The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Pronunciation: JEM-i-FLOX-a-sin MES-i-late
- 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.
Special PopulationsRenal Function Impairment
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.
Indications and Usage
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.
Dosage and AdministrationAcute Bacterial Exacerbation of Chronic Bronchitis
PO 320 mg/day for 5 days.Community-Acquired Pneumonia (Mild to Moderate Severity)
PO 320 mg/day for 5 to 7 days.Renal function impairment
Adults (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.
- Administer gemifloxacin 3 h before or 2 h after sucralfate, antacids containing magnesium or aluminum, didanosine chewable buffered tablets or pediatric powder, or other products containing iron or zinc.
- Administer prescribed dose with a full glass of water.
- Administer without regard to meals, but administer with food if GI upset occurs.
Store tablets at room temperature (59° to 86°F). Protect from light.
Drug InteractionsAntacids containing aluminum, magnesium, and calcium; didanosine; drug formulations containing divalent and trivalent cations; metal cations (eg, iron); multivitamins containing iron or zinc
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.
Laboratory Test Interactions
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.
Clostridium difficile –associated diarrhea
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.
Tendon and cartilage effects
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.
- Advise patient to read patient information leaflet before starting therapy and with each refill.
- Review dosing schedule and prescribed length of therapy with patient.
- Instruct patient to take each dose with a full glass of water.
- Advise patient that medication can be taken without regard to meals, but to take with food if GI upset occurs.
- Advise patient that if a dose is missed to take as soon as remembered. However, if it is nearing the time for the next dose, they should skip the dose and take the next dose at the regularly scheduled time. Caution patient not to take more than 1 dose of medication in a day.
- Remind patient to complete entire course of therapy, even if symptoms of infection have disappeared.
- Advise patient to inform health care provider if infection does not improve or worsens.
- Advise patient to drink fluids liberally (eg, eight 8 oz glasses of water daily) while taking this medication.
- Advise patient to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, shortness of breath, palpitations, fainting, pain, tenderness, or rupture of tendon occur.
- Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not to treat at home.
- Caution patient that drug may cause dizziness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
- Advise patient to avoid unnecessary exposure to direct and indirect sunlight or tanning lamps, and to use sunscreen and wear protective clothing to avoid photosensitivity reactions during therapy and for several days after stopping medication. Advise patient to discontinue therapy and notify health care provider if any of the following occur following exposure to sunlight or artificial UV light (eg, sunlamp): sensation of skin burning, redness, swelling, blistering, rash, or itching.
- Inform patient not to take antacids containing magnesium and/or aluminum or products containing ferrous sulfate (iron), multivitamins containing zinc or other metal cations, or didanosine chewable buffered tablets or pediatric powder within 3 h before or 2 h after taking gemifloxacin.
- Inform patient that gemifloxacin may produce prolongation of the QTc interval on an ECG.
- Instruct patient to inform health care provider of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, or acute MI, or history of convulsions.
Copyright © 2009 Wolters Kluwer Health.