Neurology & Psychiatry · LP-152
Amitriptyline Tablets
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-152Neurology & Psychiatry
- Generic identity
- AmitriptylineTablet
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-152
- Generic ingredient
- Amitriptyline
- Dosage form
- Tablet
- Proposed strength
- 10 mg; 25 mg
- Proposed pack
- Blister 10 x 10 tablets
- Portfolio category
- Neurology & Psychiatry
About Amitriptyline
Amitriptyline is a tricyclic antidepressant with effects on neurotransmission. It is also used in some settings for particular pain conditions, with clinical aims that differ from depression treatment. The indication, patient characteristics and local authorization determine its place in care. Low tablet strength should not be interpreted as absence of serious risk, and the product is not a general-purpose sleeping aid.
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
Professional review distinguishes depression, neuropathic pain and other conditions for which a clinician may consider amitriptyline. Treatment response, functional outcomes and tolerability require follow-up rather than an assumption of immediate benefit. Older adults and people with multiple medicines often need particular attention to adverse effects. References may discuss different clinical uses, but they do not establish every use as an approved indication for this catalogue candidate.
Important safety considerations
Drowsiness, dry mouth, constipation, blurred vision and postural dizziness are important effects. Cardiac rhythm problems, urinary retention and serious toxicity in overdose can occur. Review heart disease, glaucoma, bipolar disorder, seizure history and interacting serotonergic or sedating medicines. Emerging suicidal thoughts, marked agitation or worsening mood require prompt help. Abrupt stopping after regular use can cause withdrawal symptoms; any change should be planned with the prescriber.
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 catalogue lists conventional oral tablets. Coating, scoring and suitability for splitting or crushing need product-specific confirmation. Different strengths should be identified clearly in dispensing systems because the milligram amount alone does not reveal the intended clinical purpose.
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
Assess the diagnosis, mental-health and suicide risk, cardiac and anticholinergic burden, other medicines and a follow-up plan. Dispense against the exact authorized presentation and prescription.
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
- Amitriptyline
- Dosage form / presentation
- Tablet
- Catalogue strength
- 10 mg; 25 mg
- Catalogue pack
- Blister 10 x 10 tablets
- Portfolio category
- Neurology & Psychiatry
Layer 02
Unresolved product-specific fields
- The catalogue states amitriptyline tablets but does not identify the exact salt, coating, scoring or suitability for division/crushing. Comparator amitriptyline-hydrochloride labels do not define 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: Amitriptylinegovernment-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-152, 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-152.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.