Pimidel (Capsules) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

J01MB04 (Pipedemic acid)

Active Substance

Pipemidic acid (Rec.INN registered by WHO)

Dosage Form

Pimidel

Capsules 200 mg: 10, 20, or 1000 pcs.

Dosage Form, Packaging, and Composition

Capsules are two-colored, opaque, hard, gelatin, with a dark green cap and an ivory-colored body; the capsule contents are a powder from white to slightly yellowish in color, partially lumpy.

Excipients: lactose monohydrate, colloidal anhydrous silicon dioxide, sodium starch glycolate, magnesium stearate.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs – boxes.
10 pcs. – blister packs (100) – cardboard boxes (1) – boxes.

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 in 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 ( two 200 mg capsules) taken twice daily.

Maintain this regimen for a full treatment course of 10 days, even if symptoms improve earlier.

For moderate to severe infections, a single dose increase to 600 mg ( three 200 mg capsules) twice daily may be warranted, as determined by a physician.

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

Adjust dosage in patients with mild to moderate renal impairment; the drug is contraindicated in severe renal impairment (creatinine clearance less than 10 ml/min).

Take doses at approximately 12-hour intervals to maintain consistent plasma levels.

Complete the entire prescribed course to ensure eradication of the pathogen and prevent the development of antibiotic 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 benefit for the mother outweighs the potential risk of side effects in 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 25°C (77°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.