Lespenephryl (Solution) Instructions for Use

Marketing Authorization Holder

UCB Healthcare (France)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Lespedeza capitata (Group Grouping name)

Dosage Form

Lespenephryl

Oral solution: bottle 120 ml

Dosage Form, Packaging, and Composition

120 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug reducing azotemia, with a diuretic effect

Pharmacotherapeutic Group

Hypoazotemic agent of plant origin

Indications

• Chronic renal failure of various origins, both in the initial and advanced stages, to reduce azotemia and improve renal function parameters.
• As part of complex therapy for edematous syndrome associated with impaired renal function, due to its diuretic properties.
• Supportive treatment for conditions accompanied by hyperazotemia, to aid in the elimination of nitrogenous waste products from the body.

Contraindications

• Hypersensitivity to the active substance (Lespedeza capitata) or to any of the excipients in the formulation.
• Severe, acute inflammatory kidney diseases (e.g., acute glomerulonephritis) where the use of diuretics may exacerbate the condition.
• Severe hepatic impairment or hepatic failure, due to the potential for altered metabolism and increased risk of complications.
• Anuria (complete cessation of urine production), as the drug’s action is dependent on some level of residual renal function.
• Pregnancy and breastfeeding due to the lack of sufficient clinical data on safety during these periods.
• Children and adolescents under 18 years of age, as safety and efficacy have not been established in this population.

Dosage Regimen

The dosage is determined individually by the attending physician, depending on the severity of the condition and the patient’s response to therapy. The solution is taken orally, diluted in a small amount of water (approximately 1/3 glass) before meals.

For adults, the usual recommended dose is 1 to 2 teaspoonfuls (which corresponds to 5 ml to 10 ml) of the solution, taken two to three times a day. The maximum daily dose should generally not exceed 30 ml (6 teaspoonfuls).

The duration of treatment is set by the physician and depends on the therapeutic effect achieved. Long-term use may be required for chronic conditions, with periodic monitoring of renal function parameters (blood urea nitrogen, creatinine) and electrolyte levels.

Adverse Reactions

Lespenephryl is generally well-tolerated; however, like any drug, it can cause adverse reactions. Adverse reactions are usually mild and transient.

From the gastrointestinal system: Nausea, epigastric discomfort, or diarrhea may occur rarely, especially at the beginning of treatment. These symptoms often resolve with continued use.

Allergic reactions: In rare cases, skin rash, pruritus, or urticaria may develop. In patients with known hypersensitivity to plants of the Fabaceae family, the risk of allergic reactions may be increased.

From the nervous system: Dizziness or headache has been reported very rarely in individual cases.

If any of the side effects become severe or if you notice any other side effects not listed in this leaflet, you should inform your doctor.

Drug Interactions

Formal interaction studies have not been conducted. Based on the pharmacological profile, caution should be exercised with concurrent use of the following agents.

Other diuretics (e.g., furosemide, hydrochlorothiazide, spironolactone): Concomitant use may lead to an additive diuretic effect, potentially increasing the risk of dehydration and electrolyte imbalances (such as hypokalemia or hyponatremia). Close monitoring of clinical status and electrolyte levels is recommended.

Antihypertensive drugs: As Lespenephryl has a diuretic effect, it may potentiate the blood pressure-lowering effect of antihypertensive medications (e.g., ACE inhibitors, angiotensin II receptor blockers, beta-blockers). Blood pressure should be monitored to avoid excessive hypotension.

Lithium: Diuretics can reduce the renal clearance of lithium, leading to increased lithium plasma concentrations and an elevated risk of lithium toxicity. If concomitant use is unavoidable, frequent monitoring of lithium levels is essential.

Nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, diclofenac, naproxen): NSAIDs may reduce the diuretic and antihypertensive efficacy of Lespenephryl by inhibiting renal prostaglandin synthesis. They can also increase the risk of nephrotoxicity.

Patients should inform their physician about all medications they are taking, including prescription, over-the-counter, and herbal products.

Overdose

There are no reported cases of overdose with Lespenephryl. Given its pharmacological action, symptoms of overdose would be expected to be related to excessive diuresis.

This could manifest as profuse diuresis, leading to dehydration, electrolyte disturbances (notably hypokalemia, which can cause muscle weakness, cramps, and cardiac arrhythmias), hypotension, dizziness, and weakness.

There is no specific antidote. Treatment should be symptomatic and supportive. It is necessary to discontinue the drug, monitor vital signs, correct fluid and electrolyte imbalances, and maintain renal function. Gastric lavage or administration of activated charcoal is unlikely to be of significant benefit due to the nature of the preparation. In case of severe symptoms, seek immediate medical attention or contact a poison control center.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.