Gemifloxacin mesylate 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.
Xemi Tablet: Each film-coated tablet contains Gemifloxacin mesylate INNequivalent to Gemifloxacin 320 mg.
1. Acute bacterial exacerbation of chronic bronchitis2. Community-acquired pneumonia
Gemifloxacin can be taken with or without food and should be swallowed whole with a liberal amount of liquid.Acute bacterial exacerbation of chronic bronchitis: One 320 mg tablet daily for 5 daysCommunity-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 daysCommunity-acquired pneumonia (of mild to moderate severity)due to known or suspected MDRSP, K. pneumoniae, or M. catarrhalis infection : One 320 mg tablet daily for 7 daysUse in Renally Impaired Patients:Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance =40 mL/min. Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with mild, moderate or severe hepatic impairment. Use in the Elderly:No dosage adjustment is recommended.
Gemifloxacin is contraindicated in patients with a history of hypersensitivityto Gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components.
Fluoroquinolones, including Xemi, are associated with an increased risk of tendinitis and tendon rupture in all ages. Xemi should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Xemi should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders and patients receiving antiarrhythmic agents. Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including Xemi. As with other fluoroquinolones, Xemi should be used with caution in patients with CNS diseases such asepilepsy or patients predisposed to convulsion.
Pediatric Use: Safety and effectiveness in children and adolescents less than 18 years of age have not been established.
Pregnancy Category C. The safety of Gemifloxacin in pregnantwomen has not been established.Nursing Mothers: There is no information on excretion of Gemifloxacin into human milk. Therefore, Gemifloxacin should not be used in lactating women unless the potential benefit to the mother outweighs the risk.
The systemic availability of Gemifloxacin is significantly reduced when analuminum- and magnesium- containing antacid is concomitantly administered. Calcium carbonate (1000 mg) given either 2 hr before or 2 hr after Gemifloxacin administration showed no notable reduction in Gemifloxacin systemic availability. When sucralfate (2 g) was administered 3 hours prior to Gemifloxacin, the oral bioavailability of Gemifloxacin wassignificantly reduced. Gemifloxacin 320 mg at steady-state did not affect the repeat dose pharmacokinetics of theophylline. Gemifloxacin 320 mg at steady-state did not affect the repeat dose pharmacokinetics of digoxin. The effect of an oral estrogen/progesterone contraceptive product (once daily for 21 days) on the pharmacokinetics of Gemifloxacin are not consideredclinically significant. The effect of co-administration of a single dose of 320 mg Gemifloxacin with cimetidine 400 mg four times daily for 7 days are not considered clinically significant. The effect of co-administration of a single dose of 320 mg Gemifloxacin with omeprazole 40 mg once daily for 4 days are not considered clinically significant. Administration of repeated doses ofGemifloxacin (320 mg once daily for 7 days) to healthy subjects on stable warfarin therapy had no significant effect on warfarin-induced anticoagulant activity.
The majority of adverse reactions include rash, nausea, diarrhea, urticaria, vomiting, headache, abdominal pain, dizziness and vertigo. Additional drug-related adverse events included: anorexia, constipation, dermatitis, dry mouth, dyspepsia, fatigue, flatulence, fungal infection, gastritis, increased creatine phosphokinase, insomnia, leukopenia, pruritus, somnolence, taste perversion, thrombocythemia, and vaginitis. Other adverse events thatoccurred in patients were: abnormal urine, abnormal vision, anemia, arthralgia, asthenia, back pain, bilirubinemia, dyspnea, eczema, eosinophilia, facial edema, flushing, gastroenteritis, granulocytopenia, hot flashes, increased non-protein nitrogen, leg cramps, moniliasis, myalgia, nervousness, non-specified gastrointestinal disorder, pain, pharyngitis,photosensitivity/phototoxicity reactions, pneumonia, thrombocytopenia, tremor. The majority of the post-marketing adverse events reported were rash, anaphylactic reaction, erythema multiforme, skin exfoliation, facial swelling; hemorrhage, increased international normalized ratio (INR), retinal hemorrhage; peripheral edema; renal failure; prolonged QT, supraventricular tachycardia, syncope, transient ischemic attack; tendon rupture.
Store at a cool and dry place, protected from light and moisture.
Xemi Tablet: Box containing 2x4's tablets in Alu-Alu blister pack.
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