Gatiflox Tablet
Gatifloxacin 400 mg Tablet

Presentation

Gatiflox  tablet: Each tablet contains Gatifloxacin INN 400 mg.

Description

Gatifloxacin is an 8-methoxyfluoroquinolone with in vitro activity against a wide range of gram-negative and gram-positive microorganisms. 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. It appears that the C-8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of gram-positive bacteria compared to the nonmethoxy C-8 moiety.

Indications and uses

Gatiflox is indicated in the following infections-

Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.

Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.

Community-acquired pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.

Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus or Streptococcus pyogenes.

Uncomplicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Pyelonephritis due to Escherichia coli.

Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.

Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.

Dosage and administration

Gatiflox can be administered without regard to food.

Infection                                                                   Daily dose               Duration

Acute Bacterial Exacerbation of Chronic Bronchitis        400 mg                    5 days

Acute Sinusitis                                                           400 mg                  10 days

Community-acquired Pneumonia                                 400 mg                 7-14 days

Uncomplicated Skin and Skin Structure Infections         400 mg                 7-10 days

Uncomplicated Urinary Tract Infections                        400 mg               Single Dose or                                                                            200 mg                 3 days

Complicated Urinary Tract Infections                           400 mg             7-10 days

Acute Pyelonephritis                                                   400 mg             7-10 days

Uncomplicated Urethral Gonnorrhea in Men;                 400 mg             Single dose

Endocervical and Rectal Gonorrhea in Women

Doses in impaired renal function

Since gatifloxacin is eliminated primarily by renal excretion, a dosage modification of Gatifloxacin is recommended for patients with creatinine clearance <40 mL/min, including patients on hemodialysis and on CAPD.

Recommended Dosage of Gatifloxacin in Adult Patients with Renal Impairment

Creatinine Clearance                                 Initial Dose       Subsequent Dose

40 mL/min                                               400 mg             400 mg every day

< 40 mL/min                                            400 mg             200 mg every day

Hemodialysis                                            400 mg             200 mg every day

Continuous peritoneal dialysis                    400 mg             200 mg every day

Contraindications

Gatifloxacin is contraindicated in patients with a history of hypersensitivity of Gatifloxacin, quinolone antimicrobial agents, or any other components of this product.

Precautions

Gatifloxacin should be administered with caution in the presence of renal insufficiency.

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).The pharmacokinetics of gatifloxacin is not altered by digoxin. No significant pharmacokinetic interactions occur when cimetidine, midazolam, theophylline, warfarin, or glyburide is administered concomitantly with Gatifloxacin.

Use in pregnancy and lactation

Pregnancy: Gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Lactation: It is not known whether Gatifloxacin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.

Pediatric use

The safety and effectiveness of gatifloxacin in pediatric populations (<18 years of age) have not been established.

Side-effects

In gatifloxacin studies, the majority of adverse reactions were described as mild in nature. Drug-related adverse events with a frequency of  3% in patients receiving gatifloxacin are as follows: nausea, vaginitis, diarrhea, headache, dizziness.

Overdose

Gatifloxacin exhibits a low potential for acute toxicity in animal studies. 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.

Commercial pack

Gatiflox  tablet: Each box contains 2 strips of 10 tablets.