CALCIUM GLUCONATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM GLUCONATE MONOHYDRATE (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

Amneal Pharmaceuticals Private Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution supplied as follows: Strength Each Unit of Sale 1,000 mg per 50 mL (20 mg per mL) NDC 80830-2362-1 1 Single-dose Intravenous Bag in an Overwrap NDC 80830-2362-9 Unit of 24 NDC 80830-2362-2 2,000 mg per 100 mL (20 mg per mL) NDC 80830-2363-1 1 Single-dose Intravenous Bag in an Overwrap NDC 80830-2363-9 Unit of 24 NDC 80830-2363-2 The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Product should be used within 60 days of removal from overwrap. Preservative Free. Discard any unused portion in the single-dose container immediately.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM GLUCONATE- CALCIUM GLUCONATE INJECTION, SOLUTION
AMNEAL PHARMACEUTICALS PRIVATE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM GLUCONATE IN
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION.
CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1941
INDICATIONS AND USAGE
Calcium gluconate in sodium chloride injection is a form of calcium
indicated for pediatric and adult
patients for the treatment of acute symptomatic hypocalcemia. (1)
Limitations of Use: The safety of calcium gluconate injection for long
term use has not been
established. (1)
DOSAGE AND ADMINISTRATION
Contains 20 mg of calcium gluconate per mL which contains 1.86 mg
(0.093 mEq) of elemental
calcium. (2.1)
Administer intravenously (bolus or continuous infusion) via a secure
intravenous line. (2.1)
See Full Prescribing Information (FPI) for administration rates and
appropriate monitoring. (2.1)
Do not dilute calcium gluconate in sodium chloride injection prior to
use. Any unused portion should be
discarded. (2.1)
Individualize the dose within the recommended range in adults and
pediatric patients depending on the
severity of symptoms of hypocalcemia, the serum calcium level and the
acuity of onset of
hypocalcemia. See Table 2 in the FPI for dosing recommendations in mg
of calcium gluconate for
neonates, pediatric and adult patients. (2.2)
Measure serum calcium during intermittent infusions every 4 hours to 6
hours and during continuous
infusion every 1 hour to 4 hours. (2.3)
Calcium gluconate injection is not physically compatible with fluids
containing phosphate or
bicarbonate. Precipitation may result if mixed. See FPI for all drug
incompatibilities. (2.5)
DOSAGE FORMS AND STRENGTHS
Injection: (3)
Single-dose container: 1,000 mg per 50 mL (20 mg per mL)
Single-dose container: 2,000 mg per 100 mL (20 mg per mL)
CONTRAINDICATIONS
Hypercal