ROPIVACAINE HYDROCHLORIDE injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Caplin Steriles Limited

Mode d'administration:

EPIDURAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Ropivacaine Hydrochloride 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 observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the MRHD of 250 mg for nerve block use, based on body surface area (BSA) comparisons and a 60 kg human weight (see Animal data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity[see Clinical Pharmacology (12)]. The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal Adverse reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Data Animal data No malformations were reported in embryo-fetal development toxicity studies conducted in pregnant New Zealand white rabbits and Sprague-Dawley rats. During gestation days 6 to 18, rabbits received daily subcutaneous doses of ropivacaine at 1.3, 4.2, or 13 mg/kg/day (equivalent to 0.03, 0.10, and 0.33 times the maximum recommended human dose (MRHD) of 770 mg/24 hours, respectively, and 0.10, 0.32, and 1.0 times the MRHD of 250 mg for nerve block use, respectively based on body surface area (BSA) comparisons and a 60 kg human weight). Rats received daily subcutaneous doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.14, and 0.33 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively, based on BSA comparisons) during GD 6 to 15. No treatment-related effects on late fetal development, parturition, litter size, lactation, neonatal viability, or growth of the offspring were reported in a prenatal and postnatal reproductive and development toxicity study; however functional endpoints were not evaluated. Female rats were dosed daily subcutaneously from GD 15 to Lactation Day 20 at doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.1, and 0.3 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively), with maternal toxicity exhibited at the high dose. No adverse effects in physical developmental milestones or in behavioral tests were reported in a  2-generational reproduction study, in which rats received daily subcutaneous doses of 6.3, 12, and 23 mg/kg/day (equivalent to 0.08, 0.15, and 0.29 times the MRHD for epidural use, respectively, and 0.24, 0.45, and 0.88 times the MRHD for nerve block use, respectively, based on BSA comparisons) for 9 weeks before mating and during mating for males, and for 2 weeks before mating and during mating, pregnancy, and lactation, up to day 42 post coitus for females. Significant pup loss was observed in the high dose group during the first 3 days postpartum, from a few hours up to 3 days after delivery compared to the control group, which was considered secondary to impaired maternal care due to maternal toxicity. No differences were observed in litter parameters, or fertility, mean gestation time, or number of live births were observed between the control (saline) and treatment groups [see Carcinogenesis, Mutagenesis, Impairment of Fertility (13.1)]. Risk Summary One publication reported that ropivacaine is present in human milk at low levels following administration of ropivacaine in women undergoing cesarean section. No adverse reactions were reported in the infants. There is no available information on the drug’s effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ropivacaine Hydrochloride and any potential adverse effects on the breastfed child from Ropivacaine Hydrochloride or from the underlying maternal condition. The safety and efficacy of Ropivacaine Hydrochloride in pediatric patients have not been established. Of the 2,978 subjects that were administered Ropivacaine Hydrochloride Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. Ropivacaine Hydrochloride Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3)]. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations [see Warning and Precautions (5.11)]. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3)].

Descriptif du produit:

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%) and 10 mg/mL (1%) concentrations. Storage Solutions should be stored at 20 °C to 25 °C (68 °F to 77 °F) [see USP Controlled Room Temperature].                         Ropivacaine Hydrochloride Injection, USP Single-Dose Vials Ropivacaine Hydrochloride container closure is not made with natural rubber latex. For single-dose vials: Discard unused portion.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ROPIVACAINE HYDROCHLORIDE - ROPIVACAINE HYDROCHLORIDE INJECTION
CAPLIN STERILES LIMITED
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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 RX ONLY
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.
Surgical Anesthesia: epidural block for surgery including caesarean
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%), 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 CAPLIN STERILES LIMITED
AT 1-866-978-
6111 OR FDA AT 1-800-