Lomflox^® (Tablets) Instructions for Use

Marketing Authorization Holder

Ipca Laboratories Ltd. (India)

ATC Code

J01MA07 (Lomefloxacin)

Active Substance

Lomefloxacin (Rec.INN registered by WHO)

Dosage Form

Lomflox®

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

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, capsule-shaped, biconvex, with a score on one side and the inscription “LOMFLOX 400” on the other side; the appearance of the tablet on a cross-section: a thin coating and a homogeneous core mass of white or almost white color.

Excipients: lactose – 92.1 mg, corn starch – 33.72 mg, povidone – 7.5 mg, sodium carboxymethyl starch – 31.28 mg, crospovidone – 2 mg, talc – 10.05 mg, sodium lauryl sulfate – 6.5 mg, magnesium stearate – 3.5 mg, macrogol – 2.05 mg, colloidal silicon dioxide – 5 mg.

Coating composition: hypromellose – 6.8 mg, titanium dioxide – 4.1 mg, 2-propanol*, methylene chloride*.

* removed during the manufacturing process.

5 pcs. – blisters (1) – cardboard packs.
5 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Systemic antibacterial agents; quinolone derivatives; fluoroquinolones

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.

Moderately sensitive to lomefloxacin are 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).

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

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 in 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, the 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.

Prophylaxis 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

Administer one 400 mg tablet once daily for most infections.

For urinary tract infections (cystitis, pyelonephritis), the standard course is 7-10 days.

For chronic prostatitis, extend the treatment duration to 28 days.

For lower respiratory tract infections (bronchitis, pneumonia), treat for 7-14 days.

For skin and soft tissue infections, the typical duration is 7-14 days.

For acute, uncomplicated gonorrhea, administer a single 800 mg dose (two 400 mg tablets).

For chlamydial infections, a 14-day course is required.

For surgical prophylaxis of urinary tract infections, administer 400 mg 2-6 hours preoperatively.

Take tablets with a full glass of water, at least 2 hours before or 2 hours after meals.

In patients with renal impairment, adjust the dosage based on creatinine clearance (CrCl).

For CrCl 10-40 mL/min, administer 400 mg initially, then 200 mg daily.

For CrCl <10 mL/min, administer 400 mg initially, then 200 mg every 48 hours.

For ophthalmic use, instill 1-2 drops into the affected eye(s) every 2-4 hours for the first 2 days.

Subsequently, reduce frequency to 2-4 times daily for a total treatment period of 7-10 days.

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

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 occurring 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 lactation (breastfeeding).

Use in Renal Impairment

In case of impaired renal function, dose adjustment is required depending on the CC values.

Pediatric Use

Contraindicated in children and adolescents under 15 years of age.

Special Precautions

Use with caution in severe cerebral atherosclerosis, epilepsy and other CNS diseases.

In case of impaired renal function, dose adjustment is required depending on the CC values.

During treatment, prolonged exposure to sunlight and the use of artificial ultraviolet illumination 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 lomefloxacin application.

It should be borne in mind that when using fluoroquinolones, the following are possible: peripheral neuropathy; adverse effects on tendons (including ruptures) both during and after therapy; accumulation of caffeine, leading to CNS stimulation; pseudomembranous colitis; QT_c interval prolongation (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, seizures may develop.

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.