Gatibac0.3%

Gatibac 0.3% 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.

4-Quinolone preparations

Gatibac 0.3% is a fluoroquinolone antibacterial which acts by inhibiting DNA synthesis in susceptible organisms via inhibition of both DNA gyrase (essential for bacterial reproduction) and topoisomerase IV (essential during bacterial cell division).

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

Gatibac 0.3% can be administered without regard to food.

Gatibac 0.3% is contraindicated in patients with a history of hypersensitivity of Gatibac 0.3%, quinolone antimicrobial agents, or any other components of this product.

Gatibac 0.3% is generally well tolerated. The most common side effects that can occur while taking this drug are usually mild and include nausea, vomiting, stomach pain, diarrhea, dizziness,and headache .

Pregnancy: Gatibac 0.3% should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.Lactation: It is not known whether Gatibac 0.3% is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gatibac 0.3% is administered to a nursing woman.

Gatibac 0.3% should be administered with caution in the presence of renal insufficiency.

Gatibac 0.3% 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.

Renal Impaired patient: Creatinine Clearance 40 mL/min: 400 mg every day. Creatinine Clearance < 40 mL/min: 400 mg 200 mg every day. Dialysis patients: Hemodialysis: 400 mg 200 mg every day. Continuous peritoneal dialysis: 400 mg 200 mg every day. Pediatric use: The safety and effectiveness of Gatibac 0.3%acin in pediatric populations (<18 years of age) have not been established.