Stalevo

Basic Stalevo information

• INN (international nonproprietary name): Levodopa, Carbidopa, Entacapone
• Brand names available in the United Kingdom: Stalevo — film-coated tablets
• ATC code: N04BA03
• Forms and dosages: Film-coated tablets containing 200 mg entacapone with the following combinations — Stalevo 50 (12.5/50/200), 75 (18.75/75/200), 100 (25/100/200), 125 (31.25/125/200), 150 (37.5/150/200), 200 (50/200/200)
• Manufacturers in the United Kingdom: Novartis/Orion
• Registration status in the United Kingdom: MHRA-licensed prescription-only medicine
• OTC / Rx classification: Prescription-only medicine (POM)

Legal status and availability in the UK

Stalevo is a prescription-only medicine (POM) in the UK.

In our online pharmacy, Stalevo is available without a prescription, with discreet delivery to the United Kingdom in 9–21 days.

Wearing off in Parkinson’s disease

Patients commonly report motor fluctuations known as “wearing off” and the need to take levodopa more frequently to maintain control.

Experience in the UK focuses on balancing reduced off-time with new tolerability issues such as nausea and dyskinesia.

Strengths and regulatory status

Stalevo is a prescription-only medicine in the UK, supplied as film-coated tablets.

All strengths contain 200 mg entacapone plus levodopa/carbidopa in the amounts listed above: Stalevo 50, 75, 100, 125, 150 and 200.

Indication and when to discuss Stalevo with the prescriber

Practical clinical trigger points

When should Stalevo be discussed with the prescriber?

Stalevo is approved for adults with Parkinson’s disease who experience motor fluctuations or “wearing off” despite standard levodopa/DDCI therapy.

Stalevo may be considered when a patient reports increasing off-time, needs more frequent levodopa doses, or has inconsistent symptom control between doses.

Stalevo is prescription-only and initiation should be arranged by a GP or neurologist.

Dosage forms, strengths and switching guidance

Tablet strengths, matching prior regimen, max doses

How do you choose the correct Stalevo tablet when switching from a levodopa/DDCI product?

All Stalevo tablets contain 200 mg entacapone plus set amounts of levodopa and carbidopa.

Practical switching rule: match the levodopa component of the patient’s existing levodopa/DDCI dose to the closest Stalevo tablet and keep the same dosing frequency initially.

Typical dosing is one tablet per dose given three to seven times daily, adjusted to clinical response.

Maximum limits from the product information are not to exceed 200 mg levodopa per dose and not to exceed 2,000 mg levodopa per day.

Titration checklist: confirm current levodopa amount, pick nearest Stalevo strength, advise unchanged timing, monitor for increased dyskinesia when adding COMT inhibition.

Counselling: how to take Stalevo and daily practicalities

Administration, missed dose, storage and travel

What should patients know to take Stalevo safely and consistently?

Patients may take Stalevo orally with or without food unless the prescriber specifies otherwise.

Advise maintaining consistent timing in relation to meals if that has been part of the patient’s previous levodopa routine.

If a dose is missed, the patient should take it as soon as they remember and then continue the regular schedule.

Patients should be warned never to double the next dose to make up for a missed one.

In the event of suspected overdose, emergency care is required; symptoms may include dyskinesia, confusion and arrhythmia.

Storage recommendations are to keep the tablets below 30°C and protected from moisture and light.

When travelling, advise keeping Stalevo in its original packaging and carrying a copy of the prescription or treatment letter.

• Counselling summary: dose timing, what to do if a dose is missed, common side effects to expect, red flags that need urgent contact.

Explain benign urine discolouration and recommend contacting the prescriber if severe nausea or psychosis occurs.

Contraindications and clinical cautions

Absolute vs relative contraindications and monitoring needs

Which conditions mean Stalevo must not be supplied?

Absolute contraindications are prominent safety issues and need to be highlighted to prescribers and patients.

• Known hypersensitivity: allergy to any component — do not supply.
• Narrow-angle glaucoma: contraindicated due to risk of pupil dilation and pressure rise.
• Severe liver disease: avoid because entacapone exposure increases and liver disease is a contraindication.
• Phaeochromocytoma: contraindicated because of hypertension risk and possible hypertensive crisis.

Relative cautions that require monitoring or specialist advice include severe cardiovascular disease, severe renal impairment, history of psychosis and recent or current use of non-selective MAO inhibitors.

Recent liver and renal function should be checked if available, and the prescriber informed if psychotropic therapy or MAOI use is present.

Side-effect profile and management in practice

Common, less common and serious adverse effects

What side effects should you warn patients about and which require urgent action?

Common mild to moderate effects include nausea, diarrhoea, dyskinesia, urine discolouration, dizziness and insomnia.

Urine may turn a brownish colour with entacapone and this is benign but alarming if not warned about.

Serious events that require urgent medical assessment include severe psychosis, cardiac arrhythmias and severe hepatic reactions.

Practical points:

• Advise patients to stay hydrated and rise slowly from sitting to reduce orthostatic dizziness.
• Explain that increased dyskinesia can follow the addition of a COMT inhibitor and discuss monitoring plans with the prescriber.
• Recommend immediate contact with the GP or A&E if the patient develops severe confusion, hallucinations or signs of liver injury.

Document adverse events and encourage reporting of suspected serious reactions via the MHRA Yellow Card scheme.

Drug interactions and common UK polypharmacy issues

High-risk combinations

Which medicines and classes require a pharmacist check when Stalevo is prescribed?

Stalevo interacts with several drug classes and needs careful screening in the UK polypharmacy setting.

Key interaction concerns are with non-selective MAO inhibitors, antipsychotics that may antagonise levodopa, antihypertensives with additive orthostatic effects and drugs that alter levodopa absorption or metabolism.

High-risk combinations include:

1. Non-selective MAO inhibitors — contraindicated with Stalevo.
2. Antipsychotics such as older dopamine antagonists — may reduce efficacy.
3. Metoclopramide — may exacerbate extrapyramidal effects or reduce benefit; check use.
4. Antihypertensives — additive risk of orthostatic hypotension; counsel patients to stand slowly.
5. QT-prolonging medicines — consider arrhythmia risk if dyskinesia or cardiac symptoms appear.
6. Other COMT inhibitors or duplicate entacapone exposure — avoid duplication.
7. Drugs altering gastric emptying or intestinal absorption — check nitrates and anticholinergics as needed.
8. Antidepressants — review for MAOI status and psychotropic polypharmacy carefully.

Record interactions and advice in the patient medication records and liaise with the GP or neurologist before making changes.

Prescribing and NHS logistics

MHRA, prescription status and formularies

How is Stalevo prescribed in the NHS?

Stalevo is a prescription-only medicine licensed by the MHRA.

NHS prescribing guidance typically treats Stalevo as a specialist option for management of wearing-off in Parkinson’s disease and local formulary status can vary.

Pharmacists should check local formularies and any shared-care arrangements before accepting repeat requests or advising changes.

Comparison with other levodopa products

Sinemet, Madopar, Comtan and combination rationale

When is it better to use a fixed triple-combination tablet rather than separate components?

Stalevo uniquely combines levodopa, a dopa-decarboxylase inhibitor and entacapone in one tablet, simplifying dosing and ensuring COMT inhibition is co-delivered with each levodopa dose.

Use case: consider Stalevo when a patient is already taking levodopa/DDCI plus entacapone separately or when pill burden and adherence are the main issues.

Special populations: elderly, renal, hepatic and paediatric notes

Adjustments, monitoring and contraindications

What specific adjustments and monitoring are required for vulnerable groups?

Stalevo is not indicated for patients under 18 years and safety in children is unestablished.

Elderly patients may require lower starting doses and closer monitoring for orthostatic hypotension and neuropsychiatric effects.

Renal impairment requires caution and monitoring for adverse events.

Hepatic impairment increases entacapone exposure and severe liver disease is an absolute contraindication; avoid or reduce dose as advised by the prescriber.

Liver and renal impairment should be flagged, with specialist review recommended if severe impairment is recorded.

Overdose, pregnancy, lactation and legal safety

Emergency actions and legal classification

What immediate steps should be taken in suspected overdose and what are the legal rules on supply?

Overdose signs include dyskinesia, confusion and arrhythmia and require emergency care and supportive therapy.

Stalevo is a Prescription Only Medicine and must be dispensed according to UK prescription regulations.

Storage and transport guidance is to keep below 30°C and protect from moisture and light, with original packaging preferred for transit.

For pregnancy and lactation, consult the current SPC and specialist obstetric or paediatric advice.

Report suspected adverse drug reactions to the MHRA Yellow Card scheme.

Delivery across the United Kingdom