Hospital Injectable Products · LP-199
Phenytoin Injection
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-199Hospital Injectable Products
- Generic identity
- PhenytoinInjection
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-199
- Generic ingredient
- Phenytoin
- Dosage form
- Injection
- Proposed strength
- 50 mg/mL
- Proposed pack
- Ampoule 5 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
About Phenytoin
Phenytoin injection is a parenteral antiseizure preparation used in selected supervised neurological settings. It differs from oral phenytoin and from fosphenytoin, a related prodrug with distinct administration characteristics. Cardiac and local tissue risks make the exact product, route and monitoring essential. An ampoule entry cannot be used as a conversion guide or as a self-treatment instruction.
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 use may involve a specific seizure-related emergency or circumstances in which oral therapy is temporarily unsuitable. Seizure diagnosis, concurrent medicines, serum protein binding and organ function influence clinical assessment. The injection is one component of a wider care pathway and does not replace emergency stabilization or monitoring. This page omits administration rates, dilution methods and treatment schedules and does not claim product-specific authorization for any listed context.
Important safety considerations
Serious hypotension and cardiac arrhythmias can occur during or after administration. Local tissue injury, including swelling and discoloration around the injection site, requires urgent assessment. Severe skin reactions, liver injury, blood-cell disorders and pregnancy-related fetal risks are additional concerns. Review cardiac conduction disease, low albumin, renal or hepatic impairment and interacting medicines. Appropriate cardiac and clinical monitoring is essential during use of the actual authorized formulation.
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 source lists 50 mg/mL ampoules. Confirm phenytoin salt, solvent system, authorized routes and compatibility before preparation. Fosphenytoin units and preparation instructions must not be applied to a phenytoin ampoule.
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 the neurological indication, precise product, cardiac status, interaction history and required monitoring. Use trained staff and the exact local label or institutional protocol.
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
- Phenytoin
- Dosage form / presentation
- Injection
- Catalogue strength
- 50 mg/mL
- Catalogue pack
- Ampoule 5 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
Layer 02
Unresolved product-specific fields
- The 50 mg/mL injection concentration does not establish the exact phenytoin salt, solvent system, authorised route, dilution, infusion rate, compatibility or monitoring instructions.
- Fosphenytoin is a distinct prodrug; its presentation and dose-expression conventions must not be applied to this record.
- 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: Phenytoin Injectiongovernment-hosted medicine monograph
- DailyMed: phenytoin sodium injection — external reference labelgovernment-hosted external product label
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
- Sterile product specification confirming active chemical form, concentration, container/volume, authorised route(s), excipients/preservatives, compatibility and preparation/administration controls.
- 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-199, 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
- MedlinePlus: Phenytoin Injection — ingredient/formulation reference
- DailyMed: phenytoin sodium injection 50 mg/mL — external reference label
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-199.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.