Indication
Gemifloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
Dosage & Administration
Gemifloxacin can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of Gemifloxacin is 320 mg daily, according to the following table.
Recommended Dosage Regimen
The clinical decision regarding the use of a 5 day or 7 day regimen should be guided by results of the initial sputum culture.
|
Indication |
|
Dose |
|
Duration |
|
Acute bacterial exacerbation of chronic bronchitis (AECB) |
|
One 320 mg tablet daily |
|
5 days |
|
Community acquired pneumonia (CAP) [mild to moderate severity] |
||||
|
due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection |
|
One 320 mg tablet daily |
|
5 days |
|
due to known or suspected MDRSP*, K. pneumoniae, or M. catarrhalis infection |
|
7 days |
||
*MDRSP, multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC = 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
The recommended dose and duration of Gemifloxacin should not be exceeded.
Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance < 40 mL/min.
|
Creatinine Clearance (mL/min) |
Dose |
|
>40 |
See Usual Dosage |
|
<40 |
160 mg every 24 hours |
a marked effect on Gemifloxacin pharmacokinetics, and no dosage adjustment is required.
Use in Elderly: No dosage adjustment is recommended.
Precautions
Before taking Gemifloxacin, cautions should be taken if you are allergic to it; or to other quinolones. Before using this medication, tell your doctor about your brain or nervous system disorders if any (e.g., cerebral arteriosclerosis, tumors, increased intracranial pressure), heart problems (e.g., cardiomyopathy, slow heart rate, QTc prolongation), history of seizures, kidney disease, liver disease, muscle/joint/tendon problems, untreated mineral imbalance (e.g., low potassium or magnesium). This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid prolonged sun exposure. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects. Caution is advised when using this drug in children. This medication should be used only when clearly needed during pregnancy. Consult your doctor before breast-feeding.
