USA - engelsk - NLM (National Library of Medicine)

vensun pharmaceuticals, inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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 mil

USA - engelsk - NLM (National Library of Medicine)

cardinal health 107, llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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.

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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 mil

USA - engelsk - NLM (National Library of Medicine)

proficient rx lp - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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 mil

USA - engelsk - NLM (National Library of Medicine)

granules pharmaceuticals inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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 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 to 4% and 15 to 20%, respectively. risk summary the normal potass

USA - engelsk - NLM (National Library of Medicine)

fresenius kabi usa, llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - potassium chloride in 5% dextrose injection is indicated as a source of water, electrolytes and calories. potassium chloride in 5% dextrose injection is contraindicated in patients with: - known hypersensitivity to potassium chloride and/or dextrose [see warnings and precautions 5.1)] - clinically significant hyperkalemia [see warnings and precautions (5.2)] - clinically significant hyperglycemia [see warnings and precautions (5.3)] risk summary appropriate administration of potassium chloride in 5% dextrose injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with potassium chloride in 5% dextrose 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 defec

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - 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 mil

USA - engelsk - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - 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 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