ZINNAT 500MG 10 TAB

Indications

Approved Uses

Acute streptococcal tonsillitis and pharyngitis, Acute bacterial otitis media, Acute bacterial maxillary sinusitis, Acute bacterial exacerbations of chronic bronchitis, Uncomplicated skin and soft-tissue infections, Uncomplicated urinary tract infections, Cystitis, Pyelonephritis, Uncomplicated gonorrhea, Early Lyme disease.

Off-Label Uses

Off-label uses may include bite-wound infections and selected surgical prophylaxis regimens (institution/protocol dependent).

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 exacerbation of chronic bronchitis 250-500 mg PO q12h x 10 days; Community-acquired pneumonia 500 mg PO q12h x 10 days; Uncomplicated UTI 125-250 mg PO q12h x 7-10 days; Uncomplicated skin/skin-structure infections 250-500 mg PO q12h x 10 days; Uncomplicated gonorrhea 1 g PO once; Early Lyme disease 500 mg PO q12h x 20 days.

Initial Dose

250-500mg twice daily depending on indication

Maintenance Dose

250-500mg every 12 hours

Maximum Dose

1000 mg every 12 hours for some indications; 1000mg single dose for uncomplicated gonorrhea.

Children's Dosage

Pediatric patients younger than 13 years who can swallow tablets whole: Acute bacterial otitis media 250 mg every 12 hours x 10 days; Acute bacterial maxillary sinusitis 250 mg every 12 hours x 10 days. Pediatric patients 3 months to 12 years: Use oral suspension (dosage per FDA label for suspension).

Dose Adjustment Notes

Dose adjustment is required in renal impairment; typical thresholds are CrCl <30 mL/min (with further reduction/interval extension as renal function declines). No routine hepatic dose adjustment is required.

How to Take

Swallow the coated tablet whole with water; do not crush or chew (bitter taste). Take after food to enhance absorption.

Side Effects

Common Side Effects

Diarrhea, nausea, vomiting, abdominal pain, headache, dizziness; rash/urticaria; vaginal candidiasis/vaginitis; transient liver enzyme elevations; positive direct Coombs test (± rare hemolytic anemia).

Side Effect Frequency

Common (1-10%): diarrhea/loose stools, nausea, vomiting; other reactions (e.g., abdominal pain, rash/urticaria, headache, dizziness, transient liver enzyme elevations, positive Coombs test, vaginitis) are reported but their exact frequencies vary by source and are not reliably classifiable from the provided model claims alone; serious hypersensitivity and severe cutaneous reactions are rare.

Safety & Warnings

Contraindications

Hypersensitivity to cefuroxime, other cephalosporins, or any excipients; contraindicated in patients with a history of immediate severe hypersensitivity (e.g., anaphylaxis) to other beta‑lactams (e.g., penicillins/carbapenems) due to cross-reactivity risk.

Warnings & Precautions

Assess for beta-lactam allergy and monitor for hypersensitivity; risk of C. difficile-associated diarrhea; use caution and adjust dosing in renal impairment (monitor renal function in at-risk patients); prolonged use may cause overgrowth of non-susceptible organisms (e.g., Candida); use caution in patients with history of GI disease/colitis; may interfere with certain urine glucose tests (copper reduction methods).

Age Restriction

Oral tablets: generally for children ≥12 years (younger children should use the oral suspension). Oral suspension: can be used from 3 months of age; not recommended in infants <3 months due to limited data.

Drug Interactions

Drug Interactions

Probenecid increases cefuroxime exposure; acid-suppressing agents (antacids, H2 blockers, PPIs) can reduce absorption of cefuroxime axetil; oral anticoagulants (e.g., warfarin) may have increased anticoagulant effect/INR-monitor; oral contraceptive efficacy may be reduced (advise backup if vomiting/diarrhea or per local guidance).

Food Interaction

Take with food (after meals) to increase 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 x 10 days; Acute bacterial maxillary sinusitis 250 mg every 12 hours x 10 days. Pediatric patients 3 months to 12 years: Use oral suspension (dosage per FDA label for suspension).

Elderly

Standard adult dosing. Dose should be adjusted according to renal function as elderly patients are more likely to have decreased renal function.

Kidney Impairment

Adjust by extending dosing interval: 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 usual individual dose after dialysis.

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed course even if symptoms improve; do not stop early unless advised by a clinician (e.g., serious adverse reaction).

Overdose

Overdose may cause GI upset and CNS toxicity (e.g., seizures/encephalopathy), especially with renal impairment; management is supportive, consider decontamination if early, and cefuroxime can be removed by hemodialysis-seek urgent medical care.

Patient Counseling

Take after food; swallow whole (do not crush/chew due to bitterness). Complete the full prescribed course. Seek care for allergy (rash, swelling, breathing difficulty) or severe/persistent diarrhea (possible C. difficile). Inform the prescriber about penicillin/cephalosporin allergy and anticoagulant use (may need INR monitoring). Store below 30°C in original blister.

Pharmacology

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), which prevents the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, leading to cell lysis and death.

Onset of Action

Peak plasma concentrations typically occur about 2-3 hours after an oral dose; 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

About 1-1.5 hours in patients with normal renal function (prolonged in renal impairment).

Bioavailability

Approximately 37% fasting, increasing to about 52% when taken with food.

Metabolism

Cefuroxime axetil is a prodrug hydrolyzed by esterases (primarily in the intestinal mucosa) to active cefuroxime; cefuroxime undergoes essentially no further metabolism.

Excretion

Primarily excreted unchanged in the urine via glomerular filtration and tubular secretion.

Protein Binding

33-50%.

Product Information

Available Dosage Forms

Cefuroxime axetil: oral coated tablets and oral suspension/granules for reconstitution; cefuroxime (as sodium): injection (IV/IM) is a different formulation (not axetil).

Composition per Dose

Each tablet: 500mg cefuroxime as cefuroxime axetil

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad

Antibiotic Class

Cephalosporin

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