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International generic name
Calcium gluconate Calcium levulinate
Drug form and composition
Solution for injection. One ampoule of 10 ml contains: 760 mg Calcium gluconate
(76 mg/ml); 164 mg Calcium levulinate (16.4 mg/ml) - calcium ion equivalent 89.4
mg (8.94 mg/ml).
Indications
In cases with acute hypocalcemia; hyperkalemia; hypermagnesemia; electrolyte
dysbalanse; cardiac arrest.
Dosage and administration
In adult patients the solution is administered as a slow intravenous injection
in dose 10-20 ml, as the dose may be repeated if necessary. In children the dosage
is 2-5 ml intravenously. Intravenous injection should be made slowly - 5 ml for
3-5 minutes, and the patient should be in supine position.
Contraindications
The preparation should not be administered in patients with primary or secondary
hypercalcemia; hypercalciuria; renal stones with calcium deposits; sarcoidosis;
renal failure; intoxication with digitalis.
Special warnings and precautions
Intravenous drug administration should be made slowly and very carefully with
blood pressure monitoring. Blood calcium level and calcium excretion should be monitored
in case high dose of preparation are administered parenterally, particularly in
chronic renal diseases and in pediatric patients. The preparation should be used
with exceptionally attention in following cases: dehydration, history for nephrolythiasis,
cardiac or renal disorders, ventricular fibrilation during a cardiopulmonal resuscitation.
The preparation should be administered with particularly care in pregnant and nursing
women. After an intravenous injection the patient should not drive for several hours.
Drug interactions
Absorbtion of the calcium is reduced by following compounds: coffeine, nicotine,
antiacid preparations, and is increased by estrogenes, vitamin A, vitamin D, magnesium.
Calcium salts reduce absorbtion of the tetracyclines. Concomitant administration
of the preparation with cardiac glycosides enhances the risk of arrhythmias.
Adverse reactions
Usually adverse reactions are seen in calcium overdosage. Clinical manifestation
includes constipation, mouth drying, headache, anxiety, thirst, appetite loss, depression,
metal taste, fatigue, and weakness. In fast parenteral injection nausea, vomiting,
diarrhea, bradicardia, hypotension and, rarely, collapse may appear.
Pharmacological mechanisms
Calcium is a basic element of the human organism and occurs in most high concentrations
in the bones and the teeth (99%). In lower concentrations calcium occurs in the
extracellular fluid and cellular cytoplasm. Calcium ion plays an important physiology
role and is necessary for the morphology and the functional integrity of the neural,
muscular and skeletal systems. It plays an important role in the normal functioning
of the heart, kidneys, respiratory system, bones, blood coagulation (clothing factor
IV), and permeability of the cell membrane also. It possesses prominent antiallergic
action. The regulation of the serum level of the calcium is realized by the parathyroid
hormone, calcitonin, and vitamin D.
Supplied
50 ampoules of 10 ml.
Expiry
2 years.
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