| a) Generic Name |
Cefuroxime axetil INN
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Film Coated Tablet.
Each tablet contains Cefuroxime axetil equivalent to Cefuroxime INN 500 mg.
|
| b) Indications |
lPharyngitis/tonsillitis. lAcute bacterial otitis media lAcute bacterial maxillary sinusitis lLower respiratory tract infections including pneumoniae lAcute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis lSkin and Skin-Structure Infections lUrinary tract infections lBone and Joint Infections lGonorrhea: Uncomplicated and disseminated gonococcal infections due to Neiseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females lEarly Lyme disease (erythema migrans) lSepticemia lMeningitis lSurgical Prophylaxis: Prophylaxis against infections in abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal and vascular surgery where there is increased risk for infection.
|
| c) Dosage & administration |
Adolescents & adults (13 years & above)
Pharyngitis or Tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbation of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin & skin-structure infections
Uncomplicated urinary tract infection
Uncomplicated gonorrhea
Lyme disease
Paediatric patients (Upto 12 years)
(Who can swallow tablets whole)
Pharyngitis or Tonsillitis
Acute otitis media
Acute bacterial maxillary sinusitis
|
| d) Contraindications |
Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.
|
| e) Side Effects
|
Generally Cefuroxime is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
|
| f) Warnings & Precautions
|
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis
|
| g) Drug Interactions: |
Concomitant administration of probenecid with Cefuroxime increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
|
| h) Use in Pregnancy |
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime has been safely used in later pregnancy to treat urinary and other infections.
|
| i) Use in Lactation |
Cefuroxime is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
|
| j) Over dosage |
Signs and symptoms: Overdosage of Cefuroxime can cause cerebral irritation leading to convulsions.
|
| k) Package Quantity |
To be submitted at the time of inclusion.
|
