Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CALCIUM GLUCONATE MONOHYDRATE (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB)
Nivagen Pharmaceuticals, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
Calcium Gluconate Injection, USP is a clear, colorless to slightly yellow solution free from visible particles supplied as follows: 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. 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.
Abbreviated New Drug Application
CALCIUM GLUCONATE - CALCIUM GLUCONATE INJECTION, SOLUTION NIVAGEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALCIUM GLUCONATE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1941 INDICATIONS AND USAGE 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 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. DOSAGE FORMS AND STRENGTHS Injection: (3) Single-dose vial: 1,000 mg per 10 mL (100 mg per mL) CONTRAINDICATIONS Hypercalcemia (4) Neonates (28 days of age or younger) receiving ceftriaxone (4) WARNINGS AND PRECAUTIONS _Arrhythmias with Concomitant Cardiac Glycoside Use:_ If concomitant therapy is necessary, Calcium Gluconate Injection should Прочитать полный документ