Pelox-400 (Tablets) Instructions for Use

Marketing Authorization Holder

Wockhardt Ltd. (India)

ATC Code

J01MA03 (Pefloxacin)

Active Substance

Pefloxacin (Rec.INN registered by WHO)

Dosage Form

Pelox-400

Film-coated tablets, 400 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, capsule-shaped, with an engraving “PELOX” on one side and a score line on the other.

Excipients: corn starch, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, purified talc, tabcoat TC 2034, polyethylene glycol, titanium dioxide.

10 pcs. – blisters (1) – cartons.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

A broad-spectrum antimicrobial drug from the fluoroquinolone group. It acts bactericidally. The drug inhibits the bacterial enzyme DNA gyrase, resulting in disruption of DNA replication and synthesis of bacterial cellular proteins.

The drug is active against gram-positive bacteria Streptococcus spp., Acinetobacter spp., Clostridium perfringens; gram-negative bacteria Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Neisseria gonorrhoeae; intracellular microorganisms Chlamydia spp., Mycoplasma spp.

Gram-negative anaerobic bacteria Bacteroides spp. (except for Bacteroides fragilis), Mycobacterium tuberculosis, Spirochaeta are resistant to the drug.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug

• Kidney and urinary tract infections;
• Upper and lower respiratory tract infections;
• ENT infections;
• Digestive system infections (including mouth, teeth, jaws), gallbladder and biliary tract infections;
• Skin, mucous membrane and soft tissue infections;
• Musculoskeletal system infections;
• Abdominal and pelvic organ infections;
• Gonorrhea, chlamydia, prostatitis;
• Severe systemic infections: septicemia, bacteremia, endocarditis, meningoencephalitis, osteomyelitis;
• Surgical and hospital-acquired infections.

ICD codes

Dosage Regimen

The dosage regimen is set individually, depending on the location and severity of the infection, as well as the sensitivity of the microorganisms.

The drug is prescribed at 400 mg 2 times/day.

For patients with impaired renal function (with CrCl<20 ml/min) the single dose is 50% of the average daily dose with a frequency of administration of 2 times/day or the full single dose is administered once/day.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, dysbacteriosis.

From the CNS: headache, dizziness, insomnia, tremor, convulsions.

From the cardiovascular system: tachycardia.

From the hematopoietic system: thrombocytopenia, neutropenia.

From the musculoskeletal system: myalgia, arthralgia, tendinitis.

Allergic reactions: skin hyperemia, skin itching, urticaria.

Other: photosensitization, candidiasis.

Contraindications

• Epilepsy;
• Glucose-6-phosphate dehydrogenase deficiency;
• Pregnancy;
• Lactation (breastfeeding);
• Children and adolescents under 15 years of age;
• Hypersensitivity to pefloxacin or other drugs from the fluoroquinolone group.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

In hepatic insufficiency, adjustment of the dosage regimen is necessary (reduction of the single dose and frequency of administration proportional to the degree of functional impairment).

Use in Renal Impairment

For patients with impaired renal function (with CrCl<20 ml/min) the single dose is 50% of the average daily dose with a frequency of administration of 2 times/day or the full single dose is administered once/day.

Pediatric Use

The drug is contraindicated in children and adolescents under 15 years of age.

Special Precautions

The drug should be prescribed with caution in cerebral atherosclerosis, convulsive syndrome of unknown etiology.

During treatment, patients should receive plenty of fluids to prevent crystalluria.

Due to possible photosensitization during treatment with Pelox-400, UV radiation (contact with direct sunlight) should be avoided.

In renal and hepatic insufficiency, adjustment of the dosage regimen is necessary (reduction of the single dose and frequency of administration proportional to the degree of functional impairment).

Effect on ability to drive vehicles and operate machinery

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

Overdose

To date, no cases of overdose of Pelox-400 have been reported.

Drug Interactions

Concomitant administration of pefloxacin and theophylline may lead to an increase in the plasma concentration of theophylline due to competitive inhibition at cytochrome P₄₅₀ binding sites, which leads to an increase in the half-life of theophylline and an increased risk of its toxic effects.

Concomitant administration of antacids, as well as drugs containing aluminum, zinc, iron and magnesium ions, may cause a decrease in the absorption of pefloxacin, so the interval between the administration of these drugs should be at least 4 hours.

With simultaneous use of pefloxacin and anticoagulants, bleeding time is prolonged.

Probenecid slows down the excretion of pefloxacin.

Histamine H₂-receptor blockers prolong the half-life, reduce the total and renal clearance of pefloxacin.

Storage Conditions

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

Shelf Life

Shelf life – 3 years.

Pharmacy supply conditions

The drug is dispensed by prescription.

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.