Pipelin (Capsules) Instructions for Use

Marketing Authorization Holder

Skopinsky Pharmaceutical Plant, CJSC (Russia)

ATC Code

J01MB04 (Pipedemic acid)

Active Substance

Pipemidic acid (Rec.INN registered by WHO)

Dosage Form

Pipelin

Capsules 200 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the quinoline group

Pharmacotherapeutic Group

Antimicrobial agent, quinolone

Pharmacological Action

Uroantiseptic, a 4-quinolone derivative. It exerts a bactericidal effect by binding divalent iron ions and inhibiting 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 the drug orally.

The standard adult dosage is 400 mg taken twice daily.

Adhere to a treatment course of 10 days.

For more severe infections, a single dose may be increased to 600 mg under medical supervision.

For frequent acute urinary tract infections in women, apply the drug intravaginally in conjunction with oral administration.

Take capsules with a full glass of water.

To ensure adequate drug concentration, maintain consistent intervals between doses, approximately every 12 hours.

Do not exceed the prescribed daily dose.

Complete the entire prescribed course of therapy, even if symptoms improve.

In case of a missed dose, take it as soon as remembered unless it is almost time for the next dose; do not double the dose.

For all dosage adjustments, strictly follow the prescribing physician’s instructions.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea.

Allergic reactions skin rash, itching.

Contraindications

Severe renal impairment (CC<10 ml/min), severe hepatic impairment, I and III trimesters of pregnancy, childhood, hypersensitivity to pipemidic acid.

Use in Pregnancy and Lactation

Pipemidic acid is contraindicated for use in the I and III trimesters of pregnancy. Use in the II 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 (CC<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 alkalinize the 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.