Potassium orotat tablets 500 mg

Instructions for use of Potassium orotate tablets 500 mg

Registration number: LS-000402

Proprietary name of the drug: Potassium Orotate

International nonproprietary name of the drug: Orotic Acid

Dosage form: tablets

Composition per one tablet:

Active substance: potassium orotate 500.0 mg

Excipients: lactose monohydrate, stearic acid, medical gelatin, potato starch.

Description:

Round, flat-cylindrical, white tablets with a bevel and a score line. 

Pharmacotherapeutic group: metabolic agent.

ATC code: A05BA

Pharmacological properties:

Pharmacodynamics
Orotic acid is one of the precursors of pyrimidine nucleotides that are part of nucleic acids, which are involved in the synthesis of protein molecules. Therefore, salts of orotic acid are considered as substances with an anabolic action and are used for disorders of protein metabolism to stimulate it. The potassium salt of orotic acid (potassium orotate) is usually used. Potassium orotate stimulates the synthesis of nucleic acids, the production of albumin in the liver (especially under conditions of prolonged hypoxia), increases appetite, and has diuretic and regenerative properties.

Pharmacokinetics After oral administration, 10% of the ingested dose is absorbed in the gastrointestinal tract. It is converted to orotidine-5-phosphate in the liver. Excreted by the kidneys (30% as metabolites).

Indications for use

• As an auxiliary agent for diseases of the liver and biliary tract (caused by acute and chronic intoxication, excluding organic lesions of the liver and biliary tract);
• as part of combination therapy for chronic heart failure and cardiac arrhythmias;
• alimentary and alimentary-infectious hypotrophy in children;
• chronic physical overexertion.

Contraindications

• Hypersensitivity to any component of the drug;
• acute and chronic organic liver damage;
• ascites;
• nephrourolithiasis;
• renal failure;
• lactose intolerance;
• lactase deficiency;
• glucose-galactose malabsorption;
• age under 3 years.

Dosage and administration

Should be taken orally 1 hour before meals or 4 hours after meals. Adults: 250-500 mg 2-3 times daily. The treatment course lasts on average 20-30 days. If necessary, treatment can be repeated after 1 month. In exceptional cases, the dose for adults can be increased to 3 g per day. Children: 10-20 mg/kg of body weight per day, divided into 3-4 doses (for example, if the child's body weight is 25 kg, then the permitted dose is from 25 x 10 = 250 mg (1/2 tablet) to 25 x 20 = 500 mg (1 tablet per day, divided into 3-4 doses). The course of treatment is 3-5 weeks. If symptoms of the disease persist, consult a doctor.

Overdose

No overdose data available.

Adverse reactions

Potassium orotate is usually well tolerated. In some cases, allergic skin reactions may occur, which disappear after discontinuation of treatment. Potassium orotate may also cause mild digestive disorders (nausea, vomiting). When used in high doses against a background of a low-protein diet, liver dystrophy may develop.

If adverse reactions occur, consult a doctor.

Interaction with other medicinal products

Potassium orotate somewhat reduces the toxicity of cardiac glycosides; the effect is enhanced when combined with magnesium preparations. Astringent and coating agents may somewhat reduce the absorption of potassium orotate in the gastrointestinal tract. Potassium orotate impairs the absorption of iron, tetracycline, and sodium fluoride (the interval between taking the drug should be at least 2-3 hours). Oral contraceptives, diuretics, muscle relaxants, glucocorticosteroids, and insulin reduce the effect of the drug.

Use during pregnancy and lactation

The drug should be used with caution during pregnancy and breastfeeding.

Special instructions

During treatment, it is advisable to follow a diet (Diet No. 5). Effect on ability to drive vehicles and operate machinery.

Does not cause drowsiness or a decrease in the speed of psychomotor reactions.

Pharmaceutical form

Tablets 500 mg.

10 tablets in a contour non-blister pack made of paper with polymer coating or made of combined film material.

10 tablets in a contour blister pack made of polyvinyl chloride film and printed lacquered aluminum foil.

30, 40, or 50 tablets in polymer jars or polymer bottles.
Each jar, bottle, or 1, 2, 3, 4 or 5 contour blister packs or contour non-blister packs together with the instructions for use are placed in a cardboard carton.

Shelf life

4 years. Do not use after the expiration date printed on the packaging.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C.
Keep out of reach of children.

Prescription status

Over-the-counter.

Name and address of the legal entity in whose name the registration certificate is issued / organization accepting claims:

JSC "AVVA RUS", Russia, 121614, Moscow, Krylatskie Kholmy st., 30, building 9.

Tel.: +7 (495) 956-75-54

avva.com.ru

Address of the production site:

JSC "AVVA RUS", Russia, 610044, Kirov region, Kirov, Luganskaya st., 53a.

Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.