dministration. 7.2 calcium channel blockers administration of calcium may reduce the response to calcium channel blockers. 7.3 drugs that may cause hypercalcemia vitamin d, vitamin a, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. monitor plasma calcium concentrations in patients taking these drugs concurrently.

needed. (5.3) • hypotension, bradycardia, and cardiac arrhythmias with rapid administration: to avoid adverse reactions that may follow rapid intravenous administration, calcium gluconate in sodium chloride injection should be infused slowly, with careful ecg monitoring for cardiac arrhythmias. (5.4) • aluminum toxicity: this product contains aluminum, up to 25 mcg per liter, that may be toxic. (5.5) 5.1 arrhythmias with concomitant cardiac glycoside use cardiac arrhythmias may occur if calcium and cardiac glycosides are administered together. hypercalcemia increases the risk of digoxin toxicity. administration of calcium gluconate in sodium chloride injection should be avoided in patients receiving cardiac glycosides. if concomitant therapy is necessary, calcium gluconate in sodium chloride injection should be given slowly in small amounts and with close ecg monitoring [see drug interactions (7.1)] . 5.2 end-organ damage due to intravascular ceftriaxone-calcium precipitates concomitant use of ceftriaxone and calcium gluconate in sodium chloride injection is contraindicated in neonates (28 days of age or younger) due to cases of fatal outcomes in neonates in which a crystalline material was observed in the lungs and kidneys at autopsy after ceftriaxone and calcium were administrated simultaneously through the same intravenous line. concomitant administration can lead to the formation of ceftriaxone-calcium precipitates that may act as emboli, resulting in vascular spasm or infarction [see contraindications (4)]. in patients older than 28 days of age, ceftriaxone and calcium gluconate in sodium chloride injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. do not administer ceftriaxone simultaneously with calcium gluconate in sodium chloride injection via a y-site in any age group. 5.3 tissue necrosis and calcinosis intravenous administration of calcium gluconate in sodium chloride injection and local trauma may result in calcinosis cutis due to transient increase in local calcium concentration. calcinosis cutis can occur with or without extravasation of calcium gluconate in sodium chloride injection, is characterized by abnormal dermal deposits of calcium salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration. tissue necrosis, ulceration, and secondary infection are the most serious complications. if extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and treat as needed. 5.4 hypotension, bradycardia, and cardiac arrhythmias with rapid administration rapid injection of calcium gluconate in sodium chloride injection may cause vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest. to avoid adverse reactions that may follow rapid intravenous administration, calcium gluconate in sodium chloride injection should be infused slowly. if rapid intravenous bolus of calcium gluconate injection is required, the rate of intravenous administration should not exceed 200 mg/minute in adults and 100 mg/minute in pediatric patients and ecg monitoring during administration is recommended [see dosage and administration (2.1)] . 5.5 aluminum toxicity calcium gluconate in sodium chloride injection contains aluminum, up to 25 mcg per liter, that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 mcg/kg/day to 5 mcg/kg/day accumulate aluminum levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration.

ug incompatibilities. (2.5) 2.1 important administration instructions see table 1 for amounts of elemental calcium in calcium gluconate in sodium chloride injection. table 1. amounts of calcium gluconate and elemental calcium total strength per total volume strength per ml elemental calcium (mg) per ml elemental calcium (meq) per ml total amount of elemental calcium (mg) per total volume total amount of elemental calcium (meq) per total volume 1,000 mg per 50 ml 20 mg/ml 1.86 mg 0.093 meq 93 mg per 50 ml 4.65 meq per 50 ml 1,000 mg per 100 ml 10 mg/ml 0.93 mg 0.0465 meq 93 mg per 100 ml 4.65 meq per 100 ml 2,000 mg per 100 ml 20 mg/ml 1.86 mg 0.093 meq 186 mg per 100 ml 9.3 meq per 100 ml • do not dilute calcium gluconate in sodium chloride injection prior to use. any unused portion should be discarded. • inspect calcium gluconate in sodium chloride injection visually prior to administration. the solution should appear clear and colorless. do not administer if there is particulate matter or discoloration. • administer calcium gluconate in sodium chloride injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see warnings and precautions (5.3)]. administer calcium gluconate in sodium chloride injection by continuous infusion at the rate recommended in table 1 [see dosage and administration (2.2)] and monitor patients, vitals, calcium and ecg during the infusion [see warnings and precautions (5.4)] . 2.2 recommended dosage individualize the dose of calcium gluconate in sodium chloride injection within the recommended range depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia. table 2 provides dosing recommendations for calcium gluconate in sodium chloride injection in mg of calcium gluconate for neonates, pediatric and adult patients. table 2. dosing recommendations in mg of calcium gluconate for neonate, pediatric, and adult patients patient population initial dose subsequent doses (if needed) bolus continuous infusion neonate (less than 1 month to 1 month) 100 mg/kg to 200 mg/kg 100 mg/kg to 200 mg/kg every 6 hours initiate at 17 mg/kg/hour to 33 mg/kg/hour pediatric (greater than 1 month to less than 17 years) 29 mg/kg to 60 mg/kg 29 mg/kg to 60 mg/kg every 6 hours initiate at 8 mg/kg/hour to 13 mg/kg/hour adult (17 years and greater) 1,000 mg to 2,000 mg 1,000 mg to 2,000 mg every 6 hours initiate at 5.4 mg/kg/hour to 21.5 mg/kg/hour for bolus administration, do not exceed an infusion rate of: •200 mg/minute in adult patients •100 mg/minute in pediatric patients for continuous infusions, adjust rate as needed based on serum calcium levels 2.3 serum calcium monitoring measure serum calcium every 4 to 6 hours during intermittent infusions with calcium gluconate in sodium chloride injection and measure serum calcium every 1 to 4 hours during continuous infusion. 2.4 dosage in renal impairment for patients with renal impairment, initiate calcium gluconate in sodium chloride injection at the lowest dose of the recommended dose ranges for all age groups and monitor serum calcium levels every 4 hours. 2.5 drug incompatibilities • do not mix ca lc ium gluc ona te in sodium chloride i njec tion with ceftr iax one . c onc urre nt use of intra ve nous cef tr iax one a nd ca lc ium gluc ona te in sodium chloride i njec tion ca n lea d to the f orma tion of cef tr iax one-calc ium prec ipita te s. c onc omitan t use of ceftr iax one a nd intra ve nous ca lc ium-c onta ining pr oduc ts is c ontra indica te d in ne onate s ( 28 day s of ag e or y ou nger ) [see contraindications (4)] . i n pa tie nts olde r tha n 28 day s of age , cef tr iax one a nd ca lc ium-c onta ining pr oduc ts ma y be a dministered se que ntia lly , pr ovide d th e inf usion line s ar e thoro ug hl y f lushe d be twee n inf usions with a c ompa tible f luid. cef tr iax one must n ot be a dministere d simulta ne ousl y with intra ve nou s ca lc ium-c onta inin g solutions via a y- site in an y a ge gr oup [see warnings and precautions (5.2), drug interactions (7.3)]. • do not mix ca lc ium gluc ona te in sodium chloride i njec tion with f luids c onta ining bicar bonat e or phospha te . ca lc ium gluc ona te i njec tion is not phy sica ll y c ompa tible with fl uids c onta ining ph ospha te or bicar bona te . prec ipita tion ma y re sult if mixe d. • do not mix ca lc ium gluc ona te in sodium chloride i njec tion with minocyc line injec tion. ca lc ium c omplexe s minocyc line re nder in g it inac tive.

actions : local soft tissue inflammation, local necrosis, calcinosis cutis and calcification due to extravasation the most common adverse events with calcium gluconate injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation. other adverse events include vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, and cardiac arrest. (6) to report suspected adverse reactions, contact wg critical care, llc at 1-866-562-4708 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

dministration. 7.2 calcium channel blockers administration of calcium may reduce the response to calcium channel blockers. 7.3 drugs that may cause hypercalcemia vitamin d, vitamin a, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. monitor plasma calcium concentrations in patients taking these drugs concurrently.

ntaneous 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. 8.2 lactation 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. 8.4 pediatric use 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 25 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)] . 8.5 geriatric use 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. 8.6 renal impairment 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)]. 8.7 hepatic impairment 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.

osteal 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.

rnings and precautions (5.2)] . this product contains up to 25 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)] .

). elimination studies have shown a relationship between urinary calcium excretion and the intravenous administration of calcium gluconate, with a significant increase in urinary calcium excretion observed after the intravenous administration of calcium gluconate.

e.