Pediatrics · LP-014
Amoxicillin + clavulanic acid Powder for oral suspension
Medicine dossier. Catalogue identity is separated from unresolved product-specific fields and from external scientific references.
Development record
This dossier integrates an archived editorial source review dated 2026-09-11. Website reconciliation does not constitute a new medical or regulatory review. Controlled product approval, use instructions and supply status remain unestablished.
- Portfolio reference
- LP-014Pediatrics
- Generic identity
- Amoxicillin + clavulanic acidPowder for oral suspension
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Layers 01–02 · Evidence boundary
What this public record establishes — and what remains held.
- Portfolio reference
- LP-014
- Generic identity
- Amoxicillin + clavulanic acid
- Presentation
- Powder for oral suspension
- Catalogue strength
- 125 mg + 31.25 mg/5 mL; 250 mg + 62.5 mg/5 mL; 400 mg + 57 mg/5 mL
- Catalogue pack
- Bottle for reconstitution 60 mL / 100 mL
- Public status
- Development presentation
Layer 01 · Controlled catalogue facts
- Generic identity: amoxicillin + clavulanic acid.
- Dosage form: powder for oral suspension.
- Three proposed two-component concentration rows, each expressed per 5 mL.
- General proposed final-volume bottle options: 60 mL and 100 mL.
Layer 02 · Unresolved product-specific fields
- Concentration-to-bottle mapping; do not infer six SKUs.
- Final excipients/flavour, amount of water, mixing method, dosing, storage after preparation and shelf life.
- Approved indications/contraindications and full label.
- Registration, manufacturing route and supply status.
02 · Variants
Preserve each catalogue row without inferring missing SKU relationships.
| Variant | Proposed strength / concentration | Dosage form | Presentation detail | Pack relationship | Evidence status |
|---|---|---|---|---|---|
| A | 125 mg + 31.25 mg/5 mL | Powder for oral suspension | — | 60/100 mL bottle options not mapped | Both component quantities must remain together. |
| B | 250 mg + 62.5 mg/5 mL | Powder for oral suspension | — | 60/100 mL bottle options not mapped | Both component quantities must remain together. |
| C | 400 mg + 57 mg/5 mL | Powder for oral suspension | — | 60/100 mL bottle options not mapped | Ratio differs from the first two rows; do not identify the variant by amoxicillin alone. |
The table reproduces or structures catalogue-level fields. It does not create an approved SKU, instruction or specification where the source record does not provide one.
03 · External reference context
Ingredient and dosage-form background
Amoxicillin with clavulanic acid combines a penicillin antibiotic with a beta-lactamase inhibitor. Clavulanic acid can protect amoxicillin from some bacterial resistance enzymes, but the combination does not overcome every resistance mechanism. The ratio of the two ingredients matters when comparing presentations. This educational discussion is not Luang Pharma approved labeling and does not imply that different tablet or suspension strengths can be substituted without review.
Clinical context and therapeutic role
A clinician may select this combination for particular bacterial infections when its antibacterial spectrum is appropriate. Infection site, likely pathogen, microbiology, previous antibiotics and local guidance inform that decision. The combination should not be regarded as automatically preferable to a narrower antibiotic. The prescriber also reviews whether an oral route is suitable and whether allergy, organ impairment or a history of treatment-related liver injury changes the choice.
Selected safety context
Serious penicillin allergy and severe skin reactions are important risks. Diarrhoea and nausea are common, while severe or bloody diarrhoea needs evaluation. The combination may cause liver injury, including jaundice; a history of liver problems associated with this medicine must be disclosed. Kidney function and interacting medicines, including anticoagulants and methotrexate, require review. A volume or tablet substitution can unintentionally change the clavulanic-acid exposure because product ratios differ.
Selected external context only. It is not a complete risk profile or Luang Pharma approved labelling. The exact authorised IFU/label and applicable professional guidance control product use.
Formulation, presentation and handling evidence
This presentation is a powder intended to become an oral suspension after product-specific reconstitution. The stated concentration should be interpreted using the registered label, including the final volume. Water volume, preparation method and excipients require confirmation; another product’s instructions cannot be used as a substitute.
Reconstitution should follow the exact supplied instructions and appropriate pharmacy practice. Record the relevant preparation information and use the correct oral measuring device. Check the authorized storage conditions and period after reconstitution; no universal refrigeration rule or discard interval is assumed.
Final instructions, storage conditions, shelf life and any after-opening/in-use limits require the exact controlled product documentation; none is created from a comparator reference.
Points for professional review
A pediatric clinician or pharmacist should confirm the diagnosis, authorized age range, weight-related assessment where relevant, concentration and measuring device. Catalogue placement in a pediatric category is not evidence of approval for children.
04 · Layer 04 · Documentation gate
Controlled product documents must close the held fields.
Before this medicine record can support product-specific clinical, technical or supply claims, the exact finished-product documentation must resolve the held fields.
Finished-product formula/specification.
Approved label/leaflet including preparation, dosing, warnings, storage and shelf life.
Concentration-to-pack SKU matrix.
Registration/market-status and manufacturing-site evidence.
Editorial source check: archived record dated 2026-09-11.
Qualified product/medical review: Not recorded at B06 checkpoint
Approved Luang Pharma label: Not provided or established
Registration / availability / supply: not established by this public record.
05 · Layer 03 · Sources & review
External references are attributed, not adopted as Luang Pharma labelling.
| Source | Recorded revision / check | How it is used |
|---|---|---|
| NHS: Co-amoxiclavArchived source classification: public-health medicine reference | Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling or evidence of equivalence. |
| MedlinePlus: Amoxicillin and clavulanic acidArchived source classification: NLM-hosted medicine monograph | Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling or evidence of equivalence. |
| U.S. FDA — AUGMENTIN prescribing informationArchived source classification: current authorised comparator label | Source revision recorded: July 2026; Archived access check: 2026-09-11 | External authorised comparator; supports scientific/strength-expression context only, not LP-014 labelling or equivalence. |
External sources may describe authorised products, public-health guidance or device classes. They do not establish equivalence, approval, model performance, manufacturing status or supply eligibility for LP-014.
Professional enquiries
Request product-specific evidence for LP-014.
State the exact presentation or configuration, organisation, destination and evidence you need. The public portfolio record is not an offer of supply.