Calcium Gluconate

CALCIUM GLUCONATE- calcium gluconate monohydrate injection, solution
WG Critical Care, LLC

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Calcium Gluconate in Sodium Chloride Injection contains 20 mg of calcium gluconate per mL which contains 1.86 mg (i.e., 0.093 mEq) of elemental calcium. See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection.

Table 1. Amounts of Calcium Gluconate and Elemental Calcium

Total Strength per

Total Volume

Strength per mL

Total Amount of Elemental Calcium (mg) per

Total Volume

Total Amount of Elemental Calcium (mEq) per

Total Volume

1,000 mg per 50 mL

20 mg/mL

93 mg per 50 mL

4.65 mEq per 50 mL

2,000 mg per 100 mL

20 mg/mL

186 mg per 100 mL

9.3 mEq per 100 mL

Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. Any unused portion should be discarded.
Inspect Calcium Gluconate in Sodium Chloride Injection visually prior to administration. The solution should appear clear and colorless. Do not administer if there is particulate matter or discoloration.
Administer Calcium Gluconate in Sodium Chloride Injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions (5.3)].

Administer Calcium Gluconate in Sodium Chloride Injection by continuous infusion 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)].

2.2 Recommended Dosage

Individualize the dose of Calcium Gluconate in Sodium Chloride 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 2 provides dosing recommendations for Calcium Gluconate in Sodium Chloride Injection in mg of calcium gluconate for neonates, pediatric and adult patients.

Table 2. 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 (less than 1 month to 1 month)

100 mg/kg to 200 mg/kg

100 mg/kg to 200 mg/kg every 6 hours

Initiate at 17 mg/kg/hour to 33 mg/kg/hour

Pediatric (greater than 1 month to less than 17 years)

29 mg/kg to 60 mg/kg

29 mg/kg to 60 mg/kg every 6 hours

Initiate at 8 mg/kg/hour to 13 mg/kg/hour

Adult (17 years and greater)

1,000 mg to 2,000 mg

1,000 mg to 2,000 mg every 6 hours

Initiate at 5.4 mg/kg/hour to 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 in Sodium Chloride 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 in Sodium Chloride 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 Ca lc ium Gluc ona te in Sodium Chloride I njec tion with ceftr iax one . C onc urre nt use of intra ve nous cef tr iax one a nd Ca lc ium Gluc ona te in Sodium Chloride I njec tion ca n lea d to the f orma tion of cef tr iax one-calc ium prec ipita te s. C onc omitan t use of ceftr iax one a nd intra ve nous ca lc ium-c onta ining pr oduc ts is c ontra indica te d in ne onate s ( 28 day s of ag e or y ou nger ) [see Contraindications (4)]. I n pa tie nts olde r tha n 28 day s of age , cef tr iax one a nd ca lc ium-c onta ining pr oduc ts ma y be a dministered se que ntia lly , pr ovide d th e inf usion line s ar e thoro ug hl y f lushe d be twee n inf usions with a c ompa tible f luid. Cef tr iax one must n ot be a dministere d simulta ne ousl y with intra ve nou s ca lc ium-c onta inin g solutions via a Y- site in an y a ge gr oup [see Warnings and Precautions (5.2), Drug Interactions (7.3)].

• Do not mix Ca lc ium Gluc ona te in Sodium Chloride I njec tion with f luids c onta ining bicar bonat e or phospha te . Ca lc ium Gluc ona te I njec tion is not phy sica ll y c ompa tible with fl uids c onta ining ph ospha te or bicar bona te . Prec ipita tion ma y re sult if mixe d.

• Do not mix Ca lc ium Gluc ona te in Sodium Chloride I njec tion with minocyc line injec tion. Ca lc ium c omplexe s minocyc line re nder in g it inac tive.

3 DOSAGE FORMS AND STRENGTHS

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

Injection:

• Calcium gluconate 1,000 mg per 50 mL (20 mg/mL) single-dose bags

• Calcium gluconate 2,000 mg per 100 mL (20 mg/mL) single-dose bags

Each mL of Calcium Gluconate in Sodium Chloride Injection contains 20 mg of calcium gluconate which contains 1.86 mg (0.093 mEq) of elemental calcium.

Page 1 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.