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Gatiflox (Gatifloxacin)
Therapeutic Group: Anti Bacterial
Presentation
Gatiflox

Each tablet contains Gatifloxacin INN 400 mg.

Descriptions
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
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 & 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.
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.
Precautions
Gatifloxacin should be administered with caution in the presence of renal insufficiency.
Contraindications
Gatifloxacin is contraindicated in patients with a history of hypersensitivity of Gatifloxacin, quinolone antimicrobial agents, or any other components of this product.
Use in Pregnancy & 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.
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 Packaging
Each box contains 2 strips of 10 tablets.
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