Instructions for Gepadif powder for solution for injection 942.05 mg vial No. 5
Composition
active ingredients: one bottle contains carnitine orotate 300.0 mg (equivalent to orotic acid 147.6 mg, carnitine 152.4 mg), carnitine hydrochloride 184.0 mg (equivalent to carnitine 150.0 mg), antitoxic fraction of liver extract 25.0 mg (cyanocobalamin content not less than 0.00025 mg), adenosine 5.0 mg, pyridoxine hydrochloride 25.0 mg, cyanocobalamin 0.25 mg;
excipients: mannitol (E 421), methyl parahydroxybenzoate (E 219), propyl parahydroxybenzoate (E 217).
Dosage form
Powder for solution for injection.
Main physicochemical properties: heterogeneous porous mass from light pink to brownish pink in color.
Pharmacotherapeutic group
Agents affecting the digestive system and metabolic processes. Combinations with amino acids. ATX code A16A A.
Pharmacological properties
Pharmacodynamics.
Gepadif® is a combined drug, the effects of which are due to the complex action of the components included in its composition. Stimulates the metabolism of fats - components of β-oxidative transformation of free fatty acids in the mitochondria of hepatocytes, biosynthetic processes, prevents hepatocyte necrosis, normalizes the process of hepatocyte proliferation, the system of liver enzymes and restores normal liver function. The presence of adenosine, which is a component of coenzymes, nucleic acids, ensures the regulation of hematopoiesis processes. Vitamins of group B (cyanocobalamin, pyridoxine) regulate redox processes, participate in protein, fat and carbohydrate metabolism, in the metabolism of tryptophan, methionine, cysteine, glutamic acid and other amino acids. Pyridoxine contributes to the normalization of lipid metabolism, the functioning of the peripheral and central nervous systems. Cyanocobalamin participates in the process of transmethylation, hydrogen transport, the formation of methionine, nucleic acids, choline, creatine, contributes to the normalization of impaired liver, nervous system, and hematopoiesis functions, and increases the ability of tissues to regenerate. Cyanocobalamin and pyridoxine reduce fatty infiltration of the liver, reduce hyperhomocysteinemia
Carnitine regulates fat metabolism, promotes the breakdown of long-chain fatty acids and the replacement of the fatty acid metabolic shunt with carbohydrates, reduces the indicators of fatty liver dystrophy, and improves food absorption.
The antitoxic fraction of liver extract contains essential and non-essential amino acids that participate in protein synthesis, are donors of sulfhydryl and methyl groups, and have detoxification and antioxidant effects.
The drug stimulates bile secretion, promotes food digestion, facilitates the absorption of carbohydrates in the small intestine, is necessary for maintaining normal intestinal microflora. It helps improve glycogen-fixing, synthetic, antitoxic functions of the liver, increases the sensitivity of cells to the action of insulin, and promotes the secretion of insulin.
Pharmacokinetics.
After intravenous drip administration, the distribution of the active components of the drug - water-soluble B vitamins (cyanocobalamin, pyridoxine), carnitine, antitoxic fraction of bovine liver extract, adenosine occurs mainly in the liver and kidneys. Pyridoxine is metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate, pyridoxaminophosphate), distributed in the muscles, liver, central nervous system. Excretion is carried out mainly by the kidneys.
Indication
As part of complex therapy:
acute and chronic hepatitis, liver cirrhosis;
fatty liver disease (hepatic steatosis);
alcoholic liver damage;
intoxication due to prolonged use of antitumor and antituberculosis drugs.
Contraindication
Individual hypersensitivity to the components of the drug. Nephrolithiasis, erythremia, erythrocytosis, thromboembolism, gastric and duodenal ulcer in the acute stage.
Interaction with other medicinal products and other types of interactions
Vitamin B6 weakens the effect of levodopa, prevents or reduces toxic manifestations observed with the use of isoniazid and other anti-tuberculosis drugs.
PASK, cimetidine, calcium preparations, ethanol reduce the absorption of vitamin B12.
Interactions due to the presence of cyanocobalamin
Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations reduce the absorption of the drug and affect its kinetics.
When used simultaneously with kanamycin, neomycin, polymyxins, tetracyclines, the absorption of cyanocobalamin decreases.
Pharmaceutically incompatible with ascorbic acid, heavy metal salts (inactivation of cyanocobalamin); thiamine bromide, pyridoxine, riboflavin (the cobalt ion contained in the cyanocobalamin molecule destroys other vitamins).
Thiamine – the risk of allergic reactions caused by thiamine increases.
Chloramphenicol – reduces the hematopoietic response to the drug.
Citamen – with simultaneous use, the effect of Citamen is reduced.
Oral contraceptives – reduce the concentration of cyanocobalamin in the blood.
Diuretics – when used in combination with pyridoxine, the effect of diuretics is enhanced.
Hormonal contraceptives, cycloserine, penicillamine, isoniazid, hydralazine sulfate, ethionamide, immunosuppressants - when used in combination with pyridoxine, the effect of the latter is weakened.
Sleeping pills and sedatives - when used in combination with pyridoxine, the sleeping pill effect is reduced.
Antiparkinsonian drugs – when used in combination with pyridoxine, the effectiveness of drugs for the treatment of Parkinson's disease is reduced.
Phenytoin – when used in combination with pyridoxine, the effect of phenytoin is weakened.
Corticosteroids – when used in combination with pyridoxine, the amount of vitamin B6 in the body decreases.
Glutamic acid, aspartame – when used in combination with pyridoxine, resistance to hypoxia increases.
Cardiac glycosides – when used in combination with pyridoxine, the synthesis of contractile proteins in the myocardium increases.
Tricyclic antidepressants – when used in combination with pyridoxine, the latter eliminates the side effects of tricyclic antidepressants associated with their anticholinergic activity (dry mouth, urinary retention).
Levomycetin preparations of resorptive action - when used in combination with pyridoxine, the latter prevents ophthalmological complications that occur with prolonged use of levomycetin preparations of resorptive action (synthomycin, chloramphenicol).
Application features
Use with caution in patients with a history of gastric and duodenal ulcers (due to possible increased acidity of gastric juice), severe heart and kidney diseases, and neoplasms.
Use of the drug may result in a false-positive test for urobilinogen using Ehrlich's reagent.
Parenteral administration of vitamin B12 may temporarily interfere with the diagnosis of funicular myelosis or pernicious anemia.
Cyanocobalamin should not be used with drugs that increase blood clotting.
For people with a tendency to thrombosis and patients with angina pectoris, caution should be exercised and blood clotting should be monitored during treatment.
You should not drink alcoholic beverages during treatment.
Use during pregnancy or breastfeeding
The negative effect of the drug during pregnancy or breastfeeding has not been registered, however, when prescribing Gepadif® to pregnant or breastfeeding women, it is necessary to carefully weigh the benefit of using the drug against the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
No negative effects on the ability to drive or operate other mechanisms have been recorded.
Method of administration and doses
Gepadif® should be administered intravenously by drip once a day. The average daily dose for adults is 8.625 mg of powder/kg body weight – the contents of 1 vial of the drug dissolved in 400-500 ml of 5% glucose solution. The maximum daily dose is 17.25 mg of powder/kg body weight – the contents of 2 vials of the drug dissolved in 400-500 ml of 5% glucose solution.
No dose adjustment is required for the elderly.
Children aged 7-14 years: the daily dose of the drug does not differ from the average daily dose for adults. The dose is prescribed by the doctor individually.
The duration of treatment depends on the course of the underlying disease and is determined by the doctor individually.
Children.
Use for children aged 7 and over.
Overdose
Symptoms: nausea, vomiting, diarrhea, increased manifestations of adverse reactions. With prolonged use in high doses, peripheral neuropathy is possible.
Pyridoxine hydrochloride. Long-term use of vitamin B6 (over 6-12 months) in doses exceeding 50 mg daily or in doses exceeding 1000 mg daily (over 2 months) may lead to reversible peripheral sensory neuropathy. If symptoms of peripheral sensory neuropathy (paresthesia) occur, the dose of the drug should be adjusted and, if necessary, treatment should be discontinued.
Neuropathies with ataxia and sensory disturbances, cerebral convulsions with EEG changes, and in isolated cases hypochromic anemia and seborrheic dermatitis have been described after administration of more than 2 g per day.
Cyanocobalamin. After parenteral administration (in rare cases after oral administration) of doses of the drug higher than recommended, allergic reactions, eczematous skin disorders and benign acne have been observed.
With prolonged use in high doses, liver enzyme activity disorders, pain in the heart area, and hypercoagulation are possible.
Treatment: gastric lavage, use of activated charcoal, hyperosmotic laxatives.
Side effects
The drug is usually well tolerated.
On the part of the blood: hypercoagulation.
Cardiovascular system: tachycardia, pain in the heart area.
Respiratory system: difficulty breathing.
Metabolic: acne, bullous rashes, nausea, sweating, purine metabolism disorders, decreased folic acid levels.
On the part of the immune system: allergic reactions (hypersensitivity reactions), including skin manifestations, including hyperemia, urticaria, rash, itching, dermatitis, photosensitization, edema, including Quincke's edema; respiratory disorders, including suffocation, anaphylactic shock, angioedema, anaphylactoid reactions.
Gastrointestinal: dyspepsia, abdominal pain and discomfort, epigastric pain, heartburn, increased gastric secretion, nausea, vomiting, diarrhea, constipation, loose stools.
From the reproductive system and mammary glands: suppression of lactation during the lactogenic period.
General disorders: malaise, weakness, fever.
Local reactions: changes at the injection site, including hyperemia, burning, itching, pain, swelling, induration, and necrosis at the injection site.
The presence of methyl parahydroxybenzoate (E 219) and propyl parahydroxybenzoate (E 217) in the composition of the drug may cause allergic reactions (possibly delayed), and in some cases - bronchospasm.
Incompatibility
Use only the solutions specified in the instructions for dilution.
Do not mix in the same container with other medicines.
Expiration date
3 years.
The drug cannot be used after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
942.05 mg of powder in a glass vial. 1 or 5 or 10 vials in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC "VALARTIN PHARMA".
Address
Ukraine, 08135, Kyiv region, Kyiv-Svyatoshynskyi district, Chayky village, Hrushevskoho st., building 60.
