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Gemifloxacin as gemifloxacin mesylate INN
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.
Gemitab Tablet: Each film coated tablet contains Gemifloxacin Mesylate INN equivalent to 320 mg Gemifloxacin.
Indications And Uses
Gemifloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms. Gemifloxacin can be taken with or without food and should be swallowed whole with a liberal amount of liquid.
Dosage And Administration
"The recommended dose of Gemifloxacin is 320 mg daily, according to the following table. Recommended Dosage Regimen: The clinical decision regarding the use of a 5 days or 7 days regimen should be guided by results of the initial sputum culture. Acute exacerbation of chronic bronchitis 5 days Community acquired pneumonia 5-7* days Acute bacterial sinusitis 5 days Otitis Media 7 days Uncomplicated Urinary tract infections 3 days. The recommended dose and duration of Gemifloxacin should not be exceeded. Use 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. > 40: See Usual Dosage < 40: 160 mg every 24 hours "
Nausea, stomach upset, loss of appetite, diarrhea, drowsiness, dizziness, headache, dry mouth, altered taste, constipation, or trouble sleeping may occur. A serious allergic reaction to this drug is unlikely.
Before taking Gemifloxacin, cautions should be taken if you are allergic to it; or to other Quinolones. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid prolonged sun exposure. Caution is advised when using this drug in elderly because they may be more sensitive to its side effects. Caution is advised when using this drug in children. This medication should be used only when clearly needed during pregnancy.
May interact with blood thinners (e.g., Insulin), Probenecid, live vaccines. Report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with Gemifloxacin, such as Phenothiazines (e.g., Thioridazine), Tricyclic antidepressant (e.g Amitriptyline), Isoniazid (INH), or Theophylline.
No specific antidote is known. 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 and treated symptomatically with appropriate hydration maintained.
Gemifloxacin is contraindicated in patients with a history of hypersensitivity to Gemifloxacin, Fluoroquinolone antibiotic agents, or any of the product components.
Box containing 1x10 tablets in Alu-Alu blister pack