Trade Name: GATIGEN TABLET 400 MG
Generic Name: Gatifloxacin INN

Presentation:

Each tablet contains Gatifloxacin INN 400 mg

Indications:

• Acute bacterial exacerbation of chronic bronchitis

• Acute sinusitis

• Community acquired pneumonia

• Uncomplicated UTI

• Complicated UTI

• Pyelonephritis

• Uncomplicated urethral and cervical gonorrhea

• Acute uncomplicated rectal infections in women

• Chronic prostatitis

• Uncomplicated skin & soft tissue infection

Dosage & administration:

Paediatric use- Safety and efficacy not established in children or adolescents younger than 18 years.

Geriatric use- No dosage adjustment is necessary.

Adverse effects:

Adverse effects occurring in 3% or more of patients receiving gatifloxacin include nausea, vaginitis, diarrhea, headache, dizziness.

Contraindications:

Hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.

Pracautions:

The following precautions should be maintained during the use of the drug. Gatifloxacin may prolong the QT interval. The drug should be avoided in patient with known prolongation of QT intervals, those with uncorrected hypokalemia, and in patients receiving antiarrhythmic agents or drugs that affect QT interval like erythromycin, antipsychotic agents, tricyclic antidepressants.

Disturbance of blood glucose including symptomatic hyperglycemia and hypoglycemia have been reported in diabetic, and  monitoring of blood glucose is recommended in diabetic patients.

Use in pregnancy and lactation:

Because there are no adequate and well-controlled studies in pregnant women, Gatifloxacin should be used during pregnacy only if the potential benefit outweighs the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs is excreted in human milk, caution should be exercised when Gatifloxacin is administered to a nursing women.

Drug interactions:

• Antacids: Gatifloxacin should be taken at least 4 hours before antacid that contain aluminum or magnesium. Antacids containing calcium, calcium supplements, and milk have no clinically important interactions with Gatifloxacin.

• Iron, Multivitamin, and Mineral Supplements: Pharmacokinetic interaction (decreased absorption)

• Didanosine: Decrease absorption of Gatifloxacin

• Probenecid: Pharmacokinetic interaction (increased systemic exposure to gatifloxacin.)

• Antiarrhythmic agents

• Cimetidine

Commercial pack:

Each box contains 5 alu-alu blister strips of 4 tablets.