Cal Glu/nacl 1gm/50ml Inj, 50ml

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 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. It's used to quickly raise calcium levels in your blood if they are too low, or to protect your heart if your potassium levels are too high, or to reverse the effects of too much magnesium in your body. It helps your muscles, nerves, and heart 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 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 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 by a healthcare professional.
  • Report any discomfort or pain at the injection site immediately.
  • Report any new or worsening symptoms, such as nausea, vomiting, confusion, or muscle weakness.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For acute symptomatic hypocalcemia: 1-2 g (10-20 mL of 10% solution) IV over 10-20 minutes. For hyperkalemia/magnesium toxicity: 1-3 g (10-30 mL of 10% solution) IV over 5-10 minutes.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

acute_hypocalcemia: 1-2 g IV over 10-20 minutes, may repeat as needed.
hyperkalemia_cardiac_stabilization: 1-3 g IV over 5-10 minutes, may repeat if ECG changes persist.
magnesium_toxicity: 1-2 g IV over 5-10 minutes, may repeat if needed.
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Pediatric Dosing

Neonatal: Hypocalcemia: 50-100 mg/kg/dose IV over 5-10 minutes, then 200-500 mg/kg/day continuous infusion or divided doses.
Infant: Hypocalcemia: 50-100 mg/kg/dose IV over 5-10 minutes, then 200-500 mg/kg/day continuous infusion or divided doses.
Child: Hypocalcemia: 50-100 mg/kg/dose IV over 5-10 minutes, then 200-500 mg/kg/day continuous infusion or divided doses. Hyperkalemia/Magnesium toxicity: 60-100 mg/kg/dose IV over 5-10 minutes.
Adolescent: Dosing similar to adult for specific indications, adjusted for weight if necessary.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor serum calcium and renal function closely.
Moderate: No specific dose adjustment, but monitor serum calcium and renal function closely. Use with caution.
Severe: No specific dose adjustment, but monitor serum calcium and renal function closely. Use with extreme caution due to impaired calcium excretion and risk of hypercalcemia.
Dialysis: Monitor serum calcium closely. Dosing may need to be adjusted based on pre-dialysis and post-dialysis calcium levels and patient's clinical status.

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 maintaining the functional integrity of the nervous, muscular, and skeletal systems, as well as cell membrane and capillary permeability. It is crucial for normal cardiac function, blood coagulation, and bone formation. Calcium gluconate provides a 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 in magnesium toxicity.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (immediate effect with IV)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.35 L/kg (distributes throughout extracellular fluid and bone)
ProteinBinding: Approximately 45% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Variable, depends on calcium homeostasis; plasma half-life of injected calcium is very short (minutes) as it rapidly equilibrates with bone and other tissues.
Clearance: Not readily quantifiable as a single value due to complex homeostatic mechanisms.
ExcretionRoute: Primarily renal (glomerular filtration and tubular reabsorption); also fecal excretion.
Unchanged: Not applicable (calcium is an ion)
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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

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. Contact your doctor or seek medical help if you experience:

Constipation
Any other side effects that bother you or do not go away

Reporting Side Effects

If you have questions or concerns about side effects, 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:

  • Nausea or vomiting
  • Constipation
  • Increased thirst or urination
  • Muscle weakness or fatigue
  • Confusion or drowsiness
  • Dizziness or lightheadedness
  • Slow or 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 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 disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments. Never start, stop, or adjust 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 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 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, shortened QT interval, heart block)
  • Hypotension
  • Renal failure

What to Do:

Immediate medical attention is required. Treatment involves discontinuing calcium administration, hydration with IV fluids (saline), loop diuretics (if renal function is adequate), and potentially calcitonin, bisphosphonates, or dialysis in severe cases. Monitor ECG and serum calcium levels closely. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Digoxin (concurrent IV administration, especially in hypercalcemia, due to increased risk of arrhythmias)
  • Ceftriaxone (in neonates, due to risk of precipitation in lungs and kidneys)
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Major Interactions

  • Thiazide diuretics (may increase risk of hypercalcemia)
  • Calcium channel blockers (calcium may antagonize their effects)
  • Phosphates (may form insoluble precipitates)
  • Bicarbonates (may form insoluble precipitates)
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Moderate Interactions

  • Tetracyclines (oral, calcium may decrease absorption)
  • Fluoroquinolones (oral, calcium may decrease absorption)
  • Iron supplements (oral, calcium may decrease absorption)
  • Levothyroxine (oral, calcium may decrease absorption)

Monitoring

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Baseline Monitoring

Serum Calcium (total and ionized)

Rationale: To establish baseline calcium status and guide dosing.

Timing: Prior to administration

ECG

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

Timing: Prior to administration (especially for cardiac indications)

Renal Function (BUN, Creatinine)

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

Timing: Prior to administration

Magnesium, Potassium, Phosphate levels

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

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.

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 persist/worsen.

ECG

Frequency: Continuous monitoring during acute administration; periodically thereafter as clinically indicated.

Target: Normal sinus rhythm, resolution of specific abnormalities (e.g., prolonged QT, peaked T waves).

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

Vital Signs (HR, BP, RR)

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

Target: Within patient's normal range.

Action Threshold: Significant changes (e.g., bradycardia, hypotension).

Injection Site

Frequency: Continuously during infusion, then regularly.

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

Action Threshold: Any signs of irritation or extravasation; discontinue infusion immediately.

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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)

Special Patient Groups

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Pregnancy

Calcium gluconate is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Calcium requirements increase during pregnancy, and calcium is essential for fetal skeletal development. However, excessive calcium administration can lead to hypercalcemia in the mother and fetus.

Trimester-Specific Risks:

First Trimester: No specific data suggesting increased risk, but generally avoid non-essential medications.
Second Trimester: Used for specific indications (e.g., hypocalcemia, magnesium toxicity). Monitor maternal and fetal calcium levels.
Third Trimester: Used for specific indications. Monitor maternal and fetal calcium levels. Excessive calcium can potentially affect fetal parathyroid function.
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Lactation

Calcium is a normal component of breast milk. Calcium gluconate is generally considered compatible with breastfeeding when administered to the mother, as it is an essential nutrient. Monitor the infant for any signs of hypercalcemia, though this is unlikely with appropriate maternal dosing.

Infant Risk: Low risk. Calcium is naturally present in breast milk. Excessive maternal doses could theoretically increase infant calcium, but this is rare.
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Pediatric Use

Dosing is weight-based and varies by indication. Careful monitoring of serum calcium, vital signs, and ECG is crucial due to potential for rapid changes and higher risk of adverse effects, especially in neonates and infants. Avoid rapid IV push due to risk of bradycardia and arrhythmias.

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Geriatric Use

Use with caution in elderly patients, as they may have age-related decreases in renal function, which can impair calcium excretion and increase the risk of hypercalcemia. Monitor renal function and serum calcium levels closely. Start with lower doses and titrate carefully.

Clinical Information

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Clinical Pearls

  • Administer IV calcium gluconate slowly (typically over 5-10 minutes for bolus doses) to minimize the risk of cardiac arrhythmias (bradycardia) and hypotension.
  • Avoid rapid IV push, especially in pediatric patients and those on digoxin.
  • Calcium gluconate is less irritating to veins than calcium chloride, making it generally preferred for peripheral IV administration, though central line is still preferred for higher concentrations or continuous infusions.
  • Ensure patency of IV line and monitor injection site closely for extravasation, which can cause tissue necrosis and calcification.
  • Do NOT mix calcium gluconate with bicarbonate or phosphate solutions in the same IV line or syringe, as precipitation will occur.
  • Correct hypomagnesemia if present, as magnesium is necessary for parathyroid hormone function and calcium homeostasis.
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Alternative Therapies

  • Calcium chloride (provides more elemental calcium per gram, but is more irritating to veins and typically reserved for central line administration or cardiac arrest)
  • Oral calcium supplements (for chronic hypocalcemia, not acute)
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Cost & Coverage

Average Cost: Low cost per 10mL or 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 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. Properly dispose of any unused or expired medications. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.