Facticin

• Acute bacterial exacerbation of chronic bronchitis - caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis
• Community-acquired pneumonia (mild to moderate) - caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, Klebsiella pneumoniae

Gemifloxacin is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.

Acute bacterial exacerbation of chronic bronchitis:

• 320 mg once daily for 5 days

Community-acquired pneumonia (Mild to moderate):

• S. pneumoniae, H. influenzae, M. pneumoniae, C. pneumoniae: 320 mg once daily for 5 days
• Multi-drug resistant S. pneumoniae, K. pneumoniae, M. catarrhalis: 320 mg once daily for 7 days

Renal Impairment (CrCl <40 mL/min): 160 mg once daily

* Use as directed by the registered physician

Common Side Effects:

• Abdominal pain
• Diarrhea
• Headache
• Nausea
• Rash
• Vomiting
• Dizziness

Infrequent Side Effects: Fungal overgrowth, insomnia, urticaria, pruritus, maculopapular erythematous skin rash.

Use in Pregnancy: Unsafe during pregnancy. There is definite evidence of risk to the developing baby.

Precautions:

• Dose adjustment needed in severe renal impairment (160 mg once daily).
• Maintain adequate hydration to prevent crystalluria.
• May cause dizziness - do not drive or operate machinery.
• Tendonitis and tendon rupture - especially in elderly or corticosteroid users.
• Caution in patients predisposed to QTc interval prolongation.

Overdose: No specific antidote. Dialysis is not sufficient. Gastric lavage and supportive care.

Storage: Keep below 30°C, away from light and moisture. Keep out of reach of children.