AMOXICILLIN — 250 mg / 500 mg capsules and tablets
📦 Product Snapshot
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🧠 Overview
Amoxicillin is a broad‑spectrum aminopenicillin antibiotic that has been a cornerstone of primary care prescribing since its introduction in 1972. It is a modification of ampicillin with improved oral bioavailability, allowing less frequent dosing and better gastrointestinal tolerance. Amoxicillin remains one of the most frequently prescribed antibiotics worldwide for community‑acquired infections.
Mechanism of action: Like all penicillins, amoxicillin exerts its bactericidal effect by inhibiting the synthesis of bacterial cell walls. It binds to penicillin‑binding proteins (PBPs) located inside the bacterial cell wall, inhibiting the final transpeptidation step of peptidoglycan synthesis. This leads to activation of autolytic enzymes, cell lysis, and death. Amoxicillin is active against a wide range of Gram‑positive and Gram‑negative bacteria, although bacterial resistance via beta‑lactamase production has become widespread.
Clinical indications: Amoxicillin is indicated for infections caused by susceptible strains of bacteria, including upper and lower respiratory tract infections (sinusitis, bronchitis, community‑acquired pneumonia), otitis media, pharyngitis and tonsillitis (especially streptococcal infections), skin and skin structure infections, urinary tract infections, and as part of Helicobacter pylori eradication therapy (with clarithromycin and a proton pump inhibitor). It is also used for Lyme disease (early localized), anthrax prophylaxis, and endocarditis prophylaxis in at‑risk patients undergoing dental procedures.
Key distinction from Augmentin: Amoxicillin alone is effective against bacteria that do not produce beta‑lactamase enzymes. If beta‑lactamase‑producing bacteria are suspected or confirmed (e.g., Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, many Enterobacteriaceae), amoxicillin is ineffective and amoxicillin/clavulanate (Augmentin) is required. Unnecessary use of clavulanate increases the risk of hepatotoxicity and diarrhea.
🏷️ Strengths & Brand Examples
- Oral capsules: 250 mg, 500 mg.
- Oral tablets: 500 mg, 875 mg (scored, functional scoring).
- Chewable tablets: 125 mg, 200 mg, 250 mg, 400 mg.
- Oral suspension (powder for reconstitution): 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL; pediatric drops 50 mg/mL.
- Extended‑release tablets (Moxatag): 775 mg (once‑daily for pharyngitis/tonsillitis).
- Intravenous injection: 250 mg, 500 mg, 1 g vials.
- Amoxil® (GSK) — capsules 250 mg, 500 mg; chewable tablets; oral suspension; pediatric drops.
- Trimox® (Bristol‑Myers Squibb) — discontinued, but name still recognized.
- Moxatag® (extended‑release tablets 775 mg, for once‑daily dosing).
- Generic versions widely available from multiple manufacturers.
- Amoxil® (GSK) — capsules 250 mg, 500 mg; oral suspension 125 mg/5 mL, 250 mg/5 mL; sachets 3 g.
- Generic amoxicillin widely prescribed under national formularies.
- Amoxil 250, Amoxil 500 (GlaxoSmithKline Pharmaceuticals Ltd) — capsules and syrup.
- Mox 250, Mox 500 (Cipla) — capsules and dry syrup.
- Almod 250, Almod 500 (Alkem Laboratories) — capsules and suspension.
- Amox 250, Amox 500 (Sun Pharma) — capsules.
- Amoxy 250, Amoxy 500 (Torrent Pharmaceuticals) — capsules.
- Biotrax 250, Biotrax 500 (Zydus Cadila) — capsules.
- Wymox 250, Wymox 500 (Wyeth) — capsules.
- Generic versions available from numerous manufacturers (Intas, Lupin, Dr. Reddy’s, Mankind, etc.).
- With clavulanate (see Augmentin card).
- With probenecid (to increase amoxicillin levels).
- In H. pylori triple therapy: amoxicillin + clarithromycin + PPI.
⚠️ Safety, Side Effects & Monitoring
- Diarrhea or loose stools (most common, up to 20%) — may be mild or severe.
- Nausea, vomiting, indigestion.
- Skin rash (non‑allergic) — incidence higher in patients with mononucleosis (up to 90%).
- Black hairy tongue (reversible, harmless).
- Vaginal candidiasis (thrush).
- Dysgeusia (metallic taste).
- Headache, dizziness.
• Severe cutaneous adverse reactions (SCAR): Stevens‑Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Acute Generalized Exanthematous Pustulosis (AGEP) reported. Discontinue at first sign of skin rash, blistering, or mucosal lesions.
• Rash in mononucleosis: High incidence of rash (up to 90%) in patients with infectious mononucleosis. Avoid amoxicillin in suspected or confirmed mono.
• Clostridioides difficile‑associated diarrhea (CDAD): Reported with all antibiotics, severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs during or after treatment (even months later). Do not use anti‑diarrhea drugs that slow motility.
• Drug‑induced enterocolitis syndrome (DIES): Rare but serious reaction with severe vomiting, diarrhea, hypotension, and pallor within hours of dosing. Discontinue immediately.
• Hepatic dysfunction: Transient elevations of liver enzymes reported. Rare cholestatic jaundice. Monitor in patients with pre‑existing liver disease.
• Renal impairment: Dose adjustment required in severe renal impairment (GFR less than 30 mL/min). Reduce dose or extend dosing interval.
• Microbial overgrowth: Prolonged use may result in superinfection with resistant bacteria or fungi (Candida).
• Phenylketonuria (PKU): Chewable tablets and oral suspension may contain aspartame (phenylalanine). Check product labeling.
• Jarisch‑Herxheimer reaction: May occur during treatment for spirochetal infections (Lyme disease). Temporary worsening of symptoms due to bacterial die‑off; not an allergic reaction.
- History of serious hypersensitivity reaction (e.g., anaphylaxis) to amoxicillin, any penicillin, or other beta‑lactam antibiotics (cephalosporins, carbapenems).
- Known hypersensitivity to any component of the formulation.
- Probenecid: Decreases renal tubular secretion of amoxicillin, increasing and prolonging amoxicillin blood levels. May be used intentionally to increase amoxicillin levels.
- Oral anticoagulants (warfarin): May increase INR and bleeding risk. Monitor coagulation parameters closely, especially during and after treatment.
- Allopurinol: Concomitant use increases risk of rash.
- Oral contraceptives: Limited evidence suggests amoxicillin may rarely reduce efficacy of hormonal contraceptives due to disruption of gut flora affecting enterohepatic recirculation. Risk appears low, but advise patients to use additional non‑hormonal contraception during treatment and for 7 days after stopping if they have concerns or if diarrhea/vomiting occurs.
- Methotrexate: Penicillins may reduce methotrexate clearance, increasing toxicity risk. Monitor methotrexate levels.
- Mycophenolate mofetil: Amoxicillin may reduce mycophenolic acid concentrations. Monitor for reduced efficacy.
- Tetracyclines, macrolides, chloramphenicol: Bacteriostatic antibiotics may antagonize bactericidal action of penicillins. Avoid concurrent use if possible.
- Typhoid, cholera, BCG vaccines: Antibiotics may reduce vaccine effectiveness. Avoid concurrent administration.
- Pregnancy: Generally considered safe (FDA Category B). Animal studies do not indicate direct or indirect harmful effects. Widely used in pregnancy when indicated.
- Breastfeeding: Amoxicillin is excreted in breast milk in small amounts. Considered compatible with breastfeeding; monitor infant for diarrhea, rash, or thrush.
- Pediatric use: Safety established. Dosing based on weight and age. Neonates and young infants: 20‑30 mg/kg/day divided every 12 hours. Older children: 20‑50 mg/kg/day divided every 8‑12 hours depending on infection severity.
- Geriatric use: No specific problems demonstrated, but elderly more likely to have age‑related renal impairment; dose adjustment may be needed.
- Renal impairment: GFR 10‑30 mL/min: 250‑500 mg every 12 hours. GFR less than 10 mL/min: 250‑500 mg every 24 hours. Hemodialysis: 250‑500 mg during dialysis and after.
- Hepatic impairment: Use with caution in severe liver disease; monitor liver function tests.
- Symptoms: Nausea, vomiting, diarrhea, abdominal pain, agitation, drowsiness, crystalluria (with high doses).
- Management: Supportive care, fluid monitoring, correction of electrolyte imbalances. Activated charcoal may be considered if recent ingestion. Hemodialysis removes amoxicillin.
❓ FAQ
📚 Official References
- DailyMed — Amoxicillin capsules (Preferred Pharmaceuticals Inc.) full prescribing information
- Drugs.com — Amoxicillin patient information
- NHS UK — Amoxicillin: antibiotic to treat bacterial infections
- WebMD — Amoxicillin oral: uses, side effects, interactions
- MedlinePlus — Amoxicillin: MedlinePlus Drug Information