Hospital Injectable Products · LP-186
Gentamicin Injection
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-186Hospital Injectable Products
- Generic identity
- GentamicinInjection
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-186
- Generic ingredient
- Gentamicin
- Dosage form
- Injection
- Proposed strength
- 40 mg/mL (80 mg per 2 mL ampoule)
- Proposed pack
- Ampoule 2 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
About Gentamicin
Gentamicin is an aminoglycoside antibiotic used for selected serious bacterial infections. It acts on bacterial protein synthesis and has a benefit-risk profile that requires attention to kidney function and auditory or vestibular effects. Injectable gentamicin is not a general response to any suspected infection. Selection depends on organisms, site, severity, susceptibility and the wider antimicrobial plan.
How to read this profile
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.
02 · Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Clinical context and therapeutic role
Clinical teams assess microbiology and local guidance, sometimes using gentamicin within a combination-treatment strategy. Monitoring may include renal function and medicine concentrations according to the patient and protocol. Changes in renal function can alter exposure, and treatment should be reviewed as diagnostic information becomes available. The catalogue’s concentration and ampoule amount are presentation data, not a treatment schedule or evidence of an approved infection indication.
Important safety considerations
Kidney toxicity and hearing or balance injury are major risks; auditory damage can be permanent. Neuromuscular blockade and respiratory effects can occur in susceptible settings. Review dehydration, renal impairment, hearing disorders, neuromuscular disease and other nephrotoxic or ototoxic medicines. Pregnancy requires appropriate assessment. New hearing changes, severe dizziness, reduced urine output or breathing difficulty should be reported promptly to the clinical team.
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 listed 40 mg/mL and 80 mg/2 mL describe concentration and total content that need clear presentation. Confirm the strength basis, salt, preservatives and authorized route. No dilution, compatibility or use-after-opening period is established here.
Professional preparation must follow the authorized label and local aseptic procedures. Confirm the correct container, concentration, route and expiry before use. Storage, transport, dilution compatibility and any period after opening or reconstitution require product-specific evidence; this page does not establish them.
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
Confirm susceptibility-based rationale, renal and auditory risks, interactions and the institution’s monitoring approach. Independently verify concentration and container content.
03 · Product enquiry
Documentation & regulatory status
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
- Gentamicin
- Dosage form / presentation
- Injection
- Catalogue strength
- 40 mg/mL; 80 mg/2 mL
- Catalogue pack
- Ampoule 2 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
Layer 02
Unresolved product-specific fields
- P020 — “40 mg/mL” and “80 mg/2 mL” may describe the same concentration/presentation, but the catalogue does not establish whether they are duplicate expressions or distinct SKUs. They are therefore retained exactly and not mechanically counted twice or collapsed.
- Exact gentamicin salt, preservative system, authorised route, dilution, compatibility and monitoring instructions require controlled product evidence.
- 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: Gentamicin Injectiongovernment-hosted medicine monograph
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 presentation matrix confirming whether the concentration and total-content/fill-volume expressions describe one presentation or distinct SKUs, without duplicate counting.
- Destination-market authorisation or other lawful supply-route evidence plus the approved label/leaflet/IFU, where applicable.
- Product-specific composition/excipient, storage, shelf-life and pack-control documentation.
- Manufacturing-site and supply-status evidence before any public claim of installed capability, registration, availability or equivalence.
For LP-186, 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.
04 · External sources
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.
Professional enquiries
Request product-specific evidence for LP-186.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.