TAG

Gatifloxacin

Composition:

Tag-400 Tablet: Each film-coated tablet contains Gatifloxacin INN 400 mg.

Indications:

Tag  (Gatifloxacin) is indicated for the treatment of the following infections when caused by susceptible bacteria

• Community acquired pneumonia

• Acute bacterial exacerbation of chronic bronchitis

• Acute bacterial sinusitis

• Uncomplicated Urinary Tract Infections (cystitis)

• Complicated Urinary Tract Infections

• Acute Pyelonephritis

• Uncomplicated urethral gonorrhea in men and endocervical & rectal gonorrhea in women. Severe clinical studies showed that Gatifloxacin is also effective in the treatment of uncomplicated skin and soft tissue infection.

Dosage and Administration: 

The recommended dosages for Tag (Gatifloxacin) Tablets are shown in the following table. Doses of Gatifloxacin are administered once every 24 hours. Gatifloxacin can be administered without regard to food, including milk and dietary supplements containing calcium. Gatifloxacin can be administered without regard to age (≥ 18 years), gender.

Infection	Once-daily dose	Total duration
Community-acquired pneumonia	400 mg	7-14 days
Acute Bacterial Exacerbation of Chronic Bronchitis	400 mg	7-10 days
Acute bacterial Sinusitis	400 mg	10 days
Uncomplicated Urinary Tract Infections (cystitis)	400 mg or 200 mg	Single dose 3 days
Complicated Urinary Tract Infections	400 mg	7-10 days
Acute Pyelonephritis	400 mg	7-10 days
Uncomplicated Urethral Gonorrhea in Men; Endocervical and Rectal Gonorrhea in Women	400 mg	Single dose
Skin & soft tissue infection	400 mg	7-10 days

Since Gatifloxacin is eliminated primarily by renal excretion, a dosage modification 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 are:

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

 *Start of subsequent dose on day 2 of dosing.

Contraindication:

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

Side Effects:

The majority of adverse events are described as mild in intensity. The main common adverse events reported with Gatifloxacin are nausea, vomiting, vaginitis, diarrhea, headache, dizziness and abdominal pain.

Drug Interactions:

No significant interactions with milk or calcium carbonate have been observed when administered to healthy volunteers concomitantly with Gatifloxacin. No significant pharmacokinetic interactions occurred when Gatifloxacin was administered to healthy volunteers concomitantly with drugs metabolized by the cytochrome P450 (CYP) system, i.e., cimetidine, midazolam, theophylline, warfarin, No significant pharmacokinetic interactions have been observed when glibenclamide was adminstered concomitantly with Gatifloxacin. Ferrous sulfate or dietary supplements containing zinc, magnesium, or iron (such as multivitamin products) can be taken 2 hours before or 2 hours after Gatifloxacin and aluminum/ magnesium-containing antacids can be taken 2 hours before or 4 hours after Gatifloxacin administration without any significant pharmacokinetic interactions

Concomitant administration of Gatifloxacin and digoxin did not produce significant alteration of the pharmacokinetics of Gatifloxacin. Systemic exposure to Gatifloxacin is significantly increased following the concomitant administration of Gatifloxacin and probenecid.

Use in Pregnancy & Nursing mother:

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

Nursing Mothers: It is not known whether this drug is excreted in human milk, but it is excreted in rat milk. Because Gatifloxacin may be excreted in human milk, caution should be exercised when Gatifloxacin is administered to a nursing woman.

Use in Pediatric & Geriatric patients:

Pediatric Use: The safety and effectiveness of Gatifloxacin in persons < 18 years of age have not been established.

Geriatric Use: No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients; however, greater sensitivity of some older individuals cannot be ruled out

Packing:

Tag-400 Tablet: Box containing 3 x 10’s tablets in Alu - Alu blister pack.