Calcium Gluc 100mg/ml Inj, 100ml

Manufacturer SOMERSET THERAPEUTICS 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 Supplement; 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. It is used to quickly raise calcium levels in your blood if they are too low, to protect your heart if your potassium levels are too high, or to reverse the effects of too much magnesium in your body.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided to you. It is essential to follow the dosage instructions closely. 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 proper storage method.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • This medication is typically administered in a hospital or clinic setting by a healthcare professional.
  • 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 by indication. For acute symptomatic hypocalcemia: 1-2 grams IV over 5-10 minutes. For hyperkalemia (cardiac stabilization): 1-2 grams IV over 5-10 minutes. For magnesium toxicity: 1-2 grams IV over 5-10 minutes.
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

acuteHypocalcemia: 1-2 grams (10-20 mL of 10% solution) IV over 5-10 minutes, may repeat as needed.
hyperkalemia: 1-2 grams (10-20 mL of 10% solution) IV over 5-10 minutes, with ECG monitoring. May repeat in 5 minutes if ECG changes persist.
magnesiumToxicity: 1-2 grams (10-20 mL of 10% solution) IV over 5-10 minutes, with close monitoring of patient response and magnesium levels.
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Pediatric Dosing

Neonatal: Hypocalcemia: 50-100 mg/kg/dose (0.5-1 mL/kg of 10% solution) IV over 5-10 minutes, may repeat every 6-8 hours. Max 500 mg/kg/day.
Infant: Hypocalcemia: 50-100 mg/kg/dose (0.5-1 mL/kg of 10% solution) IV over 5-10 minutes, may repeat every 6-8 hours. Max 500 mg/kg/day.
Child: Hypocalcemia: 50-100 mg/kg/dose (0.5-1 mL/kg of 10% solution) IV over 5-10 minutes, may repeat every 6-8 hours. Max 500 mg/kg/day. Hyperkalemia: 60-100 mg/kg (0.6-1 mL/kg of 10% solution) IV over 5-10 minutes, with ECG monitoring. Max 3 grams/dose.
Adolescent: Hypocalcemia: 1-2 grams (10-20 mL of 10% solution) IV over 5-10 minutes, may repeat as needed. Hyperkalemia: 1-2 grams (10-20 mL of 10% solution) IV over 5-10 minutes, with ECG monitoring.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor calcium levels closely.
Moderate: Use with caution, monitor calcium levels closely. Dosage reduction may be necessary if hypercalcemia develops.
Severe: Use with extreme caution, monitor calcium levels and ECG closely. Dosage reduction likely required. Avoid if hyperphosphatemia is present.
Dialysis: Use with caution. Calcium levels should be monitored frequently. May be used to treat hypocalcemia in dialysis patients, but consider total calcium load.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Calcium is an essential electrolyte that plays a vital role in many physiological processes, including nerve impulse transmission, muscle contraction, bone formation, and blood coagulation. As an intravenous calcium salt, calcium gluconate directly increases serum calcium levels. In hyperkalemia, calcium ions stabilize the cardiac cell membrane, reducing excitability and antagonizing the cardiotoxic effects of potassium without 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 administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.2 L/kg (distributes throughout extracellular fluid and bone)
ProteinBinding: Approximately 40-50% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Variable, dependent on calcium homeostasis; plasma half-life of injected calcium is biphasic, with initial rapid distribution phase (minutes) and slower elimination phase (hours to days) as it is incorporated into bone or excreted.
Clearance: Primarily renal, with some fecal excretion.
ExcretionRoute: Renal (glomerular filtration), Fecal (unabsorbed dietary calcium)
Unchanged: Not applicable (ion)
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Pharmacodynamics

OnsetOfAction: Immediate (within minutes for IV administration)
PeakEffect: Within minutes
DurationOfAction: Short (approximately 30 minutes to 2 hours for acute effects, 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 medical attention immediately:

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
Symptoms that may occur if the medication is administered too quickly, such as:
+ Flushing
+ Slow or abnormal heartbeat
+ Signs of low blood pressure, including severe dizziness or fainting
Tissue damage at the injection site, characterized by:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid

If you experience any of these symptoms, notify your doctor or nurse immediately.

Other Possible 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 if they persist or bother you, contact your doctor:

* Constipation

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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:

  • Nausea or vomiting
  • Constipation
  • Increased thirst or urination
  • Muscle weakness or fatigue
  • Confusion or drowsiness
  • Irregular heartbeat
  • Pain, swelling, or redness at the injection site
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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 symptoms you experienced.
If you have high calcium levels in your blood.
* If you are currently taking ceftriaxone or digoxin.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help prevent potential interactions and ensure your safety while taking this medication.
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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 medication may interfere with certain lab tests, so it is crucial to notify all healthcare providers and laboratory personnel that you are taking this drug.

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 you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia (calcium levels too high)
  • Nausea, vomiting, constipation
  • Polyuria, polydipsia
  • Muscle weakness, lethargy, confusion, stupor, coma
  • Cardiac arrhythmias (bradycardia, heart block)
  • Hypotension
  • Renal dysfunction

What to Do:

Immediate discontinuation of calcium gluconate. Treatment involves hydration with normal saline, loop diuretics (e.g., furosemide) to promote calcium excretion, and potentially calcitonin or bisphosphonates in severe cases. Close monitoring of serum calcium, electrolytes, renal function, and ECG is essential. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

  • Digoxin (concurrent IV administration, especially with rapid infusion, can precipitate severe arrhythmias due to synergistic effects on cardiac contractility and excitability. If calcium is essential, administer slowly with continuous ECG monitoring and only if hypocalcemia is severe and life-threatening.)
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Major Interactions

  • Thiazide diuretics (may decrease calcium excretion, leading to hypercalcemia)
  • Phosphates (IV administration can lead to precipitation of calcium phosphate)
  • Bicarbonates (IV administration can lead to precipitation of calcium carbonate)
  • Calcium channel blockers (calcium may antagonize the effects of calcium channel blockers)
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Moderate Interactions

  • Tetracyclines (oral calcium can chelate tetracyclines, reducing absorption; not relevant for IV calcium gluconate)
  • Fluoroquinolones (oral calcium can chelate fluoroquinolones, reducing absorption; not relevant for IV calcium gluconate)

Monitoring

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Baseline Monitoring

Serum Calcium (total and ionized)

Rationale: To establish baseline and guide dosing, especially in hypocalcemia.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm and identify signs of hyperkalemia or digoxin toxicity, and to monitor for adverse cardiac effects during infusion.

Timing: Prior to administration and continuously during rapid infusion

Renal Function (BUN, Creatinine)

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

Timing: Prior to administration

Serum Magnesium (if indicated for magnesium toxicity)

Rationale: To establish baseline and monitor response to treatment.

Timing: Prior to administration

Serum Potassium (if indicated for hyperkalemia)

Rationale: To establish baseline and monitor response to treatment.

Timing: Prior to administration

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Routine Monitoring

Serum Calcium (total and ionized)

Frequency: Every 4-6 hours initially, then daily or as clinically indicated, especially in continuous infusions.

Target: Total: 8.5-10.5 mg/dL; Ionized: 1.12-1.32 mmol/L

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

Electrocardiogram (ECG)

Frequency: Continuous during rapid infusion; periodically during maintenance infusions.

Target: Normal sinus rhythm, absence of arrhythmias or conduction abnormalities.

Action Threshold: Bradycardia, arrhythmias, QT interval changes, or widening QRS complex require immediate intervention.

Vital Signs (HR, BP, RR)

Frequency: Every 15-30 minutes during infusion, then every 1-4 hours.

Target: Within patient's normal limits.

Action Threshold: Significant changes (e.g., hypotension, bradycardia) may indicate adverse reaction.

IV Site Inspection

Frequency: Regularly during infusion.

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

Action Threshold: Signs of extravasation require immediate discontinuation and management.

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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)
  • Cardiac rhythm changes (bradycardia, arrhythmias)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Calcium is an essential nutrient. While calcium gluconate is used to treat acute, life-threatening conditions, its use should be carefully weighed against potential risks. Animal reproduction studies have not been conducted. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Risk of teratogenicity is generally low for essential electrolytes, but data are limited.
Second Trimester: Generally considered safe for acute, necessary use.
Third Trimester: Generally considered safe for acute, necessary use. Close monitoring of maternal and fetal calcium levels may be warranted if prolonged or high-dose therapy is required.
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Lactation

Calcium is a normal component of breast milk. While calcium gluconate is excreted into breast milk, the amount is unlikely to cause adverse effects in a breastfed infant when administered acutely. Use with caution, but generally considered compatible with breastfeeding.

Infant Risk: Low risk. Monitor infant for signs of hypercalcemia (e.g., constipation, poor feeding) if maternal doses are high or prolonged, though this is rare with acute IV use.
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Pediatric Use

Dosing is weight-based (mg/kg). Careful calculation and slow administration are crucial to avoid hypercalcemia and cardiac adverse effects. Close monitoring of heart rate, ECG, and serum calcium levels is essential, especially in neonates and infants due to immature renal function and smaller fluid volumes.

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Geriatric Use

Use with caution due to potential for age-related decreases in renal function, which can affect calcium excretion. Increased risk of hypercalcemia. Start with lower doses and monitor serum calcium and renal function closely. More susceptible to adverse cardiac effects, especially if on digoxin.

Clinical Information

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Clinical Pearls

  • Administer IV calcium gluconate slowly (typically over 5-10 minutes) to minimize the risk of hypotension, bradycardia, and cardiac arrhythmias.
  • Calcium gluconate is less irritating to veins than calcium chloride but still carries a risk of extravasation. Administer via a large peripheral vein or central line. Avoid intramuscular or subcutaneous injection due to risk of tissue necrosis and abscess formation.
  • Do NOT mix calcium gluconate with bicarbonate or phosphate solutions in the same IV line or syringe, as precipitation will occur.
  • Always monitor ECG during rapid IV administration, especially in patients receiving digoxin, as calcium can potentiate digoxin toxicity.
  • Correct hypomagnesemia before attempting to correct hypocalcemia, as magnesium is required for parathyroid hormone secretion and action.
  • Calcium gluconate provides 90 mg (4.5 mEq) of elemental calcium per 1 gram (10 mL of 10% solution), whereas calcium chloride provides 270 mg (13.6 mEq) of elemental calcium per 1 gram (10 mL of 10% solution). Be mindful of the elemental calcium content when switching between salts.
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Alternative Therapies

  • Calcium Chloride Injection (provides more elemental calcium per gram, but is more irritating to veins and carries a higher risk of extravasation and tissue necrosis)
  • Oral calcium supplements (for chronic hypocalcemia, not acute emergencies)
  • Vitamin D analogs (for chronic hypocalcemia related to vitamin D deficiency)
  • Magnesium sulfate (for magnesium deficiency, which can cause refractory hypocalcemia)
  • Insulin/Dextrose, Beta-agonists, Sodium Bicarbonate (for hyperkalemia, as they shift potassium intracellularly, unlike calcium which stabilizes the cardiac membrane)
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Cost & Coverage

Average Cost: Varies widely, typically low cost for generic IV solution. per 100ml 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, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs; consult with your pharmacist to learn about available options in your area. Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.