CLAVODAR 1/G FC TAB 14/FC TAB

Indications

Approved Uses

Respiratory tract infections (e.g., sinusitis, otitis media, bronchitis exacerbation, pneumonia), urinary tract infections, and skin/soft tissue infections (including dental/odontogenic infections where susceptible organisms are likely).

Off-Label Uses

Bite-wound infections (human/animal) and some diabetic foot/odontogenic infections when broader beta-lactamase coverage is desired; H. pylori regimens may include amoxicillin but amoxicillin/clavulanate is not a standard first-line component.

Dosage & Administration

Dosing by Condition

Adults (typical): 875/125 mg orally every 12 hours for most moderate infections; alternative is 500/125 mg every 8 hours depending on severity/site and local guidance; duration is indication-dependent (commonly 5-7 days for many RTIs, longer for complicated infections).

Initial Dose

1 tablet (875 mg amoxicillin/125 mg clavulanic acid) orally every 12 hours.

Maintenance Dose

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

Maximum Dose

2 tablets per day (1 tablet every 12 hours) = 1750 mg amoxicillin/250 mg clavulanic acid per day for this 875/125 mg formulation.

Children's Dosage

Children ≥40kg: adult dose. Children <40kg: 25-45mg/kg/day of amoxicillin component in divided doses every 12 hours using appropriate suspension formulation. Neonates and infants <12 weeks (<3 months): 30mg/kg/day in divided doses every 12 hours (suspension).

Dose Adjustment Notes

Renal impairment: adjust dose/interval; do NOT use the 875/125 mg tablet when CrCl <30 mL/min (use lower-strength regimens instead). Hepatic impairment: use with caution and monitor liver function.

How to Take

Swallow the film‑coated tablet whole with water and take at the start of a meal; doses are typically given every 12 hours for the 875/125 mg strength as prescribed.

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (≥10%): diarrhea. Common (1-10%): nausea, vomiting, mucocutaneous candidiasis; may include rash/urticaria in some references. Uncommon (0.1-1%): dizziness, headache, dyspepsia/indigestion, flatulence, elevated liver enzymes. Rare/very rare (<0.1%): cholestatic jaundice/hepatitis, severe cutaneous adverse reactions (SJS/TEN), anaphylaxis, blood dyscrasias, interstitial nephritis, C. difficile-associated colitis.

Safety & Warnings

Contraindications

Contraindicated in: (1) hypersensitivity to amoxicillin, clavulanate, penicillins, or other beta-lactams (e.g., prior anaphylaxis/SJS/TEN); (2) history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate. Also: this 875/125 mg strength should not be used when CrCl <30 mL/min (use lower-strength regimen).

Warnings & Precautions

Key precautions: assess history of beta-lactam allergy/cross-reactivity; stop immediately if hypersensitivity occurs; monitor for C. difficile diarrhea; use caution and monitor LFTs with hepatic disease or prolonged therapy; adjust/avoid 875/125 mg in significant renal impairment; risk of rash in infectious mononucleosis; watch for superinfection with prolonged use; maintain hydration to reduce crystalluria risk.

Age Restriction

No fixed minimum age for the amoxicillin/clavulanate combination, but this 875/125 mg tablet is generally intended for adults and pediatric patients ≥40 kg; younger/lower-weight children should use pediatric formulations with weight-based dosing.

Driving Warning

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Children ≥40kg: adult dose. Children <40kg: 25-45mg/kg/day of amoxicillin component in divided doses every 12 hours using appropriate suspension formulation. Neonates and infants <12 weeks (<3 months): 30mg/kg/day in divided doses every 12 hours (suspension).

Elderly

Standard adult dosing if renal function is adequate. Adjust dose based on renal function (CrCl), as renal clearance is commonly reduced in elderly patients.

Kidney Impairment

CrCl ≥30 mL/min: usual dosing (commonly 875/125 mg q12h). CrCl <30 mL/min: do NOT use the 875/125 mg tablet; use lower-strength amoxicillin/clavulanate with extended intervals (e.g., 250-500/125 mg q12h for CrCl 10-30; q24h for CrCl <10) and give an extra dose during/after hemodialysis per protocol.

Liver Impairment

No specific dose adjustment is defined; use with caution in hepatic impairment and monitor liver function periodically, discontinuing if hepatitis/cholestasis develops.

Storage & Patient Advice

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

If prolonged therapy or risk factors: monitor hepatic function; monitor renal function in impairment; consider CBC with prolonged courses; monitor INR if on warfarin.

Pharmacology

Mechanism of Action

Amoxicillin inhibits bacterial cell-wall synthesis by binding PBPs; clavulanic acid is a beta-lactamase inhibitor that inactivates susceptible beta-lactamases, protecting amoxicillin and extending spectrum.

Onset of Action

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

Duration of Effect

Approximately 12 hours per dose for the 875/125 mg immediate‑release regimen (supports twice‑daily dosing).

Product Information

Available Dosage Forms

Tablet (film‑coated) for oral use (this product).

Composition per Dose

Each film-coated tablet: Amoxicillin 875mg (as amoxicillin trihydrate) + Clavulanic acid 125mg (as potassium clavulanate)

Generic Availability

Yes

OTC Alternatives

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

Spectrum

Broad-spectrum

Antibiotic Class

Penicillin + Beta-lactamase Inhibitor

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.