Calcium gluconate

What is Calcium gluconate?

• Calcium gluconate is a form of calcium used for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.

Calcium gluconate

Calcium-gluconate-2D-skeletal

What are the uses of this medicine?

• Calcium gluconate Injection is used 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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine have cannot be used in patients with:

• Hypercalcemia
• Neonates (28 days of age or younger) receiving ceftriaxone

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• digoxin
• cardiac glycosides
• calcium channel blockers
• Vitamin D
• vitamin A
• thiazide diuretics
• estrogen
• calcipotriene
• teriparatide

Is this medicine FDA approved?

• Calcium gluconate came into medical use in the 1920s.
• Shortages of medical calcium gluconate were reported in November 2012 and November 2015 in the United States.

How should this medicine be used?

Recommended dosage:

• Calcium Gluconate Injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg (i.e., 0.465 mEq) of elemental calcium.
• 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.

Dosing Recommendations in mg of Calcium Gluconate for Neonate, Pediatric, and Adult Patients

Patient Population	Initial Dose	Bolus dose	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

Administration:

• Dilute Calcium Gluconate Injection prior to use in 5% dextrose or normal saline and assess for potential drug or IV fluid incompatibilities.
• 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.
• Administer Calcium Gluconate Injection by bolus administration or continuous infusion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection:
• 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)

This medicine is available in fallowing brand namesː

• Calcium Gluconate

What side effects can this medication cause?

The most common side effects of this medicine include:

• 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.

Calcium Gluconate may cause serious side effects which may include:

• Arrhythmias
• End-Organ Damage
• Tissue Necrosis and Calcinosis
• Hypotension
• Bradycardia
• Cardiac Arrhythmias
• Aluminum toxicity

What special precautions should I follow?

• Cardiac arrhythmias may occur if calcium and cardiac glycosides are administered together. If concomitant therapy is necessary, Calcium Gluconate Injection should be given slowly in small amounts and with close ECG monitoring.
• Concomitant use of ceftriaxone and Calcium Gluconate Injection is contraindicated in neonates (28 days of age or younger). Cases of fatal outcomes in neonates have occurred.
• Intravenous administration of Calcium Gluconate Injection and local trauma may result in calcinosis cutis due to transient increase in local calcium concentration. 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.
• 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, with careful ECG monitoring for cardiac arrhythmias.
• Calcium Gluconate Injection contains aluminum, up to 512 mcg per liter, that may be toxic.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypercalcemia
• depression
• weakness
• fatigue
• confusion
• hallucinations
• disorientation
• hypotonicity
• seizures
• coma
• diuresis

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• Limited available data with Calcium Gluconate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• calcium gluconate monohydrate

Inactive ingredients:

• calcium saccharate
• hydrochloric acid
• sodium hydroxide

Who manufactures and distributes this medicine?

• fresenius-kabi
• Lake Zurich, IL

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• 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.
• The diluted solution must be used immediately.

• Dailymed label info on Calcium gluconate
• FDA Calcium gluconate