Orasquin Tablet: Each film coated tablet contains Gemifloxacin Mesylate INN 398.976 mg equivalent to Gemifloxacin 320 mg.
Gemifloxacin is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.
Following oral administration of Gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender.
Acute bacterial exacerbation of chronic bronchitis- caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (of mild to moderate severity)- caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*; Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
• In acute bacterial exacerbation of chronic bronchitis Orasquin 320 mg tablet is given once daily for 5 days
• In community acquired pneumonia (of mild to moderate severity) Orasquin 320 mg tablet is given once daily for 5 days
• Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection Orasquin 320 mg tablet is given once daily for 5 days
• Due to known or suspected MDRSP*, K. pneumoniae or M. catarrhalis infection Orasquin 320 mg tablet is given once daily for 7 days
*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/ sulfamethoxazole.
Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction according to the following table-
Creatinine clearance: Dose
≥40 ml/min:Usual dose
<40 ml/min: 160 mg once daily
Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily.
Hepatic impairment: Gemifloxacin may be given to patients with hepatic impairment, with no requirement for dose adjustment.
Elderly patients: Dose adjustment is not required.