Kefuclav

Approved Uses:

• Upper Respiratory Tract Infections:
• Acute bacterial sinusitis
• Acute exacerbations of chronic bronchitis
• Pharyngitis and tonsillitis
• Lower Respiratory Tract Infections:
• Community-acquired pneumonia (mild to moderate severity)
• Ear, Nose & Throat Infections:
• Acute otitis media
• Urinary Tract Infections (UTIs):
• Acute uncomplicated cystitis
• Complicated UTIs caused by susceptible organisms
• Skin and Soft Tissue Infections:
• Uncomplicated skin infections such as cellulitis, wound infections, and abscesses

Clinically Accepted Off-Label Uses:

• Mild osteomyelitis (as part of combination therapy if beta-lactamase–producing bacteria are suspected)
• Dental infections involving resistant organisms
• Empiric outpatient therapy for mixed mild infections where anaerobes are not a concern

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults and Adolescents (13 years and above)

• Pharyngitis and tonsillitis: 250 mg twice daily for 10 days.
• Acute bacterial sinusitis: 250 mg twice daily for 10 days.
• Exacerbation of chronic bronchitis: 250–500 mg twice daily for 10 days.
• Secondary bacterial infections of acute bronchitis: 250–500 mg twice daily for 5–10 days.
• Skin and soft tissue infections: 250–500 mg twice daily for 10 days.
• Urinary tract infections: 250 mg twice daily for 7–10 days.
• Uncomplicated gonorrhea: Single 1,000 mg dose.
• Early Lyme disease: 500 mg twice daily for 20 days.

Pediatric Patients (3 months to 12 years)

• Pharyngitis and tonsillitis: 20 mg/kg/day divided into two doses for 10 days (maximum 500 mg/day).
• Acute otitis media, sinusitis, and skin infections: 30 mg/kg/day divided into two doses for 10 days (maximum 1,000 mg/day).
• Children who can swallow tablets: Typically 250 mg twice daily for 10 days.

Important Notes

• Tablets: Can be taken with or without food.
• Suspension: Must be taken with food to improve absorption.
• Short-course therapy: Some infections may be treated effectively with a 5-day course.
• Renal impairment: Dosage adjustment may be needed in patients with kidney problems.
• Treatment duration: Typically ranges from 5–20 days, depending on infection type and severity.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Cefuroxime Axetil is an orally administered prodrug that is rapidly hydrolyzed to active Cefuroxime in the gastrointestinal tract. Cefuroxime is a second-generation cephalosporin that binds to bacterial penicillin-binding proteins (PBPs), inhibiting the final stage of bacterial cell wall synthesis, which results in cell lysis and death. Clavulanic Acid is a beta-lactamase inhibitor that protects Cefuroxime from degradation by certain beta-lactamase–producing bacteria, thereby extending its antimicrobial spectrum to cover resistant strains such as Haemophilus influenzae and Moraxella catarrhalis.

Absorption:

• Cefuroxime Axetil: ~37% bioavailability when taken with food.
• Clavulanic Acid: Well absorbed orally.

Distribution:

• Both agents distribute widely into respiratory tissues, middle ear fluid, skin, and soft tissues.
• Cross the placenta and appear in small amounts in breast milk.

Metabolism:

• Cefuroxime Axetil is hydrolyzed to active Cefuroxime; minimal further metabolism.
• Clavulanic Acid undergoes hepatic metabolism to inactive metabolites.

Excretion:

• Cefuroxime is excreted unchanged by the kidneys (about 50%–70% within 6 hours).
• Clavulanic Acid is excreted renally and partly in feces.
• Half-lives: Cefuroxime ~1–1.5 hours; Clavulanic Acid ~1 hour.

Pregnancy:

• Cefuroxime: FDA Category B — animal studies have shown no harm, and human data are reassuring when used appropriately.
• Clavulanic Acid: Also considered safe when used in combination during pregnancy if clearly indicated.

Lactation:

• Both drugs pass into breast milk in small amounts and are generally considered safe for short-term use. Monitor infants for mild gastrointestinal effects such as diarrhea or thrush.

• Class: Second-generation cephalosporin antibiotic with beta-lactamase inhibitor.
• Subclass: Oral cephalosporin + beta-lactamase inhibitor combination.

• Known serious hypersensitivity to Cefuroxime, Clavulanic Acid, or any beta-lactam antibiotic.
• History of severe immediate allergic reactions (e.g., anaphylaxis) to penicillins.
• Severe unexplained hepatic dysfunction (use caution).

• Caution in patients with history of severe penicillin or cephalosporin allergy.
• Risk of severe hypersensitivity reactions, including anaphylaxis.
• May cause antibiotic-associated diarrhea or Clostridioides difficile infection — discontinue if significant diarrhea develops.
• Prolonged use may result in fungal or bacterial superinfection.
• Monitor liver function during extended therapy due to potential hepatic effects from Clavulanic Acid.
• Adjust dose in renal impairment to avoid toxicity.

Common Side Effects:

• Gastrointestinal: Diarrhea, nausea, vomiting, abdominal discomfort.
• Skin: Rash, urticaria, pruritus.
• Other: Headache, dizziness.

Serious or Rare Adverse Effects:

• Anaphylactic reactions, angioedema.
• Stevens-Johnson syndrome, toxic epidermal necrolysis (extremely rare).
• Cholestatic jaundice, hepatitis (more associated with Clavulanic Acid).
• Pseudomembranous colitis.

• Probenecid: Prolongs Cefuroxime serum levels by reducing renal excretion.
• Oral contraceptives: Possible reduced efficacy; advise additional contraception.
• Live vaccines (e.g., Typhoid): May be less effective if given during therapy.
• Food: Enhances Cefuroxime absorption; administration with meals is recommended.

Enzyme Systems:

• Not significantly metabolized by CYP450 enzymes — minimal CYP-mediated interactions.

• No major recent changes in standard approved indications or dosing.
• Continued emphasis on using beta-lactam/beta-lactamase inhibitor combinations responsibly to reduce antimicrobial resistance.
• No new black box warnings or significant labeling changes reported by FDA, EMA, or WHO.

• Store at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C are acceptable.
• Protect tablets from moisture and light.
• Reconstituted oral suspension (if dispensed) should be refrigerated (2°C to 8°C) and used within 10 days.
• Do not freeze. Shake suspension well before each dose.