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

nivagen pharmaceuticals, inc. - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical  considerations disease-associated matern

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

amneal pharmaceuticals private limited - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate in sodium chloride injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 risk maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor and possibly preeclampsia. fetal/neonatal adverse reactions infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures. infants born to mothers with hypocalcemia should be carefully monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability, apnea, cyanosis and cardiac rhythm disorders. risk summary calcium is present in human milk as a natural component of human milk. it is not known whether intravenous administration of calcium gluconate in sodium chloride injection can alter calcium concentration in human milk. there are no data on the effects of calcium gluconate injection on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcium gluconate in sodium chloride injection and any potential adverse effects on the breastfed child from calcium gluconate in sodium chloride injection or from the underlying maternal condition. the safety and effectiveness of calcium gluconate in sodium chloride injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. pediatric approval for calcium gluconate in sodium chloride injection, including doses, is not based on adequate and well-controlled clinical studies. safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see dosage and administration (2.2)] . concomitant use of ceftriaxone and calcium gluconate in sodium chloride injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. in patients older than 28 days of age, ceftriaxone and calcium gluconate injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [see contraindications (4)  and warnings and precautions (5.2)] . this product contains up to 100 mcg/l aluminum which may be toxic, particularly for premature neonates due to immature renal function. parenteral administration of aluminum greater than 4 mcg/kg/day to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see warnings and precautions (5.5)] . in general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. for patients with renal impairment, initiate calcium gluconate in sodium chloride injection at the lowest dose of the recommended dose ranges across all age groups. monitor serum calcium levels every 4 hours [see dosage and administration (2.4)]. hepatic function does not impact the availability of ionized calcium after calcium gluconate intravenous administration. dose adjustment in hepatically impaired patients may not be necessary.

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

somerset therapeutics, llc - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations disease-associated maternal risk maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. fetal/neonatal adverse reactions infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures. infants born to mothers with hypocalcemia should be carefully monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability, apnea, cyanosis and cardiac rhythm disorders. risk summary calcium is present in human milk as a natural component of human milk. it is not known whether intravenous administration of calcium gluconate injection can alter calcium concentration in human milk. there are no data on the effects of calcium gluconate injection on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for calcium gluconate injection and any potential adverse effects on the breastfed child from calcium gluconate injection or from the underlying maternal condition. the safety and effectiveness of calcium gluconate injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. pediatric approval for calcium gluconate injection, including doses, is not based on adequate and well-controlled clinical studies. safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see dosage and administration (2.2)] . concomitant use of ceftriaxone and calcium gluconate injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. in patients older than 28 days of age, ceftriaxone and calcium gluconate injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [see contraindications (4) and warnings and precautions (5.2)] . this product contains up to 512 mcg/l aluminum which may be toxic, particularly for premature neonates due to immature renal function. parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see warnings and precautions (5.5)] . in general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. for patients with renal impairment, initiate calcium gluconate injection at the lowest dose of the recommended dose ranges across all age groups. monitor serum calcium levels every 4 hours [see dosage and administration (2.4)]. hepatic function does not impact the availability of ionized calcium after calcium gluconate intravenous administration. dose adjustment in hepatically impaired patients may not be necessary.

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

a-s medication solutions - calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb) - calcium chloride injection, usp, 10% is indicated: in the treatment of hypocalcemia in conditions requiring a prompt increase in plasma calcium levels (e.g., neonatal tetany and tetany due to parathyroid deficiency, vitamin d deficiency and alkalosis) and for prevention of hypocalcemia during exchange transfusions. as adjunctive therapy in the management of acute symptoms in lead colic. in the treatment of magnesium intoxication due to overdosage of magnesium sulfate. in severe hyperkalemia, to combat deleterious effects on electrocardiographic (ecg) function, pending correction of the potassium level in the extracellular fluid. in cardiac resuscitation, particularly after open heart surgery, when epinephrine fails to improve weak or ineffective myocardial contractions. calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation.

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

bryant ranch prepack - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contains calcium acetate.  animal reproduction studies have not been conducted with calcium acetate capsules, and there are no adequate and well controlled studies of calcium acetate capsules use in pregnant women.  patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)] .  maintenance of normal serum calcium levels is important for maternal and fetal well being.  hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism.  calcium acetate capsules treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium a

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

pharmin usa, llc - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate tablet is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd).

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

atlantic biologicals corps - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see ]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. warnings and precautions (5.1) the effects of calcium acetate

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

camber pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown. a

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

exelan pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contains calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown.

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

cipla usa inc., - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown. a