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:

Nivagen Pharmaceuticals, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM GLUCONATE - CALCIUM GLUCONATE INJECTION, SOLUTION
NIVAGEN PHARMACEUTICALS, INC.
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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