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

    Composition per ml:

    Active substance: calcium gluconate - 100.0 mg.

    Excipients:

    succinic acid 5.0 mg, sodium hydroxide solution 1 M to pH 6.0-7.5, water for injection up to 1.0 ml.

    Description:Colorless transparent liquid, odorless.
    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 transmission of nerve impulses, reduction of skeletal and smooth muscles, myocardial activity, the formation of bone tissue, and the coagulation of blood.

    Pharmacokinetics:

    After parenteral administration with blood flow, it is evenly distributed in all tissues and organs. In blood plasma, about 45% of calcium ions are in complex with proteins. Passes through the placental barrier, enters the breast milk. It is excreted from the body mainly by the kidneys.

    Indications:

    - Diseases accompanied by hypocalcemia, increased permeability of cell membranes, impaired conduction of nerve impulses in muscle tissue.

    - Hypoparathyroidism (latent tetany, osteoporosis), metabolic disorders of vitamin D: rickets (spasmophilia, osteomalacia), hyperphosphatemia in patients with chronic renal insufficiency.

    - Increased need for calcium ions (pregnancy, the period of breastfeeding, the period of increased body growth), insufficient calcium ions in food, a violation of its metabolism (in the postmenopausal period).

    - Increased excretion of calcium ions (prolonged bed rest, chronic diarrhea, secondary hypocalcemia, long-term use of diuretics and antiepileptic drugs, glucocorticosteroids).

    - Bleeding of various etiologies.

    - Allergic diseases (serum sickness, urticaria, febrile syndrome, itching, itching dermatitis (s), reactions to medication administration and food intake, angioedema); bronchial asthma, dystrophic alimentary swelling, pulmonary tuberculosis, rickets, osteomalacia, lead colic; eclampsia.

    - Hyperkaliemic form of paroxysmal myoplegia.

    Contraindications:
    Increased hypersensitivity to the components of the drug, hypercalcemia (calcium concentration should not exceed 12 mg% or 6 mEq / L), hypercalciuria, nephrolithiasis (calcium), sarcoidosis, simultaneous reception of cardiac glycosides (risk of arrhythmia).
    Carefully:
    Dehydration, electrolyte disorders (risk of hypercalcemia), diarrhea, malabsorption syndrome, calcium nephrourolythiasis (in the anamnesis), moderate chronic renal failure, chronic heart failure, widespread atherosclerosis, hypercoagulation, for the / m introduction - childhood (risk of necrosis).
    Pregnancy and lactation:Possible application in pregnancy and during breastfeeding according to indications and under strict controlserum calcium concentration, since hypercalcemia adversely affects the fetus and the baby. When taking calcium supplements during the period of breastfeeding, it is possible that it penetrates into breast milk.
    Dosing and Administration:

    During treatment, it is necessary to monitor the concentration of calcium in the blood serum.

    The drug is injected deeply intramuscularly, or intravenously slowly (within 2-3 minutes), or drip, to exclude the possibility of local irritation or necrosis in case of getting the drug into the perivascular tissue.

    Because of the risk of local irritation, intramuscular injections should be performed only if intravenous injection is not possible.

    Intramuscular injections it is necessary to do deep enough in the muscle, preferably in the gluteal region.

    Adults: deep intramuscularly, slowly intravenously (for 2-3 minutes) or drip 5-10 ml of 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 age, the drug 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. The drug is injected every 2-3 days.

    Children are not recommended to enter 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.

    The solution before the introduction is warmed to body temperature. The syringe for the administration of calcium gluconate should not contain ethanol residues (in order to avoid the precipitation of calcium gluconate).

    Side effects:

    With intramuscular and intravenous administration - nausea, vomiting, diarrhea, bradycardia can be observed. With intravenous administration, burning in the oral cavity, a sensation of fever, with a rapid intravenous injection - a decrease in blood pressure, arrhythmia, fainting, cardiac arrest can be observed.

    With intramuscular injection, necrosis can be formed at the site of administration.

    Overdose:

    Development of hypercalcemia (symptoms: drowsiness, weakness, anorexia, abdominal pain, vomiting, nausea, constipation, polydipsia, polyuria, fatigue, irritability, depression, dehydration, cardiac rhythm disturbance, myalgia, arthralgia, arterial hypertension). Hypercalcaemia of severe degree (calcium more than 3.4 mmol / l) poses a threat to life and requires immediate infusion therapy.

    Treatment: discontinuation of the drug; in severe cases - parenterally calcitonin in a dose of 5-10 IU / kg body weight per day (when diluted in 500 ml sterile 0.9% saline solution of sodium chloride), intravenously drip for 6 hours. Perhaps intravenously-jet-slow administration 2-4 times a day.

    Interaction:

    It is pharmaceutically incompatible with ethanol, carbonates, salicylates, sulfates (it forms insoluble or hardly soluble calcium salts). Forms insoluble complexes with antibiotics of the tetracycline series (reduces the antibacterial effect).

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

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

    During the treatment with cardiac glycosides, parenteral calcium gluconate is not recommended (cardiotoxic effect of cardiac glycosides may be increased).

    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.

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

    During treatment, the concentration of calcium in the serum should be carefully monitored.

    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 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.

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

    Calcium salts should be used with caution and only after careful determination of indications in patients with nephrocalcinosis, heart disease, in elderly patients.

    Impaired renal function may be associated with hypercalcemia and secondary hyperparathyroidism. Therefore, in patients with impaired renal function, parenteral administration of calcium should be given only after a careful determination of the indications, while it is necessary to control the calcium phosphate balance.

    In patients with minor hypercalciuria, a decrease in glomerular filtration or with nephrourolythiasis in history, treatment should be controlled by the concentration of calcium ions in the urine.

    Drinking plenty is recommended to reduce the risk of nephrourolythiasis.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the concentration of attention and the speed of psychomotor reactions when driving and engaging in potentially dangerous activities.
    Form release / dosage:Solution for intravenous and intramuscular injection 100 mg / ml.
    Packaging:

    By 5 or 10 ml into ampoules of colorless neutral glass with a color fracture ring or with a colored dot and a notch or without a kink ring, a colored dot and a notch.

    One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to the ampoules.

    5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film.

    Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.

    1, 2 or 4 contour squares or cardboard tracks together with the instructions for use and the ampoule or ampoule ampoule or with a scarifier, or without ampoule ampoule scraper and ampoule knife are placed in a cardboard package (bundle).

    Storage conditions:In the dark place at a temperature of 20 ° C to 30 ° C. Do not freeze. Keep out of the reach of children.
    Shelf life:2 years. Do not use the drug with expired shelf life.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000140 / 01
    Date of registration:02.04.2012 / 15.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.11.2017
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