GEMIFLOXACIN FILM-COAT TB 320 MG 20 UNITS FACTIVE LG CHEM

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GEMIFLOXACIN FILM-COAT TB 320 MG 20 UNITS FACTIVE LG CHEM E

Contents Gemifloxacin mesylate Indications/Uses Mild to moderate community-acquired pneumonia. Dosage/Direction for Use Pneumonia due to S pneumoniae, H influenzae, M pneumoniae or C pneumoniae infection 1 tab once daily for 5 days. Pneumonia due to MDRSP, K pneumoniae or M catarrhalis infection 1 tab once daily for 7 days. Severe renal impairment, haemodialysis & continuous ambulatory peritoneal dialysis (CAPD) patient 160 mg once daily. Administration May be taken with or without food: Swallow whole w/ liberal amount of liqd. Contraindications Hypersensitivity to gemifloxacin or other fluoroquinolones. History of gemifloxacin or other fluoroquinolone-associated tendonitis & tendon rupture. Pregnancy & lactation. Childn or adolescents <18 yr. Special Precautions Discontinue use if photosensitivity, peripheral neuropathy, 1st sign of tendinitis or hypoglycemia occur; at 1st appearance of skin rash, jaundice or any other sign of hypersensitivity; Clostridium difficile-associated diarrhea is suspected or confirmed. Not to be used if signs of tendinopathy occurs. Avoid use in patients w/ known history of myasthenia gravis; prolonged QTc interval, uncorrected electrolyte disorders eg, hypokalemia or hypomagnesemia. Increased risk of retinal detachment. History of aneursym disease, preexisting aortic aneursym &/or aortic dissection, risk factors or conditions predisposing for aortic aneurysm & dissection eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, HTN, known atherosclerosis. Previous tendon disorder eg, RA; CNS diseases eg, epilepsy or predisposed to convulsions; ongoing proarrhythmic conditions eg, acute myocardial ischaemia; G6PD deficiency; risk factors or conditions predisposing for heart valve regurgitation/incompetence eg, congenital or preexisting heart valve disease, connective tissue disorders, Turner syndrome, RA, infective endocarditis; kidney, heart or lung transplants. Monitor blood glucose in diabetic patients. Ensure adequate hydration during treatment. Avoid excessive sun or UV light exposure. Avoid use of corticosteroids; class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmics. Concurrent use w/ erythromycin, antipsychotics & TCAs. May affect ability to drive & use machines. Renal & hepatic impairment. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly >60 yr. Adverse Reactions Diarrhea, headache, nausea, rash, abdominal pain, dizziness, vomiting. Thrombocythemia; constipation, dry mouth, dyspepsia, flatulence, gastritis; fatigue; fungal infection; increased ALT, AST, alkaline phosphatase & creatinine phosphokinase; anorexia, hyperglycemia; taste perversion; insomnia, somnolence; moniliasis genital, genital pruritus, vaginitis; dermatitis, pruritus, urticarial. Drug Interactions Reduced absorption w/ Al- &/or Mg-containing antacids, Fe sulfate, Ca prep, Zn- or Fe-containing multivit prep. Reduced oral bioavailability w/ sucralfate. Increased INR or prothrombin time &/or clinical bleeding episodes w/ warfarin & its derivatives. Reduced mean renal clearance w/ probenecid. Not to be taken w/ didanosine w/in 3 hr prior to treatment. MIMS Class Quinolones ATC Classification J01MA15 - gemifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

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