Indications for FACTIVE:
Susceptible infections including acute bacterial exacerbation of chronic bronchitis (ABECB) and mild-to-moderate community-acquired pneumonia. For ABECB: reserve for those who have no alternative treatment options.
≥18yrs: Swallow whole. Take with full glass of water. 320mg once daily. ABECB: treat for 5 days. Community-acquired pneumonia: treat for 5 or 7 days (based on susceptible bacteria; see full labeling). Renal impairment and dialysis: CrCl ≤40mL/min: 160mg every 24hrs.
<18yrs: not established.
Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.
Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS/psychiatric effects); discontinue immediately if signs/symptoms occur. Epilepsy or predisposition to convulsions. History of myasthenia gravis; avoid. History of QT prolongation, ventricular arrhythmias, proarrhythmic conditions (eg, bradycardia, acute myocardial ischemia), electrolyte disorders (eg, hypokalemia, or hypomagnesemia); avoid. Increased risk of aortic aneurysm and dissection (esp. in elderly); reserve use only if no alternatives in patients with history or risk of. Do not exceed recommended dose and length of therapy esp. in renal or hepatic impairment; may increase QT prolongation. Monitor blood glucose in diabetic patients; discontinue if hypoglycemia occurs. Discontinue at 1st sign of a skin rash, jaundice, or any other hypersensitivity. Maintain adequate hydration. Avoid excessive sun or UV light. Elderly. Pregnancy. Nursing mothers.
Avoid drugs that prolong QTc interval (eg, Class IA or Class III antiarrhythmics, erythromycin, antipsychotics, tricyclics). Separate dosing of magnesium- or aluminum-containing antacids and didanosine (buffered forms), sucralfate, iron, zinc, other metal cations (do not take within 3hrs before or 2hrs after gemifloxacin). Potentiated by probenecid. Increased risk of tendinitis/tendon rupture with corticosteroids. Concomitant antidiabetics may increase blood glucose disturbances. Monitor warfarin.
Diarrhea, headache, nausea, rash, abdominal pain, dizziness, vomiting, urticaria, elevated liver enzymes; tendinitis/tendon rupture, peripheral neuropathy, CNS effects, aortic aneurysm/dissection, phototoxicity (discontinue if occurs), QT prolongation, C. difficile-associated diarrhea, dysglycemia.