Aciflox^®

Aciflox® is the preparation of Sparfloxacin which is a synthetic, board spectrum bactericidal agent from the fluoroquinolone family. Mechanism of action: Sparfloxacin is a specific inhibitor of bacterial DNA gyrase and therefore bacterial DNA transcription and replication is disrupted resulting in DNA strand scission leading to rapid bactericidal effect.

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Aciflox® is indicated for the treatment of following infections due to susceptible microorganism - Upper and lower respiratory tract infections including sinusitis, acute exacerbation of chronic bronchitis, community acquired and hospital acquired pneumonia. - Urinary tract infections including gonococcal and nongonococcal urethritis, chancroid and other sexually transmitted diseases. - Skin and soft tissue infections. - Treatment of infections of prostate, for prophylaxis of ophthalmic surgeries like cataract removal, vitrectomy and in the treatment of endophthalmitis. - Other uses include treatment of tuberculosis in combination with rifampicin and isoniazid, treatment of leprosy in combination with standard drugs.

Route of administration: Aciflox® should be taken in oral route. It can be taken with or without food. The recommended daily dose of Aciflox® in patient with normal renal function is two 200 mg tablets taken on the first day as a loading dose. Thereafter, take one 200 mg tablet every 24 hours for a total of 4 to 9 days. Patients with renal impairment: The recommended daily dose of Aciflox® in patient with renal impairment (creatinine clearance < 50 ml/min), is two 200 mg tablets taken on the first day as a loading dose. Thereafter, one 200 mg tablet every 48 hours for 5 days of therapy.

No adequate studies are available. Sparfloxacin should be administered only if the potential benefits justify the risk to the fetus or neonates. Use in children and adolescents Safety of sparfloxacin in children below 12 years has not been established.

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Dose adjustment is required in patient with renal impairment (creatinine clearance< 50 ml/min).

The most common side effects of sparfloxacin are nausea, vomiting, diarrhea and less frequent side effects are anxiety, nightmares, hallucinations, rash, pruritus, urticaria. Photosensitivity reactions are most common with sparfloxacin.

Sparfloxacin is contraindicated in patient with known hypersensitivity to sparfloxacin or any of fluoroquinolones. It is also contraindicated in pregnancy, lactation, history of Achilles tendinitis following the use of fluoroquinolones, glucose-6-phosphate dehydrogenase (G6PD) deficiency and patient with a history of cardiac disease taking agents and medications known to prolong the QT intervals.

There is extremely low incidence of increased risk of cardiac arrhythmia on concomitant administration with bretylium disopyramide, quinidine sotalol, erythromycin, astemizole, terfenadine and vinca alkaloids due to prolonged QT interval.

Overdose experience is limited. Hydration, gastric lavage, supportive and symptomatic treatment are the mainstay of therapy. Dialysis is not useful due to high tissue uptake.

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Store in a cool (below 30'C) and dry place protected from light. Keep away from the reach of children.

Aciflox® 200 tablet: Each coated tablet contains Sparfloxacin INN 200 mg.

Aciflox® 200 tablet: Carton of 10 tablets in blister pack.