Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

fresenius kabi usa, llc - potassium phosphate, monobasic (unii: 4j9fj0hl51) (phosphate ion - unii:nk08v8k8hr), potassium phosphate, dibasic (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr) - potassium phosphate, monobasic 224 mg in 1 ml - potassium phosphates injection, usp is indicated as a source of phosphate, for addition to large volume intravenous fluids to prevent or correct hypophosphatemia 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 of nutrient solutions. potassium phosphates is contraindicated in diseases where high potassium, high phosphate or low calcium levels may be encountered.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

hospira, inc. - monobasic potassium phosphate (unii: 4j9fj0hl51) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr), dibasic potassium phosphate (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr, potassium cation - unii:295o53k152) - potassium phosphate, monobasic 224 mg in 1 ml - potassium phosphates injection, usp, 3 mm p/ml is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia 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. the concomitant amount of potassium (k+ 4.4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions.     safety has not been established for parenteral nutrition in pediatric patients due to the risk of aluminum toxicity. (see warnings) potassium phosphate is contraindicated in diseases where high potassium, high phosphorus or low calcium levels may be encountered.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

cmp pharma, inc. - potassium phosphate, monobasic (unii: 4j9fj0hl51) (phosphate ion - unii:nk08v8k8hr), potassium phosphate, dibasic (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr) - potassium phosphates injection is indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. potassium phosphates injection is indicated as a source of phosphorus for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated. limitations of use safety has not been established for parenteral nutrition in adults weighing less than 45 kg or pediatric patients less than 12 years of age or weighing less than 40 kg due to the risk of aluminum toxicity [see warnings and precautions (5.5), use in specific population (8.4) ]. potassium phosphates injection is contraindicated in patients with: - hyperkalemia [see warnings and precautions (5.3) ] - hyperphosphatemia [see warnings and precautions (5.4) ] -

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

fresenius kabi usa, llc - potassium phosphate, monobasic (unii: 4j9fj0hl51) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr), potassium phosphate, dibasic (unii: ci71s98n1z) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr) - potassium phosphates injection is indicated as a source of phosphorus: - in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. - for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. potassium phosphates injection is contraindicated in patients with: - hyperkalemia [see warning and precautions (5.3)] - severe renal impairment (egfr less than 30 ml/min/1.73m2 ) or end stage renal disease [see warning and precautions (5.3)] - hyperphosphatemia [see warning and precautions (5.4)] - hypercalcemia or significant hypocalcemia [see warning and precautions (5.4)] risk summary administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with potassium phosphates inj

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amneal pharmaceuticals private limited - potassium phosphate, monobasic (unii: 4j9fj0hl51) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr), potassium phosphate, dibasic (unii: ci71s98n1z) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr) - potassium phosphates injection is indicated as a source of phosphorus: - in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. - for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. potassium phosphates injection is contraindicated in patients with: - hyperkalemia [see warning and precautions (5.3)]. - hyperphosphatemia [see warning and precautions (5.4)]. - hypercalcemia or significant hypocalcemia [see warning and precautions (5.4)] .  - severe renal impairment (egfr less than 30 ml/min/1.73 m2 ) or end stage renal disease [see warning and precautions (5.3)] . risk summary administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with potassium phosphates 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. clinical considerations disease-associated maternal and/or embryo-fetal risk phosphorus is an essential mineral element. parenteral supplementation with potassium phosphates should be considered if a pregnant woman’s requirements cannot be fulfilled by oral or enteral intake. risk summary phosphorus and potassium are present in human milk. administration of the recommended dose of potassium phosphates injection is not expected to cause harm to a breastfed infant. there is no information on the effects of potassium phosphates on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for potassium phosphates injection and any potential adverse effects on the breastfed child from potassium phosphates injection or from underlying maternal condition. safety and effectiveness of potassium phosphates injection have been established in pediatric patients as a source of phosphorus: - in intravenous fluids to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated. - for parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated. because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with potassium phosphates injection may be at higher risk of aluminum toxicity [see warnings and precautions (5.6)] . in general, dose selection of potassium phosphates injection for an elderly patient should be cautious, starting at the low end of the dosing range because of the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. it may be useful to monitor renal function during treatment [see use in specific populations (8.6)] . potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to potassium phosphates injection may be greater in patients with impaired renal function [see warnings and precautions (5.3, 5.4, 5.5)] . potassium phosphates injection is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (egfr less than 30 ml/min/1.73 m2 ) or end stage renal disease [see contraindications (4)] . in patients with moderate renal impairment (egfr ≥ 30 ml/min/1.73 m2 to < 60 ml/min/1.73 m2 ), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium and magnesium concentrations [see dosage and administration (2.2, 2.4)].

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

american regent, inc. - potassium phosphate, monobasic (unii: 4j9fj0hl51) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr), potassium phosphate, dibasic (unii: ci71s98n1z) (potassium cation - unii:295o53k152, phosphate ion - unii:nk08v8k8hr) - potassium phosphates injection is indicated as a source of phosphorus: - in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. - for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. potassium phosphates injection is contraindicated in patients with: - hyperkalemia [see warning and precautions (5.3)] - hyperphosphatemia [see warning and precautions (5.4)] - hypercalcemia or significant hypocalcemia [see warning and precautions (5.4)] - severe renal impairment (egfr less than 30 ml/min/1.73m2 ) or end stage renal disease [see warning and precautions (5.3)] risk summary administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with potassium phosphates inj

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

atlantic biologicals corp. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - potassium chloride 20 meq in 15 ml - potassium chloride is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. potassium chloride is contraindicated in patients on potassium sparing diuretics pregnancy category c animal reproduction studies have not been conducted with potassium chloride. it is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity. the normal potassium ion content of human milk is about 13 meq per liter. since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. the safety and effectiveness of potassium chloride have been demonstrated in children with diarrhea and malnutrition from birth to18 years. clinical studies of potassium chloride did not include s

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 750 mg - potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride is contraindicated in patients on triamterene or amiloride. risk summary there are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively. risk summary the normal potassium ion content of human milk is about 13 meq per liter. since potassium from oral supplements such as potassium chloride extended-release tablets becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. safety and effectiveness of potassium chloride extended-release tablets in children have not been established. clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger 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 of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic 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. doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. patients with impaired renal function, particularly if the patient is on raas inhibitors or nsaids, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see drug interactions ( 7.2 , 7.3 )] . the serum potassium level should be monitored frequently. renal function should be assessed periodically.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

padagis us llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 600 mg - potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride is contraindicated in patients on triamterene and amiloride. risk summary there are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively. risk summary the normal potassium ion content of human milk is about 13 meq per liter. since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. safety and effectiveness in the pediatric population have not been established. clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger 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 of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic 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. based on publish literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see clinical pharmacology (12.3)]. patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia [see warnings and precautions (5.2)] . patients with impaired renal function, particularly if the patient is on raas inhibitors or nsaids, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see drug interactions (7.2, 7.3)] . the serum potassium level should be monitored frequently. renal function should be assessed periodically.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

atlantic biologicals corps - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - potassium chloride 20 meq in 15 ml - potassium chloride is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. potassium chloride is contraindicated in patients on potassium sparing diuretics pregnancy category c animal reproduction studies have not been conducted with potassium chloride. it is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity. the normal potassium ion content of human milk is about 13 meq per liter. since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. the safety and effectiveness of potassium chloride have been demonstrated in children with diarrhea and malnutrition from birth to18 years. clinical studies of potassium chloride did not include s