Gemifloxacin

Introduction: Gemifloxacin is an antibiotic used in the treatment of bacterial infections. It is also used in treating infections of the urinary tract, nose, throat, skin and soft tissues and lungs (pneumonia). It cures the infection by stopping the further growth of the causative microorganisms.

How it works: Gemifloxacin is a fluoroquinolone antibiotic. The bactericidal action of gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Important Information: Complete the full course of treatment as advised by your doctor. Diarrhea may occur as a side effect which should stop when your course is complete. Inform your doctor if you get a rash, itchy skin or have difficulty in breathing.

• 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

4-Quinolone preparations

Fluoroquinolone antibiotic

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.

Gemifloxacin inhibits DNA gyrase and topoisomerase IV enzymes to prevent bacterial DNA synthesis, thereby stopping bacterial growth and reproduction.

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

Oral tablet. Can be taken with or without food. Swallow whole, do not chew or crush.

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

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

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

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.

Contraindications:

• Hypersensitivity to Gemifloxacin or other quinolones
• Patients who have previously suffered tendon damage with fluoroquinolones
• Children under 18 years of age
• Patients receiving class IA or III antiarrhythmics

Drug Interactions:

• Aluminum or magnesium containing antacids and iron salts reduce absorption (take 2 hours before or 3 hours after).
• Sucralfate: Take 2 hours before.
• Probenecid reduces renal clearance.
• Increased risk of tendon disorders with corticosteroids (especially in elderly >60 years).

Food Interactions:

• Consuming alcohol with Gemifloxacin does not cause any harmful side effects.

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

Use in Lactation: Should be used with caution during breastfeeding. Breastfeeding should be held until treatment is completed.

Pediatric Use: Not recommended for children under 18 years of age.

Geriatric Use: Elderly patients (>60 years) have higher risk of tendon disorders - caution required.

Renal Impairment: Use with caution in kidney disease. CrCl <40 mL/min: 160 mg once daily.

Hepatic Impairment: Safe in liver disease. No dose adjustment required.

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.

Gemifloxacin Tablet