Urseptia capsules 200mg, No. 20

Acute and chronic / infectious and inflammatory diseases of the urinary tract caused by microorganisms sensitive to pipemidic acid, including: pyelonephritis, cystitis, prostatitis.

Inside.

The average daily dose is 800 mg, divided into 2 doses, i.e. 400 mg (2 capsules) every 12 hours, morning and evening before meals with water.

The course of treatment is on average 10 days. If necessary, the course of treatment can 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 impairment (CC> 10 and <30 ml / min), the dose should be reduced.

In elderly patients with normal renal function, as well as in patients with mild to moderate hepatic insufficiency, dose adjustment is not required.

During therapy, the patient is advised to drink plenty of fluids.

For one capsule:

Active ingredient: pipemidic acid trihydrate - 236.0 mg, in terms of 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:

cover: titanium dioxide, brilliant blue dye, quinoline yellow dye, gelatin;

body : titanium dioxide, gelatin.

- Hypersensitivity to pipemidic acid or any of the components of the drug;

- severe liver dysfunction (including cirrhosis);

- severe renal dysfunction (creatinine clearance (CC) <10 ml / min;

- diseases of the central nervous system (epilepsy and other neurological conditions with a low seizure threshold);

- porphyria;

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

- history of allergic reactions to quinolones;

- pregnancy and the period of breastfeeding;

- children's age up to 18 years (the period of formation and growth of the skeleton).

Carefully:

- Patients with renal insufficiency (CC> 10 and <30 ml / min);

- old age (over 70 years old);

- violation of cerebral circulation;

- deficiency of glucose-6-phosphate dehydrogenase.

Dosage form: capsules

Composition:

For one capsule:

Active ingredient: pipemidic acid trihydrate - 236.0 mg, in terms of 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:

cover: titanium dioxide, brilliant blue dye, quinoline yellow dye, gelatin;

body : titanium dioxide, gelatin.

Description:

Hard gelatin capsules No. 1 with a white body and a green lid. The contents of the capsules are powder from white with a yellowish tinge to light yellow, powder clumping is allowed.

Pharmacotherapeutic group:

Antimicrobial agent - quinolone

Pharmacodynamics:

It 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, which leads to the disintegration of bacterial DNA. This effect is more pronounced in relation to microorganisms that are in the proliferation phase.

High concentrations of pipemidic acid inhibit both RNA synthesis and bacterial protein synthesis. The drug has a bactericidal effect on most gram-negative aerobic microorganisms ( Proteus vulgaris, Proteus mirabilis, Klebsiella pneumoniae, Pneudomonas aeruginosa, Escherichia coli, Neisseria spp ., Etc.).

The incidence of resistance ranges from 10% ( Escherichia coli, Staphylococcus aureus) to 62% (Pneudomonas aeruginosa ).

Gram-positive microorganisms are resistant to pipemidic acid.

Not active against anaerobes.

Pipemidic acid creates high concentrations in urine, the activity is enhanced by alkalinization of urine.

Pharmacokinetics:

After oral administration, it is rapidly absorbed, bioavailability is 30-60%. After oral administration in a dose of 400 mg, the maximum concentration of pipemidic acid (3.5 ?g / ml) is reached after 70-80 minutes.

Plasma protein binding is approximately 30% and depends on the concentration of pipemidic acid in the blood serum.

High concentrations of pipemidic acid are created in the kidneys, urine, and prostate fluid. Pipemidic acid, like other quinolone compounds, crosses the placenta and in trace amounts into breast milk. Pipemidic acid is mostly excreted from the body through the kidneys in an unchanged form. In daily urine, 50-85% of the administered dose of the drug is determined. The release of pipemidic acid is in direct proportion to creatinine clearance.

The half-life of the drug with normal renal function is 2 hours 15 minutes, and the total clearance is 6.3 ml / min.

Patients with impaired renal function have slightly higher plasma concentrations of pipemidic acid than healthy volunteers. The half-life of blood plasma is somewhat lengthened and amounts to 5.7-16 hours.

Indications:

Acute and chronic / infectious and inflammatory diseases of the urinary tract caused by microorganisms sensitive to pipemidic acid, including: pyelonephritis, cystitis, prostatitis.

Contraindications:

- Hypersensitivity to pipemidic acid or any of the components of the drug;

- severe liver dysfunction (including cirrhosis);

- severe renal dysfunction (creatinine clearance (CC) <10 ml / min;

- diseases of the central nervous system (epilepsy and other neurological conditions with a low seizure threshold);

- porphyria;

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

- history of allergic reactions to quinolones;

- pregnancy and the period of breastfeeding;

- children's age up to 18 years (the period of formation and growth of the skeleton).

Carefully:

- Patients with renal insufficiency (CC> 10 and <30 ml / min);

- old age (over 70 years old);

- violation of cerebral circulation;

- deficiency of glucose-6-phosphate dehydrogenase.

Pregnancy and lactation:

The use of the drug during pregnancy is contraindicated.

Pipemidic acid is excreted in breast milk, therefore, when prescribing the drug during lactation, breastfeeding should be discontinued.

Method of administration and dosage:

Inside.

The average daily dose is 800 mg, divided into 2 doses, i.e. 400 mg (2 capsules) every 12 hours, morning and evening before meals with water.

The course of treatment is on average 10 days. If necessary, the course of treatment can 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 impairment (CC> 10 and <30 ml / min), the dose should be reduced.

In elderly patients with normal renal function, as well as in patients with mild to moderate hepatic insufficiency, dose adjustment is not required.

During therapy, the patient is advised to drink plenty of fluids.

Side effects:

From the digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis, gastralgia, anorexia, heartburn, bloating or abdominal pain, constipation.

From the nervous system: visual impairment, vertigo, headache, agitation, depression, confusion, hallucinations, tremors, prolonged convulsions associated with cerebral edema, sleep disorders, sensory disturbances.

On the part of the skin: itching, rash, photosensitivity with erythema, toxic epidermal necrolysis.

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

Others : superinfection, acute arthropathy, tendonitis.

Overdose:

There are no reports of death or life-threatening side effects due to drug overdose. There is no specific antidote.

Symptoms : nausea, vomiting, dizziness, headache, confusion, tremors, seizures.

Treatment : gastric lavage after a recent intake (less than 4 hours), intake of activated charcoal, forced diuresis, hemodialysis, if side effects from the nervous system (including epileptic seizures) appear, symptomatic therapy (diazepam) is prescribed.

In case of overdose, the patient should be under medical supervision.

Pipemidic acid inhibits the P450 enzyme, and therefore, when used simultaneously with pipemidic acid, the metabolism of theophylline and caffeine slows down.

The half-life of theophylline increases with the simultaneous use of pipemidic acid, its concentration in serum increases by 40-80%. It is necessary to control the concentration of theophylline in the blood plasma during the use of pipemidic acid.

Against the background of the use of pipemidic acid, like other quinolone antibiotics, there is an increase in the concentration of caffeine in the blood serum (2-4 times).

Antacids and sucralfate significantly slow down the absorption of pipemidic acid. The interval between taking these drugs should be at least 2-3 hours. At the same time, a similar effect was not observed with the simultaneous use of cimetidine and ranitidine.

Pipemidic acid can enhance the anticoagulant effect of warfarin when taken simultaneously.

With simultaneous use with non-steroidal anti-inflammatory drugs, seizures may occur.

When combined with aminoglycosides, synergism is observed with respect to the bactericidal effect.

Special instructions:

Side effects in most cases are mild and transient, usually not requiring discontinuation of the drug. If you experience allergic reactions to the drug, you must stop using it.

During treatment, ultraviolet radiation should be avoided due to the high risk of photosensitization. Hemolytic anemia may develop in patients with glucose-6-phosphate dehydrogenase deficiency.

With prolonged use of the drug, you should monitor the general blood counts, determine the functions of the liver and kidneys, and repeat the determination of the sensitivity of the microflora to the drug.

During the course of treatment, it is necessary to increase the amount of fluid consumed (under the control of diuresis).

Prescribe with caution to patients over 70 years of age (due to the increased incidence of side effects in the elderly) and patients with impaired renal function (CC> 10 and <30 ml / min) (contraindicated in oliguria and anuria, CC <10 ml / min), dose adjustment and regular monitoring of the patient's condition are required.

Exercise caution when prescribing the drug to patients with a history of cerebrovascular accident (including cerebral hemorrhage, cerebral vasospasm), as well as convulsions.

There may be a false positive urinary glucose reaction when using Benedict's reagent or Felling's solution. It is recommended to use enzymatic reactions with glucose oxidase.

Impact on the ability to drive vehicles. Wed and fur .:

During the period of treatment, the patient should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form / dosage :

Capsules, 200 mg.

Packaging:

On 10, 15 or 20 capsules in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.

40, 60, 80 capsules in a polypropylene jar with a high-pressure polyethylene tightening lid or in a low-pressure polyethylene plastic jar with a low-pressure polyethylene tightening lid or with a low-pressure polyethylene screw-on lid.

Each can or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 blisters with instructions for use are placed in a cardboard box.

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription