CALCIUM GLUCONATE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

A-S Medication Solutions

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 maternal

Proizvod sažetak:

Product: 50090-3398 NDC: 50090-3398-0 10 mL in a VIAL, PLASTIC / 25 in a TRAY

Status autorizacije:

New Drug Application

Svojstava lijeka

CALCIUM GLUCONATE - CALCIUM GLUCONATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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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 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)
DOSAGE FORMS AND STRENGTHS
Injection: (3)
Single-dose vial: 1,000 mg per 10 mL (100 mg per mL)
Single-dose vial: 5,000 mg per 50 mL (100 mg per mL)
Pharmacy bulk package: 10,000 mg per 100 mL (100 mg p