CALCIUM GLUCONATE injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM GLUCONATE MONOHYDRATE (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
Medical Purchasing Solutions, LLC
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 recogniz
Product summary:
Calcium Gluconate Injection is a clear, colorless to slightly yellow solution 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 or the Pharmacy Bulk Package vial within 4 hours after initial closure puncture. Each dose dispensed from the Pharmacy Bulk Package vial must be used 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:
New Drug Application
Authorization number:
71872-7222-1

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CALCIUM GLUCONATE- calcium gluconate injection, solution

Medical Purchasing Solutions, LLC

----------

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 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 be given slowly in small amounts and close ECG monitoring is recommended ( 5.1)

End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone

may cause life-threatening precipitates. Cases of fatal outcomes in neonates have occurred. ( 4, 5.2)

Tissue Necrosis and Calcinosis: Calcinosis cutis can occur with or without extravasation of Calcium Gluconate Injection.

Tissue necrosis, ulceration, and secondary infection are the most serious complications. If extravasation occurs or

clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and

treat as needed. ( 5.3)

Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration: To avoid adverse reactions that may

follow rapid intravenous administration, Calcium Gluconate Injection should be diluted with 5% dextrose or normal

saline and infused slowly, with careful ECG monitoring for cardiac arrhythmias. ( 5.4)

Aluminum Toxicity: This product contains aluminum, up to 512 mcg per liter, that may be toxic. ( 5.5)

ADVERSE REACTIONS

The most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis,

calcinosis cutis and calcification that are related to extravasation. Other adverse events include vasodilation, decreased

blood pressure, bradycardia, cardiac arrhythmia, syncope, and cardiac arrest. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at

1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Cardiac Glycoside: Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. (

7.1)

Calcium Channel Blockers: Administration of calcium may reduce the response. ( 7.2)

Drugs that may cause hypercalcemia: Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide

administration may cause hypercalcemia. Monitor plasma calcium concentrations in patients taking these drugs

concurrently. ( 7.3)

USE IN SPECIFIC POPULATIONS

Geriatric use: Dosing in elderly patients should be cautious, usually starting at the low end of the dosage range. ( 8.5)

Renal impairment: Initiate with the lower limit of the dosage range and monitor serum calcium levels every 4 hours. (

8.6, 2.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Recommended Dosage

2.3 Serum Calcium Monitoring

2.4 Dosage in Renal Impairment

2.5 Drug Incompatibilities

2.6 Preparation of Pharmacy Bulk Package

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Arrhythmias with Concomitant Cardiac Glycoside Use

5.2 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates

5.3 Tissue Necrosis and Calcinosis

5.4 Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration

5.5 Aluminum Toxicity

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Cardiac Glycosides

7.2 Calcium Channel Blockers

7.3 Drugs that may cause Hypercalcemia

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Calcium Gluconate Injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg

(i.e., 0.465 mEq) of elemental calcium.

Dilute Calcium Gluconate Injection prior to use in 5% dextrose or normal saline and assess for

potential drug or IV fluid incompatibilities [see Dosage and Administration ( 2.5)].

Inspect Calcium Gluconate Injection visually prior to administration. The solution should appear

clear and colorless to slightly yellow. Do not administer if there is particulate matter or

discoloration.

Use the diluted solution immediately after preparation.

Administer Calcium Gluconate Injection intravenously via a secure intravenous line to avoid

calcinosis cutis and tissue necrosis [see Warnings and Precautions ( 5.3)] .

Administer Calcium Gluconate Injection by bolus administration or continuous infusion:

For bolus intravenous administration:

Dilute the dose [see Dosage and Administration ( 2.2)] of Calcium Gluconate Injection in

5% dextrose or normal saline to a concentration of 10-50 mg/mL prior to administration. Administer

the dose slowly and DO NOT exceed an infusion rate of 200 mg/minute in adults or 100 mg/minute

in pediatric patients, including neonates. Monitor patients, vitals and electrocardiograph (ECG)

during administration [see Warnings and Precautions ( 5.4)] .

For continuous intravenous infusion:

Dilute Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 5.8-10

mg/mL prior to administration. Administer at the rate recommended in Table 1 [see Dosage and

Administration ( 2.2)] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings

and Precautions ( 5.4)] .

Sections or subsections omitted from the full prescribing information are not listed.

Calcium Gluconate Injection is supplied in single-dose vials and pharmacy bulk packages [see

Dosage and Administration ( 2.6)].

2.2 Recommended Dosage

Individualize the dose of Calcium Gluconate Injection within the recommended range depending on the

severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of

hypocalcemia.

Table 1 provides dosing recommendations for Calcium Gluconate Injection in mg of calcium gluconate

for neonates, pediatric and adult patients.

Table 1. Dosing Recommendations in mg of Calcium Gluconate for Neonate, Pediatric, and

Adult Patients

Patient

Population

Initial Dose

Subsequent Doses (if needed)

Bolus

Continuous Infusion

Neonate

(1 month)

100 – 200 mg/kg

100 - 200 mg/kg

every 6 hours

Initiate at

17-33 mg/kg/hour

Pediatric

(> 1 month to

< 17 years)

29 - 60 mg/kg

29 - 60 mg/kg

every 6 hours

Initiate at

8-13 mg/kg/hour

Adult

1000 - 2000 mg

1000 - 2000 mg

every 6 hours

Initiate at

5.4 - 21.5 mg/kg/hour

For bolus administration, DO NOT exceed an infusion rate of:

200 mg/minute in adult patients

100 mg/minute in pediatric patients

For continuous infusions, adjust rate as needed based on serum calcium levels

2.3 Serum Calcium Monitoring

Measure serum calcium every 4 to 6 hours during intermittent infusions with Calcium Gluconate

Injection and measure serum calcium every 1 to 4 hours during continuous infusion.

2.4 Dosage in Renal Impairment

For patients with renal impairment, initiate Calcium Gluconate Injection at the lowest dose of the

recommended dose ranges for all age groups and monitor serum calcium levels every 4 hours.

2.5 Drug Incompatibilities

Do not mix Calcium Gluconate Injection with ceftriaxone. Concurrent use of intravenous

ceftriaxone and Calcium Gluconate Injection can lead to the formation of ceftriaxone-calcium

precipitates. Concomitant use of ceftriaxone and intravenous calcium-containing products is

contraindicated in neonates (28 days of age or younger) [see Contraindications ( 4)] . In patients

older than 28 days of age, ceftriaxone and calcium-containing products may be administered

sequentially, provided the infusion lines are thoroughly flushed between infusions with a

compatible fluid. Ceftriaxone must not be administered simultaneously with intravenous calcium-

containing solutions via a Y-site in any age group [see Warnings and Precautions ( 5.2), Drug

Interactions ( 7.3)].

Do not mix Calcium Gluconate Injection with fluids containing bicarbonate or phosphate. Calcium

Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate.

Precipitation may result if mixed.

Do not mix Calcium Gluconate Injection with minocycline injection. Calcium complexes

minocycline rendering it inactive.

2.6 Preparation of Pharmacy Bulk Package

The pharmacy bulk package (PBP) of Calcium Gluconate Injection is intended for dispensing of single

doses to multiple patients in a pharmacy admixture program. Penetrate the container closure only one

time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the

contents. Use the PBP only in a suitable ISO Class 5 work area such as a laminar flow hood (or an

equivalent clean air compounding area). Complete dispensing from the pharmacy bulk vial within 4

hours after the container closure is penetrated. Each dose dispensed from the Pharmacy Bulk Package

vial must be used immediately.

3 DOSAGE FORMS AND STRENGTHS

Calcium Gluconate Injection is a clear, colorless to slightly yellow, solution available in the following:

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 per mL)

Each mL of Calcium Gluconate Injection contains 9.3 mg (0.465 mEq) of elemental calcium.

4 CONTRAINDICATIONS

Calcium Gluconate Injection is contraindicated in:

Hypercalcemia

Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions ( 5.2)]

5 WARNINGS AND PRECAUTIONS

5.1 Arrhythmias with Concomitant Cardiac Glycoside Use

Cardiac arrhythmias may occur if calcium and cardiac glycosides are administered together.

Hypercalcemia increases the risk of digoxin toxicity. Administration of Calcium Gluconate Injection

should be avoided in patients receiving cardiac glycosides. If concomitant therapy is necessary,

Calcium Gluconate Injection should be given slowly in small amounts and with close ECG monitoring

[see Drug Interactions ( 7.1)] .

5.2 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates

Concomitant use of ceftriaxone and Calcium Gluconate Injection is contraindicated in neonates (28 days

of age or younger) due to cases of fatal outcomes in neonates in which a crystalline material was

observed in the lungs and kidneys at autopsy after ceftriaxone and calcium were administrated

simultaneously through the same intravenous line. Concomitant administration can lead to the formation

of ceftriaxone-calcium precipitates that may act as emboli, resulting in vascular spasm or infarction [see

Contraindications ( 4)].

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. Do not administer Ceftriaxone simultaneously with Calcium Gluconate Injection via a Y-site in any

age group.

5.3 Tissue Necrosis and Calcinosis

Intravenous administration of Calcium Gluconate Injection and local trauma may result in calcinosis cutis

due to transient increase in local calcium concentration. Calcinosis cutis can occur with or without

extravasation of Calcium Gluconate Injection, is characterized by abnormal dermal deposits of calcium

salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema,

swelling, or induration. Tissue necrosis, ulceration, and secondary infection are the most serious

complications.

If extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue

intravenous administration at that site and treat as needed.

5.4 Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration

Rapid injection of Calcium Gluconate Injection may cause vasodilation, decreased blood pressure,

bradycardia, cardiac arrhythmias, syncope and cardiac arrest. To avoid adverse reactions that may

follow rapid intravenous administration, Calcium Gluconate Injection should be diluted with 5%

dextrose or normal saline and infused slowly. If rapid intravenous bolus of Calcium Gluconate Injection

is required, the rate of intravenous administration should not exceed 200 mg/minute in adults and

100 mg/minute in pediatric patients and ECG monitoring during administration is recommended [see

Dosage and Administration ( 2.1)] .

5.5 Aluminum Toxicity

Calcium Gluconate Injection contains aluminum, up to 512 mcg per liter, that may be toxic. Aluminum

may reach toxic levels with prolonged parenteral administration if kidney function is impaired.

Premature neonates are particularly at risk because their kidneys are immature, and they require large

amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients

with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum

at greater than 4 mcg/kg/day to 5 mcg/kg/day accumulate aluminum levels associated with central

nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

6 ADVERSE REACTIONS

The following serious adverse reactions are also described elsewhere in the labeling:

Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions ( 5.1)]

End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and

Precautions ( 5.2)]

Tissue Necrosis and Calcinosis [see Warnings and Precautions ( 5.3)]

Hypotension, Bradycardia, and Cardiac Arrhythmias [see Warnings and Precautions ( 5.4)]

Aluminum toxicity [see Warnings and Precautions ( 5.5)]

The following adverse reactions associated with the use of calcium gluconate were identified in the

literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not

always possible to estimate their frequency reliably or to establish a causal relationship to drug

exposure.

Cardiovascular: Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope,

cardiac arrest

Administration site reactions: Local soft tissue inflammation, local necrosis, calcinosis cutis and

calcification due to extravasation

7 DRUG INTERACTIONS

7.1 Cardiac Glycosides

Hypercalcemia increases the risk of digoxin toxicity, while digoxin may be therapeutically ineffective

in the presence of hypocalcemia. Synergistic arrhythmias may occur if calcium and cardiac glycosides

are administered together. Avoid administration of Calcium Gluconate Injection in patients receiving

cardiac glycosides; if considered necessary, administer Calcium Gluconate Injection slowly in small

amounts and monitor ECG closely during administration.

7.2 Calcium Channel Blockers

Administration of calcium may reduce the response to calcium channel blockers.

7.3 Drugs that may cause Hypercalcemia

Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may

cause hypercalcemia. Monitor plasma calcium concentrations in patients taking these drugs

concurrently.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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 risk

Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and

dysfunctional labor, and possibly preeclampsia.

Fetal/Neonatal adverse reactions

Infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism,

which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption,

osteitis fibrosa cystica and neonatal seizures. Infants born to mothers with hypocalcemia should be

carefully monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability,

apnea, cyanosis and cardiac rhythm disorders.

8.2 Lactation

Risk summary

Calcium is present in human milk as a natural component of human milk. It is not known whether

intravenous administration of Calcium Gluconate Injection can alter calcium concentration in human milk.

There are no data on the effects of Calcium Gluconate Injection on the breastfed infant, or on milk

production. The developmental and health benefits of breastfeeding should be considered along with

the mother’s clinical need for Calcium Gluconate Injection and any potential adverse effects on the

breastfed child from Calcium Gluconate Injection or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of Calcium Gluconate Injection have been established in pediatric patients

for the treatment of acute, symptomatic hypocalcemia.

Pediatric approval for Calcium Gluconate 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 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 512 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 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 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 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 Injection is a sterile, preservative-free, nonpyrogenic, supersaturated solution of

calcium gluconate, a form of calcium, for intravenous use.

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

Molecular formula: C

H

Molecular weight: 448.39

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

Calcium Gluconate Injection is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50

mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy

bulk package.

Each mL of Calcium Gluconate Injection contains 100 mg of calcium gluconate (equivalent to 94 mg of

calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium

hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial

agent.

Each mL of Calcium Gluconate Injection contains 9.3 mg (0.465 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 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 Injection is a clear, colorless to slightly yellow solution supplied as follows:

Calcium Gluconate Total Product

Strength (Concentration)

Carton NDC and Package

Configuration

Vial NDC

1,000 mg calcium gluconate per 10 mL

(100 mg per mL)

63323-360-19

25 x 10 mL single dose vials

63323-360-01

5,000 mg calcium gluconate per 50 mL

(100 mg per mL)

63323-360-59

25 x 50 mL single dose vials

63323-360-03

10,000 mg calcium gluconate per 100

(100 mg per mL)

63323-360-61

20 x 100 mL pharmacy bulk

package vials

63323-360-05

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 or the Pharmacy Bulk

Package vial within 4 hours after initial closure puncture.

Each dose dispensed from the Pharmacy Bulk Package vial must be used 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.

17 PATIENT COUNSELING INFORMATION

Advise the patient that the risks associated with infusion including local tissue inflammation, local

necrosis and calcinosis. [see Warnings and Precautions ( 5.3)] .

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451463B

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