Lomacin (Tablets) Instructions for Use

Marketing Authorization Holder

Wave Pharmaceuticals, Ltd. (India)

ATC Code

J01MA07 (Lomefloxacin)

Active Substance

Lomefloxacin (Rec.INN registered by WHO)

Dosage Form

Lomacin

Film-coated tablets, 400 mg: 5, 10, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white in color, capsule-shaped, white on the fracture.

Excipients: corn starch, microcrystalline cellulose, povidone, sodium carboxymethyl starch, colloidal silicon dioxide, purified talc, magnesium stearate.

Shell composition hypromellose, propylene glycol, titanium dioxide, purified talc, macrogol 6000, dichloromethane, isopropyl alcohol, chloroform.

5 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

Antimicrobial agent of the fluoroquinolone group. It has a bactericidal effect. Inhibits the activity of DNA gyrase, an enzyme involved in the transcription and replication of bacterial DNA.

It is highly active against aerobic gram-negative bacteria: Escherichia coli, Salmonella spp., Citrobacter diversus, Enterobacter cloacae, Haemophilus influenzae, Klebsiella pneumoniae, Proteus vulgaris, Morganella morganii, Legionella pneumophila, Neisseria gonorrhoeae, Neisseria meningitidis, Moraxella catarrhalis.

Proteus mirabilis, Proteus stuartii, Providencia rettgeri, Pseudomonas aeruginosa, Serratia liquefaciens, Serratia agglomerans, Haemophilus parainfluenzae, Providencia alcalifaciens, Aeromonas hydrophila, Hafnia alvei, Mycobacterium tuberculosis, Chlamydia trachomatis, as well as some gram-positive aerobic bacteria (Staphylococcus aureus, Staphylococcus epidermidis) are moderately sensitive to lomefloxacin.

Streptococcus spp., Pseudomonas cepacia, Ureaplasma urealyticum, Mycoplasma hominis and anaerobic bacteria are resistant to lomefloxacin.

Lomefloxacin has antituberculosis activity, acting on both extracellular and intracellular Mycobacterium tuberculosis.

Pharmacokinetics

After oral administration, Lomefloxacin is almost completely absorbed from the gastrointestinal tract, absorption is 95-98%. Plasma protein binding is 10%.

It is widely distributed in the body. Concentrations in body tissues and fluids are generally 2-7 times higher than in plasma, especially in prostate tissue and urine.

The T_1/2 of lomefloxacin is 7-9 hours. About 70-80% is excreted unchanged in the urine within 24 hours.

In patients with impaired renal function, T_1/2 is significantly increased.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to lomefloxacin, including urinary tract infections (cystitis, pyelonephritis), prostatitis; lower respiratory tract infections; acute and chronic purulent soft tissue infections, infected wounds, osteomyelitis; cholera (severe form); tuberculosis (as part of combination therapy); acute and chronic gonorrhea; acute and recurrent chlamydia.

Prevention of infectious complications of the urinary tract before and after transurethral surgical operations.

For topical use in ophthalmology: bacterial infections of the anterior segment of the eye (including conjunctivitis, blepharitis, blepharoconjunctivitis).

ICD codes

Dosage Regimen

Take one 400 mg tablet once daily for most infections, including urinary tract infections (cystitis, pyelonephritis), lower respiratory tract infections, and soft tissue infections.

For prostatitis and osteomyelitis, administer one 400 mg tablet twice daily (total daily dose 800 mg).

For uncomplicated gonorrhea, take a single 400 mg dose.

For tuberculosis as part of combination therapy, the usual dose is 400 mg once daily.

For surgical prophylaxis of urinary tract infections, take a single 400 mg dose 2-6 hours before the procedure.

The standard treatment duration is 7-14 days, depending on the severity and type of infection. Continue treatment for at least 3 days after symptoms have resolved.

Take the tablet with a full glass of water, at least 2 hours before or 2 hours after meals, antacids, or mineral supplements.

In patients with renal impairment, adjust the dosage based on creatinine clearance (CrCl). For CrCl < 40 mL/min/1.73 m² or serum creatinine > 2.4 mg/dL, reduce the dose to one 400 mg tablet every 24 hours.

For ophthalmic use, instill 1-2 drops into the affected eye(s) every 4-6 hours (2-3 times/day) for 7-10 days. Apply more frequently at the beginning of treatment if necessary.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea.

From the CNS headache, anxiety, sleep disorders.

Dermatological reactions in some cases – photosensitivity, skin rash.

Effects due to chemotherapeutic action: with prolonged use, candidiasis is possible.

Local reactions rarely – a burning sensation that occurs immediately after instillation.

Contraindications

Pregnancy, lactation (breastfeeding), children and adolescents under 15 years of age, hypersensitivity to quinolone derivatives.

Use in Pregnancy and Lactation

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

Use in Renal Impairment

In case of impaired renal function, correction of the dosage regimen is required depending on the CC values.

Pediatric Use

Contraindicated in children and adolescents under 15 years of age.

Special Precautions

It should be used with caution in severe cerebral atherosclerosis, epilepsy and other diseases of the central nervous system.

In case of impaired renal function, correction of the dosage regimen is required depending on the CC values.

During treatment, prolonged exposure to sunlight and the use of artificial ultraviolet lighting should be avoided.

Do not use topically simultaneously with antibiotics for use in ophthalmology that act bacteriostatically.

Vitamins with mineral supplements should be taken 2 hours before or 2 hours after taking lomefloxacin.

It should be borne in mind that when using fluoroquinolones, peripheral neuropathy is possible; adverse effects on tendons (including ruptures) both during and after therapy; accumulation of caffeine, leading to stimulation of the central nervous system; pseudomembranous colitis; prolongation of the QT_c interval (risk of ventricular arrhythmia, including torsades de pointes).

Drug Interactions

With simultaneous use with antacids and sucralfate, chelate complexes are formed, which reduces the bioavailability of lomefloxacin (antacids and sucralfate should not be taken within 4 hours before and 2 hours after taking lomefloxacin).

With simultaneous use with rifampicin (in patients with tuberculosis), antagonism of action is observed.

With simultaneous use, Lomefloxacin practically does not inhibit the metabolism of theophylline.

With simultaneous use of lomefloxacin and caffeine in high doses, an increase in the T_1/2 of the latter is possible.

Drugs that block tubular secretion slow down the excretion of lomefloxacin.

With simultaneous use, Lomefloxacin increases the activity of oral anticoagulants and increases the toxicity of NSAIDs.

With simultaneous use of fluoroquinolones with NSAIDs, the development of seizures is possible.

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.