Active substanceCalcium gluconateCalcium gluconate
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Calcium gluconate monohydrate 94 mg

    Excipients:

    Calcium saccharate 5 mg

    Water for injection up to 1 ml.

    Description:

    Transparent colorless or slightly colored liquid (with a brownish hue of liquid).

    Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
    ATX: & nbsp

    A.12.A.A.03   Calcium gluconate

    A.12.A.A   Calcium preparations

    Pharmacodynamics:

    The preparation of calcium replenishes the deficiency of calcium ions necessary for the process of nerve impulse transmission, reduction of skeletal and smooth muscles, myocardial activity, bone formation, and blood clotting.

    With intravenous injection stimulates the sympathetic department of the autonomic nervous system, increases the adrenal secretion of the adrenal glands.

    Pharmacokinetics:

    After parenteral administration calcium gluconate with blood flow evenly distributed in all tissues and organs. In the blood plasma, calcium is found both in bound form (in combination with proteins and with anions of organic and inorganic acids (bicarbonate, phosphate, lactate, calcium citrate)) and in free ionized form. Penetrates through the placental barrier, enters the breast milk. It is excreted from the body mainly by the kidneys.

    Indications:

    Treatment of acute hypocalcemia. To reduce the permeability of capillaries in allergic conditions, netrombotsitopenicheskoy purpura and exudative dermatoses, for example, herpetiform dermatitis and itching rash due to the use of certain medications.

    Contraindications:

    Hypersensitivity to calcium gluconate and 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 (Burnett's syndrome)), hypercalciuria, cardiac glycoside intoxication, simultaneous treatment with cardiac glycosides; for intramuscular injection - children's age.

    Carefully:

    Dehydration, electrolyte disorders (risk of hypercalcemia), diarrhea, malabsorption syndrome, calcium nephrourolythiasis (in the anamnesis), minor hypercalciuria, moderate chronic renal failure, widespread atherosclerosis, hypercoagulation, in elderly patients, especially in the presence of one or more of the above conditions, nephrocalcinosis , pathology of the cardiovascular system, sarcoidosis, chronic heart failure, simultaneous treatment with epinephrine. Before using the drug, you should consult your doctor.

    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 for strict control of serum calcium concentration, since hypercalcemia negatively affects the fetus and the baby.

    Dosing and Administration:

    Normally, the concentration of total calcium in the blood serum is 2.25-2.75 mmol / l or 4.45-5.5 cq / l. Therapy with calcium gluconate is aimed at restoring the normal concentration of calcium in the blood plasma. Solutions containing calcium should be administered slowly in order to minimize peripheral vasodilation and inhibition of cardiac activity.

    The preparation is heated to the body temperature before administration. The drug is injected deeply intramuscularly or intravenously slowly (for 2-3 minutes), or drip, to exclude the possibility of local irritation or necrosis in case of getting the drug into the perivascular tissue. Intravenous injections should be carried out under close monitoring of the heart rate and electrocardiogram, because with too fast administration of calcium gluconate, bradycardia with vasodilation and arrhythmias can occur.

    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 in the event that,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.

    During treatment, it is necessary to carefully monitor the concentration of calcium in the blood plasma, when administered in high doses - in addition to control the rate of calcium excretion in the urine.

    Adults: deep intramuscularly, intravenously slowly (for 2-3 min) or drip 5-10 ml of 100 mg / ml (10% solution) daily, every other day or 2 days (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 mode of administration depend on the degree of development of hypocalcemia, 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 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% glucose 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 indicating an adverse tolerance of calcium gluconate to elderly patients are not available, however, age-related changes, such as renal dysfunction and metabolic slowdown, may require a dose reduction.

    The procedure for working with a polymer ampoule:

    - Take an ampoule and shake it, holding it by the neck.

    - Rotate the valves and turn off the valve.

    - Through the formed hole, immediately connect the syringe loer with the ampoule.

    - Type the contents of the ampoule into the syringe.

    - Put the needle on the syringe.

    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 1/1000.

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

    From the digestive system: nausea, vomiting, diarrhea.

    Common violations: sensation of heat, sweating.

    Violations at the place of administration: when administered intramuscularly, pain or erythema (≤ 1/10, ≥ 1/100), with infringement of intramuscular technique - infiltration into adipose tissue, followed by abscess formation, tissue tightening and necrosis; with intravenous administration - skin hyperemia, burning sensation or pain with possible development of tissue necrosis (with occasional perivascular injection).

    A case of calcification of soft tissues with subsequent possible damage to the skin and necrosis due to the release of calcium from the vessel into the tissue has been reported.

    Overdose:

    Symptoms of hypercalcemia: anorexia, 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 decreasing 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:

    A syringe filled with a calcium gluconate solution should not contain any residual ethyl alcohol, since in the presence of the latter 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 the antibacterial effect.

    Weaken the action of blockers of "slow" calcium channels (intravenous calcium gluconate before or after taking verapamil reduces its hypotensive effect, but has little effect on its antiarrhythmic effect).

    With simultaneous application with quinidine, it is possible to slow intraventricular conduction and increase the toxicity of quinidine.

    It is not recommended to use 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 preparation is heated to the body temperature before administration.The drug is injected deeply intramuscularly or intravenously slowly (for 2-3 minutes), or drip, to exclude the possibility of local irritation or necrosis in case of getting the drug into the perivascular tissue. Intravenous injections should be carried out under close monitoring of the heart rate and electrocardiogram, because with too fast administration of calcium gluconate, bradycardia with vasodilation and arrhythmias can occur.

    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.

    During treatment, it is necessary to carefully monitor the concentration of calcium in the blood plasma, when administered in high doses - in addition to control the rate of calcium 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 patients receiving epinephrine, 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 careful determination of the indices, 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. Exceptions are dilutions prepared in controlled aseptic conditions. After the preparation of the solution, the terms and conditions of its storage prior to administration are the responsibility of the user and should not exceed 24 hours at a temperature of 2 to 8 ° C. Remaining unused quantities of the drug are subject to destruction.

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

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

    Form release / dosage:

    Solution for intravenous and intramuscular injection 100 mg / ml.

    Packaging:

    By 5 or 10 ml per ampoule (Polivist) from low-density polyethylene or polypropylene that meets the requirements of the European Pharmacopoeia for polyethylene for parenteral preparations, with a curled cap for needleless sampling of the preparation, or in ampoules of colorless or colored glass.

    10 ampoules of low-density polyethylene or polypropylene together with instructions for use in a pack of cardboard.

    By 5 ampoules of glass in a contoured cell pack of a film of polyvinyl chloride or polyethylene terephthalate with a film of polymer or foil of aluminum lacquered or without a film of polymeric and foil, aluminum lacquered or in the form of cardboard with cells for laying ampoules.

    2 contour squares or cardboard forms together with instruction for use and scarifier with or without ampoule in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004435
    Date of registration:29.08.2017
    Expiration Date:29.08.2022
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.09.2017
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