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ropivacaine 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.

ropivacaine hydrochloride injection, USP Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Ropivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia for surgery and for acute pain management.

...
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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

There have been adverse event reports of chondrolysis in patients receiving intra-articular...

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3 DOSAGE FORMS AND STRENGTHS

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

Single-Dose Vials

0.2%, 20 mg per 10 mL (2 mg/mL), in...
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4 CONTRAINDICATIONS

Ropivacaine Hydrochloride Injection, USP is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide-type.

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5 WARNINGS AND PRECAUTIONS

5.1 General Warnings and Precautions

Prior to receiving major blocks the general condition of the patient should be optimized and the...

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6 ADVERSE REACTIONS

Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma...

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7 DRUG INTERACTIONS

Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available human data on use of ropivacaine Injection in...

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10 OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or...

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11 DESCRIPTION

Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S‑(‑)‑enantiomer...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals...

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14 CLINICAL STUDIES

Ropivacaine was studied as a local anesthetic both for surgical anesthesia and for acute pain management [see Dosage and...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Ropivacaine Hydrochloride Injection, USP is a clear, colorless solution supplied in single-dose vials in packages of 10 vials per carton as follows:

...
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17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients and Caregivers

When appropriate, patients should be informed in advance that they may experience...

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