Trade Names:Factive- Tablets 320 mg
Interferes with microbial DNA synthesis.
Rapidly absorbed from the GI tract. Bioavailability is approximately 71%. C max is about 1.61 mcg/mL, and the AUC is about 9.93 mcg•h/mL.
Protein binding ranges from 55% to 73%. Mean Vd ss is 4.18 L/kg.
Metabolized to a limited extent by the liver.
61% in the feces and 36% in the urine as unchanged drug and metabolites. The half-life is approximately 7 h. The mean renal Cl following multiple doses was approximately 11.6 L/h.
Average increase in AUC of approximately 70% in patients with renal insufficiency. Dosage modification is recommended for patients with CrCl of 40 mL/min or less.Hepatic Function Impairment
No dosage adjustment is recommended in patients with mild, moderate, or severe hepatic impairment.
Treatment of acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia (mild to moderate) caused by susceptible strains of designated microorganisms.
Hypersensitivity to gemifloxacin, any member of the quinolone class of antimicrobial agents, or any component of the product.
PO 320 mg/day for 5 days.Community-Acquired Pneumonia (Mild to Moderate Severity)Adults
PO 320 mg/day for 5 to 7 days.Renal function impairmentAdults (CrCl 40 mL/min or less)
PO 160 mg every 24 h. Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis should receive 160 mg every 24 h.
Store tablets at room temperature (59° to 86°F). Protect from light.
May decrease the bioavailability of gemifloxacin. Do not take within 3 h before or 2 h after gemifloxacin.Probenecid
The renal Cl of gemifloxacin may be decreased, increasing the bioavailability and AUC.Sucralfate
May decrease the bioavailability of gemifloxacin. Take at least 2 h before sucralfate.Warfarin
Anticoagulant effect may be increased.
None well documented.
Prolonged QT, supraventricular tachycardia, syncope, transient ischemic attack (postmarketing).
Headache (4%); dizziness (2%).
Rash (4%); erythema multiforme, skin exfoliation (postmarketing).
Retinal hemorrhage (postmarketing).
Diarrhea (5%); nausea (4%); abdominal pain, vomiting (2%); pseudomembranous colitis (postmarketing).
Renal failure (postmarketing).
Hemorrhage, increased INR (postmarketing).
Increased ALT (2%); increased AST, platelets (1%).
Tendon rupture (postmarketing).
Anaphylactic reaction, facial swelling, peripheral edema, photosensitivity/phototoxicity reaction (postmarketing).
Gemifloxacin has been associated with an increased risk of tendonitis and tendon rupture in patients of all ages. The risk is increased in patients older than 60 yr of age, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants.
MonitorResponse to therapy
Monitor patient's response to therapy.
Category C .
Undetermined; however, other fluoroquinolones have been shown to be excreted in breast milk.
Safety and efficacy not established.
Mild to life-threatening. Discontinue drug at first sign of hypersensitivity reaction.
Reduced Cl may occur; decrease the dose in patients with CrCl of 40 mL/min or less.
Use of antibiotics may result in bacterial or fungal overgrowth.
Photosensitivity reaction may occur.
Use with caution in patients with CNS disease (eg, epilepsy) or patients predisposed to convulsions.
Sensory or sensorimotor axonal polyneuropathy, resulting in paresthesias, hypesthesia, dysesthesias, and weakness, has been reported in patients taking quinolones.
Consider possibility in patients with diarrhea.
Gemifloxacin may prolong the QT interval in some patients; avoid in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorder (eg, hypokalemia or hypomagnesemia), and patients receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents. Use gemifloxacin with caution in patients receiving drugs that prolong the QTc interval (eg, erythromycin, tricyclic antidepressants, antipsychotics) and in patients with ongoing proarrhythmic conditions (eg, clinically important bradycardia, acute MI).
Clinical manifestations of serious and sometimes fatal reactions that have been reported with gemifloxacin include acute hepatic necrosis or failure, acute renal insufficiency or failure, agranulocytosis, allergic pneumonitis, anemia (including hemolytic and aplastic), arthralgia, fever, hepatitis, interstitial nephritis, jaundice, leukopenia, myalgia, pancytopenia, rash, serum sickness, Stevens-Johnson syndrome, thrombocytopenia (including thrombotic thrombocytopenic purpura), toxic epidermal necrolysis, and vasculitis.
Tendonitis and rupture of the shoulder, hand, and Achilles tendons, requiring surgical repair and resulting in prolonged disability, have been reported in patients receiving fluoroquinolones. The risk may be increased in patients receiving corticosteroids, especially in elderly patients.
Possible QTc prolongation.
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