CLAVODAR 625/MG FC TAB 20/FC TAB

Indications

Approved Uses

Susceptible infections including: upper/lower respiratory tract infections (e.g., sinusitis, otitis media, bronchitis/pneumonia), urinary tract infections, skin/soft tissue infections, and odontogenic (dental) infections; other indications may be included per local label (e.g., certain intra‑abdominal/bone & joint infections) but are not universal across all product labels.

Dosage & Administration

Dosing by Condition

Adults (immediate-release 500/125 mg as in SFDA CLAVODAR): typical regimens are 500/125 mg every 8 hours for more severe infections, or 500/125 mg every 12 hours for mild-to-moderate infections when clinically appropriate; duration is indication- and severity-dependent (commonly ~5-7 days for many respiratory/skin infections, longer for complicated infections).

Initial Dose

500mg/125mg every 8 hours or 875mg/125mg every 12 hours, depending on infection severity.

Maintenance Dose

500mg/125mg every 8 hours or 500mg/125mg every 12 hours, depending on infection severity.

Maximum Dose

For adults, typical maximum amoxicillin exposure is up to 4 g/day (with appropriate clavulanate limits depending on formulation); for this 500/125 mg tablet, usual adult maximum is 1 tablet every 8 hours (amoxicillin 1.5 g/day; clavulanate 375 mg/day).

Children's Dosage

Children under 12 years or under 40kg: oral suspension preferred. Dosing based on amoxicillin component: 25-45mg/kg/day in divided doses every 8-12 hours depending on severity. Children 12 years and over or over 40kg: adult dosing applies (625mg every 8-12 hours).

Dose Adjustment Notes

Renal impairment: dose/interval adjustment is required (avoid/adjust if CrCl <30 mL/min depending on regimen); hepatic impairment: use with caution and monitor liver function, especially with prolonged therapy.

How to Take

Swallow whole with water; take at the start of a meal to improve GI tolerability (and clavulanate absorption); doses should be spaced evenly as prescribed and the full course completed.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Contraindicated in: (1) hypersensitivity to amoxicillin, clavulanate, penicillins, or other beta‑lactams (e.g., prior anaphylaxis/SJS/TEN); (2) previous cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate.

Warnings & Precautions

Key precautions: assess history of beta‑lactam allergy/cross-reactivity; monitor for C. difficile diarrhea; use caution and monitor LFTs in hepatic dysfunction or prolonged therapy; adjust dose in renal impairment to reduce seizure risk; watch for superinfection with prolonged use; avoid in infectious mononucleosis due to high rash risk; counsel to take with food to improve GI tolerability.

Age Restriction

No specific minimum age restriction for the amoxicillin/clavulanate combination, but this 500/125 mg film‑coated tablet is generally not suitable for young children; use age/weight-appropriate pediatric formulations and dosing (neonates/young infants require specialist dosing due to immature renal clearance).

Drug Interactions

Food Interaction

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

Special Populations

Children

Children under 12 years or under 40kg: oral suspension preferred. Dosing based on amoxicillin component: 25-45mg/kg/day in divided doses every 8-12 hours depending on severity. Children 12 years and over or over 40kg: adult dosing applies (625mg every 8-12 hours).

Kidney Impairment

Dose adjustment is required when CrCl <30 mL/min; the 500/125 mg tablet is typically reduced to 500/125 mg every 12 hours for CrCl 10-30 mL/min and every 24 hours for CrCl <10 mL/min; avoid 875/125 mg tablets when CrCl <30 mL/min; give an extra dose after hemodialysis when used.

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep in original packaging to protect from moisture. Keep out of reach of children.

Missed Dose

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

Stopping the Medicine

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

Monitoring Requirements

No routine labs for short courses in otherwise healthy patients; monitor renal function if renal impairment, liver function if hepatic disease or prolonged therapy, and INR if on warfarin/other VKAs; consider CBC if prolonged therapy.

Pharmacology

Mechanism of Action

Amoxicillin inhibits bacterial cell-wall synthesis by binding PBPs; clavulanic acid irreversibly inhibits many beta-lactamases, protecting amoxicillin and extending spectrum against beta-lactamase-producing organisms.

Onset of Action

Peak concentrations occur about 1-2 hours after an oral dose; clinical improvement is typically expected within 48-72 hours if the pathogen is susceptible.

Duration of Effect

Approximately supports dosing every 8-12 hours (immediate-release), depending on infection severity and renal function.

Product Information

Composition per Dose

Each film-coated tablet: Amoxicillin 500mg (as amoxicillin trihydrate) + Clavulanic acid 125mg (as potassium clavulanate)

OTC Alternatives

No OTC alternative - prescription antibiotic required

Spectrum

Broad-spectrum

Antibiotic Class

Penicillin

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