Calcium gluconate stabilized - instructions for use, dose, side effects, contraindications

The preparation of calcium replenishes the deficiency of calcium ions, which are necessary for carrying out the process of transmission of nerve impulses, reduction of skeletal and smooth muscles, myocardial activity, formation of bone tissue, and clotting of blood.

When administered intravenously, it stimulates the sympathetic part of the autonomic nervous system, has a moderate diuretic effect, increases adrenaline secretion by the adrenals.

Pharmacokinetics:

After parenteral administration calcium gluconate evenly distributed in all tissues and organs. In blood plasma, about 45% of the drug is in combination with proteins. Penetrates through the placental barrier, enters the breast milk. It is excreted from the body mainly by the kidneys.

Indications:

Treatment of acute hypocalcemia.

Reducing permeability of capillaries in allergic conditions, non-morbocytopenic purpura and excydermatoses, for example, herpetiform dermatitis and itchy rash due to the use of certain medications.

Contraindications:

Hypersensitivity to calcium gluconate or other components of the drug, hypercalcemia (including in patients with hyperparathyroidism, hypervitaminosis D, decalcifying malignant neoplasms, renal insufficiency, osteoporosis associated with immobilization, sarcoidosis, milk-alkaline syndrome (Barnett syndrome)).

Hypercalciuria, intoxication with cardiac glycosides, simultaneous treatment with cardiac glycosides.

For intramuscular injection: children's age.

Carefully:

Nephrocalcinosis, pathology of the cardiovascular system, simultaneous treatment with epinephrine, elderly age, sarcoidosis.

Pregnancy and lactation:

Calcium penetrates the placental barrier, enters the breast milk. The use of the drug during pregnancy and during breastfeeding is possible only under strict control of serum calcium concentration, t. Hypercalcemia can adversely affect the fetus and the baby.

Dosing and Administration:

Normally, the concentration of total calcium in the serum is 2.25-2.75 mmol / l or 4.5-5.5 mEq / L. Therapy with calcium gluconate is aimed at restoring the normal concentration of calcium in the blood serum. During treatment, the concentration of calcium in the serum should be carefully monitored.

Solutions containing calcium should be administered slowly in order to minimize the possibility of peripheral vasodilation and inhibition of cardiac activity.

Adults: deep intramuscularly, or intravenously slowly (for 2-3 min), or drip 5-10 ml of 100 mg / ml (10% solution) depending on the nature of the disease and the clinical condition of the patient. The subsequent doses are determined in accordance with the concentration of calcium in the blood serum.

Children under 18 years: the dose and method of administration depend on the degree of development of hypercalcemia, the nature and severity of the symptoms.

Children, depending on the age, the drug at a concentration of 100 mg / ml (10% solution) is administered in the following doses: up to 6 months - 0.1-1 ml; 7-12 months - 1-1.5 ml; 1-3 years - 1.5-2 ml; 4-6 years - 2-2.5 ml; 7-14 years - 3-5 ml; over 14 years - doses, both for adults.

Children should not inject the drug intramuscularly because of the possible development of necrosis.

It is recommended only slow intravenous injection or intravenous infusion after dilution, in order to achieve sufficiently low rates of administration and to exclude the possibility of local irritation or necrosis with accidental ingestion of the drug into the perivascular tissue.

For intravenous infusion, the drug is diluted 1:10 to 10 mg / ml with the following infusion solutions: 0.9% sodium chloride solution or 5% dextrose solution. The rate of intravenous administration should not exceed 50 mg of calcium gluconate per minute.Dilution should be carried out under aseptic conditions.

Elderly patients: Data showing an unfavorable calcium intolerance to gluconate in elderly patients are not available, however, age-related changes in the body, such as renal dysfunction and metabolic slowdown, may require a dose reduction.

Side effects:

The frequency of side effects is directly related to the rate of administration and the dose of calcium gluconate. With the correct introduction, the frequency of their occurrence is less than 1: 1000.

From the side of the cardiovascular system: lowering of arterial pressure, bradycardia, arrhythmia, vasodilation, circulatory collapse (including fatal outcome), "hot flashes" of blood, most often with rapid administration.

From the digestive system: nausea, vomiting.

Common violations: sensation of heat, sweating.

Violations at the place of administration: when intramuscular injection - pain or erythema (<1:10,> 1: 100), in violation of the technique of intramuscular injection - infiltration into adipose tissue, followed by the formation of an abscess, tissue tightening and necrosis; with intravenous injection - skin hyperemia, burning sensation or pain with possible development of tissue necrosis (with occasional perivascular injections).

Cases of calcification of soft tissues with subsequent possible damage to the skin and necrosis due to the release of calcium from the vessels into the tissues have been reported.

Overdose:

Symptoms of hypercalcemiaAnorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, calcification of the kidneys, drowsiness, hypersomnia, confusion, increased blood pressure, in severe cases - arrhythmia (up to cardiac arrest ) and coma.

Treatment: is aimed at reducing the elevated concentration of calcium in the blood plasma. Initial therapy includes rehydration, with severe hypercalcemia may require the introduction of 0.9% sodium chloride solution intravenously infusion to increase the amount of extracellular fluid. To reduce the concentration of calcium in the serum can be used calcitonin.

Furosemide can be used to increase calcium excretion, but do not use "thiazide" diuretics, as they can increase the absorption of calcium in the kidneys. Hemodialysis or peritoneal dialysis is performed if other measures are not effective or if symptoms of hypercalcemia persist.Treatment of overdose is carried out under close monitoring of the concentration of electrolytes in the blood serum.

Interaction:

Before filling with a calcium solution of gluconate, the syringe should not contain the remains of ethyl alcohol, since in the presence of alcohol calcium gluconate precipitates.

Pharmaceutically incompatible with carbonates, salicylates, sulfates and ceftriaxone (forms insoluble or hardly soluble calcium salts with them).

Forms insoluble complexes with antibiotics of the tetracycline series, reducing their antibacterial effect.

Reduces the effect of blockers of "slow" calcium channels (intravenous calcium gluconate before and after verapamil reduces its hypotensive effect).

With simultaneous application with quinidine, it is possible to slow intraventricular conduction and increase the toxicity of quinidine. It is not recommended parenteral application of calcium gluconate during treatment with cardiac glycosides (cardiotoxic effect of cardiac glycosides is possible).

When combined with thiazide diuretics can increase hypercalcemia.

Reduces the effect of calcitonin in hypercalcemia.

Reduces the bioavailability of phenytoin.

Special instructions:

The drug is administered by deep intramuscular injection or by slow intravenous injection (during 2-3 minutes) or infusion, to exclude the possibility of local irritation or necrosis in the case of contact with the drug in the perivascular tissue. Intravenous injection should be carried out under carefully monitored heart rate or electrocardiogram, because at too rapid administration of calcium may have a vasodilatation bradycardia or arrhythmia.

With intravenous administration, a feeling of heat can be felt throughout the body, which quickly passes.

Because of the risk of local irritation, intramuscular injections should be performed only if intravenous injection is not possible. Intramuscular injections must be performed deep enough in the muscle, preferably in the gluteal region. For patients suffering from obesity, a longer needle should be chosen for safe insertion into the muscle, rather than in fatty tissue. If repeated injections are required, the injection site should be changed each time.

Children administer the drug only intravenously. The solution before the introduction is warmed to body temperature.

When parenteral administration in high doses should be monitored the concentration of calcium in the blood plasma and the rate of excretion in the urine.

With the intravenous administration of calcium gluconate, in exceptional cases, patients receiving cardiac glycosides need cardiac monitoring and conditions for urgent treatment of cardiac complications such as severe arrhythmias should be provided.

Calcium salts should be used with caution and only after careful determination of indications in patients with nephrocalcinosis, cardiovascular pathology, sarcoidosis (Beck's disease), in elderly patients.

Impaired renal function may be associated with hypercalcemia and secondary hyperparathyroidism. Therefore, in patients with impaired renal function, parenteral calcium administration should be administered only after a careful determination of the indications, while controlling the calcium-phosphate balance.

When used simultaneously with other medicines, a doctor's supervision is required.

Use the solution only if it is clear and the ampoule is not damaged.

The preparation should be diluted immediately after opening the ampoule.When diluting the drug requires strict adherence to the rules of asepsis. In terms of microbiological safety, the diluted drug should be used immediately. The ampoule is for single use only.

Effect on the ability to drive transp. cf. and fur:

During drug treatment, care should be taken when carrying out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions (vehicle management, working with moving mechanisms, dispatcher and operator work).

Form release / dosage:

Solution for intravenous and intramuscular injection, 100 mg / ml.

Packaging:

5 or 10 ml into neutral glass ampoules.

For 10 ampoules with instruction for use and a knife for opening ampoules or a scarifier ampullum is placed in a box of cardboard.

By 5 or 10 ampoules per contour cell packaging of polyvinyl chloride film or polyethylene terephthalate and aluminum foil or paper with polyethylene coating or without foil, or without paper.

For 1 or 2 contour squares with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard.

When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

Storage conditions:

In the dark place at a temperature of 20 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004114

Date of registration:31.01.2017

Expiration Date:31.01.2022

The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia

Manufacturer: & nbsp

NOVOSIBHIMFARM, OJSC Russia

Representation: & nbspNOVOSIBHIMFARM, OJSCNOVOSIBHIMFARM, OJSC

Information update date: & nbsp24.02.2017

Illustrated instructions

Instructions

Calcium gluconate, stabilized (Calcium gluconate stabilisate)