Accutane
In brief
- Accutane (isotretinoin) is a prescriptionâonly medicine (POM) in the UK and should be used under medical supervision.
- Accutane is used for severe, recalcitrant nodular or cystic acne unresponsive to other treatments; isotretinoin is an oral retinoid that reduces sebaceous gland size and sebum production, normalises follicular keratinisation and has antiâinflammatory effects.
- The usual dose is 0.5â1 mg/kg/day divided into two doses (some regimens up to 2 mg/kg/day in special cases); typical cumulative target dose is about 120â150 mg/kg over the course of therapy.
- Administration is by oral capsules (typical strengths 5 mg, 10 mg, 20 mg, 40 mg); take with food to maximise absorption.
- Some patients notice initial improvement within 1â2 weeks, but meaningful clinical response is commonly seen after 4â8 weeks; acne may transiently worsen in the early weeks for some people.
- Standard treatment duration is 15â20 weeks for a course; many patients achieve longâterm remission after a single course, depending on cumulative dose and individual response.
- Avoid excessive alcohol while taking Accutane â alcohol increases risk of liver injury and elevated blood lipids and should be discussed with your prescriber; routine monitoring of liver function and lipids is standard.
- The most common side effect is dry lips (cheilitis); other frequent effects include dry skin and mucous membranes, nosebleeds, dry eyes, skin fragility, muscle/joint aches and increased sun sensitivity.
- Would you like to try Accutane without a prescription?
Legal status and availability in the UK
In our online pharmacy, Accutane is available without a prescription, with discreet delivery to the United Kingdom in 9â21 days.
Basic Accutane information
- INN (international nonproprietary name): Isotretinoin (13âcisâretinoic acid)
- Brand names available in the United Kingdom: Roaccutane; generic isotretinoin capsules
- ATC code: D10BA01
- D10: Dermatologicals
- D10B: Antiâacne preparations
- D10BA: Retinoids for treatment of acne
- D10BA01: Isotretinoin
- Forms and strengths: oral capsules 5 mg, 10 mg, 20 mg, 40 mg
- Manufacturers in the United Kingdom: Mylan, Accord
- Registration status in the United Kingdom: Licensed (MHRA)
- OTC / Rx classification: Prescription only (Rx)
Clinical effectiveness in the UK
Do NHS patients actually get better and feel better after a course?
Within NHS dermatology services isotretinoin (INN: isotretinoin; ATC D10BA01) is the standard for severe, treatmentâresistant nodular acne.
Inflammatory lesion counts usually fall markedly across a 15â20âweek course, and quality of life typically improves during and after treatment.
Common challenges include lip and skin dryness, the monthly monitoring burden and the contraception checks for women of childbearing potential.
Discontinuation rates are driven mainly by intolerable dryness or biochemical abnormalities rather than lifeâthreatening events.
Prescribers balance cumulative dose targets (typically 120â150 mg/kg) against tolerability and some NHS centres favour lower continuous dosing to reduce sideâeffects.
Indications and expanded uses â MHRAâapproved versus offâlabel practice
Can isotretinoin be used for anything beyond severe nodular acne?
MHRA and SmPC guidance confines isotretinoin to severe recalcitrant nodular acne unresponsive to conventional therapies.
Dermatologists sometimes use isotretinoin offâlabel for severe variants such as acne conglobata or aggressive scarring acne under specialist supervision.
Offâlabel prescribing must be justified in the clinical record and the same monitoring precautions should apply.
Absolute constraints on use are grounded in teratogenicity and organ toxicity that demand strict prevention measures.
- MHRAâapproved indication: Severe recalcitrant nodular acne unresponsive to other treatments.
- Common offâlabel indications: Treatmentâresistant acne conglobata, severe scarring acne under specialist care.
Before prescribing, clinicians typically:
- Confirm failure of oral antibiotics and topical therapy.
- Discuss teratogenic risk and contraception with women of childbearing potential.
- Arrange baseline LFTs, fasting lipids and pregnancy test where applicable and plan 4âweekly monitoring.
- Document informed consent and rationale for offâlabel use if chosen.
Composition and UK brand landscape â active ingredient, packaging and ATC
Which brands and strengths are available in the UK?
The active ingredient is isotretinoin (13âcisâretinoic acid), INN, ATC D10BA01.
In the UK, isotretinoin is supplied as Roaccutane and as generic capsules, for example from Mylan and Accord.
Capsule strengths commonly available are 5 mg, 10 mg, 20 mg and 40 mg.
Roche is the originator company.
Capsules are soft gelatin oral forms and should be taken with food to improve absorption.
Brands and strengths:
| Brand name | Capsule strengths | Major supplier |
|---|---|---|
| Roaccutane | 5 mg, 10 mg, 20 mg, 40 mg | Roche / Licensed holders |
| Generic isotretinoin | 5 mg, 10 mg, 20 mg, 40 mg | Mylan |
All isotretinoin products are prescription only and packaging differs by marketing authorisation holder though strengths are standardised.
Contraindications and special precautions â highârisk groups and lifestyle restrictions
Who must never take isotretinoin and who needs extra care?
Absolute contraindications from the SmPC and MHRA include pregnancy, hypersensitivity to isotretinoin or excipients, severe hepatic or renal insufficiency, uncontrolled hyperlipidaemia and concurrent tetracyclines.
Relative precautions include current or past psychiatric disorders, diabetes, low bone mass and age under 12.
UK counselling routinely emphasises strict contraception for women of childbearing potential and avoidance of excessive alcohol.
Patients should be advised about skin fragility, increased photosensitivity and to stop and report any visual disturbance.
Key contraindications and precautions:
- Pregnancy: absolute contraindication (highly teratogenic).
- Tetracycline use: contraindicated due to raised risk of pseudotumour cerebri.
- Severe liver disease or uncontrolled lipids: avoid or monitor closely.
Monitoring by group:
| Highârisk group | Monitoring steps |
|---|---|
| Women of childbearing potential | Baseline and monthly pregnancy tests; documented contraception plan |
| Hepatic Impairment | Generally avoid; if used, frequent LFTs and specialist review |
| Hyperlipidaemia | Baseline fasting lipids and repeat checks; treat or stop if severe |
Dosage guidelines â NHSârecommended regimens and special population adjustments
How will my dose be chosen and how often will I be reviewed?
Standard dosing in adults and adolescents aged 12 and over is 0.5â1 mg/kg/day divided into two doses for a typical duration of 15â20 weeks.
The usual cumulative total is aimed at 120â150 mg/kg over the course.
Maximum dosing may reach up to about 2 mg/kg/day in selected refractory cases and repeat courses are only after at least 8 weeks off therapy.
Administration advice is to take capsules with food to enhance absorption.
Special population adjustments include avoiding routine use in children under 12 and starting low with cautious titration in the elderly or those with renal impairment.
Monitoring frequency is baseline LFTs, fasting lipids and pregnancy status where applicable and then normally at 4âweekly intervals.
Dosing by weight band and monitoring schedule:
| Weight band | Typical daily dose | Monitoring |
|---|---|---|
| <50 kg | 0.5â1 mg/kg (e.g. 20â40 mg/day) | Baseline LFTs, lipids; 4âweekly review |
| 50â75 kg | 25â75 mg/day (divided) | Baseline and monthly checks |
| >75 kg | ~0.5â1 mg/kg adjusted to capsule strengths | Baseline and monthly checks; cumulative dose aim 120â150 mg/kg |
Interactions overview â drugs, food and Yellow Card reports
Which medicines and habits increase risk while taking isotretinoin?
Concurrent tetracyclines are contraindicated because of the risk of pseudotumour cerebri (benign intracranial hypertension).
Patients must avoid vitamin A supplements due to additive hypervitaminosis A effects.
Alcohol increases the risk of hepatotoxicity and may worsen triglyceride elevations so minimising intake is advised.
Isotretinoin is metabolised hepatically and clinicians should review other CYPâinteracting medicines for potential additive hepatotoxicity or lipid effects.
Interaction summary:
| Agent | Mechanism | Recommended action |
|---|---|---|
| Tetracyclines | Increased risk of pseudotumour cerebri | Contraindicated â stop one class before starting isotretinoin |
| Vitamin A supplements | Additive hypervitaminosis A | Avoid supplements containing vitamin A |
| Alcohol | Raises hepatotoxicity/lipid risk | Advise minimising alcohol; monitor LFTs and lipids |
There is no established interaction with caffeine or tea.
Comparable medicines and prescribing preferences â alternatives in NHS practice
What are the standard alternatives before considering isotretinoin?
Before isotretinoin NHS pathways favour oral tetracyclines such as doxycycline or lymecycline, topical retinoids and benzoyl peroxide, and hormonal options for females including the combined oral contraceptive pill or antiâandrogens where appropriate.
Isotretinoin's pros are high cure and sustained remission rates for severe disease.
Its cons include teratogenicity, systemic adverse effects and the monitoring burden.
For moderate acne long antibiotic courses are increasingly avoided because of antimicrobial resistance concerns.
Pros and cons:
- Isotretinoin: High efficacy; strict monitoring and contraception requirements.
- Oral antibiotics: Useful for inflammatory acne but stewardship concerns limit long courses.
- Hormonal therapy: Effective for hormonally driven acne in females; not suitable for everyone.
NHS practice reserves isotretinoin for severe, recalcitrant nodular acne after other lines have failed.
Frequently asked questions
Q: Will isotretinoin permanently cure my acne?
A: Many patients achieve longâterm remission; relapse occurs in a minority and may be treated with a repeat course only after at least eight weeks off therapy.
Q: How does pregnancy prevention work in the UK?
A: Women of childbearing potential must follow a documented pregnancy prevention programme with reliable contraception (often two methods), negative pregnancy tests at baseline and monthly, and informed consent documented.
Q: What monitoring is routine?
A: Baseline then typically 4âweekly checks for pregnancy where applicable, LFTs and fasting lipids, plus clinical review for mood or vision changes.
Q: Can I drink alcohol while taking isotretinoin?
A: You are advised to minimise alcohol because of potential additive effects on the liver and triglycerides.
Urgent actions:
- Contact your prescriber or local emergency service for severe mood change or visual disturbance.
- Stop the medicine and seek urgent review if pregnancy is suspected.
Guidelines for proper use â pharmacist counselling, NHS portals and support
What should the pharmacist tell me on collection?
Best practice counselling includes confirming identity and pregnancy status where relevant and explaining that capsules should be taken with food.
Advise on moisturisers and lip balms for cheilitis and instruct patients to avoid vitamin A supplements and tetracyclines.
Explain the monitoring schedule (baseline and monthly tests for pregnancy where applicable, LFTs and fasting lipids) and how to report sideâeffects.
Documented consent and recordâkeeping through NHS eârecords or clinic letters improves safety and continuity of care.
Signpost patients to NHS information and specialist nurse support and encourage Yellow Card reporting of suspected adverse reactions.
Pharmacist counselling checklist:
- Confirm pregnancy test status and contraception plan for women of childbearing potential.
- Give practical advice: take with food, use emollients and SPF, avoid excessive alcohol and vitamin A supplements.
- Provide a monitoring calendar: baseline bloods, then 4âweekly tests and clinic reviews.
Monitoring calendar: baseline bloods and pregnancy test; Week 4: bloods and review; Repeat every 4 weeks until course end.
Delivery across the United Kingdom
| City | Region | Delivery Time |
|---|---|---|
| London | Greater London | 9â21 days |
| Birmingham | West Midlands | 9â21 days |
| Manchester | Greater Manchester | 9â21 days |
| Glasgow | Scotland | 9â21 days |
| Leeds | West Yorkshire | 9â21 days |
| Liverpool | Merseyside | 9â21 days |
| Bristol | South West England | 9â21 days |
| Edinburgh | Scotland | 9â21 days |
| Sheffield | South Yorkshire | 9â21 days |
| Newcastle Upon Tyne | North East England | 9â21 days |
| Belfast | Northern Ireland | 9â21 days |
| Cardiff | Wales | 9â21 days |
| Leicester | Leicestershire | 9â21 days |
| Coventry | West Midlands | 9â21 days |