Classes
DEA Class; Rx
Common Brand Names; Factive
- Fluoroquinolones
Description
Acts by inhibiting both DNA gyrase and topoisomerase IV, which are essential for bacterial growth. Because of this dual mechanism, MIC values remain in the susceptible range for some double mutants (eg, S pneumoniae)
Indications
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis
Pneumonia (community-acquired)
Contraindications
All drugs or conditions that prolong QT interval
Documented hypersensitivity to gemifloxacin or other fluoroquinolones
Adverse Effects
- Diarrhea (5%)
- Headache (4%)
- Nausea (4%)
- Rash (4%)
- Transaminases increased (1-4%)
- Abdominal pain (2%)
- Dizziness (2%)
- Vomiting (2%)
- Neutropenia (1%)
- Platelets increased (1%)
- Thrombocythemia (1%)
- GGT increased (1%)
- Peripheral neuropathy
- Photosensitivity
- Tendon rupture
Warnings
May prolong QT interval
May cause maculopapular rash
Although not reported in gemifloxacin clinical trials, convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis reported with other fluoroquinolones
Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent
In prolonged therapy, perform periodic evaluations of organ system functions (eg, renal, hepatic, hematopoietic); adjust dose in renal function impairment; superinfections may occur with prolonged or repeated antibiotic therapy
Not drug of first choice in pediatrics due to increased incidence of adverse events compared to controls, including arthropathy; no data exist for dose for pediatric patients with renal impairment (ie, CrCl <50 mL/min)
Fluoroquinolones are associated with increased risk of tendinitis and tendon rupture in all ages, this risk is further increased in older patients usually over 60 yr, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants (see Black Box Warnings)
May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis
Pregnancy and Lactation
Limited available human data with use in pregnant women are insufficient to inform an associated risk of miscarriages, major birth defects, and/or adverse maternal or fetal outcomes; based on animal studies with gemifloxacin, therapy, may cause fetal harm; in animal reproduction studies, administration of drug to pregnant mice and rabbits during the period of organogenesis produced embryofetal toxicity at exposures up to 2 and 3 times, respectively, the maximum recommended human dose; advise pregnant women of potential risk to fetus
There is no data on presence of gemifloxacin in human milk, effects on milk production, on breastfed infant
Maximum Dosage
Acute Exacerbations of Chronic Bronchitis
320 mg PO qDay x5 days
Pneumonia (community-acquired)
(Multidrug resistant S. pneumoniae; K. pneumoniae; M. catarrhalis): 320 mg PO qDay x7 days
(S. pneumoniae; M. pneumoniae; H. influenzae; C. pneumoniae): 320 mg PO qDay x 5days
Pediatric
Safety and efficacy not established
How supplied
Gemifloxacin
tablets
- 320mg
