AVATAC FILM COATED TABLET 500 MG [SIN15341P]

Product Info

AVATAC FILM COATED TABLET 500 MG

[SIN15341P]

INDICATIONS
Treatment of adults (more than or equal to 18 years) with mild, moderate and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows. Levofloxacin injection is indicated when IV administration offers a route of administration advantageous to the patient (eg, patient cannot tolerate an oral dosage form). (See Dosage and Administration for specific recommendations.)

Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.

Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae or Moraxella catarrhalis. Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Legionella pneumophila or Mycoplasma pneumonia. Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus or Streptococcus pyogenes.

Complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Pseudomonas aeruginosa.

Acute pyelonephritis (mild to moderate) caused by Escherichia coli. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

DOSAGE AND ADMINISTRATION
Usual dose:
250 or 500 mg administered orally every 24 hrs, as indicated by infection and described in the following dosing chart. These recommendations apply to patients with normal renal function (ie, creatinine clearance >80 mL/min). For patients with altered renal function, see Table 2. Oral doses should be administered at least 2 hrs before or 2 hrs after antacids containing magnesium, aluminum, as well as sucralfate, metal cations eg, iron and multivitamin preparations with zinc or didanosine (Videx) chewable/buffered tablets or the pediatric powder for oral solution.

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance: See equation. The serum creatinine should represent a steady state of renal function.

Females:
0.85 x value calculated using formula for males.

Contraindication
Persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or any other components of Avatac.