Potassium orotate

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KALII OROTAS (KALII OROTAS)

Composition:

Active substance: kalii orotas (potassium orotate);

One tablet contains kalii orotas (calculated as 100% dry substance) – 500 mg;

Excipients: lactose monohydrate, magnesium stearate, sorbitol (E 420).

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white, flat cylindrical tablets with beveled edges (chamfered) and a score line.

Pharmacotherapeutic group. Anabolic agents for systemic use. Non-steroidal anabolic agents.
ATC code
A14B.

Pharmacological properties.

Pharmacodynamics.

Potassium orotate exerts a general stimulating effect on metabolic processes and participates in protein and carbohydrate metabolism. The main structural component of potassium orotate is orotic acid.

Orotic acid ensures the synthesis of pyrimidine bases (uracil, thymine, cytosine) during the synthesis of nucleic acids, which are involved in the synthesis of protein molecules. The role of orotic acid in carbohydrate metabolism consists in its normalizing effect on galactose metabolism.

Potassium orotate, as an anabolic agent, is used to restore impaired protein metabolism and to stimulate metabolic processes.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Potassium orotate is used as part of combination therapy for:

• Liver and biliary tract diseases caused by acute and chronic intoxications (except liver cirrhosis with ascites);
• Myocardial dystrophy;
• Myocardial infarction;
• Chronic heart failure stage II–III;
• Arrhythmias (extrasystoles);
• Alimentary and alimentary-infectious hypotrophy in children;
• Progressive muscular dystrophy;
• Anemia;
• Galactosemia;
• Dermatoses.

It is also used under conditions of increased physical exertion and during the recovery period after severe illnesses.

Contraindications.

• Hypersensitivity to the active substance or to other components of the drug;
• Liver cirrhosis with ascites;
• Acute and severe chronic renal insufficiency;
• Lymphogranulomatosis;
• Malignant diseases of the hematopoietic organs;
• Hyperkalemia.

Interaction with other medicinal products and other types of interactions.

Folic acid, cyanocobalamin: concomitant use increases the efficacy of potassium orotate.

Cardiac glycosides (e.g., digoxin, celanid): potassium orotate improves their tolerability.

Potassium-sparing diuretics, ACE inhibitors: concomitant use may lead to development of hyperkalemia.

The drug may be used simultaneously with vitamins, cardiotonic agents.

Adsorbents and coating agents (e.g., bismuth preparations, sucralfate, algedrate, magnesium hydroxide): possible reduction in gastrointestinal absorption of potassium orotate.

Glucocorticoids, insulin, muscle relaxants, oral contraceptives: concomitant use may reduce the efficacy of orotic acid.

Special precautions for use.

Potassium orotate cannot be used for potassium replacement therapy.

Potassium orotate should not be taken during meals due to the possibility of interaction with food components.

The preparation contains lactose and therefore should not be administered to patients with rare hereditary conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

The use of this medicinal product during pregnancy is justified only when the expected benefit to the mother outweighs the potential risk to the fetus. If the product is used, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product does not affect the reaction rate while driving or operating machinery.

Dosage and Administration

Take potassium orotate orally 1 hour before or 4 hours after a meal. Swallow tablets whole with 150–200 ml of water.

For adults: 250–500 mg 2–3 times daily. The daily dose is 500–1500 mg. In individual cases, if an increased therapeutic effect is required, the daily dose for adults may be increased up to 3000 mg.

Treatment duration: 3–5 weeks. If necessary, repeat the course after one month.

For children aged 5 years and older: the daily dose of potassium orotate is 10–20 mg per kg of body weight. Divide the total daily dose into 2–3 doses.

Children.
Not recommended for children under 5 years of age.

Overdose.

With prolonged use, allergic dermatoses may occur, requiring desensitizing therapy; hyperkalemia, requiring discontinuation of the drug.

When used in high doses combined with a low-protein diet, hepatic dystrophy may develop, requiring discontinuation of the drug and appropriate therapy.

Increased adverse effects are possible.

Adverse Reactions

The drug is generally well tolerated. In individual cases, allergic reactions (dermatitis, skin rashes) and dyspeptic symptoms (nausea, vomiting, diarrhea) may occur, which quickly resolve after discontinuation of the drug.

When used in high doses against a background of low-protein diet, hepatic fatty degeneration may develop.

Hyperkalemia may occur, accompanied by paresthesias and changes in ECG parameters.

Reporting of suspected adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the drug. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.
4 years.

Storage conditions.
In the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.
10 tablets per blister pack.

Supply classification.
Over-the-counter (without prescription).

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivskyi Chemical and Pharmaceutical Plant".

Limited Liability Company "Agrofarm".

Manufacturer's location and address of business activity.

Kyiv, Ukraine, 03134, Miru Street, 17.

Irpin, Kyiv Region, Ukraine, 08200, Tsentralna Street, 113-A.