Adult Dosing
Acute bacterial exacerbation of chronic bronchitis
- 320 mg PO Daily for 5 days
Community-acquired pneumonia, mild to moderate
- 320 mg PO Daily for 5-7 days
Notes- Take without regard to meals and with liberal liquids (at least 100 mL)
- Do not take with supplements, antacids or other metal cations (eg, zinc, magnesium, iron)
Bronchiectasis [Non-FDA Approved]
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <40 mL/min,: 160 mg PO Daily
- Hemodialysis, continuous ambulatory peritoneal dialysis: 160 mg PO Daily
Notes- Administer dose following hemodialysis
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of gemifloxacin, use only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria
- Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all age groups. Discontinue the treatment if pain or inflammation in a tendon occurs
- Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia)
- Elevation of liver enzymes in hepatic insufficiency
- Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including gemifloxacin. Discontinue immediately at the appearance of any sign of an immediate type I hypersensitivity skin rash or any other manifestation of a hypersensitivity reaction
- Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have occurred in patients
- Discontinue therapy if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition
- Clostridium difficile-associated diarrhea (CDAD) has been reported with use the drug and may range in severity from mild diarrhea to fatal colitis
Cautions: use cautiously in
- Renal impairment
- Known or suspected CNS disorder
- Lowered seizure threshold
- Proarrhythmic condition
- Bradycardia
- Dehydration
- Concurrent Class IA antiarrhythmics (avoid use)
- Concurrent Class III antiarrhythmics (avoid use)
- Concurrent phenothiazines
- Concurrent tricyclic antidepressants
- Congenital long QT syndrome
- Concurrent use of corticosteroids ( risk of tendinitis/tendon rupture)
- Kidney, heart, or lung transplant patients ( risk of tendinitis/tendon rupture)
- Female patients
- Elderly patients
Pregnancy Category:C
Breastfeeding: Use not recommended unless potential benefit to the mother outweighs the risk to the fetus
Pricing data from www.DrugStore.com in U.S.A.
- Factive 320 MG TABS [Box] (CORNERSTONE BIOPHARMA)
5 mg = $219.99
15 mg = $629.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Factive 320 MG Oral Tablet
Ingredient(s): Gemifloxacin
Imprint: GE;320
Color(s): White
Shape: Oval
Size (mm): 16.00
Score: 2
Inactive Ingredient(s): crospovidone / hydroxypropyl methylcellulose / magnesium stearate / microcrystalline cellulose / polyethylene glycol / povidone / titanium dioxide
Drug Label Author:
Oscient Pharmaceuticals
DEA Schedule:
Non-Scheduled
