Calcium Gluc 100mg/ml Inj, 10ml

Manufacturer AMNEAL BIOSCIENCES 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, Antidote, Cardioprotective agent
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Pharmacologic Class
Calcium salt
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Pregnancy 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 your blood. It's used for conditions where your body has too little calcium, or to protect your 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 proper storage procedure.

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 given by a healthcare professional in a hospital or clinic setting. It is not for self-administration.
  • Report any discomfort, pain, or swelling at the injection site immediately.
  • Inform your doctor about all other medications you are taking, especially heart medications like digoxin, or any diuretics.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and patient response. Administered intravenously.

Condition-Specific Dosing:

acuteHypocalcemia: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, then continuous infusion if needed.
hyperkalemia (cardiac stabilization): 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, with ECG monitoring. May repeat if ECG changes persist.
magnesiumToxicity: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, with close monitoring of respiratory rate and deep tendon reflexes.
calciumChannelBlockerOverdose: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes, may repeat or follow with infusion.
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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. Max 200 mg/kg/day.
Infant: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes. Max 200 mg/kg/day.
Child: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes. Max 200 mg/kg/day. Hyperkalemia: 60-100 mg/kg (0.6-1 mL/kg of 10% solution) IV slowly over 5-10 minutes.
Adolescent: Dosing similar to adult for specific indications, adjusted for weight.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution. Monitor serum calcium and renal function.
Moderate: Use with caution. Monitor serum calcium and renal function closely. Dosage adjustment may be necessary based on calcium levels.
Severe: Use with extreme caution. Contraindicated in hypercalcemia. Monitor serum calcium and renal function closely. Dosage adjustment may be necessary based on calcium levels.
Dialysis: Calcium levels should be carefully monitored. May be used to treat hypocalcemia in dialysis patients, but risk of hypercalcemia is increased.

Hepatic Impairment:

Mild: No specific adjustment generally needed.
Moderate: No specific adjustment generally needed.
Severe: No specific adjustment generally 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 a medication, calcium gluconate provides an immediate source of calcium ions to increase serum calcium levels. In hyperkalemia, it stabilizes the cardiac cell membrane, reducing myocardial excitability and antagonizing the cardiotoxic effects of potassium without lowering serum potassium levels. In magnesium toxicity, it directly antagonizes the neuromuscular effects of magnesium.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (IV administration, immediate effect)
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, depends on calcium homeostasis; plasma half-life of injected calcium is short (minutes to hours) as it rapidly equilibrates with bone and intracellular pools.
Clearance: Primarily renal excretion, with some fecal excretion.
ExcretionRoute: Renal (urine), Fecal
Unchanged: Not applicable (excreted as calcium ion)
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Pharmacodynamics

OnsetOfAction: Immediate (within minutes of IV administration)
PeakEffect: Within minutes
DurationOfAction: Short (approximately 30 minutes to 2 hours, depending on underlying condition and dose)
Confidence: High

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
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 any other symptoms that bother you or do not go away, contact your doctor:

* Constipation

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

  • Signs of too much calcium (hypercalcemia): feeling sick to your stomach (nausea), throwing up (vomiting), constipation, needing to urinate a lot, feeling very thirsty, muscle weakness, feeling tired, confusion.
  • Signs of injection site problems: pain, burning, swelling, or redness around where the needle was inserted.
  • Signs of rapid infusion: feeling flushed, sweating, dizziness, feeling faint, slow heartbeat.
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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 discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help determine if it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that 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 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: profound muscle weakness, lethargy, confusion, stupor, coma, severe constipation, kidney stones, bone pain, cardiac arrhythmias (e.g., bradycardia, heart block, asystole), hypotension.

What to Do:

Immediate medical attention is required. Treatment involves stopping calcium administration, hydration with IV fluids (saline), loop diuretics (if renal function is adequate), and in severe cases, calcitonin, bisphosphonates, or dialysis. Close monitoring of serum calcium, ECG, and vital signs is crucial. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Digoxin (digitalis glycosides) in patients with hypercalcemia (risk of severe arrhythmias)
  • Ceftriaxone (in neonates, due to risk of precipitation in lungs and kidneys)
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Major Interactions

  • Digoxin (digitalis glycosides) in normocalcemic patients (use with extreme caution, monitor ECG and calcium levels)
  • Phosphates (IV) - risk of precipitation
  • Bicarbonates (IV) - risk of precipitation
  • Calcium channel blockers (e.g., verapamil, diltiazem) - calcium gluconate may antagonize their effects, requiring higher doses of calcium or careful monitoring.
  • Thiazide diuretics - may increase risk of hypercalcemia by decreasing calcium excretion.
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Moderate Interactions

  • Fluorides (oral) - may form insoluble calcium fluoride.
  • Tetracyclines (oral) - decreased absorption of tetracyclines.
  • Quinolones (oral) - decreased absorption of quinolones.
  • Iron supplements (oral) - decreased absorption of iron.
  • Bisphosphonates (oral) - decreased absorption of bisphosphonates.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Serum Calcium (ionized and total)

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 digitalis toxicity, and to monitor for cardiotoxicity during infusion.

Timing: Prior to and during administration

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete calcium and guide dosing in renal impairment.

Timing: Prior to administration

Serum Magnesium, Potassium, Phosphate

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

Timing: Prior to administration

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Routine Monitoring

Serum Calcium (ionized and total)

Frequency: Every 1-4 hours during infusion, then as clinically indicated.

Target: Normal range (e.g., 8.5-10.5 mg/dL total, 1.12-1.32 mmol/L ionized)

Action Threshold: Adjust infusion rate or discontinue if hypercalcemia develops; re-dose if hypocalcemia persists.

Electrocardiogram (ECG)

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

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

Action Threshold: Bradycardia, QT shortening, arrhythmias, or other signs of hypercalcemia warrant immediate intervention.

Vital Signs (HR, BP, RR)

Frequency: Every 5-15 minutes during infusion, then as clinically indicated.

Target: Within normal limits for patient.

Action Threshold: Hypotension, bradycardia, or respiratory depression warrant immediate intervention.

IV Site

Frequency: Continuously during infusion.

Target: No signs of extravasation (swelling, pain, redness).

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, fatigue, confusion, stupor, coma, cardiac arrhythmias.
  • Signs of extravasation: pain, burning, swelling, redness at injection site.
  • Signs of rapid infusion: flushing, sweating, hypotension, bradycardia, syncope.

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Calcium is essential for fetal development, but excessive maternal calcium levels can be harmful.

Trimester-Specific Risks:

First Trimester: Risk of hypercalcemia in mother, potential for fetal effects if severe.
Second Trimester: Risk of hypercalcemia in mother, potential for fetal effects if severe.
Third Trimester: Risk of hypercalcemia in mother, potential for fetal effects if severe. May affect uterine contractility.
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Lactation

Calcium is naturally present in breast milk. While calcium gluconate is generally considered compatible with breastfeeding, caution is advised. Monitor infant for signs of hypercalcemia if high maternal doses are used.

Infant Risk: Low risk with typical therapeutic doses, but theoretical risk of hypercalcemia in infant with very high maternal doses. Monitor infant for irritability, constipation, poor feeding.
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Pediatric Use

Dosing must be carefully calculated based on weight and indication. Neonates and infants are particularly susceptible to rapid changes in calcium levels and extravasation. Close monitoring of heart rate, blood pressure, and ECG is essential.

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Geriatric Use

Use with caution due to potential for age-related decline in renal function, which can affect calcium excretion. Increased risk of hypercalcemia. Monitor renal function and serum calcium levels closely.

Clinical Information

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Clinical Pearls

  • Calcium gluconate is preferred over calcium chloride for peripheral IV administration due to lower risk of tissue necrosis if extravasation occurs, though extravasation can still cause severe injury.
  • Administer slowly (typically over 5-10 minutes) to avoid rapid changes in serum calcium, which can lead to hypotension, bradycardia, and arrhythmias.
  • Do NOT administer calcium gluconate in the same IV line as bicarbonate or phosphate solutions due to the risk of precipitation.
  • Always monitor ECG during IV administration, especially in patients on digoxin or with pre-existing cardiac conditions.
  • In hyperkalemia, calcium gluconate stabilizes the cardiac membrane but does not lower potassium levels; other treatments are needed to shift or remove potassium from the body.
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Alternative Therapies

  • Calcium Chloride Injection (provides more elemental calcium per gram but is more irritating to veins and should ideally be given via central line).
  • Oral calcium supplements (for chronic hypocalcemia, not acute emergencies).
  • Specific antidotes for underlying conditions (e.g., insulin/glucose for hyperkalemia, atropine/pacing for severe bradycardia from calcium channel blocker overdose).
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Cost & Coverage

Average Cost: $10 - $50 per 10 mL vial (10% solution)
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 and effective use of your medication, never share your prescription with others, and do not take medication that has been prescribed to someone else.

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 dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. If you are unsure about the correct disposal method, consult with your pharmacist for guidance. Many communities have drug take-back programs that provide a safe 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 assistance. In the event of a suspected overdose, immediately contact 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, as this will help healthcare professionals provide the most effective treatment.