Calcium Gluconate 10% 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 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 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 the information provided. Adhere to the dosage instructions and administration guidelines. 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 in a hospital or clinic setting, so lifestyle modifications are not directly applicable during administration.
  • Long-term calcium balance may require dietary adjustments or oral supplements, as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For acute hypocalcemia: 970 mg to 3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes. For hyperkalemia/magnesium toxicity: 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes.
Dose Range: 970 - 3000 mg

Condition-Specific Dosing:

Acute Hypocalcemia: 970 mg to 3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes, may repeat as needed.
Hyperkalemia (cardiac stabilization): 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes, with ECG monitoring. May repeat in 5 minutes if ECG changes persist.
Magnesium Toxicity: 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes, with close monitoring of respiratory rate and deep tendon reflexes.
Calcium Channel Blocker Overdose: 1-3 g (10-30 mL of 10% solution) IV slowly over 5-10 minutes, may repeat as needed based on clinical response and calcium levels.
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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 100 mg/kg/dose. Do not exceed 1 mL/min. Avoid rapid infusion. Contraindicated with ceftriaxone.
Infant: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes. Max 100 mg/kg/dose. Do not exceed 1 mL/min.
Child: Acute Hypocalcemia: 50-100 mg/kg (0.5-1 mL/kg of 10% solution) IV slowly over 5-10 minutes. Max 100 mg/kg/dose. Hyperkalemia (cardiac stabilization): 60-100 mg/kg (0.6-1 mL/kg of 10% solution) IV slowly over 5-10 minutes, with ECG monitoring. Max 3 g/dose.
Adolescent: Dosing similar to adult for acute indications, adjusted for weight and clinical response.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor serum calcium levels closely.
Moderate: No specific dose adjustment, but monitor serum calcium levels closely. Increased risk of hypercalcemia.
Severe: Use with extreme caution. Monitor serum calcium levels frequently and adjust dose based on levels and clinical response. Increased risk of hypercalcemia.
Dialysis: Calcium gluconate can be used. Monitor serum calcium levels closely, as dialysis can affect calcium balance. Avoid rapid infusion.

Hepatic Impairment:

Mild: No specific dose adjustment needed.
Moderate: No specific dose adjustment needed.
Severe: No specific dose 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, cardiac function, bone formation, and blood coagulation. Administered intravenously, calcium gluconate rapidly increases serum calcium levels. In hyperkalemia, it stabilizes the cardiac membrane by increasing the threshold potential, thereby antagonizing the cardiotoxic effects of potassium. In magnesium toxicity, it 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 40-45% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Variable, depends on calcium homeostasis; plasma half-life of ionized calcium is short (minutes to hours).
Clearance: Primarily renal, but also fecal.
ExcretionRoute: Renal (glomerular filtration, tubular reabsorption), Fecal
Unchanged: Not applicable (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 dose and underlying condition)

Safety & Warnings

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BLACK BOX WARNING

Fatal reactions have occurred in neonates (≤28 days of age) receiving concomitant intravenous calcium-containing solutions and ceftriaxone, due to precipitation of ceftriaxone-calcium salts in the lungs and kidneys. In neonates, ceftriaxone and calcium-containing solutions must not be administered simultaneously, even if different infusion lines are used. In patients older than 28 days of age, ceftriaxone and calcium-containing solutions may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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 may cause:
+ Flushing
+ Slow or abnormal heartbeat
+ Signs of low blood pressure, such as severe dizziness or fainting
If the medication leaks from the vein, it may cause tissue damage. Inform your nurse immediately if you experience:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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

This is not an exhaustive list of potential 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:

  • Tell your nurse or doctor immediately if you experience any pain, swelling, or redness at the injection site.
  • Report any new or worsening symptoms such as nausea, vomiting, constipation, increased thirst or urination, muscle weakness, confusion, or changes in heart beat.
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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 in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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 of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will instruct you to undergo regular blood work and other laboratory tests 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 both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia: Nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, lethargy, confusion, stupor, coma, cardiac arrhythmias (bradycardia, short QT interval), hypotension, renal failure.

What to Do:

Overdose is managed by discontinuing calcium gluconate, administering IV fluids (saline) to promote calcium excretion, loop diuretics (e.g., furosemide) if fluid overload is not a concern, and potentially calcitonin or bisphosphonates in severe cases. Dialysis may be required in life-threatening hypercalcemia. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Contraindicated Interactions

  • Ceftriaxone (in neonates, due to risk of precipitation in lungs and kidneys)
  • IV Phosphate solutions (risk of calcium phosphate precipitation)
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Major Interactions

  • Digoxin (increased risk of cardiac arrhythmias, especially with rapid IV calcium or pre-existing hypercalcemia)
  • Thiazide diuretics (may decrease calcium excretion, leading to hypercalcemia)
  • Calcium channel blockers (calcium gluconate may antagonize their effects, used therapeutically in CCB overdose)
  • Sodium polystyrene sulfonate (Kayexalate) (risk of intestinal necrosis when co-administered orally with sorbitol, though less relevant for IV calcium gluconate)
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Moderate Interactions

  • Tetracyclines (oral forms: calcium can chelate, reducing absorption; less relevant for IV calcium gluconate)
  • Fluoroquinolones (oral forms: calcium can chelate, reducing absorption; less relevant for IV calcium gluconate)
  • Bisphosphonates (calcium may reduce absorption if given orally, not relevant for IV calcium gluconate)
  • Iron supplements (oral forms: calcium may reduce absorption; less relevant for IV calcium gluconate)

Monitoring

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Baseline Monitoring

Serum Calcium (total and ionized)

Rationale: To establish baseline calcium status and guide initial dosing.

Timing: Prior to administration

Serum Magnesium

Rationale: To assess for co-existing electrolyte imbalances, especially in hypocalcemia or magnesium toxicity.

Timing: Prior to administration

Serum Potassium

Rationale: Essential for hyperkalemia treatment and to monitor for other electrolyte disturbances.

Timing: Prior to administration

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete calcium and guide monitoring frequency.

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 administration, especially for hyperkalemia or cardiac indications

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Routine Monitoring

Serum Calcium (ionized preferred)

Frequency: Every 1-6 hours initially, then daily or as clinically indicated, depending on indication and patient stability.

Target: Ionized: 1.12-1.32 mmol/L (4.5-5.3 mg/dL); Total: 2.1-2.6 mmol/L (8.5-10.5 mg/dL)

Action Threshold: Ionized calcium < 1.0 mmol/L or > 1.4 mmol/L; Total calcium < 8.0 mg/dL or > 11.0 mg/dL (adjust based on albumin levels)

Electrocardiogram (ECG)

Frequency: Continuous monitoring during infusion, then periodically as clinically indicated, especially in hyperkalemia or cardiac conditions.

Target: Normal sinus rhythm, resolution of pathological ECG changes.

Action Threshold: Development of new arrhythmias, worsening of pre-existing ECG abnormalities (e.g., QT prolongation, QRS widening).

Vital Signs (HR, BP, RR)

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

Target: Within patient's normal range.

Action Threshold: Significant bradycardia, hypotension, or respiratory depression.

Injection Site

Frequency: Regularly during infusion.

Target: No signs of extravasation or irritation.

Action Threshold: Redness, swelling, pain, or signs of extravasation (risk of tissue necrosis).

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Symptom Monitoring

  • Signs of hypercalcemia: Nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, lethargy, confusion, cardiac arrhythmias (bradycardia, short QT interval).
  • Signs of hypocalcemia (if underlying condition persists): Tetany, muscle cramps, paresthesias (tingling in fingers, toes, perioral area), Chvostek's sign, Trousseau's sign, seizures, prolonged QT interval.
  • Signs of extravasation: Pain, swelling, redness at injection site.

Special Patient Groups

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Pregnancy

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 can be harmful. Close monitoring of maternal calcium levels is crucial.

Trimester-Specific Risks:

First Trimester: No specific data suggesting increased risk of congenital anomalies, but caution advised.
Second Trimester: Calcium is actively transported to the fetus; monitor maternal calcium levels.
Third Trimester: Monitor maternal calcium levels to avoid hypercalcemia, which could potentially affect fetal parathyroid function.
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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 administered to the mother.

Infant Risk: Low risk with typical therapeutic doses, but theoretical risk of hypercalcemia in infant with very high maternal doses.
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Pediatric Use

Dosing is weight-based and requires careful calculation. Neonates have a specific contraindication with ceftriaxone due to precipitation risk. Close monitoring of serum calcium, heart rate, and ECG is essential, especially during rapid infusion. Avoid extravasation due to risk of tissue necrosis.

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Geriatric Use

Use with caution due to potential for age-related decrease in renal function, which can impair calcium excretion and increase the risk of hypercalcemia. Monitor serum calcium and renal function closely. Start with lower doses and titrate carefully.

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, although central line is still preferred for both if possible.
  • Administer slowly to avoid hypercalcemia, bradycardia, and hypotension. Rapid infusion can be dangerous.
  • Always dilute calcium gluconate before administration, especially in neonates and children.
  • Do NOT mix with bicarbonate or phosphate solutions in the same IV line due to precipitation risk.
  • ECG monitoring is crucial, especially when treating hyperkalemia or in patients on digoxin.
  • Ionized calcium is a more accurate reflection of physiologically active calcium than total calcium, especially in patients with albumin abnormalities.
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Alternative Therapies

  • Calcium chloride (another injectable calcium salt, higher elemental calcium content, higher risk of extravasation injury)
  • Oral calcium supplements (for chronic hypocalcemia, not acute emergencies)
  • For hyperkalemia: Insulin/dextrose, albuterol, sodium bicarbonate, potassium binders (e.g., sodium polystyrene sulfonate), dialysis.
  • For magnesium toxicity: IV fluids, loop diuretics, dialysis.
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Cost & Coverage

Average Cost: Varies, typically low cost for generic injectable. 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, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.