Other antibacterial drugs

  • Chemical Composition

    Gatifloxacin 200 mg

  • Packing

    5Coated Tablets

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Mechanism Of Action The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. Gatifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections Aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae (penicillin-susceptible strains) Aerobic gram-negative microorganisms:Escherichia coli, Haemophilus, influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Neisseria gonorrhoeae, Proteus mirabilis. Other microorganisms: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.
INDICATIONS Gatifloxacin is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. 1- Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus. 2- Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae. 3- Community-acquired pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila. 4- Uncomplicated urinary tract infections (cystitis) due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. 5- Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. 6- Pyelonephritis due to Escherichia coli. 7- Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae. 8- Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.
CONTRAINDICATIONS Gatifloxacin is contraindicated in persons with a history of hypersensitivity to gatifloxacin or any member of the quinolone class of antimicrobial agents.
Side EFFECTS Drug-related adverse events include nausea, vaginitis, diarrhea, headache, and dizziness. Additional drug-related rare adverse events include abnormal thinking, agitation, alcohol intolerance, anorexia, anxiety, asthenia, asthma (bronchospasm), ataxia, bradycardia, colitis, confusion, convulsion, cyanosis, depression, flatulence, gastrointestional hemorrhage, hyperglycemia, hypoglycemia, pruritus, pseudomembranous colitis, rectal hemorrhage, somnolence, stress, taste loss, and thirst.
WARNINGS GATIFLOXACIN MAY HAVE THE POTENTIAL TO PROLONG THE QTc INTERVAL OF THE ELECTROCARDIOGRAM IN SOME PATIENTS. DUE TO THE LACK OF CLINICAL EXPERIENCE, GATIFLOXACIN SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF THE QTc INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA, AND PATIENTS RECEIVING CLASS IA (E.G. QUINIDINE, PROCAINAMIDE) OR CLASS III (E.G. AMIODARONE, SOTALOL) ANTIARRHYTHMIC AGENTS. Gatifloxacin should be used with caution when given concurrently with the drugs that prolong the QTc interval such as erythromycin, antipsychotics, and tricyclic antidepressants, as well as in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. As with other quinolones, Gatifloxacin should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral atherosclerosis, and epilepsy. Gatifloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Pseudomembranous colitis has been reported with nearly all antibacterial agents, and may range in severity from mild to life- threatening. It is important, therefore, to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent. Treatment with antibacterial agents alters the flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is the primary cause of "antibiotic-associated colitis." Gatifloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Tendon rupture can occur during or after therapy with quinolones. Gatifloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. In patients with impaired renal function (creatinine clearance < 40mL/min, adjustment of the dosage regimen is necessary to avoid the accumulation of gatifloxacin due to decreased clearance. As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (e. g., glyburide) or with insulin. In these patients, the monitoring of blood glucose is recommended. gatifloxacin is administered to a nursing woman. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
DRUG INTERACTIONS Systemic exposure to Gatifloxacin is increased following concomitant administration of Gatifloxacin and probenecid, and is reduced by concomitant administration of Gatifloxacin and ferrous sulfate or antacids containing aluminum or magnesium salts. Gatifloxacin can be administered 4 hours before the administration of dietary supplements containing zinc, magnesium, or iron (such as multivitamins), aluminum/magnesium-containing antacids, or VIDEX (didanosine) buffered tablets, buffered solution, or buffered powder for oral suspension. Minor pharmacokinetic interactions occur following concomitant administration of gatifloxacin and digoxin, dosage adjustments of either drug are not warranted. Patients taking digoxin should be monitored for signs and/or symptoms of toxicity. The concomitant administration of nonsteroidal anti-inflammatory drugs with a quinolone may increase the risks of CNS stimulation and convulsions.
Pregnancy And lactations Gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Caution should be exercised when gatifloxacin is administered to a nursing woman
Dosage And Administration 1- Acute Bacterial Exacerbation of Chronic Bronchitis: One tablet 400mg daily, for 7-10 days. 2- Acute Sinusitis: One tablet 400mg daily, for 10 days. 3-Community-acquired Pneumonia: One tablet 400mg daily, for 7-14days. 4- Uncomplicated Urinary Tract Infections (cystitis): One tablet 400mg as a single dose and then one tablet 200mg daily for 3 days. 5- Complicated Urinary Tract Infections: One 400mg daily, for 7-10 days. 6- Acute Pyelonephritis: One tablet 400mg daily, for 7-10 days. 7- Uncomplicated Urethral Gonorrhea in Men; Endocervical and Rectal Gonorrhea in Women: Single dose of one tablet 400mg. 8- Acute, uncomplicated rectal infections in Women: One tablet 400mg daily, for 7-10 days. - Impaired Renal Function: creatinine clearance < 40 mL/ min, Hemodialysis, Continuous peritoneal dialysis: The initial dose is one tablet of TIQUININE 400mg and then one tablet 200mg every day. Product regimen for the treatment of uncomplicated urinary tract infections and gonorrhea requires no dosage adjustment in patients with impaired renal function.
OVERDOSE Clinical signs observed in case of gatifloxacin overdosage include decreased activity and respiratory rate, vomiting, tremors, and convulsions. In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed (including ECG monitoring) and given symptomatic and supportive treatment. Adequate hydration should be maintained.
Storage Conditions - store below 30°C in a dry place away of light . - keep out of reach of children