Monograph Details
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Infections & Infestations
> Bacterial infections
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FACTIVE |
| Manufacturer |
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Oscient Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Quinolone. |
| Generic Name |
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Gemifloxacin mesylate 320mg; scored tabs. |
| Indications |
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Susceptible infections including acute bacterial exacerbation of chronic bronchitis and mild to moderate community-acquired pneumonia. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: Swallow whole. Take with full glass of water. 320mg once daily. Bronchitis: treat for 5 days. Community-acquired pneumonia: treat for 5 or 7 days (based on susceptible bacteria; see literature). Renal impairment and dialysis: CrCl≤40mL/min: 160mg every 24 hours. |
| Precautions |
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Maintain adequate hydration. Discontinue if rash, other signs of hypersensitivity, phototoxicity, CNS stimulation, or tendon pain, inflammation, or rupture occurs. CNS disorders (eg, epilepsy). Avoid sunlight, UV light. History of QTc prolongation, electrolyte disorders (eg, hypokalemia), or proarrhythmic conditions. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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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, sucralfate, iron, zinc, other metal cations (do not take within 3 hours before or 2 hours after gemifloxacin). Potentiated by probenecid. Monitor warfarin. |
| Adverse Reactions |
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GI upset, rash, headache, abdominal pain, dizziness, elevated liver enzymes, photosensitivity; rarely: tendinitis/rupture, convulsions. |
| How Supplied |
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Tabs—5, 7 |
| Additional Resources |
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• Related Prescribing Note |
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