1. Introduction
Accutane (isotretinoin) is an oral retinoid used to treat severe nodular acne that has not responded to other treatments. It works by reducing sebaceous gland activity, decreasing sebum production, and preventing clogged pores, leading to long-term acne clearance.
2. Indications
- Severe Nodular Acne (Cystic Acne) (First-line in severe cases)
- Recalcitrant Acne (Acne resistant to antibiotics & topical therapy)
- Off-Label Uses:
- Hidradenitis suppurativa
- Rosacea (severe cases)
- Sebaceous hyperplasia
3. Dosage
Adults & Adolescents (≥12 years, Severe Acne):
- Typical dose: 0.5–1 mg/kg/day in two divided doses.
- Max dose: 2 mg/kg/day in very severe cases.
- Duration: 16–20 weeks (treatment course may be repeated after 8 weeks if needed).
Cumulative Dose Approach (Preferred):
- 120–150 mg/kg total cumulative dose over the treatment period reduces relapse risk.
Elderly:
- Same as adults, but monitor for increased sensitivity to side effects.
Renal Impairment:
- Start with 10 mg/day, titrate based on tolerance.
Hepatic Impairment:
- Contraindicated in severe liver disease.
- Liver function tests (LFTs) required before and during therapy.
4. Administration
- Take with food (high-fat meal enhances absorption).
- Swallow whole with water—do not crush or chew.
- Do not take with alcohol (risk of liver toxicity).
5. Forms Available
- Capsules: 10 mg, 20 mg, 30 mg, 40 mg
6. Side Effects
6.1 Common Side Effects:
- Dry skin & lips (cheilitis)
- Dry eyes & irritation
- Nosebleeds (due to dry nasal mucosa)
- Increased sun sensitivity
6.2 Less Common Side Effects:
- Joint & muscle pain
- Headaches
- Fatigue
6.3 Rare but Serious Side Effects:
- Depression, mood changes, suicidal ideation
- Severe liver toxicity (elevated ALT, AST)
- Increased triglycerides (risk of pancreatitis)
- Pseudotumor cerebri (severe headache, vision changes, nausea)
7. Warnings
- Teratogenicity (Severe Birth Defects):
- Absolutely contraindicated in pregnancy.
- Requires iPLEDGE program enrollment (USA) to prevent fetal exposure.
- Two forms of contraception required starting 1 month before treatment, during treatment, and 1 month after stopping.
- Psychiatric Effects:
- Monitor for depression, mood swings, suicidal thoughts.
- Discontinue if severe psychiatric symptoms develop.
- Liver Toxicity & Hyperlipidaemia:
- Monitor LFTs and lipid profile at baseline and during treatment.
8. Precautions
- Avoid alcohol—increases liver toxicity risk.
- Avoid blood donation during and 1 month after stopping due to teratogenic risk.
- No laser hair removal/waxing during & 6 months after stopping (risk of skin scarring).
- Caution in diabetes patients—may increase blood sugar levels.
9. Interactions
- Tetracyclines (e.g., doxycycline): Increased risk of pseudotumor cerebri (severe headache, vision changes).
- Vitamin A supplements: Avoid due to risk of hypervitaminosis A toxicity.
- Corticosteroids: May increase bone loss risk.
- Alcohol: Increases risk of liver damage & hyperlipidaemia.
10. Monitoring Parameters
- Pregnancy tests: Monthly for women of childbearing potential.
- Liver function tests (ALT, AST): Baseline, then every 4–6 weeks.
- Lipid profile (cholesterol, triglycerides): Baseline, then every 4–6 weeks.
- Mental health assessment: Monitor for mood changes, depression, or suicidal ideation.
11. Use in Children
- Approved for severe nodular acne in adolescents ≥12 years.
- Avoid in prepubertal children due to bone growth concerns.
12. Use in Pregnancy
- Category X: Severe teratogenic risk—absolutely contraindicated.
- Requires strict contraception & iPLEDGE compliance.
13. Use in Elderly
- No specific dose adjustment, but monitor lipids & liver function closely.
14. Use in Kidney Disease
- Mild-moderate impairment: Start with 10 mg/day and increase cautiously.
- Severe impairment: Avoid use.
15. Use in Liver Disease
- Mild to moderate impairment: Use with caution, frequent monitoring.
- Severe hepatic impairment: Contraindicated.
16. Patient Counselling Points
- Avoid pregnancy: Use two reliable contraception methods and monthly pregnancy tests.
- Take with food: Enhances absorption.
- Dry skin & lips are common: Use moisturisers and lip balm.
- Avoid alcohol: Increases liver toxicity & hyperlipidaemia risk.
- Wear sunscreen: Increased sun sensitivity.
- Report mood changes immediately: Risk of depression & suicidal thoughts.
17. Table of Brand Names, Manufacturer, and Prices in USD
Brand Name | Manufacturer | Strength/Dosage Form | Price (USD) |
---|---|---|---|
Accutane | Roche (Discontinued) | 10 mg, 20 mg, 40 mg Capsules | $600 (30 caps) |
Claravis | Teva Pharmaceuticals | 10 mg, 20 mg, 40 mg Capsules | $500 (30 caps) |
Absorica | Sun Pharma | 10 mg, 20 mg, 30 mg, 40 mg Capsules | $700 (30 caps) |
Amnesteem | Mylan | 10 mg, 20 mg, 40 mg Capsules | $450 (30 caps) |
Generic Isotretinoin | Various | 10 mg, 20 mg, 40 mg Capsules | $250–$400 (30 caps) |
18. 15 FAQs (Frequently Asked Questions)
1. What is Accutane used for?
It is used for severe nodular acne resistant to other treatments.
2. How does Accutane work?
It shrinks sebaceous glands and reduces oil production, preventing acne formation.
3. How long does it take to see results?
Improvement starts within 4–6 weeks, with full effects in 16–20 weeks.
4. Can Accutane cure acne permanently?
Yes, many patients achieve long-term remission, but some may need a second course.
5. Can I drink alcohol while on Accutane?
No, alcohol increases liver toxicity risk.
6. Does Accutane cause depression?
It may cause mood changes or suicidal thoughts in some individuals.
7. Can Accutane cause hair loss?
Temporary hair thinning may occur but usually reverses after stopping treatment.
8. Can I take Accutane if I am pregnant?
No, it is teratogenic (causes severe birth defects).
9. Does Accutane make acne worse at first?
Yes, initial flare-ups are common but improve over time.
10. Can I get a tan while on Accutane?
No, it increases sun sensitivity—use sunscreen.
11. Does Accutane cause weight gain?
No, weight changes are not common.
12. Can I get laser treatments while on Accutane?
No, avoid laser treatments for 6 months after stopping.