Cal Glu/nacl 2000mg/100ml Inj 100ml

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, Mineral 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, usually into a vein. It's used to quickly raise calcium levels in your blood if they are too low, or to protect your heart in certain emergencies like very high potassium levels or magnesium overdose. Calcium is important for your bones, muscles, nerves, and heart to work properly.
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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 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 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

  • Maintain a balanced diet rich in calcium and Vitamin D, as advised by your doctor, to support long-term calcium balance.
  • Report any new or worsening symptoms to your healthcare provider immediately.
  • Avoid taking other calcium supplements or antacids containing calcium unless specifically instructed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For acute hypocalcemia: 1-2 g (10-20 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: 1000 - 3000 mg

Condition-Specific Dosing:

Acute Hypocalcemia: 1-2 g IV slowly over 5-10 minutes, may repeat as needed.
Hyperkalemia (cardiac stabilization): 1-3 g IV slowly over 5-10 minutes, with continuous ECG monitoring. May repeat in 5 minutes if ECG changes persist.
Magnesium Sulfate Overdose: 1-2 g IV slowly over 5-10 minutes, may repeat as needed.
Calcium Channel Blocker Overdose: 1-3 g IV slowly over 5-10 minutes, may repeat as needed.
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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.
Adolescent: Acute Hypocalcemia: 1-2 g (10-20 mL of 10% solution) IV slowly over 5-10 minutes.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor calcium levels closely.
Moderate: Use with caution, monitor calcium levels closely. Risk of hypercalcemia increased.
Severe: Use with extreme caution, monitor calcium levels closely. Risk of hypercalcemia increased. Consider lower doses.
Dialysis: Administer post-dialysis if needed. Monitor calcium levels closely as dialysis can affect calcium balance.

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 a calcium salt, calcium gluconate provides a readily available source of calcium ions to restore normal serum calcium levels in hypocalcemic states, stabilize cardiac cell membranes in hyperkalemia, and antagonize the effects of magnesium toxicity.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Minutes (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, depends on calcium homeostasis; plasma half-life of injected calcium is very short (minutes).
Clearance: Primarily renal excretion of excess calcium.
ExcretionRoute: Renal (urine), small amounts via feces.
Unchanged: Not applicable (ionized form is active)
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Pharmacodynamics

OnsetOfAction: Immediate (IV)
PeakEffect: Minutes (IV)
DurationOfAction: Short (minutes to hours, depending on underlying condition and dose)

Safety & Warnings

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

Additional Side Effects: Notify Your Doctor

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

* Constipation

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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, vomiting, constipation, needing to urinate a lot, feeling very thirsty, muscle weakness, confusion, feeling tired.
  • Signs of too little calcium (hypocalcemia): tingling or numbness around the mouth or in fingers/toes, muscle cramps, spasms, or twitching.
  • Signs of injection site problems: pain, swelling, redness, or blistering at the site where the medicine was given.
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 potential interactions. 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 modify the dosage of any medication without first consulting your doctor.
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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 pose a 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 this medication to both you and your baby. Your doctor will help you make an informed decision about using this medication during this time.
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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, short QT interval)
  • Hypotension

What to Do:

Immediate medical attention is required. Treatment involves stopping calcium administration, hydration with IV fluids (saline), loop diuretics (e.g., furosemide) to promote calcium excretion, and in severe cases, calcitonin, bisphosphonates, or dialysis. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Contraindicated Interactions

  • Digoxin (concurrent IV administration): Risk of severe arrhythmias due to synergistic effects on cardiac contractility and conduction.
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Major Interactions

  • Thiazide diuretics: May decrease calcium excretion, leading to hypercalcemia.
  • Phosphates (e.g., potassium phosphate, sodium phosphate): May form insoluble calcium phosphate precipitates.
  • Bicarbonates (e.g., sodium bicarbonate): May form insoluble calcium carbonate precipitates.
  • Ceftriaxone: Concurrent administration is contraindicated in neonates due to risk of precipitation in lungs and kidneys. In other age groups, avoid concurrent administration or administer sequentially with thorough flushing.
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Moderate Interactions

  • Calcium channel blockers (e.g., verapamil, diltiazem): Calcium gluconate may antagonize the effects of calcium channel blockers.
  • Tetracyclines (if oral calcium): Reduced absorption of tetracyclines.
  • Fluoroquinolones (if oral calcium): Reduced absorption of fluoroquinolones.
  • Iron supplements (if oral calcium): Reduced absorption of iron.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Serum Calcium (total and ionized)

Rationale: To establish baseline levels and guide dosing.

Timing: Prior to administration

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete calcium and identify patients at higher risk for hypercalcemia.

Timing: Prior to administration

ECG

Rationale: To assess cardiac rhythm and identify pre-existing abnormalities, especially important in hyperkalemia or digoxin toxicity.

Timing: Prior to administration

Serum Magnesium, Potassium, Phosphate

Rationale: To assess overall electrolyte balance, as these interact with calcium.

Timing: Prior to administration

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Routine Monitoring

Serum Calcium (ionized preferred)

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

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

Action Threshold: Adjust dose if outside target range; discontinue if hypercalcemic symptoms or levels are too high.

ECG

Frequency: Continuous monitoring during rapid IV administration, especially for hyperkalemia or cardiac arrest. Intermittent monitoring as clinically indicated.

Target: Normal sinus rhythm, absence of arrhythmias, resolution of hyperkalemic ECG changes.

Action Threshold: Bradycardia, arrhythmias, QTc prolongation, or persistent hyperkalemic changes require immediate intervention.

Vital Signs (HR, BP, RR)

Frequency: Every 15-30 minutes during infusion, then as clinically indicated.

Target: Within normal limits for age.

Action Threshold: Significant changes (e.g., bradycardia, hypotension) may indicate rapid infusion or hypercalcemia.

IV Site

Frequency: Continuously during infusion, then regularly.

Target: No redness, swelling, pain, or signs of 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, blistering at injection site)
  • Signs of rapid infusion (flushing, sweating, nausea, vomiting, dizziness, cardiac arrhythmias, hypotension)

Special Patient Groups

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Pregnancy

Calcium is essential during pregnancy for fetal development. Calcium gluconate is used when clinically indicated for acute conditions (e.g., hypocalcemia, magnesium toxicity). Use with caution and monitor maternal and fetal calcium levels.

Trimester-Specific Risks:

First Trimester: Generally considered safe when indicated for acute, life-threatening conditions. Risk of hypercalcemia to mother and fetus if over-administered.
Second Trimester: Generally considered safe when indicated for acute, life-threatening conditions. Risk of hypercalcemia to mother and fetus if over-administered.
Third Trimester: Generally considered safe when indicated for acute, life-threatening conditions. Risk of hypercalcemia to mother and fetus if over-administered. Close monitoring of maternal and fetal heart rate is advised.
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Lactation

Calcium is a normal component of breast milk. Exogenous calcium gluconate is generally considered compatible with breastfeeding when administered to the mother for acute indications. Monitor the infant for signs of hypercalcemia, though systemic absorption by the infant from breast milk is unlikely to cause issues.

Infant Risk: Low
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Pediatric Use

Dosing is weight-based and requires careful calculation. Neonates are particularly sensitive to rapid infusion and precipitation with ceftriaxone. Close monitoring of heart rate, blood pressure, and calcium levels is crucial.

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Geriatric Use

Elderly patients may have impaired renal function, increasing the risk of hypercalcemia. Use with caution and monitor calcium levels and renal function closely. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Always administer IV calcium gluconate slowly to avoid cardiac arrhythmias (bradycardia, asystole) and hypotension.
  • Ensure proper IV access and monitor for extravasation, as calcium gluconate is irritating to tissues and can cause necrosis.
  • Do NOT administer calcium gluconate concurrently with ceftriaxone, especially in neonates, due to the risk of fatal precipitation.
  • Calcium gluconate contains less elemental calcium per gram than calcium chloride (90 mg vs 270 mg elemental calcium per gram, respectively). Dosing adjustments are necessary if switching between the two.
  • Continuous ECG monitoring is essential during rapid IV administration, particularly in patients with hyperkalemia or those on digoxin.
  • Correct hypomagnesemia if present, as magnesium is required for proper calcium homeostasis.
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Alternative Therapies

  • Calcium Chloride Injection (provides more elemental calcium per gram, but is more irritating to veins and should only be given via central line if possible)
  • Oral Calcium Supplements (for chronic hypocalcemia, not acute emergencies)
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Cost & Coverage

Average Cost: $5 - $20 per 100 mL (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 guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour 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 proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices and inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

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 aid healthcare professionals in providing appropriate treatment.