ZAMUR 500/MG FC TAB 10/FC TAB

Indications

Approved Uses

Community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, pharyngitis and tonsillitis, otitis media, uncomplicated urinary tract infections, uncomplicated skin and skin structure infections, uncomplicated gonorrhea, early Lyme disease (Borrelia burgdorferi infection)

Dosage & Administration

Dosing by Condition

Adults (typical): Pharyngitis/tonsillitis 250 mg PO q12h x 10 days; Acute bacterial maxillary sinusitis 250 mg PO q12h x 10 days; Acute bacterial exacerbations of chronic bronchitis 250-500 mg PO q12h x 10 days; Uncomplicated skin and skin-structure infections 250-500 mg PO q12h x 10 days; Uncomplicated UTI 250 mg PO q12h x 7-10 days

Initial Dose

250-500mg twice daily depending on indication

Maintenance Dose

250-500mg every 12 hours

Maximum Dose

1000mg/day (for most indications); 1000mg as single dose for gonorrhea

Children's Dosage

Pediatric patients younger than 13 years who can swallow tablets whole: Acute bacterial otitis media: 250 mg every 12 hours for 10 days; Acute bacterial maxillary sinusitis: 250 mg every 12 hours for 10 days. Tablets not substitutable for suspension on mg/mg basis.

Dose Adjustment Notes

Dose adjustment is required in renal impairment (reduce dose and/or extend interval as creatinine clearance declines); no routine hepatic dose adjustment is needed.

How to Take

Swallow the film‑coated tablet whole with water and take with/after food; do not crush or chew.

Side Effects

Common Side Effects

Diarrhea, nausea/vomiting, abdominal pain, headache/dizziness, rash/urticaria; possible candidiasis; transient elevations in liver enzymes.

Side Effect Frequency

Common (≥1% to <10%): diarrhea, nausea/vomiting, abdominal pain; rash/urticaria and transient liver enzyme elevations can occur. Serious but rare: hypersensitivity (including anaphylaxis), C. difficile-associated diarrhea, hematologic reactions (e.g., hemolytic anemia, thrombocytopenia), and interstitial nephritis.

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to cefuroxime, other cephalosporins, or any excipients; avoid/use contraindicated in those with a history of immediate severe hypersensitivity (e.g., anaphylaxis) to other beta‑lactams (e.g., penicillins, carbapenems).

Warnings & Precautions

Key warnings/precautions: assess history of beta‑lactam allergy (cross‑reactivity risk); dosage adjustment required in renal impairment; tablets and oral suspension are not bioequivalent and not substitutable

Age Restriction

Film‑coated tablets: generally for children ≥12 years (or ≥40 kg); younger children should use the oral suspension (approved from 3 months).

Drug Interactions

Drug Interactions

Key interactions: probenecid (↑ cefuroxime exposure); agents that reduce gastric acidity such as antacids/H2‑blockers/PPIs (↓ absorption/bioavailability of cefuroxime axetil); oral anticoagulants (e.g., warfarin-may ↑ INR/bleeding risk); combined oral contraceptives (possible reduced efficacy-advise backup if significant diarrhea/vomiting); additive nephrotoxicity risk with other nephrotoxic drugs (e.g., aminoglycosides/loop diuretics) especially in renal impairment.

Interaction Severity

Probenecid: clinically significant (avoid or monitor; increases cefuroxime levels). Antacids/H2-blockers/PPIs: moderate (reduce absorption-separate/avoid if possible). Warfarin/other anticoagulants: moderate (possible increased INR-monitor). Oral contraceptives: possible reduced efficacy due to antibiotic-associated GI effects-advise backup if vomiting/diarrhea or per local guidance.

Food Interaction

Take with food (food increases cefuroxime axetil absorption).

Alcohol Interaction

Safe

Special Populations

Children

Pediatric patients younger than 13 years who can swallow tablets whole: Acute bacterial otitis media: 250 mg every 12 hours for 10 days; Acute bacterial maxillary sinusitis: 250 mg every 12 hours for 10 days. Tablets not substitutable for suspension on mg/mg basis.

Elderly

Standard adult dosing; monitor renal function as age-related decline in renal function may necessitate dose adjustment

Kidney Impairment

Adjust for reduced renal function: CrCl 10-29 mL/min-give the usual individual dose every 24 hours; CrCl <10 mL/min-give the usual individual dose every 48 hours; hemodialysis-give an additional dose after dialysis.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not double the dose

Stopping the Medicine

Complete the full prescribed course even if symptoms improve; do not stop early unless advised due to adverse effects or clinician instruction.

Overdose

Overdose may cause GI upset and CNS excitation (including seizures/convulsions); management is supportive, and cefuroxime levels can be reduced by hemodialysis (and peritoneal dialysis).

Patient Counseling

Take with/after food; swallow whole (do not crush/chew); take doses evenly spaced and complete the full course; seek care for severe allergy symptoms or severe/persistent watery diarrhea; separate from antacids/acid-suppressing agents if possible; if on warfarin, monitor for bleeding/INR changes; consider backup contraception if significant vomiting/diarrhea occurs.

Pharmacology

Mechanism of Action

Beta-lactam cephalosporin that binds PBPs and inhibits the final transpeptidation/cross-linking step of peptidoglycan cell-wall synthesis, leading to bacterial cell lysis.

Onset of Action

Peak plasma concentration typically ~2-3 hours after an oral dose (faster with food); clinical improvement is usually seen within 48-72 hours if the pathogen is susceptible.

Duration of Effect

Approximately 12 hours (supports twice-daily dosing).

Half-Life

Approximately 1-1.5 hours in adults with normal renal function (prolonged in renal impairment).

Bioavailability

Oral bioavailability is ~37% fasting and increases to ~52% when taken with food.

Metabolism

Cefuroxime axetil is a prodrug hydrolyzed by esterases in the intestinal mucosa and blood to cefuroxime; cefuroxime undergoes no (or negligible) further metabolism and is excreted unchanged.

Excretion

Primarily renal excretion as unchanged cefuroxime (most of the dose) via glomerular filtration and active tubular secretion.

Protein Binding

33-50%.

Product Information

Available Dosage Forms

Film‑coated tablet; powder/granules for oral suspension (reconstituted oral suspension).

Composition per Dose

Each film-coated tablet: 500mg cefuroxime as cefuroxime axetil

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad

Antibiotic Class

Cephalosporin

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