Gemifloxacin 320 mg tablets
Each tablet contains:
Gemifloxacin (as mesilate) 320mg
- Chronic bronchitis , acute bacterial exacerbation of (treatment):
Gemifloxacin is indicated in the treatment of acute bacterial exacerbations of chronic bronchitis caused by Haemophilus influenza , Haemophilus parainfluenza ,Moraxella catarrhalis , or Streptococcus pneumoniae .
- pneumonia community-acquired(treatment):
Gemifloxacin is indicated in the treatment of mild to moderate community- acquired pneumonia caused by Chlamydia pneumoniae , H. influenzae , Klebsiella pneumoniae , M .catarrhalis, Mycoplasma pneumoniae, and S . pneumoniae (including multidrug-resistant strains of S. pneumonia).
Except under special circumstances , this medication should not be used when the following medical problem exists:
- Electrolyte disorders, uncorrected , including hypokalemia or hypomagnesemia: use should be avoided in patients with these conditions .
- Hypersensitivity to gemifloxacin , fluoroquinolone antibiotic agents, or any of the product components.
- QTc prolongation , history of: use should be avoided in patients with a history of prolongation of the QTc interval.
Precaution & warnings:
- Risk – benefit should be considered when the following medical problems exist :
- Central l nervous system (CNS) disorders , including epilepsy or predisposed to seizures (fluoroquinoiones can cause CNS effect , gemifloxacin should be used with caution and should be discontinued if symptoms occur.
- Proarrhythmic condition , such as bradycardia , clinically significant or, myocardial ischemia , acute: gemifloxacin should be used with caution in patients with these conditions
- Renal impairment or, hepatic impairment: gemifloxacin levels may be increased leading to increased risk of QTc prolongation.
- Cross – sensivity and/or related problems: Patients allergic to one fluoroquinoione or other chemically related quinolone derivatives (e.g , cinoxacin , nalidixic acid ) may be allergic to other fluoroquinoiones also.
- The following may be especially important in patient monitoring:
- Diarrhea: Pseudomembranous colitis has been reported with nearly all antibiotic agents, and ranges in severity from mild to life –threatening .
- Rash: Gemifloxacin treatment should be discontinued in patients developing a rash while on treatment ; rashes usually appear 8 to 10 days after start of therapy .
- Possible phototoxicity reaction ; using broad spectrum sunblock if in bright sunlight.
- Caution when driving or doing anything else requiring alertness because of possible dizziness , drowsiness , or light – headedness
- Discontinuing gemifloxacin and notifying physician if pain , inflammation ,or rupture of a tendone is experienced ; resting and refraining from exercise until the diagnosis of tendinitis or tendon rupture has been excluded.
- Discontinuing gemifloxacin and contacting physician if a patient develops seizures.
Pregnancy and breastfeeding:
- FDA Pregnancy Category C.
- should not be used in nursing mothers unless the potential benefit to the mother outweighs the risk.
Dosage and administration:
Acute Bacterial Exacerbation of Chronic Bronchitis
320mg qd for 5 days
- Community-Acquired Pneumonia
Mild to Moderate Severity:
Due to Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae:
320mg qd for 5 days
Due to Multidrug Resistant S. pneumoniae, Klebsiella pneumoniae, or Moraxella catarrhalis:
320mg qd for 7 days
- Renal Impairment
CrCl ≤40mL/min or Dialysis: 160mg q24h
- Safety and efficacy have not been established in patients up to 18 years of age.
Diarrhea, rash, nausea, vomiting, headache, abdominal pain, dizziness.
- Avoid Mg2+- or aluminum-containing antacids, ferrous sulfate (iron), and multivitamin preparations containing zinc or other metal cations, within 3 hrs before or 2 hrs after therapy and sucralfate within 2 hrs of therapy.
- Calcium carbonate may decrease levels.
- Reduced levels with oral estrogen/progesterone contraceptive product.
- Increased levels with cimetidine, omeprazole, probenecid.
- Avoid Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics.
- Caution with drugs that prolong the QTc interval (eg, erythromycin, antipsychotics, TCAs).
- Increased INR or PT and/or clinical episodes of bleeding reported with warfarin or its derivatives.
Store below 30°C, protect from light.
Keep out of reach of children.
USP DI 2007