Generic Name and Formulations:
Gemifloxacin mesylate 320mg; scored tabs.
Merus Labs International, Inc.
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. 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 (Cat.C), nursing mothers: not recommended.
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, rash, nausea, urticaria, headache, abdominal pain, vomiting, dizziness, elevated liver enzymes; tendinitis/tendon rupture, peripheral neuropathy, CNS effects, phototoxicity (discontinue if occurs), QT prolongation, C. difficile-associated diarrhea, dysglycemia.