Sitaflo^®

Sitaflo is the preparation of Sitafloxacin, which is a broad-spectrum fluoroquinolone antibiotic with potent activity against Gram-positive, Gram-negative, anaerobic and atypical pathogens. Sitafloxacin exerts its bactericidal action by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription repair and recombination. Inhibition of these enzymes results in the disruption of bacterial DNA processes leading to rapid bacterial cell death. Sitafloxacin is active against a wide range of aerobic and anaerobic bacteria, including resistant strains.

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Sitaflo is indicated for the treatment of infections caused by susceptible organisms including:

• Acute bacterial sinusitis
• Community-acquired pneumonia
• Chronic bronchitis (Acute exacerbations)
• Uncomplicated and complicated urinary tract infections
• Prostatitis
• Pelvic inflammatory disease
• Skin and soft tissue infections

Route of administration: Sitaflo should be taken in oral route. Sitafloxacin should be taken after meals to improve gastrointestinal tolerance.
The usual adult dosage is 50 mg of Sitaflo twice daily.
If a dose is missed, dose should be taken as soon as possible. If it is almost time for the next dose, skip the missed dose and continue regular dosing schedule. Two doses at one time should never be taken.

Renal impairment
In patients with renal impairment the dosage should be adjusted based on creatinine clearance levels. Dose adjustment is recommended in patients with moderate to severe renal dysfunction (creatinine clearance < 50 mL/min), as sitafloxacin is primarily excreted via the kidneys.

Use in pregnancy and lactation
Sitafloxacin is contraindicated during pregnancy and lactation due to the potential risk of cartilage damage in the developing fetus and neonates.

Use in children and adolescents
The safety and efficacy of sitafloxacin in pediatric patients have not been established. Its use in individuals under 18 years is generally not recommended due to the risk of arthropathy.

Sitafloxacin should be used with caution in patients with CNS disorders (e.g., epilepsy) due to risk of seizures. Avoid concurrent use with other drugs that prolong the QT interval. Ensure adequate hydration to prevent crystalluria. Discontinue therapy immediately at the first sign of tendon pain or inflammation.

The most common side effects are nausea, diarrhea, abdominal pain, dyspepsia, dizziness headache, insomnia, anxiety, eosinophilia, leukopenia, rash, pruritus, urticaria, arthralgia, tendonitis.

Contraindication
It is contraindicated in patients with known hypersensitivity to sitafloxacin or other fluoroquinolones or any other components of this product. It is also contraindicated in patients with history of tendon disorders related to quinolone use. It is contraindicated in pregnancy and lactation.

Drug interaction with medication: Concomitant use with antacids containing magnesium or aluminum, sucralfate, iron or multivitamins can significantly reduce absorption of Sitafloxacin, this should be taken at least 2 hours apart. Co-administration with non-steroidal anti-inflammatory drugs (NSAIDs) may increase CNS stimulation and risk of seizures. Use with caution alongside drugs that prolong QT interval (e.g., antiarrhythmics, certain antidepressants, macrolides).

Drug interaction with food and others: Not applicable.

In case of overdose, supportive care and symptomatic treatment are recommended. Gastric lavage may be performed in recent ingestion. Adequate hydration must be maintained. Sitafloxacin is not significantly removed by dialysis.

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Sitaflo 50 Tablet: Each coated tablet contains Sitafloxacin 50 mg as Sitafloxacin Hydrate INN.

Storage
Keep away from the reach of children. Store below 30°C in a dry place, protectedfrom light.

Packing
Sitaflo 50 Tablet: Carton of 10 tablets in blister pack.