Gemicin® Tablet: Each film-coated tablet contains Gemifloxacin Mesylate INN, equivalent to 320 mg of Gemifloxacin.
Gemicin® is a synthetic, broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form.
Gemicin® is indicated for the treatment of infections caused by susceptible strains of designated microorganisms in the following conditions:
Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (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.
Gemicin® can be taken with or without food and should be swallowed whole with a liberal amount of liquid.
Acute bacterial exacerbation of chronic bronchitis
Dose/Duration: One 320 mg tablet daily for 5 days.
Community-acquired pneumonia (mild to moderate severity)
Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection
Dose/Duration: One 320 mg tablet daily for 5 days.
Due to known or suspected multi-drug resistant S. pneumoniae, K. pneumoniae, or M. catarrhalis infection
Dose/Duration: One 320 mg tablet daily for 7 days.
The recommended dose and duration of Gemicin® should not be exceeded.
No dose adjustment is required for patients with a creatinine clearance >40 mL/min.
For patients with creatinine clearance ≤40 mL/min, the dose should be 160 mg every 24 hours.
Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160 mg every 24 hours.
No dosage adjustment is recommended for patients with mild, moderate, or severe hepatic impairment.
No dosage adjustment is recommended for elderly patients.
Gastrointestinal: Nausea, upper GI discomfort
CNS: Headache, insomnia, dizziness, hallucinations, depression, psychotic reactions (rare)
Renal: Interstitial nephritis
Cardiovascular: QTc prolongation, torsades de pointes, arrhythmias
Skin: Rash
QT interval prolongation: Avoid concurrent use with other drugs that prolong the QT interval and in patients with risk factors for torsades de pointes (e.g., hypokalemia, significant bradycardia, cardiomyopathy).
Divalent cations: Aluminum, magnesium, zinc, iron, calcium, antacids, sucralfate—reduced bioavailability of quinolones (can cause therapeutic failure).
Category C: Risk unknown. Human studies are inadequate.
Store in a cool, dry place, away from light and moisture.
