This dosage information may not include all the information needed to use Gemifloxacin safely and effectively. See additional information for Gemifloxacin.
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Bronchitis
Acute bacterial exacerbation of chronic bronchitis: 320 mg orally once a day for 5 days
Usual Adult Dose for Pneumonia
Mild to moderately severe community-acquired pneumonia: 320 mg orally once a day
Infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae should be treated for 5 days. Infections caused by multi-drug resistant S pneumoniae, Klebsiella pneumoniae, or Moraxella catarrhalis should be treated for 7 days.
Renal Dose Adjustments
CrCl 40 mL/min or less: 160 mg orally every 24 hours
Liver Dose Adjustments
No adjustment recommended.
Fluoroquinolones, including gemifloxacin, have been associated with an increased risk of tendonitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in kidney, heart, or lung transplant recipients, and with the use of concomitant corticosteroids. Independent risk factors include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis; however, cases have been reported in patients with no known risk factors. Tendon rupture may occur during or up to several months after completion of therapy. Patients should be advised to discontinue gemifloxacin, rest and avoid exercise, and contact their healthcare provider if they experience tendon pain, swelling, inflammation, or rupture.
Fluoroquinolones, including gemifloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Patients should contact their healthcare provider at once if worsening muscle weakness or breathing problems develop. Gemifloxacin should be avoided in patients with a known history of myasthenia gravis.
Gemifloxacin should be avoided in patients with a history of prolonged QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients taking Class IA or III antiarrhythmic agents. Caution is recommended in patients taking drugs that prolong the QTc interval and in patients with ongoing proarrhythmic conditions (such as clinically significant bradycardia or acute myocardial ischemia). Recommended doses should not be exceeded due to increased risk of QT interval prolongation. Patients should be advised to contact their physician if they experience syncope, irregular heartbeats, or palpitations.
Central nervous system (CNS) effects have been reported infrequently with gemifloxacin. The drug should be used with caution in patients with CNS disorders such as epilepsy or patients predisposed to convulsions. Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported with other fluoroquinolones. Other fluoroquinolones may also cause CNS stimulation, resulting in tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts. Gemifloxacin should be discontinued and appropriate measures taken if these reactions occur. Patients should be advised to avoid driving or engaging in other tasks requiring alertness and coordination until they know how the drug affects them.
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported. Such reactions may occur after the first dose. The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support, and airway management as clinically indicated.
Gemifloxacin should be discontinued in patients developing a rash or urticaria. In clinical trials, rash was more commonly associated with younger age (especially less than 40 years), female gender, use of hormone replacement therapy, and longer duration of therapy (more than 5 days).
Patients should be advised to avoid excessive exposure to sunlight or artificial ultraviolet light during and for several days after treatment. The drug should be discontinued if photosensitivity or signs of phototoxicity (e.g., sunburn-like reaction, redness, oozing, burning, itching, rash, blistering, edema) occur.
Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following quinolone therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.
Patients should be well hydrated to prevent formation of highly concentrated urine.
Renal, hepatic, and hematopoietic function should be monitored periodically during prolonged therapy.
Dosage adjustments are recommended for renally impaired patients. Caution and monitoring is recommended for elderly patients, who may be at a greater risk of adverse reactions due to declining renal function.
Liver enzyme elevations have been reported during therapy with gemifloxacin; however, this was not associated with clinical symptoms. The recommended dosage and duration of therapy should not be exceeded.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Conventional hemodialysis or CAPD: 160 mg orally every 24 hours
Gemifloxacin may be taken without regard to meals. Antacids containing aluminum or magnesium, supplements containing iron, zinc, or other metal cations, buffered didanosine, and sucralfate should be taken at least 3 hours before or 2 hours after gemifloxacin. Patients should be advised to drink plenty of fluids.