Sparfloxacin INN

To be submitted at the time of inclusion.

Tablet
Each tablet contains Sparfloxacin INN 200 mg.

Sparfloxacin is indicted for the treatment of following infections due to susceptible microorganisms:
• Upper and lower respiratory tract infection 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
• Prophylactic uses in different urological and ophthalmic surgeries.
• Other uses include treatment of tuberculosis in combination with rifampicin and isoniazid, treatment of leprosy in combination with standard drugs.

Sparfloxacin can be taken with or without food. In patients with normal renal function the recommended daily adult dose is two tablets of 200 mg on first day as a loading dose, thereafter one tablet of 200 mg every 24 hours for a total of 5 to 10 days of therapy. In patients with impaired renal function the recommended daily adult dose is two tablets of 200 mg on first day as a loading dose, thereafter one tablet of 200 mg every 48 hours for a total of 5 days of therapy.

Most of the adverse events are mild to moderate in severity and transient in nature. The most frequently reported events among the sparfloxacin treated patients with the recommended dosages are: Diarrhoea, nausea, dyspepsia, dizziness, insomnia, abdominal pain, tendinitis, sleep disturbances, allergy, headache, phototoxicity, cardiac rhythm disturbances have been reported in rare cases.

Patients with renal disease, dose adjustment is needed (creatinine clearance <30 ml/min).

Hypersensitivity to fluoroquinolones including sparfloxacin
• Pregnancy and lactation
• History of Achilles tendinitis following the use of fluoroquinolones
• Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency

As sparfloxacin may prolong the QT, interval it should not be administered concomitantly with other drugs known to have this effect (such as the antihistamines astemizole, terfenadine, cisapride, erythromycin, pentamidine, phenothiazine or tricyclic antidepressants). Sparfloxacin dose not appear to interact with theophiline or caffeine, nor with warfarin or cimetidine. Probenecid dose not alter the pharmacokinetics of sparfloxacin..

Sparfloxacin should be administered only if the potential maternal benefits justify the risks to the foetus/neonate.

• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.

To be submitted at the time of inclusion.