Respiratory Medicines · LP-066
Montelukast Tablets
Medicine dossier. Catalogue identity is separated from unresolved product-specific fields and from external scientific references.
Development record
This dossier integrates an archived editorial source review dated 2026-09-11. Website reconciliation does not constitute a new medical or regulatory review. Controlled product approval, use instructions and supply status remain unestablished.
- Portfolio reference
- LP-066Respiratory Medicines
- Generic identity
- MontelukastTablet
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Layers 01–02 · Evidence boundary
What this public record establishes — and what remains held.
- Portfolio reference
- LP-066
- Generic identity
- Montelukast
- Presentation
- Tablet
- Catalogue strength
- 4 mg chewable; 5 mg chewable; 10 mg
- Catalogue pack
- Blister 3 x 10 tablets
- Public status
- Development presentation
Layer 01 · Controlled catalogue facts
- Generic identity: Montelukast.
- Dosage form: Tablet.
- Catalogue strength / concentration: 4 mg chewable; 5 mg chewable; 10 mg.
- Catalogue pack: Blister 3 x 10 tablets.
- Catalogue category: Respiratory Medicines; navigation placement is not authorisation evidence.
Layer 02 · Unresolved product-specific fields
- P009: exact dosage-form character of the 10 mg entry and whether 4/5 mg chewables and 10 mg tablet share one controlled product family.
- Approved age/weight eligibility, indication and neuropsychiatric-warning wording for each exact presentation.
- Approved indication, patient eligibility, dose/administration and contraindication wording for the exact product/jurisdiction.
- Storage conditions, shelf life, registration/market status, manufacturing route and current supply status.
Identity note
P009 remains an open structured-variant hold. External montelukast references can inform safety context but do not establish Luang Pharma age authorisation or dosage-form equivalence.
02 · Variants
Preserve each catalogue row without inferring missing SKU relationships.
| Variant | Proposed strength / concentration | Dosage form | Presentation detail | Pack relationship | Evidence status |
|---|---|---|---|---|---|
| A | 4 mg chewable | Chewable tablet | Chewable | Catalogue lists blister 3 x 10 tablets; controlled strength-to-pack SKU evidence not supplied | P009: keep chewable status attached to 4 mg only; do not infer age eligibility. |
| B | 5 mg chewable | Chewable tablet | Chewable | Catalogue lists blister 3 x 10 tablets; controlled strength-to-pack SKU evidence not supplied | P009: keep chewable status attached to 5 mg only; do not infer age eligibility. |
| C | 10 mg | Tablet; chewable character not stated | — | Catalogue lists blister 3 x 10 tablets; controlled strength-to-pack SKU evidence not supplied | P009: do not propagate chewable status from 4/5 mg to 10 mg. |
The table reproduces or structures catalogue-level fields. It does not create an approved SKU, instruction or specification where the source record does not provide one.
03 · External reference context
Ingredient and dosage-form background
Montelukast is a leukotriene-receptor antagonist used in selected long-term respiratory and allergic-disease settings. It is not a medicine for immediate relief of an asthma attack. Chewable and conventional tablets have different age-related product instructions. This educational profile does not establish an approved Luang Pharma indication or claim that montelukast should replace inhaled treatment; its potential benefits must be weighed against recognized neuropsychiatric risks.
Clinical context and therapeutic role
A clinician reviews the respiratory diagnosis, current control and existing inhaler plan before considering an additional medicine. The role in allergic rhinitis depends on local authorization, symptom severity and alternatives. The person and caregivers should understand what changes in sleep, mood or behavior require attention. A product’s small tablet strength does not by itself establish pediatric suitability. Worsening asthma needs review of control, inhaler technique and adherence to the prescribed plan.
Selected safety context
Neuropsychiatric reactions can include sleep disturbance, nightmares, anxiety, agitation, depression, hallucinations and suicidal thoughts or behavior. These require prompt medical attention; immediate danger of self-harm is an emergency. Headache and abdominal symptoms may occur. Rare systemic reactions involving eosinophilic inflammation are also recognized. Do not use montelukast as rescue treatment for acute breathlessness or abruptly change other asthma medicines on the basis of this page. Age eligibility follows the exact local product information.
Selected external context only. It is not a complete risk profile or Luang Pharma approved labelling. The exact authorised IFU/label and applicable professional guidance control product use.
Formulation, presentation and handling evidence
The catalogue describes a tablet presentation. The exact salt, coating, score line and release characteristics need confirmation from the authorized product information. A milligram strength identifies ingredient quantity; it does not establish whether a tablet may be split, crushed or exchanged for another formulation.
Keep the product in its labeled packaging so the batch, expiry and instructions remain identifiable. Follow the actual label for storage conditions and disposal. Do not use a damaged or unidentified tablet, and keep all medicines securely out of children’s reach.
Final instructions, storage conditions, shelf life and any after-opening/in-use limits require the exact controlled product documentation; none is created from a comparator reference.
Points for professional review
A respiratory-care professional should verify the diagnosis, inhaled-versus-oral role, exact device and technique where applicable. The patient requires a clear plan for worsening symptoms, with regular review of control and adverse effects.
04 · Layer 04 · Documentation gate
Controlled product documents must close the held fields.
Before this medicine record can support product-specific clinical, technical or supply claims, the exact finished-product documentation must resolve the held fields.
Finished-product specification and quantitative composition for each exact presentation.
Approved/controlled label or leaflet for the intended jurisdiction.
Controlled strength/form/pack SKU matrix and packaging artwork where more than one variant or presentation is listed.
Registration/market-status and manufacturing-site evidence for the exact presentation.
Editorial source check: archived record dated 2026-09-11.
Qualified product/medical review: Not recorded at B07d checkpoint
Approved Luang Pharma label: Not provided or established
Registration / availability / supply: not established by this public record.
05 · Layer 03 · Sources & review
External references are attributed, not adopted as Luang Pharma labelling.
| Source | Recorded revision / check | How it is used |
|---|---|---|
| NHS: Montelukast — clinical backgroundArchived source classification: public-health medicine reference | Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling, product approval, registration, equivalence, manufacturing evidence or supply evidence. |
| NHS: Montelukast — side effectsArchived source classification: public-health medicine reference | Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling, product approval, registration, equivalence, manufacturing evidence or supply evidence. |
| MHRA: Montelukast — neuropsychiatric reactionsArchived source classification: regulatory safety communication | Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling, product approval, registration, equivalence, manufacturing evidence or supply evidence. |
External sources may describe authorised products, public-health guidance or device classes. They do not establish equivalence, approval, model performance, manufacturing status or supply eligibility for LP-066.
Professional enquiries
Request product-specific evidence for LP-066.
State the exact presentation or configuration, organisation, destination and evidence you need. The public portfolio record is not an offer of supply.