Pipegal (Capsules) Instructions for Use

Marketing Authorization Holder

Galenika, a.d. (Serbia)

ATC Code

J01MB04 (Pipedemic acid)

Active Substance

Pipemidic acid (Rec.INN registered by WHO)

Dosage Form

Pipegal

Capsules 200 mg: 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the quinoline group

Pharmacotherapeutic Group

Antimicrobial agent, quinolone

Pharmacological Action

Uroantiseptic, a derivative of 4-quinolone. It has a bactericidal effect due to the binding of divalent iron ions and inhibition of the enzymatic systems of the microbial cell.

It is active against most gram-negative bacteria: Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Shigella spp., Salmonella spp.

It is also active against some gram-positive bacteria, in particular Staphylococcus aureus.

Pharmacokinetics

After oral administration, C_max in blood plasma is reached after 2 hours. Bioavailability is 60%, plasma protein binding is 15%. T_1/2 is 3 hours. 50-70% is excreted in the urine.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms (including pyelonephritis, urethritis, cystitis, prostatitis).

ICD codes

Dosage Regimen

Administer orally with a full glass of water.

The standard adult dosage is 400 mg twice daily, equivalent to two 200 mg capsules per dose.

Maintain this regimen for a full 10-day course, even if symptoms improve earlier.

For more severe infections, a single dose may be increased to 600 mg (three capsules) twice daily, as determined by a physician.

In cases of frequent acute urinary tract infections in women, an intravaginal formulation may be used concurrently with oral therapy.

For all patients, ensure adequate hydration by increasing fluid intake, while monitoring urinary output.

Complete the entire prescribed course to ensure eradication of the infection and prevent the development of resistance.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea.

Allergic reactions: skin rash, itching.

Contraindications

Severe renal impairment (creatinine clearance <10 ml/min), severe hepatic impairment, first and third trimesters of pregnancy, childhood, hypersensitivity to pipemidic acid.

Use in Pregnancy and Lactation

Pipemidic acid is contraindicated for use in the first and third trimesters of pregnancy. Use in the second trimester of pregnancy and during lactation (breastfeeding) should be carried out with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects for the fetus or child.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment (creatinine clearance <10 ml/min).

Pediatric Use

Contraindicated in childhood.

Special Precautions

During treatment, ultraviolet radiation should be avoided due to the high risk of photosensitivity; increase the amount of fluid consumed (under the control of diuresis).

Drug Interactions

With simultaneous use with drugs that alkalize urine, the activity of pipemidic acid is enhanced.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.