MEGAMOX 625/MG TAB 20/TAB

Indications

Approved Uses

Treatment of susceptible infections such as upper and lower respiratory tract infections (e.g., sinusitis, otitis media, bronchitis/pneumonia), urinary tract infections, and skin/soft tissue infections; other labeled uses may include dental infections depending on local labeling.

Dosage & Administration

Dosing by Condition

Adults (typical): 500/125 mg every 8 hours OR 875/125 mg every 12 hours depending on severity/site; for this product (500/125 mg tablet), common adult regimen is 1 tablet every 8 hours for more severe infections or 1 tablet every 12 hours for mild-moderate infections when clinically appropriate.

Initial Dose

For most common infections: 875mg/125mg every 12 hours or 500mg/125mg every 8 hours.

Maintenance Dose

875mg/125mg every 12 hours or 500mg/125mg every 8 hours, depending on the infection's severity and type.

Maximum Dose

Adults: usual maximum amoxicillin 4 g/day; keep clavulanate exposure generally ≤250 mg/day in standard regimens (higher clavulanate exposure may be used only with specific high-dose products/regimens). For this 500/125 mg tablet, typical adult maximum is 1 tablet every 8 hours (3 tablets/day = 1.5 g amoxicillin + 375 mg clavulanate) unless a prescriber specifies otherwise.

Children's Dosage

Pediatric patients aged 2 months to 12 years: 45/6.4 mg/kg/day divided every 12 hours or 40/10 mg/kg/day divided every 8 hours (use oral suspension).

Dose Adjustment Notes

Renal impairment: dose/frequency adjustment is required (especially when CrCl <30 mL/min) and avoid/limit 875/125-type high-dose regimens in severe renal impairment; hepatic impairment: use with caution and monitor liver function, particularly with prolonged therapy.

How to Take

Swallow the tablet whole with water; take at the start of a meal (or with food) to improve gastrointestinal tolerability and optimize clavulanate absorption; doses should be spaced evenly as prescribed.

Side Effects

Common Side Effects

Diarrhea, nausea, vomiting, abdominal discomfort, and rash; candidiasis (e.g., vaginal thrush) can occur.

Side Effect Frequency

Very common (≥10%): diarrhea. Common (1-10%): nausea, vomiting, mucocutaneous candidiasis; rash/urticaria may occur (frequency varies by source). Uncommon (0.1-1%): dizziness, headache, indigestion, pruritus/urticaria, vaginitis; transient increases in liver enzymes. Rare/very rare: antibiotic-associated colitis (including C. difficile), hepatitis/cholestatic jaundice, severe cutaneous adverse reactions (SJS/TEN), anaphylaxis, blood dyscrasias (e.g., leukopenia, thrombocytopenia, hemolytic anemia), and seizures (more likely with high doses/renal impairment).

Safety & Warnings

Contraindications

Contraindicated in: (1) hypersensitivity to amoxicillin, clavulanate, penicillins, or other beta-lactams with a history of severe immediate reaction; (2) history of cholestatic jaundice/hepatic dysfunction associated with prior amoxicillin/clavulanate.

Warnings & Precautions

Key precautions: assess beta-lactam allergy/cross-reactivity; stop and evaluate if rash or hypersensitivity occurs; monitor for C. difficile diarrhea; use caution and adjust dosing in renal impairment; monitor liver function if prolonged therapy or hepatic risk; avoid use in infectious mononucleosis due to high rash risk; prolonged use may cause superinfection.

Age Restriction

No absolute minimum age restriction for the amoxicillin/clavulanate combination, but this 500/125 mg tablet is generally not suitable for young children; pediatric use should be weight-based using pediatric formulations (suspension/appropriate strengths), and neonates/young infants require extended dosing intervals.

Drug Interactions

Food Interaction

Take with food, preferably at the start of a meal.

Special Populations

Children

Pediatric patients aged 2 months to 12 years: 45/6.4 mg/kg/day divided every 12 hours or 40/10 mg/kg/day divided every 8 hours (use oral suspension).

Kidney Impairment

CrCl 10-30 mL/min: 500/125 mg every 12 hours; CrCl <10 mL/min: 500/125 mg every 24 hours; hemodialysis: 500/125 mg every 24 hours with an additional dose during/after dialysis. Avoid higher-strength tablets (e.g., 875/125) when CrCl <30 mL/min.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Complete the prescribed course; do not stop early unless a serious adverse reaction occurs and a clinician advises discontinuation.

Overdose

Overdose may cause GI upset (nausea/vomiting/diarrhea), crystalluria/renal impairment, and seizures (especially with very high doses or renal dysfunction); management is supportive, stop the drug, maintain hydration, correct electrolytes, and hemodialysis can remove amoxicillin (and some clavulanate) in severe cases.

Patient Counseling

Complete the full prescribed course even if you feel better. Take doses at evenly spaced times and preferably at the start of a meal/with food to reduce GI upset. Seek urgent care for any signs of allergy (rash, itching, swelling, wheeze/shortness of breath). Contact a clinician promptly for severe, persistent, or bloody diarrhea (possible C. difficile) and do not self-treat with antidiarrheals. Tell your prescriber if you have a history of penicillin/cephalosporin allergy, infectious mononucleosis, significant liver disease, or kidney impairment; and if you take warfarin/other anticoagulants, methotrexate, or probenecid (interaction/monitoring may be needed). Oral contraceptives generally do not require backup routinely, but use backup if vomiting/diarrhea occurs or if advised. Store below 30°C and keep out of reach of children.

Monitoring Requirements

Monitor for clinical response and adverse effects; for prolonged therapy or in hepatic/renal impairment: periodic renal function and liver function tests; if on warfarin: monitor INR/prothrombin time; consider CBC with prolonged courses.

Pharmacology

Mechanism of Action

Amoxicillin inhibits bacterial cell-wall synthesis by binding PBPs; clavulanic acid inhibits beta-lactamases, protecting amoxicillin and extending spectrum.

Onset of Action

Peak plasma concentrations typically occur about 1-2 hours after an oral dose; clinical improvement is usually assessed within 48-72 hours depending on infection.

Duration of Effect

Approximately 8 hours per dose for the 500/125 mg immediate-release tablet (typical dosing interval q8h; sometimes q12h in selected mild infections).

Half-Life

Amoxicillin: ~1.0-1.5 hours; Clavulanic acid: ~1.0 hour (about 0.8-1.2 hours) in normal renal function.

Bioavailability

Amoxicillin: ~70-90% (often cited ~75-90%); Clavulanic acid: ~60% (often cited ~60-70%).

Metabolism

Amoxicillin: minimal metabolism (most excreted unchanged in urine). Clavulanic acid: partially metabolized (hepatic metabolism occurs, but it is not ‘extensively’ metabolized; elimination is via both renal excretion and metabolism).

Excretion

Amoxicillin: primarily renal (60-70% unchanged in urine); Clavulanic acid: renal and metabolic (25-40% excreted unchanged in urine)

Product Information

Available Dosage Forms

For this SFDA-registered product: Tablet (oral), blister pack (20 tablets).

Composition per Dose

Each tablet: 500 mg amoxicillin as trihydrate + 125 mg clavulanic acid as potassium clavulanate

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription required for all amoxicillin/clavulanate products

Spectrum

Broad

Antibiotic Class

Penicillin

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