Calcium Gluconate (Page 3 of 3)

8.4 Pediatric Use

The safety and effectiveness of Calcium Gluconate in Sodium Chloride Injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia.

Pediatric approval for Calcium Gluconate in Sodium Chloride Injection, including doses, is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see Dosage and Administration (2.2)].

Concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days of age, ceftriaxone and Calcium Gluconate Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Contraindications (4) and Warnings and Precautions (5.2)]. This product contains up to 100 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see Warnings and Precautions (5.5)].

8.5 Geriatric Use

In general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

For patients with renal impairment, initiate Calcium Gluconate in Sodium Chloride Injection at the lowest dose of the recommended dose ranges across all age groups. Monitor serum calcium levels every 4 hours [see Dosage and Administration (2.4)].

8.7 Hepatic Impairment

Hepatic function does not impact the availability of ionized calcium after calcium gluconate intravenous administration. Dose adjustment in hepatically impaired patients may not be necessary.

10 OVERDOSAGE

Overdosage of Calcium Gluconate in Sodium Chloride 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 in Sodium Chloride Injection occurs immediately discontinue administration and provide supportive treatments to restore intravascular volume as well as promote calcium excretion in the urine if necessary.

11 DESCRIPTION

Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use.

Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is:

Structural Formula

Molecular formula: C12 H22 CaO14 • H2 O

Molecular weight: 448.39

Solubility in water: 3.5 g/100 mL at 25°C

Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) in single-dose bags.

Each mL of Calcium Gluconate in Sodium Chloride Injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sodium chloride 6.75 mg/mL as tonicity adjustor.

Each mL of Calcium Gluconate in Sodium Chloride Injection contains 1.86 mg (0.093 mEq) of elemental calcium.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Intravenous administration of calcium gluconate increases serum ionized calcium level. Calcium gluconate dissociates into ionized calcium in plasma. Ionized calcium and gluconate are normal constituents of body fluids.

12.3 Pharmacokinetics

Absorption

Calcium Gluconate Injection is 100% bioavailable following intravenous injection.

Metabolism

Calcium itself does not undergo direct metabolism. The release of ionized calcium from intravenous administration of calcium gluconate is direct and does not seem to be affected by the first pass through the liver.

Distribution

Calcium in the body is distributed mainly in skeleton (99%). Only 1% of the total body calcium is distributed within the extracellular fluids and soft tissues. About 50% of total serum calcium is in the ionized form and represents the biologically active part. 8% to 10% serum calcium is bound to organic and inorganic acid and approximately 40% is protein-bound (primarily to albumin).

Elimination

Studies have shown a relationship between urinary calcium excretion and the intravenous administration of calcium gluconate, with a significant increase in urinary calcium excretion observed after the intravenous administration of calcium gluconate.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of Calcium Gluconate in Sodium Chloride Injection. Calcium gluconate was not mutagenic with or without metabolic activation in the Ames test with Salmonella typhimurium (strains TA-1535, TA-1537, and TA-1538) or Saccharomyces cerevisiae (Strain D4). Fertility studies in animals have not been conducted with calcium gluconate administered by the intravenous route.

16 HOW SUPPLIED/STORAGE AND HANDLING

Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution supplied as follows:

Product Code Unit of Sale Strength Unit of Use
271621 NDC 65219-162-10Unit of 24 1,000 mg per 50 mL (20 mg/mL) NDC 65219-162-0150 mL fill volume in a 100 mL free flex® bag
271645 NDC 65219-164-50Unit of 24 2,000 mg per 100 mL (20 mg per mL) NDC 65219-164-01100 mL free flex® bag

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Preservative Free. Discard any unused portion in the single-dose container immediately.

17 PATIENT COUNSELING INFORMATION

  • Advise the patient of the risks associated with infusion of Calcium Gluconate in Sodium Chloride Injection including local tissue inflammation, local necrosis and calcinosis. [see Warnings and Precautions (5.3)].

Manufactured for:

Fresenius Kabi Logo

Lake Zurich, IL 60047
Made in Norway

www.fresenius-kabi.com/us

451705

PACKAGE LABEL — PRINCIPAL DISPLAY – Calcium Gluconate 1 g Bag Label

NDC 65219-162 -01

CALCIUM GLUCONATE in Sodium Chloride Injection

1 g TOTAL

1,000 mg per 50 mL

(20 mg per mL)

Do Not Dilute

PACKAGE LABEL -- PRINCIPAL DISPLAY – Calcium Gluconate 1 g Bag Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY – Calcium Gluconate 2 g Bag Label

NDC 65219-164 -01

CALCIUM GLUCONATE in Sodium Chloride Injection

2 g TOTAL

2,000 mg per 100 mL

(20 mg per mL)

Do Not Dilute

PACKAGE LABEL -- PRINCIPAL DISPLAY – Calcium Gluconate 2 g Bag Label
(click image for full-size original)
CALCIUM GLUCONATE calcium gluconate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-162
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE MONOHYDRATE (CALCIUM CATION) CALCIUM GLUCONATE MONOHYDRATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CALCIUM SACCHARATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65219-162-10 24 BAG in 1 CASE contains a BAG (65219-162-01)
1 NDC:65219-162-01 50 mL in 1 BAG This package is contained within the CASE (65219-162-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208418 06/17/2021
CALCIUM GLUCONATE calcium gluconate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-164
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE MONOHYDRATE (CALCIUM CATION) CALCIUM GLUCONATE MONOHYDRATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CALCIUM SACCHARATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65219-164-50 24 BAG in 1 CASE contains a BAG (65219-164-01)
1 NDC:65219-164-01 100 mL in 1 BAG This package is contained within the CASE (65219-164-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208418 06/17/2021
Labeler — Fresenius Kabi USA, LLC (013547657)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi Norge AS 731170932 MANUFACTURE (65219-162), ANALYSIS (65219-162), MANUFACTURE (65219-164), ANALYSIS (65219-164)

Revised: 08/2021 Fresenius Kabi USA, LLC

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