Sitafloxacin is indicated for the treatment of various bacterial infections, including laryngopharyngitis, tonsillitis, acute bronchitis, pneumonia, and secondary bacterial infections associated with chronic respiratory diseases. It is also used for urinary tract infections such as cystitis, pyelonephritis, and urethritis; gynecological infections such as cervicitis; ear and sinus infections including otitis media and sinusitis; and dental infections such as periodontitis, pericoronitis, and osteitis of the jaw.

Sitafloxacin is a broad-spectrum antibacterial agent that is active against aerobic and anaerobic Gram-positive and Gram-negative bacteria, as well as atypical bacteria. Its mechanism of action involves inhibition of bacterial DNA gyrase and topoisomerase IV, two essential enzymes required for bacterial DNA replication. By inhibiting these enzymes, Sitafloxacin exerts its bactericidal effect. Compared with other quinolone antimicrobials used as reference agents, Sitafloxacin shows stronger inhibitory activity against these enzymes. It also demonstrates potent activity against enzymes found in quinolone-resistant bacteria.

Recommended Dose: 50 mg twice daily or 100 mg once daily for all indications:

• Laryngopharyngitis, acute bronchitis & tonsillitis: 3-7 days
• Pneumonia and secondary infections of chronic respiratory diseases: 7 days
• Acute cystitis: 3 days
• Acute pyelonephritis & complicated urinary tract infection: 7-14 days
• Urethritis and cervicitis: 7 days
• Acute otitis media and sinusitis: 7 days
• Acute exacerbation of chronic otitis media and sinusitis: 7 days
• Periodontitis, pericoronitis and osteitis of jaw: 3-7 days

For patients suspected of having a poor response to the usual dosage, a dosage of Sitafloxacin 50 mg tablet may be increased to 100 mg, administered orally twice daily.  Not for use by children under 18 years.

Renal & Hepatic Impaired Patients: Careful administration should be taken with renal & hepatic impairment patients and if any abnormal symptoms occur, it should be discontinued and appropriate measure should be taken.

Sitafloxacin should be used with caution when co-administered with certain medicines, including antacids containing aluminum or magnesium, NSAIDs containing phenylacetic acid such as ketoprofen, and products containing calcium or iron.

Sitafloxacin is contraindicated in patients with a known hypersensitivity to Sitafloxacin, any of its components, or other quinolone antibiotics.

Pediatric Use :The safety of Sitafloxacin has not been established in low-birth-weight infants, newborns, infants, toddlers, children, or adolescents.

The most commonly reported adverse reactions include rash, dizziness, headache, diarrhea, loose stool, stomach discomfort, abdominal bloating, abdominal pain, constipation, indigestion, nausea, and stomatitis. If any of these symptoms occur, patients should consult a doctor or pharmacist.

Pregnancy: Sitafloxacin should not be used in pregnant women or in women who may be pregnant, as its safety in these populations has not been established.

Lactation: Breastfeeding should be avoided during treatment with Sitafloxacin. Preclinical studies in rats have shown that Sitafloxacin is excreted into milk.

Sitafloxacin should be used with caution in patients with seizure disorders such as epilepsy, or in those with a history of convulsions. Caution is also advised in patients with myasthenia gravis, and in patients with aortic aneurysm or aortic dissection, including those with a previous history, a positive family history, or risk factors for these conditions. Elderly patients should also be treated carefully, as they generally have reduced physiological function.

Phototoxicity has been observed after exposure to ultraviolet light in subjects who received oral Sitafloxacin 500 mg once or twice daily. Prolongation of the QT interval was also observed in a dose-dependent manner, with a mean fluctuation range of 10 msec or less, following intravenous administration of Sitafloxacin 400 to 800 mg twice daily.

Fourth-generation cephalosporins

Do not store above 25°C. Protect from light. Keep out of the reach of children.