Urseptia 200 mg 20 capsules

The drug URSEPTIA is indicated for use in adults aged 18 years and older.
- Acute and chronic infectious-inflammatory diseases of the urinary tract caused by microorganisms sensitive to pipemidic acid, including pyelonephritis, cystitis, prostatitis.

Orally.
The average daily dose is 800 mg, divided into 2 doses, i.e., 400 mg (2 capsules) every 12 hours, in the morning and evening before meals, taken with water.
The treatment course lasts on average 10 days. If necessary, the treatment course may be extended depending on the course of the disease, but not more than up to 4 weeks.
Treatment of cystitis in women lasts 3 days. In patients with severe renal insufficiency (GFR >10 and

Composition per capsule:
Active ingredient: pipemidic acid trihydrate - 236.0 mg, calculated as pipemidic acid - 200.0 mg.
Excipients: colloidal silicon dioxide (aerosil), magnesium stearate, sodium carboxymethyl starch (primogel, sodium starch glycolate), lactose monohydrate (milk sugar).
Composition of the gelatin capsule: cap: titanium dioxide, brilliant blue dye, quinoline yellow dye, gelatin; body: titanium dioxide, gelatin.

Hard gelatin capsules No. 1 with a white body and green cap. The contents of the capsules are a powder ranging from white with a yellowish tint to light yellow; clumping of the powder is permissible.

• Hypersensitivity to pipemidic acid or any of the components of the product.

• Severe liver dysfunction (including cirrhosis).

• Severe kidney dysfunction (creatinine clearance (CC) 10 and

Side effects are generally mild and transient, usually not requiring discontinuation of the medication. If allergic reactions to the medication occur, its use should be stopped.
During treatment, it is advisable to avoid ultraviolet exposure due to the high risk of photosensitization. In patients with glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia may develop.
With prolonged use of the medication, it is necessary to monitor complete blood counts, assess liver and kidney functions, and repeat sensitivity testing of the microflora to the medication.
Throughout the treatment course, it is important to increase fluid intake (under diuresis control).
Use with caution in patients over 70 years old (due to the increased frequency of side effects in the elderly) and in patients with impaired kidney function (creatinine clearance >10 and

Adverse reactions are presented according to the affected organs and systems in the sequence of the medical dictionary for regulatory activities (MedDRA).

Nervous system disorders: visual impairment, vertigo, headache, agitation, depression, confusion, hallucinations, tremor, prolonged seizures associated with cerebral edema, sleep disturbances, sensory disturbances.

Gastrointestinal disorders: nausea, vomiting, diarrhea, pseudomembranous colitis, abdominal pain, anorexia, heartburn, abdominal bloating or pain, constipation.

Skin and subcutaneous tissue disorders: itching, rash, photosensitivity with erythema, toxic epidermal necrolysis.

Laboratory and instrumental data: hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency), eosinophilia, reversible thrombocytopenia (in elderly patients and patients with renal insufficiency).

Other: superinfections, acute arthropathy, tendinitis.

There are no reports of fatal outcomes or life-threatening side effects due to overdose of the medication. There is no specific antidote.

Symptoms
Nausea, vomiting, dizziness, headache, confusion, tremor, seizures.

Treatment
Gastric lavage after recent intake (less than 4 hours), administration of activated charcoal, forced diuresis, hemodialysis; in case of side effects from the nervous system (including epileptic seizures), symptomatic therapy (diazepam) is prescribed. In the event of an overdose, the patient should be under medical supervision.

Pipemidic acid inhibits the P450 enzyme, which slows the metabolism of theophylline and caffeine when used concurrently. The half-life of theophylline increases with the simultaneous use of pipemidic acid, and its concentration in serum rises by 40-80%. It is necessary to monitor the concentration of theophylline in plasma during the use of pipemidic acid. During the use of pipemidic acid, as with other quinolone antibiotics, an increase in caffeine concentration in serum (2-4 times) is noted.
Antacids and sucralfate significantly slow the absorption of pipemidic acid. The interval between taking these medications should be at least 2-3 hours. At the same time, such an effect was not observed with the simultaneous use of cimetidine and ranitidine.
Pipemidic acid may enhance the anticoagulant effect of warfarin when taken together. The simultaneous use of non-steroidal anti-inflammatory drugs may lead to the occurrence of seizures.
When combined with aminoglycosides, a synergistic effect on bactericidal action is observed.

Mechanism of Action and Pharmacodynamic Effects
Belongs to the group of quinolone drugs and is used in the treatment of urinary tract infections caused by pathogens sensitive to pipemidic acid.
Pipemidic acid inhibits bacterial DNA topoisomerase II, leading to the disintegration of bacterial DNA. This action is more pronounced against microorganisms that are in the proliferation phase. High concentrations of pipemidic acid inhibit both RNA synthesis and bacterial protein synthesis.
The drug exerts a bactericidal effect on most gram-negative aerobic microorganisms (Proteus vulgaris, Proteus mirabilis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Neisseria spp., etc.).
The percentage of resistance ranges from 10% (Escherichia coli, Staphylococcus aureus) to 62% (Pseudomonas aeruginosa). Gram-positive microorganisms exhibit resistance to pipemidic acid. It is inactive against anaerobes.
Pipemidic acid creates high concentrations in urine, and its activity is enhanced by alkalinization of urine.

Absorption
After oral administration, it is rapidly absorbed, with a bioavailability of 30-60%. After an oral dose of 400 mg, the maximum concentration of pipemidic acid (3.5 mcg/ml) is reached within 70-80 minutes.
Distribution
The binding to plasma proteins is approximately 30% and depends on the concentration of pipemidic acid in the serum.
High concentrations of pipemidic acid are created in the kidneys, urine, and prostatic fluid. Pipemidic acid, like other quinolone compounds, crosses the placenta and is present in trace amounts in breast milk.
Elimination
Pipemidic acid is primarily excreted from the body through the kidneys in unchanged form. In 24-hour urine, 50-85% of the administered dose of the drug is detected. The excretion of pipemidic acid is directly dependent on creatinine clearance. The half-life of the drug with normal kidney function is 2 hours and 15 minutes, and the total clearance is 6.3 ml/min.
Renal Insufficiency
In patients with impaired kidney function, slightly higher concentrations of pipemidic acid in plasma are observed compared to healthy volunteers. The half-life from plasma is somewhat prolonged, ranging from 5.7 to 16 hours.