Bacterial infections:

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.

Adult Dosage:

≥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.

Children Dosage:

<18yrs: not established.

Boxed Warning:

Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.

FACTIVE Warnings/Precautions:

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.

FACTIVE Classification:


FACTIVE Interactions:

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.

Adverse Reactions:

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.

Generic Drug Availability:


How Supplied:

Tabs—5, 7