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Product Details

Probac®
Cefuroxime Axetil
Description:
Cefuroxime is a semi-synthetic, broad-spectrum second-generation cephalosporin antibiotic for oral administration. Cefuroxime has bactericidal activity against a wide range of common pathogens, both gram positive and gram negative including many beta-lactamase-producing strains.

Presentation:
Probac® 250 : Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg
Probac® 500 : Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg
Probac® Dry Powder for Suspension (70ml) : After reconstitution according to direction, each 5 ml suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg.

Indications:

• Pharyngitis/Tonsillitis caused by S. pyogenes.
• Acute Bacterial Otitis Media caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), M. catarrhalis (including beta-lactamase-producing strains), or S. pyogenes.
• Acute Bacterial Maxillary Sinusitis caused by S. pneumoniae or H. influenzae (non-beta-lactamase-producing strains only).
• Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by S. pneumoniae, H. influenzae (beta-lactamase negative strains), or H. parainfluenzae (beta-lactamase negative strains).
• Uncomplicated Skin and Skin-Structure Infections caused by S. aureus (including beta-lactamase-producing strains) or S. pyogenes.
• Uncomplicated Urinary Tract Infections caused by E. coli or K. pneumoniae.
• Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase-producing strains of N. gonorrhoeae and uncomplicated gonorrhea, in females, caused by non-penicillinase-producing strains of N. gonorrhoeae.
• Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
• Septicemia caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pneumoniae, E coli, H. influenzae (including ampicillin resistant strains), and Klebsiella spp.
• Meningitis caused by S. pneumoniae, H. influenzae (including ampicillin resistant strains), N. meningitidis, and S. aureus (penicillinase- and non-penicillinase-producing strains)
• Surgical Prophylaxis, Prophylaxis against infections in abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal and vascular surgery where there is increased risk for infection.

Dosage & Administration:

Oral: Probac® should be taken after food for optimum absorption

Infection Dosage Duration(days)
Tablet Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis 250 mg bid 10
Acute bacterial maxillary sinusitis 250 mg bid 10
Acute bacterial exacerbations of chronic bronchitis 250 or 500 mg bid 10
Secondary bacterial infections of acute bronchitis 250 or 500 mg bid 5-10
Uncomplicated skin and skin-structure infections 250 or 500 mg bid 10
Uncomplicated urinary tract infections 250 mg bid 7-10
Uncomplicated gonorrhea 1,000 mg once single dose
Early Lyme disease 500 mg bid 20
Pediatric Patients (who can swallow tablets whole)
Pharyngitis/Tonsillitis 125 mg bid 10
Acute otitis media 250 mg bid. 10
Acute bacterial maxillary sinusitis 250 mg bid 10
Suspension
(Must be administered with food)
Usual dose: 125mg b.i.d. or 10-15 mg/kg b.i.d.
Pediatric Patients ( 3 months to 12 years)
Pharyngitis/Tonsillitis 10 mg/kg b.i.d. 10
Acute otitis media 15 mg/kg b.i.d. 10
Acute bacterial maxillary sinusitis 15 mg/kg b.i.d. 10
Impetigo and other skin infections 15 mg/kg b.i.d. 10

Contraindications, Side effects, Warnings etc

Contraindications:
Patients with known allergy to cephalosporins & pseudomembranopus colitis are contraindicated

Side effects:
Generally Cefuroxime is well tolerated. However a few side effects like nausea,vomiting. dirrhea, abdominal discomfort or pain may occur.Prolonged administration of Cefuroxime may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, rash and serum sickness like urticaria may occur. Use in Pregnancy and Lactation: PREGNANCY: 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 indications. LACTATION: Cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with Cefuroxime axetil. Drug Interactions: Concomitant administration of probenecid with Cefuroxime axetil tablets increases the area under the serum concentration versus time curve by 50%. Drugs that reduce gastric acidity may result in a lower bioavailability of Cefuroxime compared with that of fasting state and tend to cancel the effect of postprandial absorption. Over dosage: Signs and Symptoms: Overdose of Cefuroxime can cause cerebral irritation leading to convulsions. Management: Serum levels of Cefuroxime can be reduced by haemodialysis and peritoneal dialysis. Pharmaceuticals Precautions Shake the bottle well before each use Store in a cool and dry place at a temperature below 300C. Replace cap securely after each opening. Keep away from sunlight. Keep out of the reach of children. Direction of preparation of suspension Shake the bottle well to loosen powder. To prepare 70 ml suspension add 35 ml (7 -teaspoonful) of boiled and cooled water in to the bottle. Then continue shaking the bottle until the powder completely mixes with the water. Discard the reconstituted suspension after 10 days. Commercial Pack Probac® 250 : Each box contains 4 Alu-Alu blister strip of 4 tablets Probac® 500 : Each box contains 2 Alu-Alu blister strip of 4 tablets Probac® Dry Powder for Suspension : Bottle containing cefuroxime axetil dry powder to reconstitute 70 ml suspension.