Calcium Gluconate
FDA Drug Information • Also known as: Calcium Gluconate, Calcium Gluconate In Sodium Chloride
- Brand Names
- Calcium Gluconate, Calcium Gluconate In Sodium Chloride
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is: Molecular formula: C 12 H 22 CaO 14
What Is Calcium Gluconate Used For?
1 INDICATIONS AND USAGE 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 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
2 DOSAGE AND ADMINISTRATION Contains 100 mg of calcium gluconate per mL which contains 9.3 mg (0.465 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 dilution instructions, administration rates and appropriate monitoring. ( 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 1 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 to 6 hours and during continuous infusion every 1 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 ) Supplied in a single-dose vial or pharmacy bulk package (PBP). For PBP, dispense single-doses to many patients in a pharmacy admixture program; use within 4 hours of puncture. ( 2.6 ) 2.1 Important Administration Instructions Calcium gluconate injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg (i.e. 0.465 mEq) of elemental calcium. Dilute calcium gluconate injection prior to use in 5% dextrose or normal saline and assess for potential drug or intravenous fluid incompatibilities [see Dosage and Administration (2.5) ]. Inspect calcium gluconate injection visually prior to administration. The solution should appear clear and colorless to slightly yellow. Do not administer if there is particulate matter or discoloration. Use the diluted solution immediately after preparation. Administer calcium gluconate injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions (5.3) ] . Administer calcium gluconate injection by bolus administration or continuous infusion. For bolus intravenous administration Dilute the dose [see Dosage and Administration (2.2) ] of calcium gluconate injection in 5% dextrose or normal saline to a concentration of 10 mg/mL to 50 mg/mL prior to administration. Administer the dose slowly and DO NOT exceed an infusion rate of 200 mg/minute in adults or 100 mg/minute in pediatric patients, including neonates. Monitor patients, vitals and electrocardiograph (ECG) during administration [see Warnings and Precautions (5.4) ] . For continuous intravenous infusion Dilute calcium gluconate injection in 5% dextrose or normal saline to a concentration of 5.8 mg/mL to 10 mg/mL prior to administration. Administer 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) ] . Calcium gluconate injection is supplied in single-dose vials and pharmacy...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are also described elsewhere in the labeling: Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions (5.1) ] End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.2) ] Tissue Necrosis and Calcinosis [see Warnings and Precautions (5.3) ] Hypotension, Bradycardia and Cardiac Arrhythmias [see Warnings and Precautions (5.4) ] Aluminum toxicity [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of calcium gluconate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular : Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, cardiac arrest. Administration site reactions : 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
7 DRUG INTERACTIONS Cardiac Glycoside : Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. ( 7.1 ) Calcium Channel Blockers : Administration of calcium may reduce the response. ( 7.2 ) 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. ( 7.3 ) 7.1 Cardiac Glycosides Hypercalcemia increases the risk of digoxin toxicity, while digoxin may be therapeutically ineffective in the presence of hypocalcemia. Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. Avoid administration of calcium gluconate injection in patients receiving cardiac glycosides; if considered necessary, administer calcium gluconate injection slowly in small amounts and monitor ECG closely during administration. 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.
Contraindications
4 CONTRAINDICATIONS Calcium gluconate injection is contraindicated in: Hypercalcemia. Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2) ]. Hypercalcemia. ( 4 ) Neonates (28 days of age or younger) receiving ceftriaxone. ( 4 )
Overdosage
10 OVERDOSAGE Overdosage of calcium gluconate injection may result in hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥ 12 mg/dL. Neurologic symptoms include depression, weakness, fatigue and confusion at lower levels, with patients experiencing hallucinations, disorientation, hypotonicity, seizures and coma. Effects on the kidney include diminished ability to concentrate urine and diuresis. If overdose of calcium gluconate injection occurs immediately discontinue administration and provide supportive treatments to restore intravascular volume as well as promote calcium excretion in the urine if necessary.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Gluconate Injection USP, 100 mg per mL is supplied as a sterile, clear, colorless to slightly yellow solution filled in plastic vial. It is available as follows: 1,000 mg per 10 mL (100 mg per mL): 10 mL Single-dose Vial: NDC 80830-1672-1 25 Vials in a Carton: NDC 80830-1672-5 10 Vials in a Carton: NDC 80830-1672-2 5,000 mg per 50 mL (100 mg per mL): 50 mL Single-dose Vial: NDC 80830-1673-1 25 Vials in a Carton: NDC 80830-1673-5 10 Vials in a Carton: NDC 80830-1673-2 10,000 mg per 100 mL (100 mg per mL): 100 mL Pharmacy Bulk Package Vial: NDC 80830-1674-8 25 Vials in a Carton: NDC 80830-1674-5 10 Vials in a Carton: NDC 80830-1674-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Preservative Free. Discard any unused portion in the single-dose vial immediately or the Pharmacy Bulk Package vial within 4 hours after initial closure puncture. Each dose dispensed from the Pharmacy Bulk Package vial must be used immediately. The diluted solution must be used immediately. NOTE: Supersaturated solutions are prone to precipitation. The precipitate, if present, may be dissolved by warming the vial to 60° to 80°C, with occasional agitation, until the solution becomes clear. Shake vigorously. Allow to cool to room temperature before dispensing. Use injection only if clear immediately prior to use.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.