Neurology & Psychiatry · LP-161

Phenobarbital Tablets

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

Development record

Illustrative packaging concept for Phenobarbital Tablets
Illustrative packaging concept · visual reference only · final registered artwork and brand presentation to be confirmed.
Portfolio reference
LP-161Neurology & Psychiatry
Generic identity
PhenobarbitalTablet
Registration
Not establishedProduct-specific evidence required
Availability
Not marketedNo offer of supply

01 · Ingredient reference

Record identity and reference background.

Portfolio reference
LP-161
Generic ingredient
Phenobarbital
Dosage form
Tablet
Proposed strength
30 mg; 60 mg; 100 mg
Proposed pack
Blister/bottle
Portfolio category
Neurology & Psychiatry

About Phenobarbital

Phenobarbital is a barbiturate antiseizure medicine that depresses central nervous system activity. It has longstanding clinical use for selected seizure disorders, but treatment choice depends on the seizure type and patient circumstances. Its sedating and dependence-producing effects require professional oversight. A tablet catalogue entry does not define its legal status in a particular country or establish suitability for routine insomnia treatment.

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

Care involves assessment of seizure control, alertness, cognitive effects and medicine interactions. Phenobarbital can alter the metabolism of other medicines, including hormonal contraceptives. Long-term therapy may require review of bone health and other chronic effects. Treatment continuity and a supervised plan for any change are important. The strengths and packs listed here are presentation data only and do not establish an administration schedule or authorized patient group.

Important safety considerations

Drowsiness, impaired coordination and respiratory depression are important risks, especially with alcohol, opioids or other sedatives. Physical dependence can develop, and abrupt discontinuation can cause withdrawal or seizures. Severe skin reactions, liver disease and porphyria require particular consideration. Pregnancy presents fetal and neonatal risks that need specialist assessment. Breathing difficulty, marked unresponsiveness, extensive rash or severe behavioural change requires urgent medical attention.

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

This entry describes oral tablets in several strengths. Confirm the exact preparation, tablet properties and labeling. It must not be confused with a parenteral emergency presentation or a combination product containing phenobarbital and other ingredients.

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

Review seizure diagnosis, respiratory and liver status, interacting therapies, pregnancy and dependence risks. Confirm the destination-specific controlled-medicine requirements and current local label.

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
Phenobarbital
Dosage form / presentation
Tablet
Catalogue strength
30 mg; 60 mg; 100 mg
Catalogue pack
Blister/bottle
Portfolio category
Neurology & Psychiatry

Layer 02

Unresolved product-specific fields

  • The tablet record does not establish destination-specific controlled-medicine permissions or any parenteral presentation.
  • Exact tablet formulation, scoring, coating and strength-to-pack mapping remain product-specific.
  • 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-161, 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-161.

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

Contact Luang Pharma