CALCIUM GLUCONATE
-
Chemical Name:
Calcium Gluconate -
Therapeutic Category:
Fluids and Electrolytes -
Pharmacologic Category:
Calcium Salt- Electrolyte Supplement, Parenteral -
Pharmaceutical Form:
Ampoule -
Composition:
Calcium Gluconate 10mg/100ml
CALCIUM GLUCONATE 10% ELSaad
Injection (Plastic Ampoule)
Calcium Gluconate
1-PHARMACOLOGY:
CALCIUM GLUCONATE 10% (IV) ELSaad is a sterile, nonpyrogenic, supersaturated solution of Calcium Gluconate for intravenous use only.
Calcium is the fifth abundant element in the body and is essential for maintenance of the functional integrity of nervous, muscular and skeletal systems, cell membranes and capillary permeability. It is also an important activator in many enzymatic reactions and is essential to a number of physiologic processes including transmission of nerve impulses; contraction of cardiac, smooth and skeletal muscles, renal function, respiration; and blood coagulation. Calcium also plays regulatory roles in the release and storage of neurotransmitters and hormones, in the uptake and binding of amino acids, in cyanocobalamin (vitamin B12) absorption, and gastrin secretion.
2-INDICATIONS:
CALCIUM GLUCONATE 10% (IV) ELSaad is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcaemia due to rapid growth or pregnancy. Calcium Gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, Calcium Gluconate may aid in antagonizing the cardiac toxicity, provided the patient is not receiving digitalis therapy.
3-CONTRAINDICATIONS:
Calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia. Intravenous administration of calcium is contraindicated when serum calcium levels are above normal.
4-WARNINGS & PRECAUTIONS:
For intravenous only use. The preparation should not be given by the intramuscular or subcutaneous route as necrosis can occur.
To avoid undesirable reactions that may follow rapid intravenous administration of Calcium Gluconate, the drug should be given slowly, e.g., approximately 1.5 mL over a period of one minute.
When injected intravenously, Calcium Gluconate should be injected through a small needle into a large vein in order to avoid too rapid an increase in serum calcium and extravasation of calcium solution into the surrounding tissue with resultant necrosis.
Rapid injection of Calcium Gluconate may cause vasodilatation, decreased blood pressure, bradycardia, cardiac arrhythmias and syncope.
Because of the danger involved in simultaneous use of calcium salts and drugs of the digitalis group, a digitalized patient should not receive an intravenous injection of a calcium compound unless indications are clearly defined.
5-PREGNANCY & LACTATION:
Pregnancy: Category C. Calcium Gluconate should be given to a pregnant woman only if clearly needed.
Caution should be exercised when calcium Gluconate is administered to nursing mothers.
Caution should be exercised when calcium Gluconate is administered to nursing mothers.
6-ADVERSE REACTIONS:
Patients may complain of tingling sensations, a sense of oppression or heat waves and a calcium or chalky taste following the intravenous administration of Calcium Gluconate.
Rapid intravenous injection of calcium salts may cause vasodilatation, decreased blood pressure, bradycardia, cardiac arrhythmias and syncope.
7-DRUG INTERACTIONS:
Cardiac Glycosides: The inotropic and toxic effects of cardiac glycosides and calcium are synergistic and arrhythmias may occur if these drugs are given together.
Tetracyclines: Calcium is known to complex with tetracycline antibiotics, thus rendering them inactive.
Tetracyclines: Calcium is known to complex with tetracycline antibiotics, thus rendering them inactive.
Administration of calcium may reduce the response to verapamil and other calcium channel blockers.
8-DOSAGE & ADMINISTRATION:
Calcium Gluconate is usually administered intravenously as a 10% solution, by slow direct intravenous injection, or by continuous or intermittent intravenous infusion.
The dose is dependent on the requirements of the individual patient. Intravenous Calcium Gluconate injection must be administered slowly.
Usual Dosage:
Adults: 500 mg to 2 g (5 to 20 ml).
Pediatric patients: 200 to 500 mg (2 to 5 ml)
Infants: Not more than 200 mg (not more than 2 ml)
9-PACKAGING AND COMPOSITION:
Calcium Gluconate 10% ELSaad - Injection: A pack of 7 or 100 plastic ampoules of 10 ml. Each 10 ml plastic ampoule of sterile solution contains equivalent to 10% w/v Calcium Gluconate , 0.465 mEq/ml of Ca2+.