Hepasol A (Solution) Instructions for Use

Marketing Authorization Holder

Hemofarm Koncern A.D. (Yugoslavia)

ATC Code

B05BA01 (Amino acids)

Dosage Form

Hepasol A

Solution for infusion: bottle 500 ml

Dosage Form, Packaging, and Composition

500 ml – bottles.

Clinical-Pharmacological Group

Agent for parenteral nutrition (amino acid solution), used for hepatic insufficiency

Pharmacotherapeutic Group

Parenteral nutrition agent, amino acid

Pharmacological Action

Hepasol A is a combined preparation for parenteral nutrition of patients with hyperammonemia. It has metabolic, hepatoprotective, and detoxifying effects.

Arginine is a nitrogen donor that can be used in metabolic processes. Arginine is used in the therapy of hyperammonemia because it is a precursor of ornithine in the urea cycle in the liver. Arginine and Malic acid reduce the elevated level of free phenols in the blood due to the high ability of phenol conjugation with glucuronic acid.

Malic acid and sorbitol also provide the body with energy.

Riboflavin is a water-soluble vitamin necessary for energy utilization and for the manifestation of the action of pyridoxine and nicotinic acid.

Nicotinamide is formed in the body from nicotinic acid. It serves for the synthesis of coenzymes NAD and NADP, necessary for electron transfer in oxidation and reduction reactions, as well as dehydrogenation.

Pyridoxine is necessary for the metabolism of amino acids, carbohydrates, and fats.

Dexpanthenol is incorporated into coenzyme A, which is necessary for various enzymatic reactions in the body. Dexpanthenol participates in the metabolism of carbohydrates, fatty acids, gluconeogenesis, and in the synthesis of sterols, steroid hormones, and porphyrin.

Pharmacokinetics

The action of Hepasol A is the combined action of its components, therefore conducting kinetic observations is not possible; all components together cannot be traced using markers or bioassays. For the same reason, it is impossible to detect the drug’s metabolites.

Indications

• Hepatic precoma and coma (stage I-II);
• Acute and chronic hepatitis;
• Liver cirrhosis;
• Hepatic encephalopathy;
• Condition after portocaval anastomosis;
• Bleeding from esophageal varices;
• Increased blood ammonia levels after massive tissue damage (e.g., burns).

ICD codes

Dosage Regimen

Determine the dosage individually based on the patient’s initial blood ammonia concentration and clinical condition.

Administer the solution intravenously by slow drip infusion.

Initiate therapy with an average adult dose of 500 ml per infusion.

Adjust the infusion rate to approximately 40 drops per minute.

Monitor the patient’s clinical status and biochemical parameters closely during administration.

Repeat the infusion every 12 hours as required by the patient’s condition and ammonia levels.

For severe hyperammonemia, consider a higher initial volume, not exceeding 1000 ml per infusion.

Do not exceed a total daily volume of 2000 ml without reassessment of the patient’s metabolic and fluid status.

Continuously adjust the dosage and frequency based on the dynamics of blood ammonia and clinical response.

Discontinue administration if significant adverse reactions occur.

Adverse Reactions

From the digestive system nausea, vomiting.

From the cardiovascular system arterial hypotension, tachycardia.

From the water-electrolyte balance hyperkalemia (in severe impairment of liver and kidney function), hypophosphatemia (in diabetes mellitus).

From the body as a whole increased fatigue, sweating, hyperthermia, cyanosis.

Contraindications

• Acute and chronic renal failure;
• Chronic heart failure;
• Hemophilia;
• Terminal ileitis;
• Gastric and duodenal ulcer in the acute phase;
• Gout;
• Diabetes mellitus;
• Cholecystitis;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies of the safety and efficacy of the drug during pregnancy and lactation (breastfeeding) have not been conducted.

Use in Renal Impairment

Contraindicated in acute and chronic renal failure.

Special Precautions

During the use of the drug, it is necessary to monitor the potassium content in the blood.

Overdose

Symptoms possible intensification of the manifestations of the described adverse effects.

Treatment symptomatic therapy is carried out.

Drug Interactions

Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the insulin content in the blood.

With simultaneous use of arginine with spironolactone, the level of potassium in the blood increases significantly.

Isoniazid, penicillamine, oral contraceptives reduce the metabolism and effectiveness of pyridoxine.

Riboflavin significantly reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin, and lincomycin.

Pharmaceutical interaction

When using the drug, it should be taken into account that Arginine is incompatible with thiopental, and Riboflavin is incompatible with streptomycin.

Storage Conditions

The drug should be stored in a place protected from light at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is intended for use only in a hospital setting.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.