Composition
FOXITIL-250
Each film coated tablet contains:
Cefuroxime Axetil USP Eqv. to Cefuroxime 250mg
FOXITIL-500
Each film coated tablet contains:
Cefuroxime Axetil USP Eqv. to Cefuroxime 500mg
List of Excipients
- Lactose
- Croscarmellose Sodium
- Crospovidone
- Povidone K30
- Maize Starch
- Sodium Lauryl Sulphate
- Colloidal Anhydrous Silica (For Foxitil-500)
- Magnesium Stearate
- Hypromellose E15
- Purified Talc
- Titanium Dioxide
- Isopropyl Alcohol
- Dichloromethane
Pharmacodynamic Properties
Cefuroxime axetil undergoes hydrolysis by esterase enzymes to the active antibiotic, cefuroxime. Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs).
This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.
Pediatric Data
Maximum of 250 mg twice daily or as directed by physician.
Pharmacokinetic Properties
Absorption:
After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation.
Distribution:
Protein binding has been stated as 33 to 50% depending on the methodology used.
Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in the tonsilla, sinus tissues, bronchial mucosa, bone, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum and aqueous humor. Cefuroxime passes the blood-brain barrier when the meninges are inflamed.
Biotransformation:
Cefuroxime is not metabolised.
Elimination:
The serum half-life is between 1 and 1.5 hours. Cefuroxime is excreted by glomerular filtration and tubular secretion.
Therapeutic Indications
Cefuroxime axetil is indicated for the treatment of the infections for Acute streptococcal tonsillitis and pharyngitis, Acute bacterial sinusitis, Acute otitis media, Acute exacerbations of chronic bronchitis, Cystitis, Pyelonephritis, Uncomplicated skin and soft tissue infections & Treatment of early Lyme disease.
Dosage and Administration
500 mg twice daily or as directed by physician.
Mode of Administration: Oral
Possible Side Effects
The most common side effects are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes.
Drug-Drug and Food Interaction
Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food. Cefuroxime is excreted by glomerular filtration and tubular secretion.
Concomitant use of probenecid is not recommended. Concurrent administration of probenecid significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of cefuroxime.
Concomitant use with oral anticoagulants may give rise to increased INR.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).
Warnings and Precautions for Use
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity.
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated,
Caution:
Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Pregnancy and Lactation
Cefuroxime axetil should be prescribed to pregnant women only if the benefit outweighs the risk. Cefuroxime should only be used during breastfeeding after benefit/risk assessment by the physician in charge:
Overdose
Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment.
Treatment: Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Shelf Life
36 Months
Storage Condition
Store below 30°C. Protect from light & moisture.
Date of Publication / Review
25 June 2022
Presentation
- Foxitil-250: Alu-Blister Pack of 10's, 30's, 100's & 1000's
- Foxitil-500: Alu-Blister Pack of 10's, 30's, 100's & 1000's
Manufactured by
ATOZ Pharmaceuticals Pvt. Ltd.,
No.12, Balaji Nagar, Ambattur,
Chennai - 600 053. INDIA.
a promise of hoates
Marketed by
OA&J Pharmaceuticals Ltd.,
Plot No. IND/A/71/G/11,
Tema Heavy Indl. Area, GHANA.