CEFABOLD 500 – Barter & Marcin Pharma

CEFABOLD 500mg

Cefabold (Cefuroxime Axetil Tablets IP, 500 mg)

Professional Prescribing Information

Cefabold™ 500 mg Tablets
Cefuroxime Axetil 500 mg
Broad-Spectrum Antibiotic for UTI and More

Product Overview

Cefuroxime Axetil is a second-generation cephalosporin antibiotic, formulated as film-coated tablets, and indicated for oral administration in adults and children over 3 months of age.

Each tablet contains Cefuroxime Axetil, equivalent to 500 mg cefuroxime.

Indications

Acute bacterial infections, including:

Urinary tract infections (UTIs)
Skin and soft tissue infections
Gonorrhoea
Respiratory tract infections (pharyngitis, tonsillitis, sinusitis, bronchitis, pneumonia)
Otitis media
Lyme disease (early stage)

Key Features

Broad-spectrum activity: Effective against both gram-positive and gram-negative bacteria, including Staphylococcus aureus, Staphylococcus pneumoniae, and E. coli.
Rapid bactericidal action: Provides a prompt response by inhibiting bacterial cell wall synthesis, leading to cell death.
Proven efficacy: Demonstrated effectiveness for a wide range of mild-to-moderately severe infections, meeting international quality standards.

Clinical Benefits

High affinity for penicillin-binding proteins in bacteria, especially gram-negative strains.
Resists beta-lactamase degradation, offering improved activity against certain resistant organisms.
Suitable for various patient populations, with dosage adjustments for pediatrics, geriatrics, and renal impairments.

Administration

Recommended course: 5–10 days as per clinical judgment.
Dosage and duration depend on infection severity and patient profile.

Indications

Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by susceptible strains of designated organisms in the following conditions:

Upper respiratory tract infections (pharyngitis, tonsillitis, otitis media, and sinusitis)
Lower respiratory tract infections (bronchitis, pneumonia)
Skin and soft tissue infections
Urinary tract infections
Gonorrhoea

Dosage And Administration

Adults and children 12 years and older:

Most infections: 250 mg – 500 mg every 12 hours (twice daily) depending on the severity and type.
Duration: Typically 7 to 10 days; for β-hemolytic streptococcal infections, at least 10 days.
Administration: Should be taken with food for optimal absorption.
Renal impairment: Adjust dosing based on degree of impairment.

Contraindications

Known hypersensitivity to cefuroxime, any component of the formulation, or any member of the cephalosporin class.

Warnings and Precautions

Severe hypersensitivity reactions (e.g., anaphylaxis, severe skin reactions) may occur. Immediate withdrawal and supportive management required.
Use with caution in patients with history of allergy, especially to penicillins or other beta-lactam antibiotics.
Clostridioides difficile-associated diarrhea and pseudomembranous colitis have been reported.
Cephalosporins may induce hemolytic anemia and severe cutaneous adverse reactions (SCARs).
Caution in patients with underlying gastrointestinal diseases, especially colitis.
Prolonged use may result in overgrowth of non-susceptible organisms (superinfection).
Periodic renal, hepatic, and hematopoietic function assessment recommended.

Drug Interactions

Concomitant use with potent diuretics (e.g., furosemide) or aminoglycosides can increase nephrotoxicity risk.
Drugs that reduce gastric acidity may lower bioavailability.
May reduce efficacy of oral contraceptives.

Adverse Reactions

Common adverse reactions include:

Gastrointestinal: diarrhea, nausea, vomiting, abdominal pain
CNS: headache, dizziness
Hypersensitivity: rash, pruritus, urticaria, rare anaphylaxis
Hematologic: eosinophilia, positive Coombs’ test, rare hemolytic anemia
Hepatic: transient increases in liver enzymes.
Rare: pseudomembranous colitis, Stevens-Johnson syndrome.

Microbiology

Cefuroxime is active in vitro against a range of Gram-positive and Gram-negative organisms, including:

Staphylococcus aureus (methicillin-susceptible)
Streptococcus pneumoniae
Escherichia coli
Haemophilus influenzae (including beta-lactamase positive/negative)
Moraxella catarrhalis.

Storage

Store at 15°C to 30°C (room temperature), in tightly closed containers.