Gemifloxacin is indicated for the treatment of the following bacterial infections in adults when caused by susceptible organisms:

Acute bacterial exacerbation of chronic bronchitis:Caused by: Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis.

Community-acquired pneumonia (mild to moderate severity): Caused by: Streptococcus pneumoniae (including multidrug-resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, Klebsiella pneumoniae.

Gemifloxacin is a fluoroquinolone antibiotic with bactericidal activity. It works by inhibiting bacterial DNA synthesis through the inhibition of type II topoisomerases, including DNA gyrase and topoisomerase IV, both of which are essential for bacterial growth and replication.

After oral administration, gemifloxacin is rapidly absorbed and widely distributed throughout the body. Studies in healthy individuals have shown that it penetrates quickly into target tissues and body fluids, including the lungs (epithelial lining fluid, alveolar macrophages, and bronchial tissue) as well as nasal secretions.

Following oral dosing, approximately 36% of gemifloxacin is excreted in the urine and 61% in the feces as unchanged drug and metabolites. The area under the curve (AUC) values are generally only slightly higher, by about 10%, in women compared with men. However, no dose adjustment is required based on gender.

Acute bacterial exacerbation of chronic bronchitis: Take 320 mg once daily for 5 days.

Community-acquired pneumonia (mild to moderate):

• For known or suspected infection caused by S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae: take one 320 mg tablet once daily for 5 days.
• For known or suspected infection caused by multidrug-resistant Streptococcus pneumoniae, K. pneumoniae, or M. catarrhalis: take one 320 mg tablet once daily for 7 days.

The absorption of gemifloxacin is significantly decreased when it is taken together with antacids containing aluminum or magnesium or with iron salts. To avoid this interaction, gemifloxacin should be taken at least 2 hours before or 3 hours after these medicines. Gemifloxacin should also be taken at least 2 hours before sucralfate. No clinically significant drug interactions have been reported when gemifloxacin is used together with omeprazole, theophylline, digoxin, warfarin, or oral contraceptives.

Gemifloxacin is contraindicated in patients with known hypersensitivity to gemifloxacin or other quinolone antibiotics. It should also not be used in patients who have previously experienced tendon injury or tendon disorders associated with fluoroquinolone use. In addition, gemifloxacin is not recommended for children under 18 years of age.

Common side effects of gemifloxacin include abdominal pain, diarrhea, headache, nausea, rash, and vomiting. Less commonly reported side effects include fungal overgrowth in the body, dizziness, insomnia, urticaria, pruritus, and a maculopapular erythematous skin rash.

Gemifloxacin should not be used during pregnancy or breastfeeding. Its safety and effectiveness in pregnant and lactating women have not yet been established.

In patients with severe renal impairment, the dosage should be adjusted to 160 mg once daily. Patients taking gemifloxacin should maintain adequate hydration to reduce the risk of highly concentrated urine and crystalluria. Gemifloxacin may cause dizziness. If this occurs, patients should avoid driving, operating machinery, or performing activities that require mental alertness or coordination.

Tendinitis and tendon rupture may occur during treatment with quinolones, including gemifloxacin, in patients of any age. The risk is higher in elderly patients and in those receiving corticosteroids at the same time. Gemifloxacin should be discontinued immediately if tendinitis is suspected or if the patient experiences the first signs of tendon pain or inflammation. The affected limb should also be rested. Clinical studies have shown a small average increase in the QTc interval with gemifloxacin. Therefore, it should be used with caution in patients who are prone to QTc prolongation or who are taking other medicines known to prolong the QTc interval. Gemifloxacin should also be used with caution in patients with epilepsy.

Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment. However, dose modification is recommended for patients with severe renal dysfunction. Dosage guidelines in renal impairment:

• Creatinine clearance above 40 mL/min: use the usual recommended dose
• Creatinine clearance below 40 mL/min: 160 mg once daily
• Patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should take 160 mg once daily.

Hepatic impairment: Gemifloxacin may be used in patients with hepatic impairment without any dose adjustment.

Elderly patients: No dose adjustment is required in elderly patients.

There is no specific antidote for gemifloxacin overdose. Dialysis is not effective enough to remove gemifloxacin in cases of overdose. In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by performing gastric lavage. The patient should then be closely monitored, given symptomatic treatment, and maintained with adequate hydration.

Quinolone antibacterial preparation

Store below 30°C, protected from light and moisture. Keep out of the reach of children.