ROPIVACAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ROPIVACAINE HYDROCHLORIDE (UNII: V910P86109) (ROPIVACAINE - UNII:7IO5LYA57N)

Available from:

Eugia US LLC

INN (International Name):

ROPIVACAINE HYDROCHLORIDE

Composition:

ROPIVACAINE HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration Ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. Risk Summary There are no available human data on use of ropivacaine hydrochloride injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see Clinical Considerations) . No teratogenicity was obs

Product summary:

Ropivacaine hydrochloride injection, USP is a clear colorless, and preservative-free solution, available in single-dose containers in 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) and 10 mg/mL (1%) concentrations. Storage Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Ropivacaine hydrochloride Single-Dose Vials Ropivacaine hydrochloride injection USP, 0.2 % 40 mg/20 mL (2 mg/mL): 20 mL Single-Dose Vials in a Carton of 25                                                       NDC 55150-195-20 200 mg/100 mL (2 mg/mL): 100 mL Single-Dose Infusion Bottles Packaged Individually                            NDC 55150-196-99 Ropivacaine hydrochloride injection USP, 0.5 % 100 mg/20 mL (5 mg/mL): 20 mL Single-Dose Vials in a Carton of 25                                                       NDC 55150-197-20 150 mg/30 mL (5 mg/mL): 30 mL Single-Dose Vials in a Carton of 25                                                       NDC 55150-198-30   Ropivacaine hydrochloride injection USP, 0.75 % 150 mg/20 mL (7.5 mg/mL): 20 mL Single-Dose Vials in a Carton of 25                                                       NDC 55150-199-20   Ropivacaine hydrochloride injection USP, 1 % 100 mg/10 mL (10 mg/mL): 10 mL Single-Dose Vials in a Carton of 25                                                       NDC 55150-200-10 200 mg/20 mL (10 mg/mL): 20 mL Single-Dose Vials in a Carton of 25                                                       NDC 55150-201-20 The vial stoppers are not made with natural rubber latex. For single-dose vials: Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPIVACAINE HYDROCHLORIDE - ROPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPIVACAINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ROPIVACAINE HYDROCHLORIDE INJECTION.
ROPIVACAINE HYDROCHLORIDE INJECTION, FOR EPIDURAL, PERINEURAL, OR
INFILTRATION USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Ropivacaine hydrochloride injection is an amide local anesthetic
indicated in adults for the production of
local or regional anesthesia for surgery and for acute pain
management.
Surgical Anesthesia: epidural block for surgery including cesarean
section; major nerve block; local
infiltration
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)
Injection: 2 mg/mL (0.2%) in single-dose infusion bottles (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 EU