Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

patterson dental supply, inc. - mepivacaine hydrochloride (unii: 4vfx2l7em5) (mepivacaine - unii:b6e06qe59j) - mepivacaine hydrochloride 20 mg in 1 ml - mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients. mepivacaine is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

mwi - proparacaine hydrochloride (unii: u96ol57goy) (proparacaine - unii:b4ob0jhi1x) - proparacaine hydrochloride 5 mg in 1 ml - proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction. this preparation is contraindicated in patients with known hypersensitivity to any component of the solution.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

akorn - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 5 mg in 1 ml - 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, eg, 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sandoz inc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 5 mg in 1 ml - 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, eg, 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

hospira, inc. - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - ropivacaine hydrochloride injection, usp 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 injection, usp 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 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 and any potential adverse effects on the breastfed child from ropivacaine or from the underlying maternal condition. the safety and efficacy of ropivacaine in pediatric patients have not been established. of the 2,978 subjects that were administered ropivacaine 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 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 warnings 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)] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sagent pharmaceuticals - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

eugia us llc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - 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

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

alcon laboratories, inc. - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride 5 mg in 1 ml - tetracaine hydrochloride ophthalmic solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. none. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution 0.5% in pregnant women.  animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution 0.5% or from the underlying maternal condition. no human data on the effect of tetracaine hydrochloride ophthalmic solution 0.5% on fertility are available. safety in the pediatric population has been demonstrated in clinical trials.  efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. no overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

akorn - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - 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, eg, 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

hospira, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 2.5 mg in 1 ml - bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. specific concentrations and presentations of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see dosage and administration (2.2)]. limitations of use not all blocks are indicated for use with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection given clinically significant risks associated with use [see dosage and administration (2.2), contraindications (4), warnings and precautions (5.1, 5.4, 5.5, 5.7, 5.9)] . bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated in: risk summary bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated for obstetrical paracervical block anesthesia. its use in this technique has resulted in fetal bradycardia and death [see contraindications (4), warnings and precautions (5.1)]. there are no available data on use of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (mrhd) on a body surface area (bsa) basis. based on animal data, advise pregnant women of the potential risks to a fetus (see data). local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12.3)]. 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 cns, peripheral vascular tone, and cardiac function. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations maternal adverse reactions maternal hypotension has resulted from regional anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. the supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. 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. labor or delivery epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. the use of obstetrical anesthesia may increase the need for forceps assistance. the use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. this has not been reported with bupivacaine. it is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. to do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. data animal data bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, & 40 mg/kg and to rabbits at doses of 1.3, 5.8, & 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). the high doses are comparable to the daily mrhd of 400 mg/day on a mg/m2 bsa basis. no embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. an increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal no observed adverse effect level representing approximately 0.3 times the mrhd on a bsa basis. in a rat pre- and post-natal developmental study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, & 40 mg/kg, decreased pup survival was observed at the high dose. the high dose is comparable to the daily mrhd of 400 mg/day on a bsa basis. risk summary lactation studies have not been conducted with bupivacaine. bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection should be administered to lactating women only if clearly indicated. studies assessing the effects of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in breastfed children have not been performed. studies to assess the effect of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bupivacaine and any potential adverse effects on the breastfed child from bupivacaine or from the underlying maternal condition. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is approved for use in adults. administration of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in pediatric patients younger than 12 years is not recommended. continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities. patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. in clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients. differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients [see clinical pharmacology (12.3)]. this product is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. elderly patients may require lower doses of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection, especially with repeat doses [see warnings and precautions (5.10)] . bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. this should be considered when selecting the bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection dosage [see use in specific populations (8.5)] .