ePI IG for APAC markets, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/scc88/aseanepi/ and changes regularly. See the Directory of published versions
Summary of Product Characteristics (SmPC) — ASEAN Template
This composition uses the ASEAN Common Template section headings as defined in Appendix 1 of the ASEAN ePI IG. Each section maps to a Composition.section entry in the FHIR Bundle.
2.1 Qualitative declaration
Each hard capsule contains amoxicillin trihydrate equivalent to amoxicillin 500 mg as the active substance. Excipients: magnesium stearate, sodium starch glycolate, colloidal silicon dioxide.
2.2 Quantitative declaration
Each hard capsule contains amoxicillin trihydrate 574.0 mg, equivalent to amoxicillin 500 mg. For the full list of excipients, see section 6.1.
Hard capsule. Size 0 capsule with an opaque white cap and opaque white body, filled with white to off-white powder.
4.1 Therapeutic indication
Amoxicillin 500 mg capsules are indicated for the treatment of the following infections caused by susceptible bacteria in adults and children:
4.2 Posology and method of administration
Adults and adolescents (≥18 years): 500 mg three times daily for 5–10 days depending on the type and severity of infection. Severe infections: 1,000 mg three times daily.
Route of administration: Oral. Capsules should be swallowed whole with sufficient fluid. May be taken with or without food.
4.3 Contraindication
4.4 Special warning and precautions for use
Before initiating amoxicillin therapy, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving penicillin therapy. Administer with caution in patients with renal impairment — dose reduction may be necessary.
4.5 Interactions with other medicinal products and other forms of interactions
Probenecid: decreases renal tubular secretion of amoxicillin, resulting in increased and prolonged blood levels. Methotrexate: penicillins may reduce renal clearance of methotrexate; concurrent use should be carefully monitored. Anticoagulants: prolongation of prothrombin time has been reported rarely; monitor INR when co-administered with warfarin.
4.6 Pregnancy and lactation
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of amoxicillin during pregnancy unless clearly necessary.
Breastfeeding: Amoxicillin is excreted in breast milk in small amounts. Possible effects on the breastfed infant include diarrhoea and fungal infections of the mucous membranes. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from amoxicillin therapy.
4.7 Effects on ability to drive and use machine
Amoxicillin 500 mg capsules have no known effect on the ability to drive or use machines. However, adverse reactions such as dizziness and convulsions may affect the ability to drive or use machines.
4.8 Undesirable effects
The very common side effects (≥1/10): diarrhoea. Common (≥1/100 to <1/10): nausea, vomiting, skin rash. Uncommon (≥1/1,000 to <1/100): urticaria, dizziness. Rare (≥1/10,000 to <1/1,000): reversible hyperactivity, convulsions. Very rare (<1/10,000): crystalluria, haemolytic anaemia, prolonged prothrombin time. Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis.
4.9 Overdose
Symptoms of amoxicillin overdosage include gastrointestinal symptoms, crystalluria, and in some cases, interstitial nephritis. In the event of overdose, discontinue amoxicillin, treat symptomatically, and institute supportive measures as required. Amoxicillin can be removed from the circulation by haemodialysis.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, penicillins with extended spectrum. ATC code: J01CA04.
Amoxicillin is a semi-synthetic broad-spectrum aminopenicillin with bactericidal activity against many gram-positive and gram-negative micro-organisms. It acts by inhibition of bacterial cell wall synthesis. Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria.
5.2 Pharmacokinetic properties
Absorption: Oral amoxicillin is well absorbed, rapidly and completely. Peak plasma concentrations of 7–14 mg/L are reached 1–2 hours after oral administration of a 500 mg dose. Food has no significant effect on absorption. Distribution: Protein binding is approximately 17%. Widely distributed to most tissues and body fluids. Metabolism: Partially metabolised to penicilloic acid. Elimination: Excreted primarily in the urine. Elimination half-life is approximately 1 hour in adults with normal renal function.
5.3 Preclinical safety data
Amoxicillin has been assessed in a series of genotoxicity tests and was found to be non-mutagenic. No carcinogenicity studies have been performed with amoxicillin. Animal reproductive and developmental studies have not revealed evidence of impaired fertility or harm to the foetus.
6.1 List of excipients
6.2 Incompatibilities
Not applicable. Amoxicillin should not be mixed with blood products or other proteinaceous fluids in any injectable formulation.
6.3 Shelf life
24 months. Shelf life after first opening the container: 6 months.
6.4 Special precautions for storage
Store below 25°C. Keep in the original packaging in order to protect from moisture. Keep out of the reach and sight of children.
6.5 Nature and contents of container
Amber glass bottle (Type III) with aluminium screw cap containing 16, 21, or 24 capsules. Not all pack sizes may be marketed.
HDPE bottle with child-resistant cap containing 100, 250, or 500 capsules (hospital packs).
ASEAN Pharma Pte Ltd
10 Pharma Crescent
Singapore 138668
Singapore
Tel: +65 6123 4567
Email: regulatory@aseanpharma.com
Detailed information on this medicinal product is available on the website of the ASEAN regulatory agency at www.asean-dra.org.
Organization data sourced from the OMS (Organisation Management Service) identifier system.
PackagedProductDefinition.shelfLifeStorage.period
PackagedProductDefinition.shelfLifeStorage → type (ShelfLifeType) + storage condition (specialPrecautionsForStorage)
| Indication | Population | ICD-11 Code |
|---|---|---|
| Acute bacterial sinusitis | Adults & children ≥2 years | CA0Z |
| Acute otitis media | Adults & children ≥2 months | AA40 |
| Acute streptococcal tonsillitis & pharyngitis | Adults & children | CA01.0 |
| Community-acquired pneumonia (CAP) | Adults & children ≥3 months | CA40.0Z |
| Skin and soft tissue infections | Adults & children | 1B70 |
| Uncomplicated urinary tract infections | Adults & children ≥3 months | GC08.0 |
| Interacting Substance | Mechanism | Severity | Clinical Effect |
|---|---|---|---|
| Probenecid | Pharmacokinetic — reduced renal tubular secretion | Moderate | Increased & prolonged amoxicillin plasma levels |
| Methotrexate | Pharmacokinetic — reduced renal clearance | High | Elevated methotrexate levels; risk of toxicity — monitor closely |
| Warfarin / oral anticoagulants | Pharmacodynamic — altered gut flora / vitamin K | Moderate | Rare prolongation of prothrombin time; monitor INR |
MedicationKnowledge/mk-amoxicillin-500mg → dosingGuideline[0].dosage[0] (patientCharacteristic: age ≥18y)MedicationKnowledge/mk-amoxicillin-500mg → dosingGuideline[1].dosage[0] (patientCharacteristic: age 3m–17y)