Neurology & Psychiatry · LP-155
Phenytoin Capsules
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-155Neurology & Psychiatry
- Generic identity
- PhenytoinCapsule
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-155
- Generic ingredient
- Phenytoin
- Dosage form
- Capsule
- Proposed strength
- 100 mg
- Proposed pack
- Blister 10 x 10 capsules
- Portfolio category
- Neurology & Psychiatry
About Phenytoin
Phenytoin is an antiseizure medicine used for particular seizure types. Its blood concentration can change disproportionately with alterations in exposure, so clinical monitoring and product consistency are important. Capsules, oral suspensions and injectable formulations are not automatically equivalent in administration or chemical-form details. This educational entry describes the oral capsule family and does not provide a product-switching or dose-conversion method.
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
Treatment selection depends on the seizure diagnosis and prior response. Follow-up can include seizure frequency, adverse effects, adherence, relevant laboratory measurements and interacting medicines. Protein binding and conditions such as low albumin, kidney disease or liver disease can affect interpretation of a measured concentration. A capsule should be matched to the prescription and authorized label; the source record alone does not establish immediate- versus extended-release characteristics.
Important safety considerations
Poor coordination, dizziness, eye-movement changes and cognitive effects can signal excessive exposure. Serious skin reactions, liver injury, blood-cell problems and suicidal thoughts are important concerns. Long-term treatment can affect gums and bone health. Pregnancy requires specialist review because of fetal risk, while enzyme interactions can reduce contraceptive effectiveness. New rash or systemic illness requires urgent assessment. Abrupt withdrawal can worsen seizures and must be avoided without clinical direction.
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 states a 100 mg capsule without identifying release type or the exact salt. These details must be verified before selecting a comparator label or considering substitution. Capsule appearance is not sufficient to establish pharmaceutical equivalence.
Keep the medicine in the labelled original pack with its leaflet. Check the expiry date and pack integrity before dispensing. The authorized label must determine storage temperature, protection from moisture or light, and disposal; no shelf life or in-use period can be established from a catalogue entry.
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 seizure type, clinical control, release formulation, chemical form, interaction history and monitoring needs. Review pregnancy and contraception with appropriate specialist advice.
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
- Capsule
- Catalogue strength
- 100 mg
- Catalogue pack
- Blister 10 x 10 capsules
- Portfolio category
- Neurology & Psychiatry
Layer 02
Unresolved product-specific fields
- The source does not identify the phenytoin salt or capsule release type. Do not infer extended-release character or free-acid/sodium equivalence from external references.
- Any substitution or dose-conversion relationship between this capsule record and another phenytoin formulation requires controlled product and clinical 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: Phenytoingovernment-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 product master/specification confirming exact active chemical form, dosage form, strength variant and pack mapping.
- 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-155, 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-155.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.