Urotravenol (Solution) Instructions for Use

Marketing Authorization Holder

MC Medicine, LLC (Russia)

Manufactured By

MC Ellara, LLC (Russia)

ATC Code

G04 (Drugs for the treatment of urological diseases)

Active Substance

Hydroxymethylquinoxalindioxide (Grouping name)

Dosage Form

Urotravenol

Solution for intravesical administration 1 mg/1 ml: containers 250 ml 25 pcs., 500 ml 15 pcs., 3 L 3 pcs., 5 L 2 pcs., 10 L 1 pc.

Dosage Form, Packaging, and Composition

Solution for intravesical administration in the form of a transparent or slightly colored liquid.

Excipients: glycine 15 g, water for injections up to 1 L.

250 ml – polymeric containers (25) – cardboard boxes.
500 ml – polymeric containers (15) – cardboard boxes.
3 L – containers (3) made of low-density polyethylene – cardboard boxes.
5 L – containers (2) made of low-density polyethylene – cardboard boxes.
10 L – containers (1) made of low-density polyethylene – cardboard boxes.

Clinical-Pharmacological Group

Antibacterial drug, a derivative of quinoxaline

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Urotravenol contains Hydroxymethylquinoxalindioxide, which has a broad spectrum of antibacterial action.

It is active against Proteus vulgaris, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Shigella dysenteriae, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp, Staphylococcus spp., Streptococcus spp., and pathogenic anaerobes (Clostridium perfringens).

It acts on bacterial strains resistant to other antimicrobial drugs, including antibiotics. It does not have a local irritant effect. The development of bacterial drug resistance is possible.

The use of Urotravenol during endoscopic interventions reduces the likelihood of complications of infectious etiology.

The presence of glycine in the composition ensures the iso-osmoticity of Urotravenol and thus prevents tissue damage at the cellular level during prolonged contact with the drug, which excludes the occurrence of “water intoxication syndrome” as a postoperative complication.

Glycine, when dissolved, forms zwitterions that practically do not increase the electrical conductivity of the solution, and Hydroxymethylquinoxalindioxide is not an electrolyte.

As a result, Urotravenol is non-conductive, which enables the use of electrical instruments during its use for irrigation or cavity filling in the process of endoscopic interventions.

Indications

• For filling and continuous irrigation of the urinary bladder cavity during diagnostic and operative endoscopic interventions;
• For transurethral resections (TUR) of prostate hyperplasia;
• For irrigation (lavage) of the urinary bladder in the postoperative period;
• For diagnostic and therapeutic cystoscopies to fill the urinary bladder cavity.

ICD codes

Dosage Regimen

Urotravenol is used for introduction into the urinary bladder cavity during endoscopic interventions.

This achieves the required degree of cavity filling for performing manipulations and ensures the possibility of its continuous irrigation.

The drug consumption ranges from 10 to 30 liters (TUR).

The drug can also be used for postoperative irrigation of the urinary bladder, as well as for diagnostic and therapeutic cystoscopies.

Polymer containers with a capacity of 0.25 L and 0.5 L are used for filling the urinary bladder cavity during cystoscopies and endoscopic manipulations; containers with a capacity of 3 L are used for postoperative irrigation of the urinary bladder; containers with a capacity of 5.0 L and 10.0 L are used during TUR.

Adverse Reactions

Renal failure. When using the drug, allergic reactions, headache, chills, fever, dyspeptic disorders, muscle cramps, photosensitizing effect (appearance of pigment spots on the body when exposed to sunlight), and periwound dermatitis may occur.

Contraindications

• Hypersensitivity to the drug or its components;
• Adrenal insufficiency (including in history);
• Pregnancy, lactation period;
• Age under 18 years.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated for children under 18 years of age.

Overdose

Symptoms: dystrophy, acute adrenal insufficiency.

Treatment: symptomatic, blood glucose concentration control is necessary.

Drug Interactions

Studies on interaction with other drugs have not been conducted.

Storage Conditions

At a temperature from 10°C (50°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 1 year.

Dispensing Status

For hospitals.

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.