ropivacaine hydrochloride injection, USP Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ROPIVACAINE HYDROCHLORIDE safely and effectively. See full prescribing information for ROPIVACAINE HYDROCHLORIDE.
 
ROPIVACAINE HYDROCHLORIDE injection, for epidural, perineural, or infiltration use
Initial U.S. Approval: 1996

INDICATIONS AND USAGE

Ropivacaine hydrochloride is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. (1)

Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. (1)

Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. (1)

DOSAGE AND ADMINISTRATION

•
See Table 1 for Dosage Recommendations (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose vials. (3)

CONTRAINDICATIONS

History of hypersensitivity to local anesthetics of the amide-type. (4)

WARNINGS AND PRECAUTIONS

•
Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. (5.1)
•
In performing ropivacaine hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest. (5.2)
•
Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine hydrochloride is not approved for this use. (5.3)
•
Signs of methemoglobinemia may occur. (5.4)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. (6)

 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ROPIVACAINE HYDROCHLORIDE safely and effectively. See full prescribing information for ROPIVACAINE HYDROCHLORIDE.
 
ROPIVACAINE HYDROCHLORIDE injection, for epidural, perineural, or infiltration use
Initial U.S. Approval: 1996

INDICATIONS AND USAGE

Ropivacaine hydrochloride is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. (1)

Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. (1)

Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. (1)

DOSAGE AND ADMINISTRATION

•
See Table 1 for Dosage Recommendations (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose vials. (3)

CONTRAINDICATIONS

History of hypersensitivity to local anesthetics of the amide-type. (4)

WARNINGS AND PRECAUTIONS

•
Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. (5.1)
•
In performing ropivacaine hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest. (5.2)
•
Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine hydrochloride is not approved for this use. (5.3)
•
Signs of methemoglobinemia may occur. (5.4)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. (6)

 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2023
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