Panama - inglese - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

caplin point laboratories limited - claritromicina - claritromicina....500 mg

Panama - inglese - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

caplin point laboratories limited - acetaminofÉn - acetaminofÉn....500.00 mg

Panama - inglese - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

caplin point laboratories limited - Ácido acetil salicÍlico - Ácido acetil salicÍlico ....100 mg

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - sodium nitroprusside (unii: eao03pe1tc) (nitroprusside - unii:169d1260km) - sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. sodium nitroprusside is also indicated for the treatment of acute congestive heart failure. sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting. sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (a.s.a. class 5e) coming to emergency surgery. patients with congenital (leber’s) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanate ratios. these rare condition

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone lactate injectioniscontraindicatedinpatientswhoarehypersensitive to it.

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - 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)].

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - rocuronium bromide (unii: i65mw4ofhz) (rocuronium - unii:wre554rfez) - rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see warnings and precautions (5.2)]. developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. inhibition of neuromuscular function was the endpoint for high-dose selection. the maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m2 ) from day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from day 6 to 18 of pregnancy. high-dose treatment caused acute symptoms

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j) - thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. it is also indicated when giving iv dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be g

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - in anesthesia   glycopyrrolate injection, usp is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection, usp may be used intraoperatively to counteract surgically or drug‑induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer   for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management o

Stati Uniti - inglese - NLM (National Library of Medicine)

caplin steriles limited - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride injection, usp is indicated for the following: - rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [w-p-w] and lown-ganong- levine [l-g-l] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. - temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white (w-p-w) and lown-ganong-levine (l-g-l) syndromes) in controlled studies in the united states, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of