6 Epidural Anesthesia

5.7 Use in Brachial Plexus Block

5.8 Use in Peripheral Nerve Block

5.9 Use in Head and Neck Area

5.10 Use in Ophthalmic Surgery

5.11 Hepatic Disease

5.12 Cardiovascular Impairment

5.13 Risk of Additive Effects

5.14 Malignant Hyperthermia

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

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

10.1 Treatment

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

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Epidural Administration in Surgery

14.2 Epidural Administration in Cesarean Section

14.3 Epidural Administration in Labor and Delivery

14.4 Epidural Administration in Postoperative Pain Management

14.5 Peripheral Nerve Block

14.6 Local Infiltration

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients and Caregivers

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