Ingredient reference
About Ofloxacin
Ofloxacin is a fluoroquinolone antibiotic. This catalogue record is treated as an otic (ear-drop) presentation only. An ear preparation and an eye preparation are different products with different sterility, vehicle and labelling requirements, and neither may be substituted for the other. Nothing here establishes an approved indication, a registration or the availability of a Luang Pharma product.
Scientific information relates to the ingredient and dosage-form context. It is not approved Luang Pharma labelling, a clinical recommendation, or evidence of equivalence to a referenced product. Multiple strengths or presentations represent separate proposed variants and must not be treated as interchangeable.
Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Clinical context and therapeutic role
A suspected ear infection needs assessment of the site — outer ear canal or middle ear — and of whether the eardrum is intact, because that determines which preparations may lawfully and safely be used. Topical treatment is selected against current local guidance for the specific condition. This record describes an ingredient and a dosage form; it does not identify a patient group, a duration or a regimen.
Important safety considerations
Local discomfort, itching, irritation or taste disturbance may occur. A serious hypersensitivity reaction is uncommon but needs immediate medical attention. Use in a perforated eardrum, in children, in pregnancy and alongside other ear preparations is a matter for the approved label of the specific registered product and for the treating clinician, not for a portfolio record.
These are selected considerations, not a complete list. Use the current instructions or approved label for the exact authorised product and seek appropriate professional advice.
Presentation, handling and storage
The catalogue identifies a sterile otic liquid presentation in a dropper container. Vehicle, preservative content, pH, sterility assurance and container-closure performance are formulation-specific and require controlled product documentation. The ophthalmic record (LP-040) is a separate product and its specification does not transfer to this one.
Follow hand-hygiene and applicator instructions, avoiding contact between the dropper tip and the ear or any other surface. Warm the container in the hand before use where the label directs it. Storage conditions, in-use period after opening and shelf life follow the approved product label.
Final composition, instructions, shelf life and storage conditions are not established by this portfolio entry. They must come from the controlled documentation for the specific product.
Points for professional review
A qualified prescriber should establish the infection, confirm whether the eardrum is intact, consult current local guidance and select the registered product appropriate to the patient. A catalogue entry is not prescribing information and does not indicate availability.
Evidence status
What is established — and what remains open
This record has received an editorial evidence-layer review. The review separates catalogue facts from unresolved product-specific fields and external context; it is not medical, regulatory or market-authorisation approval.
Layer 01
Controlled catalogue facts
- Generic ingredient
- Ofloxacin
- Dosage form / presentation
- Ear drops
- Catalogue strength
- 0.3%
- Catalogue pack
- Dropper bottle 5 mL
- Portfolio category
- Anti-Infectives
Layer 02
Unresolved product-specific fields
- An otic preparation and an ophthalmic preparation are separate products. Sterility, vehicle and labelling requirements do not transfer between them.
- Whether the product may be used when the eardrum is perforated is a labelled property of the registered product and is not established here.
- Approved indication, patient eligibility and dosing are not established by this portfolio record.
- Registration, manufacturing/site status, supply availability, storage conditions and shelf life remain product- and market-specific evidence items.
Layer 03
Attributed external context
- MedlinePlus: Ofloxacin Oticpublic medicine information
These references provide scientific or regulatory context only. They are not Luang Pharma product labelling, registration, manufacturing evidence, equivalence evidence or confirmation of supply.
Layer 04
Documents required to close the record
- Controlled product master/specification confirming the exact ingredient identity, dosage form, strength variant and pack mapping.
- Destination-market authorisation or other lawful supply-route evidence plus the approved label/leaflet/IFU, where applicable.
- Manufacturing-site and supply-status evidence before any public claim of installed capability, registration, availability or equivalence.
Product enquiry
Documentation & regulatory status
For LP-223, identify the destination country, intended professional use, proposed presentation and the role of your organisation. The appropriate supply route and available documentation must be confirmed for that case.
- Confirm the legal entity, manufacturing site and authorised scope for the proposed supply chain.
- Confirm product registration or another lawful route, approved labelling and the applicable destination requirements.
- Request relevant product information, specifications and supporting evidence through the company contact.
- Confirm storage, transport, traceability, complaints and safety-reporting responsibilities before any agreement.
The public catalogue extends beyond the initial planned facility modules. A listing does not mean that the dosage form is installed, qualified or licensed at Boten.
Sources and further reading
External sources are provided for reference. Their authors do not endorse Luang Pharma, and another product’s authorisation does not transfer to this portfolio record. Source availability and wording can change.
