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Dosage form: & nbspCapsules

Composition:Active substance: pipemidic acid 200 mg
Excipients: lactose monohydrate, silicon dioxide colloidal anhydrous, sodium starch glycolate, magnesium stearate.
Capsule shell composition: gelatin, titanium dioxide (E171), indigocarmine (E132), quinoline yellow (E104), iron oxide yellow (E172).

Description:Hard, gelatin capsules number 1. The cap of the capsule is dark green, the body of the capsule is cream-yellowish in color. Contents of the capsule: powder white or slightly yellowish color, it is allowed to clump the powder.

Pharmacotherapeutic group:Antimicrobial agent, quinolone.
Pharmacodynamics:Refers to the group of quinolone drugs and is used in the treatment of urinary tract infections caused by pathogens sensitive to pipemidic acid. The drug has a bactericidal effect.
Pipemidic acid binds to the enzyme DNA gyrase, which participates in the process of DNA reduplication and thus leads to inhibition of bacterial DNA replication. This effect is more pronounced with respect to microorganisms that are in the proliferation phase. High concentrations of pipemidic acid inhibit both the synthesis of RNA and the synthesis of bacterial proteins.In vivo studies have shown the effectiveness of treatment of infectious diseases caused by bacteria: Proteus vulgaris, Proteus mirabilis, Klebsiella pneumoniae,
Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Neisseria.
The percentage of occurrence of resistance is from 10% (Escherichia coli, Staphylococcus aureus) to 62% (Pseudomonas aeruginosa). Gram-positive microorganisms are resistant to pipemidic acid. Creates high concentrations in the urine, activity increases with alkalinization of urine.

Pharmacokinetics:After oral administration it is rapidly absorbed, the bioavailability is 30-60%. After oral administration at a dose of 400 mg, the maximum concentration of the drug (3.5 μg / ml) is achieved after 70-80 minutes.
High concentrations of the active substance are created in the kidneys and the prostate gland. It penetrates the placenta, penetrates into the mother's milk in trace amounts. Pipemid acid most of it is excreted from the body through the kidneys in an unchanged form. In daily urine is determined 50-85% of the administered dose of the drug. Isolation of pipemidic acid is directly dependent on the clearance of creatinine. The half-life of the drug with normal kidney function is 2 hours 15 minutes, and the total clearance 6.3 ml / min.
In patients with impaired renal function, slightly higher plasma concentrations of the drug are observed than in healthy volunteers. The half-life of plasma is somewhat longer and is 5.7-16 hours. In severe disorders of renal function in the urine, a therapeutic concentration is also created.


Indications:Acute and chronic infectious diseases of the urinary tract caused by microorganisms sensitive to the preparation (urethritis, cystitis, pyelonephritis, etc.), prostatitis. Prevention of infections during catheterization, endoscopy and side instrumental interventions.

Contraindications:- severe violations of the liver and kidneys (with a decrease in creatinine clearance below 60 ml / min, and with serum creatinine values ​​above 265 mmol / l);
- pregnancy (especially I-III trimesters) and lactation period;
- childhood;
- organic lesions of the central nervous system;
- infections caused by drug-resistant pathogens;
- hypersensitivity to pipemidic acid.

Dosing and Administration:The average dose for adults is 2 times 2 capsules per day (morning and evening) before meals.With staphylococcal infections, the dosage interval should not exceed 8 hours. In the presence of resistant microorganisms, you can increase the average dose by 2 times. The course of treatment is 10 days, if necessary, prolonged by a doctor. With kidney disease, the duration of therapy is 3 to 6 weeks, with prostatitis 6-8 weeks. During therapy, the patient is recommended to drink abundantly.

Side effects:From the gastrointestinal tract: nausea, vomiting, diarrhea.
From the nervous system: visual impairment, headache, dizziness, weakness. Very rarely - depressive disorders, hallucinations and psychoses, peripheral disorders in the form of muscle weakness and myalgia. Very rarely there can be large seizures.
On the part of the skin: photosensitivity with erythema, and also possible allergic rash, hives and itching. Pipemid acid in patients with deficiency of glucose-6-dihydrogenase can cause hemolytic anemia.

Overdose:When an overdose of the drug can be observed nausea, vomiting, headache, confusion, tremor, in more severe cases - convulsions.It is recommended to wash the stomach, monitor vital functions (circulation, breathing). Removal of the drug from the body can be accelerated with the help of forced diuresis. The drug is well excreted from the blood plasma by hemodialysis. There is no specific antidote.

Interaction:Pipemid acid causes inhibition of the hepatic enzyme P450, in connection with which, especially important reactions of interaction are noted after simultaneous application of the drug with theophylline and caffeine. A significant increase in the concentration of these two drugs in the blood plasma, as a result of a slowing of their metabolism, can be the cause of their undesirable actions.


Special instructions:When there are allergic reactions to the drug - it is necessary to stop using it. With prolonged use of the drug, you should monitor the overall blood count, perform liver and kidney tests and repeat the antibioticogram. Care should be taken when prescribing the drug for elderly people (over 70 years) and patients with impaired renal function. In the treatment avoid exposure to sunlight and quartz due to possible photosensitization.Be careful when prescribing patients who have a history of cerebral hemorrhage, cerebral circulation and cerebral vascular spasms, as well as convulsions. Patients with epilepsy should be prescribed strictly following the indications with observance of precautionary measures. Pipemidic acid is not recommended for oliguria and anuria. During the course of treatment it is recommended to increase the amount of fluid consumed (under the control of diuresis).

Form release / dosage:Capsules of 200 mg.

Packaging:10 capsules in a PVC / Al-foil blister; 2 blisters in a cardboard box, together with instructions for use.

Storage conditions:In a dry place, at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:5 years.
Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N012886 / 01
Date of registration:26.12.2007
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
KRKA, d.d. Slovenia
Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Information update date: & nbsp26.12.2007
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