Regulatory Information
ZIWELL MEDICAL (S) PTE LTD
ZIWELL MEDICAL (S) PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**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.
ORAL
Medical Information
**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.
**Contraindication** Persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or any other components of Avatac.
J01MA12
levofloxacin
Manufacturer Information
ZIWELL MEDICAL (S) PTE LTD
Meditop Pharmaceutical Ltd
Active Ingredients
Documents
Package Inserts
Avatac Film Coated Tablet 250mg and 500mg PI.pdf
Approved: March 24, 2021