Estados Unidos - inglés - NLM (National Library of Medicine)

mylan institutional llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. available data with sodium phenylacetate and sodium benzoate injection use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection. 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. there are no data on the presence of sodium phenylacetate, sodium benzoate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium phenylacetate and sodium benzoate injection and any potential adverse effects on the breastfed infant from sodium phenylacetate and sodium benzoate injection or from the underlying maternal condition. sodium phenylacetate and sodium benzoate injection has been used as a treatment for acute hyperammonemia in pediatric patients including patients in the early neonatal period [see dosage and administration (2) ]. clinical studies of sodium phenylacetate and sodium benzoate injection did not include any patients aged 65 and over to determine whether they respond differently from younger patients. urea cycle disorders are presently diseases of the pediatric and younger adult populations. no pharmacokinetic studies of sodium phenylacetate and sodium benzoate injection have been performed in geriatric patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population. pharmacokinetic parameters of sodium phenylacetate and sodium benzoate injection were compared in healthy males and females. bioavailability of both benzoate and phenylacetate was slightly higher in females than in males. however, conclusions cannot be drawn due to the limited number of subjects in this study. limited information is available on the metabolism and excretion of sodium phenylacetate and sodium benzoate in patients with impaired hepatic function. however, metabolic conjugation of sodium phenylacetate and sodium benzoate is known to take place in the liver and kidney. therefore, caution should be used in administering sodium phenylacetate and sodium benzoate injection to patients with hepatic insufficiency. the drug metabolites of sodium phenylacetate and sodium benzoate injection (phenylacetylglutamine and hippurate) and subsequently ammonia are primarily excreted by the kidney. therefore, use caution and closely monitor patients with impaired renal function who receive sodium phenylacetate and sodium benzoate injection.

Estados Unidos - inglés - NLM (National Library of Medicine)

rising pharma holdings, inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (mrhdod) based on aucs [see 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 disease-associated maternal and/or embryo/fetal risk poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. data human data   published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. animal data in embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the auc in humans at the mrhdod, respectively). risk summary a published clinical lactation study reports the presence of montelukast in human milk. data available on the effects of the drug on infants, either directly [see use in specific populations (8.4)] or through breast milk, do not suggest a significant risk of adverse reactions from exposure to montelukast sodium. the effects of the drug on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for montelukast sodium and any potential adverse reactions on the breastfed infant from montelukast sodium or from the underlying maternal condition. safety and effectiveness of montelukast sodium for asthma have been established in pediatric patients 6 to 14 years of age. use of montelukast sodium for this indication is supported by evidence from well-controlled studies. safety and efficacy data in this age group are similar to those seen in adults [see adverse reactions (6.1), clinical pharmacology, specific populations (12.3), and clinical studies (14.1, 14.2)].   the effectiveness of montelukast sodium for the treatment of seasonal allergic rhinitis in pediatric patients 2 to 14 years of age and for the treatment of perennial allergic rhinitis in pediatric patients 2 to 14 years of age have been established and is supported by extrapolation from the demonstrated effectiveness in patients 15 years of age and older with allergic rhinitis as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. the safety of montelukast sodium chewable tablets 4 mg in pediatric patients 2 to 5 years of age with asthma has been demonstrated by adequate and well-controlled data [see adverse reactions (6.1)] . effectiveness of montelukast sodium in this age group is extrapolated from the demonstrated effectiveness in patients 6 years of age and older with asthma and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. effectiveness in this age group is supported by exploratory efficacy assessments from a large, well-controlled safety study conducted in patients 2 to 5 years of age. the safety of montelukast sodium chewable tablets 4 mg and 5 mg in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma. a safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile [see adverse reactions (6.1)] . the safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. growth rate in pediatric patients a 56-week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of montelukast sodium on growth rate in 360 patients with mild asthma, aged 6 to 8 years. treatment groups included montelukast 5 mg once daily, placebo, and beclomethasone dipropionate administered as 168 mcg twice daily with a spacer device. for each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks. the primary comparison was the difference in growth rates between montelukast sodium and placebo groups. growth rates, expressed as least-squares (ls) mean (95% ci) in cm/year, for the montelukast sodium, placebo, and beclomethasone treatment groups were 5.67 (5.46, 5.88), 5.64 (5.42, 5.86), and 4.86 (4.64, 5.08), respectively. the differences in growth rates, expressed as least-squares (ls) mean (95% ci) in cm/year, for montelukast sodium minus placebo, beclomethasone minus placebo, and montelukast sodium minus beclomethasone treatment groups were 0.03 (-0.26, 0.31), -0.78 (-1.06, -0.49); and 0.81 (0.53, 1.09), respectively. growth rate (expressed as mean change in height over time) for each treatment group is shown in figure 1. of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. the plasma half-life of montelukast is slightly longer in the elderly. no dosage adjustment in the elderly is required. no dosage adjustment is recommended in patients with mild-to-moderate hepatic insufficiency [see clinical pharmacology (12.3)]. no dosage adjustment is recommended in patients with renal insufficiency [see clinical pharmacology (12.3)].

Estados Unidos - inglés - NLM (National Library of Medicine)

aurobindo pharma limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary    available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (mrhdod) based on aucs [see 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 disease-associated maternal and/or embryo/fetal risk poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. data human data published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. animal data in embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the auc in humans at the mrhdod, respectively).      risk summary a published clinical lactation study reports the presence of montelukast in human milk. data available on the effects of the drug on infants, either directly [see use in specific populations (8.4)] or through breast milk, do not suggest a significant risk of adverse reactions from exposure to montelukast sodium. the effects of the drug on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for montelukast sodium and any potential adverse reactions on the breastfed infant from montelukast sodium or from the underlying maternal condition. safety and effectiveness of montelukast sodium for asthma have been established in pediatric patients 6 to 14 years of age. use of montelukast sodium for this indication is supported by evidence from well-controlled studies. safety and efficacy data in this age group are similar to those seen in adults [see adverse reactions (6.1), clinical pharmacology, specific populations (12.3), and clinical studies (14.1, 14.2)]. the effectiveness of montelukast sodium for the treatment of seasonal allergic rhinitis in pediatric patients 2 to 14 years of age and for the treatment of perennial allergic rhinitis in pediatric patients 2 to 14 years of age have been established and is supported by extrapolation from the demonstrated effectiveness in patients 15 years of age and older with allergic rhinitis as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. the safety of montelukast sodium chewable tablets 4 mg in pediatric patients 2 to 5 years of age with asthma has been demonstrated by adequate and well-controlled data [see adverse reactions (6.1)] . effectiveness of montelukast sodium in this age group is extrapolated from the demonstrated effectiveness in patients 6 years of age and older with asthma and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. effectiveness in this age group is supported by exploratory efficacy assessments from a large, well-controlled safety study conducted in patients 2 to 5 years of age. the safety of montelukast sodium chewable tablets 4 mg and 5 mg in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma. a safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile [see adverse reactions (6.1)] .    the safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. growth rate in pediatric patients a 56-week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of montelukast sodium on growth rate in 360 patients with mild asthma, aged 6 to 8 years. treatment groups included montelukast 5 mg once daily, placebo, and beclomethasone dipropionate administered as 168 mcg twice daily with a spacer device. for each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks. the primary comparison was the difference in growth rates between montelukast sodium and placebo groups. growth rates, expressed as least-squares (ls) mean (95% ci) in cm/year, for the montelukast sodium, placebo, and beclomethasone treatment groups were 5.67 (5.46, 5.88), 5.64 (5.42, 5.86), and 4.86 (4.64, 5.08), respectively. the differences in growth rates, expressed as least-squares (ls) mean (95% ci) in cm/year, for montelukast sodium minus placebo, beclomethasone minus placebo, and montelukast sodium minus beclomethasone treatment groups were 0.03 (-0.26, 0.31), -0.78 (-1.06, -0.49); and 0.81 (0.53, 1.09), respectively. growth rate (expressed as mean change in height over time) for each treatment group is shown in figure 1. of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. the plasma half-life of montelukast is slightly longer in the elderly. no dosage adjustment in the elderly is required. no dosage adjustment is recommended in patients with mild-to-moderate hepatic insufficiency [see clinical pharmacology (12.3)]. no dosage adjustment is recommended in patients with renal insufficiency [see clinical pharmacology (12.3)].

Estados Unidos - inglés - NLM (National Library of Medicine)

par pharmaceutical, inc. - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate 0.94 g in 1 g - sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). it is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. it is important that the diagnosis be made early and treatment initiated immediately to improve survival. any episode of acute hyperammonemia should be treated as a life-threatening emergency. sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (see nutritional supplementation subsection of the dosage and administration section.) previously, neona

Estados Unidos - inglés - NLM (National Library of Medicine)

sigmapharm laboratories, llc - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate 0.94 g in 1 g - sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). it is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. it is important that the diagnosis be made early and treatment initiated immediately to improve survival. any episode of acute hyperammonemia should be treated as a life-threatening emergency. sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (see nutritional supplementation subsection of t

Estados Unidos - inglés - NLM (National Library of Medicine)

b. braun medical inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium gluconate (unii: r6q3791s76) (sodium cation - unii:lyr4m0nh37, gluconic acid - unii:r4r8j0q44b), sodium acetate (unii: 4550k0sc9b) (sodium cation - unii:lyr4m0nh37, acetate ion - unii:569dqm74sc), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), magnesium chloride (unii: 02f3473h9o) (magnesium cation - unii:t6v3lhy838, chloride ion - uni - sodium chloride 0.53 g in 100 ml - this solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent. contraindications: none known. accurate clinical and laboratory estimation of fluid and electrolyte balance in order to access benefit/risk ratio are essential prior to administration of this solution (see warnings and precautions ).

Estados Unidos - inglés - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium acetate (unii: 4550k0sc9b) (acetate ion - unii:569dqm74sc, sodium cation - unii:lyr4m0nh37) - sodium cation 328 mg in 100 ml - sodium acetate injection, usp (4 meq per ml) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. sodium acetate injection, usp (4 meq per ml) is contraindicated in patients with hypernatremia or fluid retention.

Estados Unidos - inglés - NLM (National Library of Medicine)

hospira, inc. - sodium acetate anhydrous (unii: nvg71zz7p0) (acetate ion - unii:569dqm74sc, sodium cation - unii:lyr4m0nh37) - sodium acetate anhydrous 164 mg in 1 ml - sodium acetate injection, usp (2 meq/ml) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. sodium acetate injection, usp (2 meq/ml) is contraindicated in patients with hypernatremia or fluid retention.

Estados Unidos - inglés - NLM (National Library of Medicine)

baxter healthcare corporation - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - potassium chloride 29.8 g in 1000 ml - potassium chloride injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. this highly concentrated, ready-to-use potassium chloride injection is intended for the maintenance of serum k+ levels and for potassium supplementation in fluid restricted patients who cannot accommodate additional volumes of fluid associated with potassium solutions of lower concentration. when using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance. potassium chloride injection is contraindicated in patients with:

Estados Unidos - inglés - NLM (National Library of Medicine)

b. braun medical inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - potassium chloride 14.9 g in 100 ml - potassium chloride for injection concentrate usp is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. this is a concentrated solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion. potassium chloride for injection concentrate usp is contraindicated in diseases where high potassium levels may be encountered, in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present, or where additives of potassium and chloride could be clinically detrimental.