SUPRAX D 400MG 6TAB

Indications

Approved Uses

Uncomplicated urinary tract infections, otitis media, pharyngitis, tonsillitis, acute exacerbations of chronic bronchitis, uncomplicated gonorrhea (cervical/urethral)

Dosage & Administration

Dosing by Condition

Adults (typical): 400 mg once daily or 200 mg every 12 hours for most susceptible infections; uncomplicated gonorrhea: 400 mg single dose (where still recommended/locally appropriate). Duration depends on indication (commonly 5-14 days).

Initial Dose

400mg once daily or 200mg twice daily

Maintenance Dose

400mg once daily or 200mg every 12 hours.

Maximum Dose

400mg per day.

Children's Dosage

Children 6 months to 12 years or ≤50kg: 8mg/kg/day as a single dose or divided every 12 hours (max 400mg/day). Children >50kg or >12 years: adult dose applies. Oral suspension preferred for children

Dose Adjustment Notes

Dose reduction/extended interval is required in renal impairment (e.g., CrCl <60 mL/min); no routine dose adjustment is required in hepatic impairment.

How to Take

Oral use: Disperse the 400 mg dispersible tablet in a small amount of water, stir, and drink immediately; then rinse the glass with a little water and drink. May also be swallowed whole with water if needed. Can be taken with or without food.

How to Prepare

For the dispersible tablet (cefixime 400 mg): place the tablet in a small amount of water (e.g., a glass), allow it to disperse completely, stir, and drink immediately; rinse the glass with a little more water and drink to ensure the full dose is taken (alternatively, it may be swallowed whole with water if permitted by the product leaflet).

Side Effects

Common Side Effects

Diarrhea/loose stools, nausea, abdominal pain, dyspepsia, vomiting, flatulence (gas), headache; rash can occur.

Side Effect Frequency

Common (≥1% to <10%): diarrhea/loose stools, abdominal pain, nausea. Uncommon (≥0.1% to <1%): vomiting, flatulence/dyspepsia, headache/dizziness, rash/urticaria, pruritus, transient liver enzyme elevations. Rare/very rare (<0.1%): severe hypersensitivity (including anaphylaxis), severe cutaneous adverse reactions (SJS/TEN), Clostridioides difficile-associated diarrhea/pseudomembranous colitis, blood dyscrasias (e.g., thrombocytopenia, agranulocytosis).

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to cefixime or other cephalosporins; avoid in those with a history of severe immediate hypersensitivity to other beta‑lactams (e.g., penicillins) unless benefits outweigh risks.

Warnings & Precautions

Caution with history of penicillin/beta‑lactam allergy; monitor for C. difficile diarrhea during/after therapy; adjust dose in renal impairment; prolonged use may cause superinfection; caution in GI disease/colitis; may cause false‑positive urine glucose with copper-reduction tests.

Age Restriction

Safety and efficacy not established in infants <6 months; use only if clearly needed under specialist direction.

Drug Interactions

Drug Interactions

Warfarin/coumarins (↑INR/bleeding risk), carbamazepine (↑levels), probenecid (↑cefixime exposure), live oral typhoid vaccine (reduced vaccine response-avoid/space).

Interaction Severity

MAJOR/clinically significant: Warfarin (may increase INR/bleeding-monitor closely). MODERATE: Live oral typhoid vaccine Ty21a (antibiotics can reduce vaccine efficacy-avoid during and for several days after antibiotics), Carbamazepine (may increase levels-monitor). MINOR/MODERATE: Probenecid (may increase cefixime concentrations).

Food Interaction

No restriction: may be taken with or without food; taking with food may improve GI tolerability.

Special Populations

Children

Children 6 months to 12 years or ≤50kg: 8mg/kg/day as a single dose or divided every 12 hours (max 400mg/day). Children >50kg or >12 years: adult dose applies. Oral suspension preferred for children

Elderly

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

Kidney Impairment

CrCl 21-60 mL/min: 75% of the normal daily dose (e.g., 300 mg/day). CrCl ≤20 mL/min or dialysis: 50% of the normal daily dose (e.g., 200 mg/day).

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Preparation Instructions

For the dispersible tablet (cefixime 400 mg): place the tablet in a small amount of water (e.g., a glass), allow it to disperse completely, stir, and drink immediately; rinse the glass with a little more water and drink to ensure the full dose is taken (alternatively, it may be swallowed whole with water if permitted by the product leaflet).

Stopping the Medicine

Complete the full prescribed antibiotic course; do not stop early without prescriber advice.

Overdose

No specific antidote; provide supportive care (consider activated charcoal if recent ingestion). Hemodialysis/peritoneal dialysis do not remove cefixime in significant amounts.

Patient Counseling

Take exactly as prescribed and complete the full course; disperse the tablet in a small amount of water and drink immediately (or swallow whole if needed); may take with food if stomach upset occurs; seek care urgently for allergy symptoms (rash, swelling, breathing difficulty) or severe/persistent diarrhea (possible C. difficile); inform clinician about penicillin/cephalosporin allergy and warfarin use.

Monitoring Requirements

No routine labs for short courses in healthy patients; monitor renal function in patients with significant renal impairment and monitor for severe diarrhea/C. difficile and superinfection with prolonged therapy; check INR more frequently if on warfarin.

Pharmacology

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), which disrupts the final step of peptidoglycan synthesis, leading to bacterial cell death.

Onset of Action

Peak plasma concentration (Tmax) typically occurs about 2-6 hours after an oral dose; clinical improvement is usually assessed over 48-72 hours depending on infection.

Duration of Effect

Approximately 24 hours, allowing for once-daily dosing.

Half-Life

3-4 hours.

Bioavailability

Oral bioavailability is approximately 40-50%; the oral suspension may provide modestly higher bioavailability than tablets in some studies.

Metabolism

Not significantly metabolized; largely excreted unchanged.

Excretion

Eliminated primarily via the kidneys; about ~50% of the absorbed dose is excreted unchanged in urine, with the remainder via non-renal routes (including biliary/fecal).

Protein Binding

Approximately 65-70% protein bound.

Product Information

Available Dosage Forms

For this SFDA-registered product: dispersible tablet (400 mg). Other cefixime dosage forms that may exist in general include capsules, film-coated tablets, chewable tablets, and powder for oral suspension (market-dependent).

Composition per Dose

Each dispersible tablet: 400mg cefixime (as cefixime trihydrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription antibiotic required

Spectrum

Broad-spectrum.

Antibiotic Class

Cephalosporin

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