CALCIUM GLUCONATE IN SODIUM CHLORIDE- 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:

WG Critical Care, LLC

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 in Sodium Chloride Injection for long term use has not been established. Calcium Gluconate in Sodium Chloride Injection is contraindicated in: •Hyperca lcemia • 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%, respecti

Product summary:

Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution supplied in single-dose bags with an aluminum overwrap available as: Total Strength per Total Volume Strength per mL 24 single-dose bags NDC Bag and Overwrap NDC 1,000 mg per 50 mL 20 mg/mL 44567-620-24* 44567-620-01 1,000 mg per 100 mL 10 mg/mL 44567-622-24 44567-622-01 2,000 mg per 100 mL 20 mg/mL 44567-621-24 44567-621-01 *partial fill container 50 mL volume in a 100 mL container. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product should be used within 60 days of removal from aluminum overwrap. Preservative-free. Discard any unused portion in the single-dose bag immediately.

Authorization status:

New Drug Application

Summary of Product characteristics

CALCIUM GLUCONATE IN SODIUM CHLORIDE- CALCIUM GLUCONATE INJECTION,
SOLUTION
WG CRITICAL CARE, LLC
----------
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) (1)
• Limitations of Use: The safety of Calcium Gluconate Injection for
long term use has not been
established. (1) (1)
DOSAGE AND ADMINISTRATION
• Administer intravenously (bolus or continuous infusion) via a
secure intravenous line (2.1) (2)
• See Full Prescribing Information (FPI) for administration rates,
and appropriate monitoring (2.1) (2)
• Do not dilute Calcium Gluconate in Sodium Chloride Injection prior
to use. Any unused portion should be
discarded (2.1) (2)
• 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) (2)
• Measure serum calcium during intermittent infusions every 4 to 6
hours and during continuous infusion
every 1 to 4 hours. (2.3) (2)
• 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) (2)
DOSAGE FORMS AND STRENGTHS
Injection: (3)
• Calcium gluconate 1,000 mg per 50 mL (20 mg/mL) single-dose bag
(3) (3)
• Calcium gluconate 1,000 mg per 100 mL (10 mg/mL) single-dose bag
(3) (3)
• Calcium gluconate 2,000 mg per 100 m