Cefuroxime Axetil 250mg Tab

(i) ROUTE OF ADMINISTRATION

Oral.

DOSAGE AND ADMINISTRATION

Health 2000 Cefuroxime Axetil 250mg tablets
(May be administered without regard to meals)

Adolescents and Adults(13 years and older) DosageDuration (days)
Pharyngitis/tonsillitis 250 mg b.i.d.10
Acute bacterial maxillary sinusitis 250 mg b.i.d.10
Acute bacterial exacerbations of chronic bronchitis 250 or 500mg b.i.d.10
Secondary bacterial infections of acute bronchitis 250 or 500mg b.i.d. 5-10
Uncomplicated skin and skin-structure infections 250 or 500mg b.i.d. 10
Uncomplicated urinary tract infections 125 or 250mg b.i.d. 7-10
Uncomplicated gonorrhea 1000 mg once Single dose
Early Lyme disease 500mg b.i.d. 20
Paediatric Patients ( Who can swallow tablets whole )
Adolescents and Adults(13 years and older) Dosage Duration (days)
Pharyngitis / tonsillitis 125mg b.i.d. 10
Acute otitis media 250mg b.i.d. 10
Acute bacterial maxillary sinusitis 250mg b.i.d. 10

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Cefuroxime Axetil 250mg tablet is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases :

1. Pharnygitis/Tonsillitis caused by Streptococcus pyogenes.

2. Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.

3. Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (non-beta-lactamase-producing strains only).

4. Acute bacterial exacerbations of chronic Bronchial and Secondary Bacterial infections of acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).

5. Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lacatamase-producing strains) or Streptococcus pyogenes.

6. Uncomplicated urinary tract infections caused by Escherichia coli and Klebsiella spp.

7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase and non-penicillinase-producing strains of Neisseria gonorrhoeae, rectal, in females, caused by non-penicillinase producing strains of Neisseria gonorrheae.

8. Early Lyme Disease (erythema migrans ) caused by Borrelia burgdorferi.

(iii) DESCRIPTION OF DOSAGE FORM

Cefuroxime is a semisynthetic, broad spectrum cephalosporin antibiotic. Cefuroxime has in Vitro activity against a wide range of gram-positive and gram -negative organisms, and is highly stable in the presence of beta lactamases of certain gram - negative bacteria The bacterial action of cefuroxime results from inhibition of cell wall synthesis

Cafuroxime is usually active against the following organisms in vitro : Aerobes, Gram positive Staphylococcus aureus , Staphylococcus epidermidis, Streptococcus pneumoniae and Streptococcus pyogenes
(and other streptococci)

Aerobes, Gram negative : Citrobacter spp; Enterobacter spp; E coil; Haemophilus influenzae (including ampicillin – resistant strains); Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae); Moraxella catarrhalis (including ampicillin and cephalothin resistant strains); Morganella morganii) Neisseria gonorrheae (including peniciIlinase and non penicillinase-producing strains); Neisseria meningitides; Proteus mirabilis; Provindencia rettgeri (formerly Proteus rettgeri); Salmonella spp and Shigella spp.

Anarobes
Gram positive and gram negative cocci (including Peptococcus and Peptostreptococcus spp.); gram positive bacilli (including clostridium spp); gram negative bacilli (including clostridium spp); gram-negative bacilli (including Bacterojdea and Fusobacterium spp.

(iv) CONTRAINDICATIONS

Health 2000 Cefuroxime Axetil 250mg tablets is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

WARNINGS AND PRECAUTIONS
Precautions
As with other broad-spectrum antibiotics, prolonged administration of cefuroxime tablets may result in overgrowth of nonsusceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.

Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.

Cefuroxime axetil, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety and effectiveness of cefuroxime have not been established in patients with gastrointestinal malabsorption.

Drug Interactions

Concomitant administration of probenecid with cefuroxime axetil tablets increases the area under the serum concentration versus time curve by 50%.The peak serum cefuroxime concentration after a 1.5g single dose is greater when taken with 1g of probenecid ( mean = 14.8 mcg/mL ) than without probenecid ( mean = 12.2 mcg/mL)
Drugs that reduce gastric acidity may result in a lower bioavailability of Health 2000 Cefuroxime Axetil 250mg tablets compared with that of fasting state and tend to cancel the effect of postprandial absorption.

Pregnancy : Teratogenic effect : Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing mothers
Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime.

Pediatric use
The safety and effectiveness of Health 2000 Cefuroxime Axetil 250mg tablets has been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults.

(v) SIDE EFFECTS
Health 200 Cefuroxime Axetil 250mg Tablets is generally safe and well tolerated. The side effects observed with cefuroxime are diarrhea, nausea/ vomiting abdominal pain, abdominal cramps and rash.

(vi) TOXIC EFFECTS

MUTAGENICITY & CARCINOGENICITY
In vitro studies have not shown cefuroxime to be mutagenic. Studies have not been performed to date to evaluate the carcinogenic potential of cefuroxime.

TERATOGENECITY
Reproduction studies have been performed in rats and mice at doses up to 3200 mg/Kg per day (23 times the recommended maximum human dose bases on mg/m2) and have revealed no evidence of harm to the fetus due to cefuroxime axetil. There are however ,no adequate and well controlled studies in pregnant woman.Because animal reproduction studies are not always predictive of human response,this drug should be used during pregnancy only if clearly needed.