It is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae,Haemophilus influenzae,Haemophilus parainfluenzae,or Moraxella catarrhalis. Community-acquired pneumonia (of 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. *MDRSP: multi-drug resistant Streptococcus pneumoniae,includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae),and are strains resistant to two or more of the following antibiotics: penicillin (MIC ?2 ?g/mL),2nd generation cephalosporins (e.g.,cefuroxime),macrolides,tetracyclines and trimethoprim/sulfamethoxazole. To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs,FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available,they should be considered in selecting or modifying antibacterial therapy. In the absence of such data,local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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 is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.
Following oral administration of gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender
It can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose is 320 mg daily, Recommended Dosage Regimen of it The clinical decision regarding the use of a 5 day or 7 day regimen should be guided by results of the initial sputum culture. Acute bacterial exacerbation of chronic bronchitis One 320 mg tablet daily for 5 days Community-acquired pneumonia (of mild to moderate severity) due to known or suspected S. pneumoniae,H. influenzae,M. pneumoniae,or C. pneumoniae infection One 320 mg tablet daily for 5 days due to known or suspected MDRSP*,K. pneumoniae,or M. catarrhalis infection One 320 mg tablet daily for 7 days *MDRSP: multi-drug resistant Streptococcus pneumoniae,includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae),and are strains resistant to two or more of the following antibiotics: penicillin (MIC ?2 ?g/mL),2nd generation cephalosporins (e.g.,cefuroxime),macrolides,tetracyclines and trimethoprim/sulfamethoxazole.
Gemifloxacin absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Gemifloxacin should be taken at least 2 hours before or 3 hours after these agents. Gemifloxacin should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Gemifloxacin was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.
It is contraindicated in patients with a history of hypersensitivity to gemifloxacin,fluoroquinolone antibiotic agents,or any of the product components. Tendinopathy and Tendon Rupture: Fluoroquinolones,including it,are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon,and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder),the hand,the biceps,the thumb,and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age,in those taking corticosteroid drugs,and in patients with kidney,heart or lung transplants. Factors,in addition to age and corticosteroid use,that may independently increase the risk of tendon rupture include strenuous physical activity,renal failure,and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. it should be discontinued if the patient experiences pain,swelling,inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture,and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
possibly or probably related to drug) in 2.0% of patients,primarily due to rash (0.8%),nausea (0.3%),diarrhea (0.3%),urticaria (0.2%) and vomiting (0.2%). Comparator antibiotics were discontinued because of an adverse event at an overall comparable rate of 2.1%,primarily due to diarrhea (0.5%),nausea (0.4%),vomiting (0.3%),rash (0.3%),abdominal pain (0.2%) and vertigo (0.2%). The most commonly reported adverse events with a frequency of ?2% for patients receiving 320 mg It versus comparator drug (beta-lactam antibiotics,macrolides or other fluoroquinolones) are as follows: diarrhea 5.0% vs. 6.2%; rash 3.5% vs. 1.1%; nausea 3.7% vs. 4.5%; headache 4.2% vs. 5.2%; abdominal pain 2.2% vs. 2.2%; vomiting 1.6% vs. 2.0%; and dizziness 1.7% vs. 2.6%.
It should not be used in pregnant women unless the potential benefit to the mother outweighs the risk to the fetus. There are no adequate and well-controlled studies in pregnant women. There is no information on excretion of gemifloxacin into human milk. Therefore,it should not be used in lactating women unless the potential benefit to the mother outweighs the risk.
No specific antidote is known. Dialysis does not remove Gemifloxacin sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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