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Lespeflan® (Solution, Extract) Instructions for Use

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Lespedeza bicolor (Grouping name)

Clinical-Pharmacological Group

A drug reducing azotemia, with a diuretic effect

Pharmacotherapeutic Group

Drugs used in urology; other drugs used in urology

Pharmacological Action

A plant-derived hypoazotemic agent; it has anti-inflammatory and diuretic effects.

It helps to reduce the concentration of nitrogen metabolism products in the blood, increases the clearance of nitrogenous compounds (urea, creatinine, and uric acid), and enhances glomerular filtration.

It increases the excretion of nitrogenous wastes in the urine, increases diuresis, and enhances the excretion of sodium and, to a lesser extent, potassium.

Indications

Use this medication for the following conditions as part of a comprehensive treatment plan.

  • Chronic renal failure of various origins.
  • Specifically indicated for use during the latent compensated and intermittent stages of the disease.

ICD codes

ICD-10 code Indication
N18 Chronic kidney disease
ICD-11 code Indication
GB61.Z Chronic kidney disease, unspecified stage

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the solution or extract orally, always before meals and after diluting the required dose in a small amount of water.

Initiate therapy with a loading dose of 5 to 15 ml per day. Transition to an average daily dose of 5 to 10 ml. For long-term, maintenance therapy, use a maintenance daily dose of 2.5 to 5 ml, administered for 15 consecutive days within each month.

Adverse Reactions

Monitor for potential adverse effects during treatment. Allergic reactions, including skin rash or itching, may occur.

Be aware of the potential for hyponatremia, a condition characterized by low sodium levels in the blood, which may manifest as headache, confusion, lethargy, or nausea.

Contraindications

Do not use this medication under the following circumstances.

  • Patients with a known hypersensitivity or allergy to the herbal remedy Lespedeza bicolor or any component of the formulation.
  • During pregnancy and throughout the lactation period.
  • In childhood and adolescence.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in childhood.

Special Precautions

If hyponatremia develops, it should be compensated by the administration of sodium preparations.

When used in the form of a tincture, it should be taken into account that the average daily dose contains from 2.9 to 11.6 g of ethanol.

It should not be prescribed concomitantly with drugs that depress the central nervous system, insulin, oral hypoglycemic agents (metformin, sulfonylurea derivatives), or with drugs that have a disulfiram-like effect.

When used in the form of a tincture: due to the presence of ethanol in the preparation, a decrease in the speed of psychomotor reactions is possible, which should be taken into account when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Lespeflan® Oral solution: bottle 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Solution for oral administration from light brown with an orange tint to reddish-brown in color, with a characteristic odor; precipitation is allowed during storage.

1 L
Lespedeza bicolor shoots 555.5 g

Excipients: ethanol 95% (ethyl alcohol) – to obtain 555.5 ml of extract, anise oil – 0.55 g, gelatin – 5.5 g, purified water – to obtain 1 L.

50 ml – dark glass bottles (1) – cardboard boxes.
100 ml – dark glass bottles (1) – cardboard boxes.

Marketing Authorization Holder

Pharmtsentr Vilar JSC (Russia)

Dosage Form

Bottle OTC Icon Lespeflan® Liquid extract for oral administration: 100 ml bottle

Dosage Form, Packaging, and Composition

Extract for oral administration (liquid) in the form of a liquid from light brown with an orange tint to reddish-brown in color, with a specific odor; the presence of a slight sediment during storage is allowed.

1 L
Lespedeza bicolor shoots 708 g

Excipients: ethanol 95% – 1210 ml, anise oil 0.7 g, purified water 680 ml.

100 ml – orange glass bottles (1) – cardboard boxes.

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