Calcium Gluconate 10% Inj, 50ml

Manufacturer FRESENIUS KABI USA Active Ingredient Calcium Gluconate Injection(KAL see um GLOO koe nate) Pronunciation KAL-see-um GLOO-koe-nate
It is used to treat or prevent low calcium levels.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Electrolyte replacement, Antidote
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Pharmacologic Class
Calcium salt
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Calcium gluconate is a medicine given by injection into a vein to quickly raise calcium levels in the blood. It's used for conditions where calcium levels are too low, or to protect the heart in certain emergencies like very high potassium levels or magnesium overdose.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered intravenously over a specified period.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • This medication is typically administered in a hospital or clinical setting by healthcare professionals.
  • Report any discomfort or pain at the injection site immediately.
  • Inform your doctor about all other medications you are taking, especially heart medications like digoxin.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and patient response.

Condition-Specific Dosing:

Acute Hypocalcemia: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, then infuse 1-2 g over 1 hour or as needed. Max 15 g/day.
Hyperkalemia (cardiac stabilization): 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes, with continuous ECG monitoring. May repeat if ECG changes persist.
Magnesium Toxicity: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, repeated as needed based on clinical response and serum magnesium levels.
Calcium Channel Blocker Overdose: 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes, may repeat every 10-20 minutes as needed, followed by continuous infusion if necessary.
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Pediatric Dosing

Neonatal: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes, then 200-500 mg/kg/day continuous infusion or divided doses.
Infant: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes, then 200-500 mg/kg/day continuous infusion or divided doses. Hyperkalemia: 60-100 mg/kg (0.6-1 mL/kg of 10% solution) IV slowly over 5-10 minutes.
Child: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes, then 200-500 mg/kg/day continuous infusion or divided doses. Hyperkalemia: 60-100 mg/kg (0.6-1 mL/kg of 10% solution) IV slowly over 5-10 minutes.
Adolescent: Acute Hypocalcemia: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, then infuse 1-2 g over 1 hour or as needed. Hyperkalemia: 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor calcium levels closely.
Moderate: Use with caution; monitor serum calcium and phosphorus frequently. Adjust dose based on calcium levels.
Severe: Use with extreme caution; monitor serum calcium and phosphorus frequently. Adjust dose based on calcium levels. Avoid if hypercalcemia is present.
Dialysis: Calcium gluconate may be used to treat hypocalcemia in dialysis patients, but careful monitoring of serum calcium, phosphorus, and PTH is essential to avoid hypercalcemia and soft tissue calcification.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.

Pharmacology

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Mechanism of Action

Calcium is an essential electrolyte involved in many physiological processes, including nerve impulse transmission, muscle contraction, bone formation, blood coagulation, and maintenance of cardiac function. Calcium gluconate provides an immediate source of calcium ions. In hypocalcemia, it directly replenishes calcium stores. In hyperkalemia, calcium ions antagonize the cardiotoxic effects of hyperkalemia by stabilizing the cardiac cell membrane potential, reducing excitability without directly lowering serum potassium levels. In magnesium toxicity, calcium directly antagonizes the neuromuscular effects of magnesium.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Immediate (IV)
FoodEffect: Not applicable (IV)

Distribution:

Vd: Approximately 0.2 L/kg (distributes throughout extracellular fluid and bone)
ProteinBinding: Approximately 45% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Variable, dependent on calcium homeostasis (e.g., 20-30 minutes for initial distribution phase, longer for bone incorporation)
Clearance: Primarily renal excretion, regulated by parathyroid hormone and calcitonin.
ExcretionRoute: Renal (urine), small amounts via feces and sweat.
Unchanged: Not applicable (calcium ions are physiological)
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Pharmacodynamics

OnsetOfAction: Immediate (within minutes for cardiac effects)
PeakEffect: Within minutes
DurationOfAction: Short (minutes to hours, depending on underlying condition and calcium homeostasis)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
If this medication is administered too quickly, it can cause:
+ Flushing
+ Slow or abnormal heartbeat
+ Signs of low blood pressure, such as severe dizziness or fainting
If you notice any of these symptoms, inform your doctor right away.

Additional Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

* Constipation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe pain, swelling, or redness at the injection site (may indicate extravasation)
  • Feeling unusually tired or weak
  • Nausea, vomiting, or constipation
  • Increased thirst or urination
  • Confusion or changes in mental status
  • Irregular heartbeat or feeling lightheaded
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have elevated calcium levels in your blood.
If you are currently taking ceftriaxone or digoxin.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

Your doctor and pharmacist need this information to assess the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will likely recommend regular blood tests and other laboratory evaluations to monitor your condition. Be aware that this drug may interfere with certain lab tests, so it is crucial to notify all healthcare providers and laboratory personnel that you are taking this medication.

Additionally, this medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use. This risk is particularly higher if you have kidney problems or if you are a premature infant. It is vital to discuss this potential risk with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, you must consult your doctor to weigh the benefits and risks of taking this medication to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia (calcium levels too high)
  • Nausea, vomiting, constipation
  • Muscle weakness, lethargy, confusion
  • Polyuria, polydipsia
  • Cardiac arrhythmias (bradycardia, shortened QT interval)
  • Coma, cardiac arrest

What to Do:

Stop calcium administration. Administer IV fluids (0.9% NaCl) to promote renal excretion. Loop diuretics (e.g., furosemide) may be used after rehydration. Monitor serum calcium, electrolytes, and ECG. In severe cases, calcitonin, bisphosphonates, or hemodialysis may be considered. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Digoxin (concurrent use in non-life-threatening hypocalcemia due to increased risk of arrhythmias)
  • Ceftriaxone (in neonates, due to risk of precipitation in lungs and kidneys)
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Major Interactions

  • Digoxin (increased risk of digitalis toxicity, especially with rapid IV administration or pre-existing hypercalcemia)
  • Thiazide diuretics (may increase serum calcium levels, leading to hypercalcemia)
  • Phosphate-containing solutions (may form insoluble precipitates)
  • Bicarbonate-containing solutions (may form insoluble precipitates)
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Moderate Interactions

  • Calcium channel blockers (calcium gluconate may antagonize their effects, used therapeutically in overdose)
  • Tetracyclines and fluoroquinolones (oral calcium can chelate, reducing absorption; not relevant for IV calcium gluconate)
  • Iron salts (oral calcium can reduce absorption; not relevant for IV calcium gluconate)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Serum Calcium (ionized and total)

Rationale: To establish baseline calcium status and guide dosing.

Timing: Prior to administration

Serum Electrolytes (Potassium, Magnesium, Phosphate)

Rationale: To assess overall electrolyte balance, especially in hyperkalemia or magnesium toxicity.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm and identify signs of hypocalcemia (prolonged QT) or hyperkalemia (peaked T waves, wide QRS).

Timing: Prior to and during administration

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, as calcium is renally excreted and renal impairment can affect calcium homeostasis.

Timing: Prior to administration

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Routine Monitoring

Serum Calcium (ionized and total)

Frequency: Every 1-6 hours initially, then daily or as clinically indicated, especially with continuous infusion.

Target: Ionized calcium: 1.12-1.32 mmol/L (4.5-5.3 mg/dL); Total calcium: 2.1-2.5 mmol/L (8.5-10.5 mg/dL)

Action Threshold: Adjust dose if levels are outside target range or if symptoms of hypo/hypercalcemia persist/develop.

Electrocardiogram (ECG)

Frequency: Continuous monitoring during rapid IV administration, then periodically as clinically indicated.

Target: Normal sinus rhythm, resolution of specific abnormalities (e.g., prolonged QT, hyperkalemic changes).

Action Threshold: Development of arrhythmias, worsening ECG changes, or signs of hypercalcemia (shortened QT, bradycardia).

Vital Signs (Heart Rate, Blood Pressure)

Frequency: Frequently during administration, then routinely.

Target: Within patient's normal range.

Action Threshold: Significant bradycardia, hypotension, or other signs of adverse reaction.

IV Site

Frequency: Regularly during infusion.

Target: No signs of redness, swelling, pain, or extravasation.

Action Threshold: Any signs of extravasation (stop infusion immediately, elevate limb, consider hyaluronidase).

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Symptom Monitoring

  • Signs of hypercalcemia (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, confusion, lethargy, cardiac arrhythmias)
  • Signs of hypocalcemia (tetany, paresthesias, muscle cramps, seizures, Chvostek's sign, Trousseau's sign)
  • Signs of extravasation (pain, swelling, redness at injection site)
  • Signs of cardiac toxicity (bradycardia, hypotension, arrhythmias)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy only if clearly needed. Calcium crosses the placenta. Category C indicates animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Trimester-Specific Risks:

First Trimester: No specific data indicating increased risk, but generally avoid non-essential medications.
Second Trimester: No specific data indicating increased risk.
Third Trimester: No specific data indicating increased risk. Close monitoring of maternal calcium levels is important.
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Lactation

Calcium is a normal component of breast milk. While calcium gluconate is generally considered compatible with breastfeeding, caution is advised. Monitor the infant for signs of hypercalcemia if large doses are used in the mother.

Infant Risk: Low risk with appropriate maternal dosing and monitoring. Excessive maternal doses could theoretically increase infant calcium levels.
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Pediatric Use

Dosing must be carefully calculated based on weight and indication. Neonates are particularly susceptible to adverse effects from rapid IV administration (e.g., bradycardia, arrhythmias, precipitation with ceftriaxone). Close monitoring of heart rate, ECG, and calcium levels is essential.

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Geriatric Use

No specific dose adjustments are typically required based solely on age, but elderly patients may have impaired renal function, which necessitates careful monitoring of calcium levels and renal function. They may also be more susceptible to adverse cardiac effects.

Clinical Information

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Clinical Pearls

  • Always administer IV calcium gluconate slowly to minimize the risk of bradycardia, hypotension, and arrhythmias.
  • Monitor ECG continuously during rapid IV administration, especially in patients on digoxin.
  • Avoid mixing calcium gluconate with phosphate or bicarbonate solutions due to the risk of precipitation.
  • Ensure proper IV access and monitor for extravasation, as calcium gluconate is a vesicant.
  • Calcium gluconate is preferred over calcium chloride for peripheral IV administration due to lower risk of tissue necrosis if extravasation occurs, though central line is preferred for both if possible.
  • In hyperkalemia, calcium gluconate stabilizes the myocardium but does not lower potassium levels; other treatments are needed to shift or remove potassium.
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Alternative Therapies

  • Calcium chloride (another calcium salt, higher elemental calcium content, higher risk of extravasation injury)
  • For hypocalcemia: Oral calcium supplements (for chronic management), Vitamin D analogs
  • For hyperkalemia: Insulin/glucose, albuterol, sodium bicarbonate (for shifting potassium), potassium binders (e.g., sodium polystyrene sulfonate), dialysis (for removal)
  • For magnesium toxicity: IV fluids, loop diuretics (to promote renal excretion of magnesium)
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Cost & Coverage

Average Cost: Varies, typically low cost per 50ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices. Many communities offer drug take-back programs, which can be a convenient and environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance.

In the event of a suspected overdose, it is critical to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. Be prepared to provide information about the medication taken, including the dose, time of ingestion, and any other relevant details, to ensure prompt and effective treatment.