Instructions Ascorbic acid-Darnitsa solution for injection 10% ampoule 2 ml No. 10
Composition
active ingredient: ascorbic acid;
1 ml of solution contains 100 mg of ascorbic acid;
excipients: sodium bicarbonate, sodium metabisulfite (E 223), disodium edetate, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless or slightly colored liquid.
Pharmacotherapeutic group
Simple preparations of ascorbic acid. Ascorbic acid (vitamin C). ATX code A11G A01.
Pharmacological properties
Pharmacodynamics.
Ascorbic acid (vitamin C) is a water-soluble vitamin that contributes to the optimal course of tissue metabolism. It actively participates in redox reactions, forming a hydrogen proton transfer system with dehydroascorbic acid, and exhibits antioxidant properties, thereby ensuring the stability of cell membranes. It participates in the synthesis of the main substance of the connective tissue of the vascular wall, thus preventing the development of hemorrhagic diathesis. It is not synthesized in the human body. With insufficient intake of ascorbic acid with food, bleeding from the gums and mucous membranes develops. It participates in glucose metabolism, cholesterol catabolism, and the synthesis of steroid hormones. During stress reactions, the content of ascorbic acid in the body and in the adrenal gland tissue in particular is significantly reduced, which confirms the participation of ascorbic acid in adaptation reactions. It is capable of having an antianemic effect due to its effect on iron metabolism. Reduces trivalent iron to divalent iron, which is transported in the bloodstream.
Pharmacokinetics.
Ascorbic acid after parenteral administration easily penetrates into leukocytes, platelets, and then into all tissues. It accumulates mainly in organs with an increased level of metabolic processes, in particular in the adrenal gland tissue. In the tissues it is found both in a free state and in the form of compounds. It is excreted from the body with urine both in unchanged form and in the form of metabolites.
Alcohol consumption and smoking accelerate the destruction of ascorbic acid (conversion into inactive metabolites), sharply reducing its reserves in the body.
Indication
Hypovitaminosis C; scurvy; bleeding (uterine, pulmonary, nasal, hepatic); hemorrhagic diathesis; bleeding as radiation sickness syndrome; various intoxications and infectious diseases; nephropathy of pregnant women; Addison's crisis; overdose of anticoagulants; bone fractures and flaccid wounds; various dystrophies; increased brain tension and heavy physical labor.
Contraindication
Hypersensitivity to the active substance or to other components of the drug; diabetes mellitus; increased blood clotting; tendency to thrombosis; thrombophlebitis; urolithiasis (including hyperoxaluria); renal failure; progressive malignant diseases; hemochromatosis; thalassemia; polycythemia; leukemia; sideroblastic anemia; sickle cell anemia; glucose-6-phosphate dehydrogenase deficiency.
Interaction with other medicinal products and other types of interactions
With benzylpenicillin, tetracycline, salicylates - increased concentration of drugs in the blood;
with ethinyl estradiol (ascorbic acid - at a dose of 1 g/day) - increased concentration of ethinyl estradiol (including that which is part of oral contraceptives) in the blood;
with oral contraceptives – decreased concentration of drugs in the blood;
with tetracycline and acetylsalicylic acid – increased excretion of ascorbic acid in the urine;
high doses of ascorbic acid may lower urine pH, resulting in decreased tubular reabsorption of amphetamine and tricyclic antidepressants used concurrently;
with deferoxamine – increased iron excretion;
with heparin, indirect anticoagulants, antipsychotics, phenothiazine derivatives - reduced effectiveness of drugs;
with isoprenaline – reduction of the chronotropic effect of the drug;
with short-acting sulfonamides – increased development of crystalluria;
with drugs that have an acidic reaction – slowing down the excretion of drugs by the kidneys;
with drugs that have an alkaline reaction, mexiletine, amphetamine, tricyclic antidepressants - acceleration of drug excretion by the kidneys;
with acetylsalicylic acid – increased urinary excretion of ascorbic acid and decreased excretion of acetylsalicylic acid;
with barbiturates, primidone – increased excretion of ascorbic acid in the urine;
with quinoline drugs, calcium chloride, salicylates, glucocorticosteroids - with prolonged use, depletion of ascorbic acid reserves;
with ethanol – an increase in the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body;
with disulfiram - with prolonged use or use in high doses, a disruption of the disulfiram-ethanol interaction is possible.
Ascorbic acid increases the blood concentration of salicylates (increases the risk of crystalluria).
Simultaneous administration of ascorbic acid and deferoxamine increases tissue iron toxicity, especially in the heart muscle, which can lead to decompensation of the circulatory system.
Application features
Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests, in particular a false-positive test for the presence of sugar in the urine and a negative test for the presence of occult blood in the stool, as well as underestimation of the results in studies of the concentration of lactate dehydrogenase and aminotransferases in serum.
Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor adrenal function and blood pressure.
With prolonged use of high doses, inhibition of the function of the insular apparatus of the pancreas is possible, therefore, during long-term treatment, it is necessary to regularly monitor pancreatic function.
High-dose therapy should not be administered to patients with a tendency to recurrent urolithiasis. Patients with renal failure should be provided with sufficient fluid intake (1.5–2 liters per day) to reduce the risk of crystalluria.
In patients with elevated iron levels in the body, ascorbic acid should be used in minimal doses.
Patients on a low-sodium diet should not be given high doses of the drug.
The administration of ascorbic acid to patients with rapidly proliferating and intensely metastasizing tumors may aggravate the course of the disease. Patients undergoing chemotherapy should be administered the drug no earlier than 1-3 days (depending on the half-life of the anticancer drug) after chemotherapy, since there is no clinical data on a possible interaction.
Use during pregnancy or breastfeeding
The minimum daily requirement for ascorbic acid in the II-III trimesters of pregnancy is about 60 mg. Ascorbic acid penetrates the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid taken by a pregnant woman, and then the newborn may develop ascorbic disease as a "withdrawal" reaction. Therefore, during pregnancy, the drug should not be prescribed in high doses, except in cases where the potential benefit to the mother outweighs the possible risk to the fetus.
The minimum daily requirement for ascorbic acid during breastfeeding is 80 mg. A mother's diet containing an adequate amount of ascorbic acid is sufficient to prevent deficiency in the infant. Ascorbic acid passes into breast milk. Theoretically, there is a danger to the child if the mother takes high doses of ascorbic acid (during breastfeeding it is not recommended to exceed the daily requirement for ascorbic acid). If it is necessary to prescribe increased doses of the drug, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect at recommended doses.
Method of administration and doses
The drug is administered intravenously by jet or drip and intramuscularly.
Intravenously, by jet injection over 1-3 minutes. For intravenous drip administration, a single dose of the drug is dissolved in 50-100 ml of 0.9% sodium chloride solution and administered by slow intravenous infusion at a rate of 30-40 drops per minute.
Intramuscularly injected deep into the muscle.
Doses are set individually, taking into account the nature and severity of the disease.
Adults and children from 12 years old.
The drug is prescribed in a dose of 50-150 mg (0.5-1.5 ml of 10% solution) per day. The maximum single dose is 200 mg (2 ml of 10% solution), daily dose is 1 g (10 ml of 10% solution). In acute poisoning, the maximum dose is up to 500 mg (50 ml of 10% solution) per day.
Children under 12 years old.
The drug is administered intravenously in a daily dose of 5–7 mg/kg of body weight in the form of a 5% solution (0.5–2 ml). Usually, daily doses for children are: under 6 months of age – 30 mg, 6–12 months – 35 mg, 1–3 years – 40 mg, 4–10 years – 45 mg, 11–12 years – 50 mg.
The maximum daily dose is 100 mg.
Special groups of patients.
For patients with recurrent kidney stone formation, the daily dose of ascorbic acid should not exceed 100–200 mg.
For patients with severe or end-stage renal failure (patients on dialysis), the daily dose of ascorbic acid should not exceed 50–100 mg.
For patients with glucose-6-phosphate dehydrogenase deficiency, the daily dose of ascorbic acid should not exceed 100–500 mg.
Children.
The drug is used in pediatric practice.
Overdose
Treatment: discontinuation of the drug, symptomatic therapy.
Side effects
Gastrointestinal: nausea, diarrhea, stomach cramps.
On the part of the kidneys and urinary system: hyperoxaluria, with prolonged use in high doses - damage to the glomerular apparatus of the kidneys, formation of kidney stones from calcium oxalate.
From the side of metabolism: hypervitaminosis C, with prolonged use in high doses - inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosuria) and glycogen synthesis, sodium and fluid retention, impaired zinc and copper metabolism.
From the nervous system: headache, dizziness, feeling of fatigue, with prolonged use in high doses - sleep disturbances, increased excitability of the central nervous system.
On the part of the cardiovascular system: decreased capillary permeability, deterioration of tissue trophism, with prolonged use in high doses - myocardial dystrophy, increased blood pressure, development of microangiopathies.
From the blood and lymphatic system: with prolonged use in high doses - thrombocytosis, hyperprothrombinemia, thrombocytopenia, erythrocytopenia, neutrophilic leukocytosis, in patients with glucose-6-phosphate dehydrogenase deficiency of blood cells may cause hemolysis of erythrocytes.
On the part of the immune system: hypersensitivity reactions, including rash, skin hyperemia, itching, urticaria, anaphylactic shock.
General disorders and administration site conditions: hyperthermic syndrome, with intravenous administration a feeling of heat is possible, changes at the injection site.
Pregnancy: with intravenous administration in high doses - the threat of abortion.
Expiration date
2 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Incompatibility
Ascorbic acid has a high redox potential, so it can change the chemical composition of other drugs. When considering the possibility of concomitant use with other drugs, it is necessary to ensure their compatibility.
Packaging
2 ml in an ampoule; 5 ampoules in a contour blister pack; 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
