Neurology & Psychiatry · LP-158

Sodium valproate Tablets

Generic medicine development record. Review the proposed presentation and the professional reference information below.

Development record

Illustrative packaging concept for Sodium valproate Tablets
Illustrative packaging concept · visual reference only · final registered artwork and brand presentation to be confirmed.
Portfolio reference
LP-158Neurology & Psychiatry
Generic identity
Sodium valproateTablet
Registration
Not establishedProduct-specific evidence required
Availability
Not marketedNo offer of supply

01 · Ingredient reference

Record identity and reference background.

Portfolio reference
LP-158
Generic ingredient
Sodium valproate
Dosage form
Tablet
Proposed strength
200 mg; 500 mg
Proposed pack
Blister/bottle
Portfolio category
Neurology & Psychiatry

About Sodium valproate

Sodium valproate is an antiseizure medicine with additional uses in some jurisdictions and clinical settings. It affects several mechanisms involved in neuronal excitability. Its benefit-risk assessment includes major reproductive safety considerations as well as the neurological diagnosis. Tablet strengths alone do not establish the release formulation, and valproate-related products should not be substituted simply because their names appear similar.

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 requires an appropriate specialist-led assessment of seizure type or other supported indication, previous response and available alternatives. The formulation and release characteristics influence continuity of treatment. Current pregnancy-prevention requirements and reproductive counselling must be checked in the jurisdiction of use, including advice relevant to male patients where applicable. This catalogue does not define an eligibility programme, endorse use in pregnancy or supply a treatment schedule.

Important safety considerations

Valproate can cause serious birth defects and neurodevelopmental harm following pregnancy exposure. Liver injury, pancreatitis, blood-cell abnormalities and hyperammonaemia are further major risks. Severe abdominal pain, persistent vomiting, jaundice or unusual confusion require prompt assessment. Weight gain, tremor and sedation can occur. Review liver disease, metabolic disorders, pregnancy potential and interactions. Patients should seek urgent specialist advice about pregnancy concerns and should not abruptly stop antiseizure treatment without medical 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 gives tablet strengths without a release designation. Conventional, enteric-coated and prolonged-release valproate products require separate identification. Exact chemical form, equivalence conventions and packaging must be confirmed from the product dossier.

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 diagnosis, formulation, reproductive safety requirements, relevant laboratory monitoring and interaction risks. Use current specialist guidance and the exact local product information.

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
Sodium valproate
Dosage form / presentation
Tablet
Catalogue strength
200 mg; 500 mg
Catalogue pack
Blister/bottle
Portfolio category
Neurology & Psychiatry

Layer 02

Unresolved product-specific fields

  • The catalogue states sodium valproate tablets at 200 mg and 500 mg but does not state conventional, enteric/delayed-release or prolonged-release character. Release type must remain unknown.
  • Do not infer equivalence to valproic acid, divalproex or another valproate presentation solely from shared valproate pharmacology.
  • 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

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-158, 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-158.

State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.

Contact Luang Pharma