Sitamax

Sitamax is indicated for bacterial infections like laryngopharyngitis, tonsillitis, acute bronchitis, pneumonia, and secondary infection of chronic respiratory diseases; Cystitis, pyelonephritis, and urethritis; cervicitis; otitis media and sinusitis; periodontitis, pericoronitis, and osteitis of jaw.

Sitafloxacin has a broad spectrum of antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria, as well as atypical bacteria. The mechanism of action of Sitafloxacin involves inhibition of bacterial DNA gyrase and topoisomerase IV. Bactericidal activity of Sitafloxacin results from inhibition of these enzymes. The inhibitory activity of Sitafloxacin against these enzymes was higher than that of the other quinolone antimicrobials used as comparators. Sitafloxacin also has a potent inhibitory activity against enzymes from 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.

Sitamax should be co-administered with care when administered with the following drugs. Antacids containing aluminum, magnesium, NSAIDs containing phenylacetic acid e.g., Ketoprofen, drugs containing calcium, iron.

It is contraindicated in the following patients : Patients with a history of hypersensitivity to any ingredients of Sitafloxacin or other quinolones. Pediatric patients : The safety of Sitafloxacin in low-birth-weight infants, newborn infants, infants and toddlers, children and adolescents has not been established.

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, consult with your doctor or pharmacist.

Pregnancy : Sitafloxacin must not be used in pregnant women or women suspected of being pregnant. The safety of the product in these populations has not been established. Lactation : Nursing mothers must be guided to avoid the breast-feeding during treatment with Sitafloxacin. Preclinical studies showed that Sitafloxacin is excreted into milk in rats.

Sitamax should be used with caution in patients with convulsive diseases such as epilepsy or with a history of convulsive diseases, patients with myasthenia gravis, patients complicated with aortic aneurysm or aortic dissection, or patients who have a previous history, positive family history, or risk factors of aortic aneurysm or aortic dissection., elderly patients generally have reduced physiological function.

Phototoxicity was observed after exposure to ultraviolet irradiation in subjects orally administered with Sitamax 500 mg once or twice daily. The QT interval was prolonged in a dose-dependent manner with a mean fluctuation range of 10 msec or less, following intravenous administration of Sitamax 400 to 800 mg twice daily.

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