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ropivacaine hydrochloride injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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
Indications and Usage
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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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
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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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Long-term studies in animals...
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Clinical Studies
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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How Supplied/Storage and Handling
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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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Medication Guide
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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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.