Palin^® (Capsules) Instructions for Use

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Lek d.d. (Slovenia)

ATC Code

J01MB04 (Pipedemic acid)

Active Substance

Pipemidic acid (Rec.INN registered by WHO)

Dosage Form

Palin®

Capsules 200 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Capsules opaque, size No. 1, with a white to white with a yellowish tint body and a green cap; the capsule contents are a hygroscopic powder from white to almost white with a yellowish tint.

Excipients: magnesium stearate, colloidal silicon dioxide, corn starch.

Composition of the capsule body titanium dioxide (E171), sunset yellow FCF (E110), gelatin.
Composition of the capsule cap titanium dioxide (E171), quinoline yellow (E104), patent blue V (E131), brilliant black BN (E151), sunset yellow FCF (E110), gelatin.

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

Clinical-Pharmacological Group

Antibacterial drug of the quinoline group

Pharmacotherapeutic Group

Antimicrobial agent, quinolone

Pharmacological Action

An antibacterial drug from the quinolone group. It acts bactericidally. The drug is active against gram-negative bacteria Escherichia coli, Klebsiella pneumoniae, Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Neisseria spp., Pseudomonas aeruginosa; gram-positive bacteria Staphylococcus aureus.

The drug is not active against anaerobic microorganisms.

Pharmacokinetics

Absorption

After oral administration of the drug at a dose of 400 mg, the C_max of pipemidic acid is reached in 70-80 minutes and is 3.5 µg/ml. Bioavailability is 30-60%.

Distribution

High concentrations of pipemidic acid are created in the kidneys, urine, and prostatic fluid.

Pipemidic acid crosses the placental barrier. It is excreted in breast milk in small amounts.

Elimination

Pipemidic acid is mainly excreted unchanged in the urine. 50-85% of the administered dose of the drug is determined in daily urine. The elimination of pipemidic acid is directly dependent on creatinine clearance. T_1/2 is 2 hours 15 minutes. Total clearance is 6.3 ml/min.

Pharmacokinetics in special clinical cases

In patients with impaired renal function, higher plasma concentrations of the drug are observed than in healthy volunteers.

T_1/2 is 5.7-16 hours.

Indications

Acute and chronic infectious and inflammatory diseases of the urinary tract caused by susceptible microorganisms

• Pyelonephritis;
• Urethritis;
• Cystitis;
• Prostatitis.

Prevention of infections during instrumental interventions in urological and gynecological practice.

ICD codes

Dosage Regimen

The drug is prescribed at a dose of 200 mg every 12 hours, in the morning and evening before meals.

For staphylococcal infections, the interval between doses of the drug should not exceed 8 hours (200 mg 3 times/day). The course of treatment averages 10 days. If necessary, the course of treatment can be extended depending on the course of the disease. The duration of the course of treatment is determined individually.

For kidney diseases, the course of treatment is 3-6 weeks, for prostatitis – 6-8 weeks. During therapy, the patient is recommended to drink plenty of fluids.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, gastralgia; rarely – pseudomembranous colitis with severe diarrhea.

From the central and peripheral nervous system extremely rarely – visual disturbances, headache, agitation, depression, confusion, hallucinations, tremor, convulsions, sleep disorders, sensory disturbances; very rarely – grand mal seizures.

From the hematopoietic system in patients with glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia may develop; there are isolated reports of eosinophilia development; in elderly patients and patients with impaired renal function, thrombocytopenia may develop.

Allergic reactions mild skin itching, skin rash, Stevens-Johnson syndrome.

Other photosensitivity, development of resistance, superinfection.

Contraindications

• Diseases of the central nervous system (neurological diseases with a lowered seizure threshold);
• Porphyria;
• Severe renal impairment (creatinine clearance <10 ml/min);
• Severe hepatic impairment (including cirrhosis);
• Pregnancy;
• Lactation (breastfeeding);
• Children and adolescents under 14 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The safety of Palin^® use during pregnancy and lactation has not been studied, therefore the drug is contraindicated for use during pregnancy. If it is necessary to use Palin^® during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment (including cirrhosis);

Use in Renal Impairment

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

Pediatric Use

The drug is contraindicated in children and adolescents under 14 years of age.

Special Precautions

The drug should be prescribed with caution to patients with a history of cerebrovascular accidents (including cerebral hemorrhage, cerebral vasospasm), convulsions; with epilepsy; to patients over 70 years of age (due to the increased risk of side effects in this category of patients).

During the drug intake, patients should receive plenty of fluids (under diuresis control).

Due to possible photosensitivity, UV exposure should be avoided during Palin^® intake.

Due to the possibility of developing cross-sensitivity, caution should be exercised when prescribing Palin^® to patients with a history of allergic reactions to quinolones.

With prolonged use of the drug, general blood counts should be monitored, liver and kidney functions should be determined, and the sensitivity of the microflora to pipemidic acid should be periodically determined.

When using the drug, a false-positive urine reaction for glucose may be observed when using Benedict’s reagent or Fehling’s solution. It is recommended to use enzymatic reactions with glucose oxidase.

Use in pediatrics

It is not recommended to use Palin^® in children. Pipemidic acid accumulates in cartilage. There are also reports of the development of muscle hypertonicity in newborns and children.

Effect on the ability to drive vehicles and mechanisms

When using the drug, one should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

There are no reports of the development of threatening side effects or fatal outcome with drug overdose.

Symptoms nausea, vomiting, dizziness, headache, confusion, tremor, convulsions.

Treatment there is no specific antidote. If less than 4 hours have passed since drug intake, gastric lavage followed by the administration of activated charcoal is necessary to reduce absorption. If side effects from the central nervous system develop (including epileptiform convulsions), symptomatic treatment (diazepam) is prescribed. The elimination of the drug can be accelerated by forced diuresis.

Drug Interactions

Pipemidic acid inhibits cytochrome P₄₅₀ isoenzymes, which leads to a slowdown in the metabolism of theophylline and caffeine when they are used concomitantly with Palin^®.

Concomitant use of antacids and sucralfate may cause a decrease in the absorption of pipemidic acid, so the interval between the administration of these drugs should be at least 2-3 hours.

Pipemidic acid may enhance the effects of warfarin, rifampicin, cimetidine, and NSAIDs when used concomitantly.

When pipemidic acid is used concomitantly with aminoglycosides, a synergism of bactericidal action is observed.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 5 years.

Dispensing Status

The drug is dispensed by prescription.

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.