Ascorbic acid-SOLOfarm - instructions for use, dose, side effects, contraindications

Pharmacological effects: in amounts significantly exceeding the daily requirement (90 mg), almost no effect, except for rapid elimination symptoms of hypo- and avitaminosis (scurvy).

Physiological functions: is a coenzyme of some reactions hydroxylation and amidation - transfers electrons to enzymes, providing them with a replacement equivalent. Participates in the reactions of hydroxylation of proline and lysine residues of procollagen with the formation of hydroxyproline and hydroxylizine (post-translational modification of collagen), the oxidation of the side chains of lysine in proteins with the formation of hydroxytrimethyllysine (during the synthesis of carnitine), the oxidation of folic acid to folinic, the metabolism of drugs in liver microsomes and hydroxylation dopamine with the formation of norepinephrine.

Increases the activity of amidating enzymes involved in the processing of oxytocin, antidiuretic hormone and cholecystokinin.Participates in steroidogenesis in the adrenal glands.

The main role in tissues is participation in the synthesis of collagen, proteoglycans and other organic components.

Pharmacokinetics:

Connection with plasma proteins - 25%. Normally, the concentration of ascorbic acid in the plasma is approximately 10-20 μg / ml. Easily penetrates into leukocytes, platelets, and then into all tissues: the highest concentration is achieved in glandular organs, leukocytes, liver and lens of the eye: it penetrates the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and in blood plasma. In deficient states, the concentration of ascorbic acid in leukocytes decreases later and more slowly and is considered as the best criterion for assessing the deficit than the concentration in the blood plasma.

Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic acid and ascorbate-2-sulfate.

It is excreted by the kidneys, through the intestines, with sweat, breast milk in unchanged form and in the form of metabolites.

At the appointment of high doses, the rate of excretion increases sharply. Smoking and the use of ethanol accelerate the destruction of ascorbic acid (conversion into inactive metabolites), sharply reducing the reserves in the body.

It is in hemodialysis.

Indications:

Treatment of hypo-and avitaminosis C (if necessary, rapid replenishment of vitamin C and the impossibility of oral administration).

Clinical situations associated with the need for additional administration of ascorbic acid, including: parenteral nutrition, gastrointestinal tract diseases (persistent diarrhea, small intestine resection, peptic ulcer, gastrectomy), Addison's disease.

In laboratory practice: for the marking of erythrocytes (together with sodium chromate [51Cr]).

Contraindications:

Hypersensitivity to the components of the drug. With long-term use in large doses (more than 500 mg) - diabetes mellitus, hyperoxaluria, nephrourolythiasis, hemochromatosis, thalassemia.

Carefully:

Sideroblastic anemia, urolithiasis, deficiency of glucose-6-phosphate dehydrogenase.

Pregnancy and lactation:

In pregnancy and during breastfeeding apply only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby. The minimum daily requirement for ascorbic acid in II-III trimesters of pregnancy - about 60 mg.It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which takes a pregnant woman, and then a newborn can develop the syndrome of "cancellation."

The minimum daily requirement for lactation is 80 mg. A mother's diet containing an adequate amount of ascorbic acid is sufficient to prevent her deficiency in an infant. Theoretically, there is a danger to the child when the mother uses high doses of ascorbic acid (it is recommended not to exceed the daily need for ascorbic acid by the lactating mother).

Dosing and Administration:

Intramuscularly, intravenously (slowly).

Adults from 100 to 500 mg (2-10 ml of 5% solution) per day, with scurvy therapy - up to 1000 mg per day.

Children - from 100 to 300 mg (2-6 ml of 5% solution) per day, with scurvy therapy - up to 500 mg (10 ml of 5% solution) per day.

The duration of treatment depends on the nature and course of the disease.

For the marking of erythrocytes (together with sodium chromate [51 Cr]) - 100 mg of ascorbic acid are injected into a vial of sodium chromate [51 Cr].

Side effects:

From the central nervous system (CNS): with rapid intravenous injection - dizziness, a sense of fatigue; with prolonged use of large doses (more than 1 g) - headache,increased excitability of the central nervous system, insomnia.

From the urinary system: moderate pollakiuria (with a dose of more than 600 mg / day); with prolonged use of large doses - hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys.

From the cardiovascular system: with prolonged use of large doses - a decrease in the permeability of capillaries (possibly worsening of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).

Allergic reactions: skin rash, skin hyperemia.

Laboratory indicators: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia. glucosuria.

Local reactions: pain in the place of intramuscular injection.

Other: with prolonged use of large doses (more than 1 g) - suppression of the functions of the insulin pancreas apparatus (hyperglycemia, glucosuria), with intravenous administration - the threat of abortion (due to estrogenemia), hemolysis of red blood cells.

Overdose:

Symptoms: nephrolithiasis, insomnia, irritability, hypoglycemia.

Treatment: symptomatic, effective forced diuresis.

Interaction:

Increases the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinylestradiol (including those included in oral contraceptives).

Reduces the effectiveness of heparin and indirect anticoagulants.

With simultaneous use with acetylsalicylic acid (ASA), urinary excretion of ascorbic acid increases and the excretion of ASA decreases.

Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.

Drugs quinoline series, calcium preparations, salicylates, glucocorticosteroid drugs with prolonged use deplete the stores of ascorbic acid.

With simultaneous use reduces the chronotropic effect of isoprenaline.

With prolonged use or use in high doses, it can interfere with the interaction of disulfiram and ethanol.

In high doses increases the excretion of mexiletine by the kidneys.

Barbiturates and primidon increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - derivatives of phenothiazine. tubular reabsorption of amphetamine and tricyclic antidepressants.

Pharmaceutically incompatible with aminophylline, bleomycin, cefapyrin, chlordiazepoxide, estrogens, dextrans, doxapram, erythromycin, methicillin, nafcillin, benzylpenicillin, warfarin.

Special instructions:

In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenals and arterial pressure.

High doses of ascorbic acid increase the excretion of oxalates, promoting the formation of kidney stones. In newborns, whose mothers took high doses of ascorbic acid, and in adults who took high doses,

observed "ricochet" scurvy.With prolonged use of large doses, oppression of the insular pancreas function may be possible, therefore, during the treatment it is necessary to regularly monitor the level of glycemia.

In patients with elevated iron levels in the body, ascorbic acid should be used in minimal doses.

Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood and urine content of glucose, bilirubin, activity of "hepatic" transaminases and lactate dehydrogenase).

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

During the treatment period, care must be taken when managing vehicles, mechanisms and engaging in potentially dangerous activities requiring concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection 50 mg / ml.

Packaging:In 2 ml ampoules of a colorless or colored glass. 5 or 10 vials in blisters of polyvinyl chloride or polyethylene terephthalate film with a polymer film or lacquered aluminum foil or a polymer film without an aluminum foil and lacquer or in the form of cardboard with cells for stacking ampoules.

1 the contour cellular packaging made of cardboard or form with 10 ampoules or blisters 2 or shapes from a cardboard of 5 ampoules together with instructions for use and a lancet ampulnam or without a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

1 year.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004544

Date of registration:16.11.2017

Expiration Date:16.11.2022

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp12.12.2017

Illustrated instructions

Instructions

Ascorbic acid-SOLOfarm (Ascorbic acid-SOLOpharm)