United States - English - 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.

United States - English - NLM (National Library of Medicine)

trigen laboratories, 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, 10%/10% 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. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their

United States - English - NLM (National Library of Medicine)

ailex pharmaceuticals, 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, 10%/10% 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. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their conjugation p

United States - English - NLM (National Library of Medicine)

ucyclyd pharma inc. - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - ammonul 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. pregnancy category c. animal reproduction studies have not been conducted with ammonul. it is not known whether ammonul can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, ammonul should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their conjugation products are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ammonul is administered to a nursing woman. ammonul has been used as a treat

United States - English - NLM (National Library of Medicine)

oceanside pharmaceuticals - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - 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. risk summary 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.

United States - English - NLM (National Library of Medicine)

maia pharmaceuticals, inc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - 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. g

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate and sodium benzoate injection 10% / 10% 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. risk summary available data with sodium phenylacetate and sodium benzoate injection 10% / 10% 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 10% / 10%. 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, los

United States - English - NLM (National Library of Medicine)

navinta llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate and sodium benzoate injection 10% / 10% 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. risk summary available data with sodium phenylacetate and sodium benzoate injection 10% / 10% 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 10% / 10%. 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, los

United States - English - NLM (National Library of Medicine)

woodward pharma services llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate and sodium benzoate injection, 10%/10% 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. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their conjugation p

United States - English - NLM (National Library of Medicine)

maia pharmaceuticals - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - 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 ​risk summary available data on the combination use of sodium phenylacetate and sodium benzoate 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 out