Basic Trecator-SC Information
| INN Name |
Ethionamide |
| UK Brand Names |
Trecator-SC
Ethionamide Tablets 250 mg (generic) |
| ATC Code |
J04AD03 |
| Forms & Dosages |
Film-coated tablets (250 mg) |
| Manufacturers |
Pfizer/Wyeth (originator)
Generics (e.g., Mylan) |
| Registration Status |
MHRA & EMA approved |
| Classification |
Prescription-only (POM) |
Trecator-SC is the primary UK brand name for ethionamide, an essential second-line medication specifically developed for complex tuberculosis cases. This 250mg film-coated tablet formulation contains ethionamide as its active ingredient, categorized under the J04AD03 ATC code as a thioamide antimycobacterial agent.
Understanding Trecator-SC in the UK Market
In British pharmacies, Trecator-SC may appear in two forms: branded packs from Pfizer/Wyeth or generic equivalents simply labelled "Ethionamide Tablets 250 mg". Both variants contain identical active ingredients but may differ in packaging aesthetics. These tablets consistently come in 250mg doses, packaged either in:
- Blister packs (typically 30, 50, or 100 tablets)
- Amber prescription bottles for larger quantities
According to MHRA standards, UK packaging must clearly display the black triangle symbol denoting intensive safety monitoring and include comprehensive patient leaflets.
Regulatory Status and Approval
Trecator-SC maintains prescription-only status across all UK regions under medicines legislation. Both the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) continuously evaluate its safety profile through ongoing pharmacovigilance monitoring. Pharmaceutical suppliers must meet rigorous quality assurance standards overseen by these regulatory bodies.
Contraindications and Precautions for Trecator-SC
Ethionamide-containing medication like Trecator-SC comes with life-threatening restrictions for certain patient groups. History of hypersensitivity to thioamide derivatives mandates complete avoidance. Severe pre-existing liver conditions warrant absolute exclusion due to potentially fatal hepatotoxic reactions. Patients with acute porphyria face unacceptable risks since the drug potentially triggers haem synthesis pathway disruption.
Situations Requiring Heightened Vigilance
Several conditions necessitate cautious management if treatment proceeds:
- Psychiatric vulnerabilities: Those with anxiety/depression history require mood monitoring due to neuropsychiatric effect risks
- Neurological disorders: Existing seizure conditions or neuropathy demand neurological assessments every 3 months
- Thyroid dysfunction: Baseline thyroid screening with periodic TSH checks recommended
- Pregnancy and breastfeeding: Contraindicated in nursing mothers due to drug excretion in milk
Essential Monitoring Protocols
Monthly liver enzyme tests and blood counts remain non-negotiable safety requirements. The Medicines and Healthcare products Regulatory Agency highlights hepatotoxicity as a critical black box warning. Clinical vigilance for early signs like jaundice, dark urine or unexplained fatigue might prevent irreversible damage. Consider vitamin B6 prophylaxis (50-100mg daily) to mitigate peripheral neuropathy risks.
Side Effects: From Common to Severe
Trecator-SC frequently triggers predictable reactions requiring practical management strategies. Over 10% users report gastrointestinal discomfort including persistent nausea and metallic taste alterations. Appetite suppression and dizziness pose additional adherence barriers during initial treatment phases.
Temporary Reactions and Management Approaches
Timing medication intake with substantial meals dramatically reduces stomach irritation. Strategies include:
- Dividing doses throughout the day
- Using antiemetics like domperidon before dosing
- Temporary dose reduction until tolerance develops
Potentially Critical Adverse Events
Some reactions signal urgent intervention:
- Visual disturbances: Blurring requires immediate ophthalmology referral
- Depression indicators: Withdrawal, disrupted sleep or emotional numbness
- Liver impairment signs: Yellowing skin, persistently dark urine or clotting issues
- Neurotoxicity markers: Unsteady gait, slurring or extremity numbness
Discontinuation becomes mandatory for severe reactions like hepatitis or neurological deterioration requiring emergency care.
Patient Experiences and Tips for Adherence
Technology-assisted reminders significantly boost regimen consistency. Setting phone alarms at dosing times prevents forgetfulness. Pill organisers with compartments reduce confusion in complex regimens incorporating 4-6 TB medications.
Patterns Observed Across Therapy Journeys
UK-based peer forums reveal recurring themes: Many acknowledge bitter aftertaste diminishing after weeks but report manageable fatigue throughout treatment. One Manchester patient noted:
- "I split my 500mg dose into smaller portions taken hourly to control vomiting - worked before breakfast"
- "Vitamin B6 stopped the tingling numbness in my fingers about month three"
Overcoming Adherence Obstacles
Gastrointestinal distress drives one-quarter of treatment interruptions. Practical solutions include:
- Consistent timing with high-calorie snacks
- Consulting pharmacists about anti-sickness options
- Treating mouth soreness with saltwater rinses
Open communication prescribers about struggles prevents unnecessary discontinuation. Multidrug-resistant TB often requires 18-24 month commitments requiring resilient routines.
Trecator-SC Compared to Alternatives for MDR-TB
The nuanced selection between second-line tuberculosis medicines balances clinical priorities against socioeconomic factors. NHS prescribers prioritise cost-effective options while reserving premium-priced alternatives for extensively resistant cases.
| Treatment |
Annual Therapy Cost (UK) |
Effectiveness Profile |
Tolerability Concerns |
Logistical Factors |
| Trecator-SC |
£500 |
Moderate efficacy requiring combination |
GI/neurological events |
Hospital pharmacy access |
| Linezolid |
£12,000 |
Superior bacterial kill rates |
Bone marrow suppression |
Specialist prescriptions only |
| Prothionamide |
£400 (import) |
Comparable to ethionamide |
Overlapping toxicity concerns |
Import license delays |
UK tuberculosis specialists prefer ethionamide formulations like Trecator-SC for initial MDR-TB treatment due to budget considerations and familiarity. Linezolid remains reserved for extensively drug-resistant cases as NHS-sponsored salvage therapy despite thrombocytopenia risks requiring biweekly monitoring. Most community pharmacists stock Trecator-SC in limited quantities under supervised supply protocols.
Availability & Packaging: Getting Trecator-SC in the UK
Accessing Trecator-SC (ethionamide) in the UK follows strict distribution channels due to its specialised nature. Unlike common medications, you won't find it stocked at high-street pharmacies like Boots or Superdrug. Supplies are managed through NHS hospital pharmacies, specifically those treating tuberculosis cases. Treatment initiation requires specialist oversight from infectious disease consultants rather than GPs.
Cost and Procurement Details
With no NHS tariff pricing, patients face costs of £110-£130 per 100 tablets. Packaging typically features white HDPE medicine bottles or foil blisters accompanied by bilingual leaflets (English/Scots Gaelic). Demand remains relatively stable at 300-400 annual prescriptions nationally for MDR-TB cases, though pandemic-related delays affected imports temporarily.
Visualising Availability
A mock hospital pharmacy display would highlight Trecator-SC among other TB medications - distinct packaging standing alongside combination therapy drugs. Predominant labelling features include "Hospital Use Only" warnings and refrigeration symbols where cold chain storage applies during distribution.
Research Developments and Patent Status
The therapeutic landscape for ethionamide undergoes active evolution. Nanoparticle encapsulation trials (2023-2025) spearhead innovations aiming to reduce dosing frequency using microscopic carriers, now progressing through Phase II studies across European and Indian sites. Recent Cochrane analyses reinforced ethionamide's position within MDR-TB regimens despite acknowledged side effects.
Generic Projections and Combination Therapies
A significant patent shift approaches when Wyeth's exclusivity expires post-2030, opening production to 8+ generic manufacturers. Current UK supplies rely on imports like Biocon generics until domestic alternatives emerge. Pipeline focus targets fixed-dose combinations pairing ethionamide with cycloserine to simplify complex multi-drug regimens.
Affordability Support Through NHS Pathways
Navigating NHS procedures involves specialised commissioning approval via NHS England regional teams. Costs fall directly under hospital budgets with no patient co-payments required. Those holding private prescriptions face monthly expenditures of £90-£160 unless pursuing hardship relief programmes. Practical access methods include requesting generic ethionamide formulations where identical bioavailability exists.
Funding Framework Insights
Cases failing NHS commissioning criteria may nevertheless qualify through application trusts' exceptional funding pathways. Pharmacists often assist patients navigate reimbursement tiers - particularly where non-formulary exceptions apply to persistent infection scenarios.
Patient Queries: Addressing Common Concerns
Patients frequently voice questions regarding medication interactions and safety protocols - distilled from UK patient forums seeking practical insights.
Compatibility Questions
Alcohol consumption receives strong avoidance recommendations due to synergy that escalates nausea and dizzy spells. Regarding hormonal contraception, no interaction evidences exists requiring additional contraceptive measures. Feared fertility impacts currently lack clinical substantiation though preconception counselling remains advised.
Dosing Situations
If vomiting occurs within 60 minutes of taking Trecator-SC, redosing proves necessary. Beyond this window, patients should await their next scheduled administration rather than doubling doses. Restricted UK pharmacy dispensing occurs exclusively through hospital settings under specialist supervision.
Using Trecator-SC Safely: Practical Guidance
Consistency underpins successful ethionamide treatment. Strict adherence to daily timing using phone alerts supports therapeutic levels. Administering tablets alongside meals dramatically reduces common gastrointestinal irritation - separating pills from strong spices/hot foods preserves mucosal comfort.
Critical Safety Practices
Avoid alcohol entirely throughout therapy and consult pharmacists before introducing OTC products like antacids which disrupt absorption. Original packaging suffices for medicine preservation away from humidity. Dose management prohibits tablet crushing to prevent esophageal irritation while requiring monthly blood testing.
Emergency Symptoms Watchlist
Immediately report specific reactions:
- Visual changes including blurred sight
- Yellowed skin or sclera indicating potential hepatotoxicity
- Neurological disturbances like numbness or depression
Dedicated surveillance exceeds symptom checklist reliance - structured support reinforces safety.
