TEMAVIT-C [Ascorbic acid] 500 mg/5 ml Solution for intramuscular injection, intravenous injection
TEMAVIT-C
instructions for medical use of the medicinal product
Tradename
Temavit-C, Темавит -C
International non-proprietary name
Ascorbic acid,
Compound
Each 5 ml ampoule contains:
active substance : ascorbic acid 500 mg
excipients : sodium bicarbonate, sodium metabisulphite, cysteine hydrochloride, disodium edetate, water for injections
Dosage form
Injection.
Pharmacotherapeutic group
Pharmacological properties
Pharmacodynamics
Ascorbic acid (vitamin C) is a water-soluble vitamin that contributes to the optimal course of tissue metabolism. Actively participates in redox reactions, forming a hydrogen proton transfer system with dehydroascorbic acid, exhibits antioxidant properties, due to which it ensures the stability of cell membranes. 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. Participates in glucose metabolism, cholesterol catabolism, synthesis of steroid hormones. During stress reactions, the content of ascorbic acid in the body and in the tissue of the adrenal glands in particular is significantly reduced, which confirms the participation of ascorbic acid in adaptation reactions. Able to provide anti-anemic action due to the effect on iron metabolism. Restores ferric iron to ferrous 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 tissues of the adrenal glands. It is found in tissues both in the free state and in the form of compounds. It is excreted from the body with urine both unchanged and in the form of metabolites.
Drinking alcohol and smoking accelerate the destruction of ascorbic acid (turning into inactive metabolites), sharply reducing its reserves in the body.
Indications for use
Hypovitaminosis C, scurvy, bleeding (uterine, pulmonary, nasal, hepatic), hemorrhagic diathesis, bleeding like radiation sickness syndrome, various intoxications and infectious diseases, bone fractures and sluggish wounds, burns, methemoglobinemia.
Contraindications
Hypersensitivity to ascorbic acid or to any of the auxiliary 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 deficiency 6 -phosphate dehydrogenase.
Dosage and administration
Can be administered intramuscularly or intravenously. Intravenous administration should be performed with a slow infusion, as rapid administration may cause temporary dizziness.
Depending on the severity of the disease, 500 mg is prescribed once or twice a day.
The dose and course of treatment depends on the nature and course of the disease.
Special instructions and precautions
When used in high doses, it is necessary to control kidney function, blood pressure (stimulation of corticosteroid formation by ascorbic acid), as well as pancreatic function (depression of the insular apparatus).
Therapy in high doses should not be carried out in patients prone to recurrent urolithiasis. Patients with renal insufficiency to reduce the risk of crystalluria must ensure adequate fluid intake (1.5-2 liters per day).
The use of large doses of ascorbic acid can affect the results of some laboratory tests: a false positive test for the presence of sugar in the urine and a negative test for the presence of occult blood in the feces, as well as a decrease in the results in studies of the concentration of lactate dehydrogenase and aminotransferases in the blood serum.
Patients with high iron content in the body should use ascorbic acid in minimal doses.
The appointment of ascorbic acid to patients with tumors that rapidly proliferate and intensively metastasize can aggravate the course of the process. In patients undergoing chemotherapy, the drug should be administered no earlier than 1-3 days (depending on the half-life of the anticancer drug) after chemotherapy, since there is no clinical evidence of a possible interaction.
Influence on the ability to drive vehicles and mechanisms
The drug in recommended doses does not affect the ability to drive vehicles or other mechanisms.
Use during pregnancy and during breastfeeding
Before using the drug, consult your doctor.
If during treatment you notice that you are pregnant, immediately notify your doctor.
Interaction with other drugs
Ascorbic acid increases the blood concentration of salicylates (increases the risk of crystalluria), ethinylestradiol, benzylpenicillin and tetracyclines, reduces the blood level of oral contraceptives. Increases the excretion of drugs that have an alkaline reaction (including alkaloids). In high doses, it increases the renal excretion of mexiletin.
Tetracyclines and acetylsalicylic acid increase the excretion of ascorbic acid in the urine.
With simultaneous appointment with salicylates and short-acting sulfonamides, the risk of urinary calculus formation increases.
High doses of ascorbic acid can lower the pH of the urine, resulting in reduced tubular reabsorption of amphetamine and tricyclic antidepressants used simultaneously.
Reduces the anticoagulant effect of coumarin and heparin derivatives, the effectiveness of antibiotics.
Increases neutralization and total clearance of ethyl alcohol.
Reduces the chronotropic effect of isoprenaline and the therapeutic effect of phenothiazine derivatives.
With simultaneous use with barbiturates, primidone increases the excretion of ascorbic acid in the urine.
Simultaneous intake of ascorbic acid and deferoxamine increases the tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. Vitamin C can only be taken 2 hours after deferoxamine injection.
When used in large doses of ascorbic acid and the simultaneous use of alcohol, disulfiram-like reactions may develop.
Side effect
From the blood and lymphatic system: with prolonged use in high doses - thrombocytosis, hyperprothrombinemia, thrombosis, erythrocytopenia, neutrophilic leukocytosis.
From the side of the nervous system: headache, fatigue, with prolonged use in high doses - sleep disturbance, increased excitability of the central nervous system.
From the digestive tract: nausea, diarrhea, stomach cramps.
From the urinary system: hyperoxalaturia; with prolonged use in high doses - damage to the glomerular apparatus of the kidneys, the formation of kidney stones from calcium oxalate.
On the part of the skin and subcutaneous tissue: very rarely - skin rash, skin flushing, itching, urticaria.
On the part of metabolism, 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.
On the part of the cardiovascular system: a decrease in capillary permeability, deterioration of tissue trophism with prolonged use in high doses - myocardial dystrophy, increased blood pressure, the development of microangiopathies.
General disorders: when administered, a feeling of heat, fever, changes at the injection site are possible.
Pregnancy: when administered in high doses - the threat of termination of pregnancy.
From the immune system: very rarely - hypersensitivity reactions, including anaphylactic shock.
If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
Symptoms: Gastrointestinal disorders including diarrhea, hyperoxaluria and oxalate stone formation. Doses of more than 600 mg per day show a diuretic effect.
With a single use of excessive doses of the drug, nausea, vomiting, bloating, abdominal pain, itching, skin rashes, and irritability may occur.
With intravenous administration in high doses, there may be a threat of termination of pregnancy.
Treatment: discontinuation of the drug, symptomatic therapy.
Storage conditions
Store in a dry place, at a temperature not exceeding 30 0 C.
Keep out of the reach of children.
Best before date
2 years. Do not use after the expiry date stated on the packaging.
Holiday conditions
Released by prescription.
Release form
5 ampoules of 5 ml with instructions for use in a cardboard box.