SRK Pharmaceuticals

Lower Parel, Mumbai, Maharashtra

qualitative and quantitative composition

each tablet contains 200mg cefixime (anhydrous).

it is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of gram-positive and gram-negative organisms.

it is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:

upper respiratory tract infections (urti): e.g. Otitis media; and other urti where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.

lower respiratory tract infection: e.g. Bronchitis.

urinary tract infections: e.g. Cystitis, cystourethritis, uncomplicated pyelonephritis.

clinical efficacy has been demonstrated in infections caused by commonly occuring pathogens including streptococcus pneumoniae, streptococcus pyogenes, escherichia coli, proteus mirabilis, kliebsiella species, haemophilus influenzae (beta-lactamase positive and negative), branhamella catarrhalis (beta- lactamase positive and negative) and enterobacter species. Suprax is highly stable in the presence of beta-lactamase enzymes.

most strains of enterococci (streptococcus faecalis, group d streptococci) and staphylococci (including coagulase positive and negative strains and meticillin- resistant strains) are resistant to suprax. In addition, most strains of pseudomonas, bacteriodes fragalis, listeria monocytogenes and clostridia are resistant to suprax.

Each film-coated tablet contains 400 mg of ofloxacin.

Excipient with known effect:

Each film-coated tablet also contains 228.00 mg of lactose, anhydrous.

The following indications are restricted to adults.

Ofloxacin is suitable for treatment of the following bacterial infections if these are caused by pathogens sensitive to ofloxacin

Lower respiratory tract infections including pneumonia, bronchitits and acute exacerbations of chronic bronchitis caused by gram negative aerobic bacteria. (Ofloxacin tablets are not the drug of first choice in pneumonia caused by Streptococcus pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae);

Upper and lower urinary tract infections, including uncomplicated (cystitis) and complicated urinary tract infections.

Uncomplicated urethral and cervical gonorrhoea, non-gonococcal urethritis and cervicitis.

Consideration should be given to official guidance on the appropriate use of anti-bacterial agents.

Posology

The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily.

Up to 400 mg may be given as a single dose, preferably in the morning. Generally, individual doses should be given at approximately equal intervals.

In individual cases it may be necessary to increase the dose to a maximum total dose of 800 mg daily, which should be given as 400 mg twice daily, at approximately equal intervals. This may be appropriate in infections due to pathogens known to have reduced or variable susceptibility to ofloxacin, in severe and/or complicated infections (e.g. of the respiratory or urinary tracts) or if the patient does not respond adequately.

Mechanism of action

Ofloxacin inhibits bacterial DNA replication by inhibiting bacterial topoisomerases, particularly DNA gyrase and topoisomerase IV. It is active after oral administration.

Therapeutic doses of ofloxacin are devoid of pharmacological effects on the voluntary or autonomic nervous system.

The NCCLS MIC breakpoint recommendations are as follows:

S 2 mg/l and R 8 mg/l

Intermediate susceptibility at 4 mg/l

Haemophilus influenzae and Neissaria gonorrhoea are exceptions with breakpoints at S 0.25 mg/l and R 1 mg/l

The BSAC general recommendations are S 2 mg/l and R 4 mg/l

According to DIN 58 940, the following limits apply for ofloxacin:

S mg/L, I = 3 mg/L, R 4 mg/L.

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. This information gives only an approximate guidance on probabilities whether micro-organisms will be susceptible to ofloxacin or not.

Only those pathogens relevant to the indications are listed.