Disclaimer: This article is for informational purposes only and does not constitute medical advice. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition.
Overview
Accutane is a brand name for isotretinoin, a retinoid medicine related to vitamin A that is taken by mouth. Health Canada has authorized it for severe nodular or inflammatory acne, acne conglobata and acne that has not responded to standard treatments. It comes as 10 mg and 40 mg capsules. Other isotretinoin capsules are also sold in Canada, including Epuris and generic isotretinoin.
Because of its serious side effects, Accutane is meant only for acne that has not cleared with other treatments, including antibiotics. It causes severe birth defects, so anyone who could become pregnant must follow a strict pregnancy prevention program. All patients sign a consent form before starting, and treatment involves blood tests and monthly follow-up visits.
Isotretinoin should be prescribed only by doctors experienced with this type of medicine, often a dermatologist. If you have acne that is not improving, BC residents can speak with a BC-licensed doctor by phone through Avee Health about their symptoms and next steps, including whether a referral is needed.
In Canada, Accutane is authorized to treat:
- Severe nodular or inflammatory acne
- Acne conglobata, a severe form of acne with deep, connected lumps
- Acne that has not responded to standard treatments
It is not a first treatment for milder acne. It is not recommended for children under 12. For teens aged 12 to 17, doctors weigh its use carefully, especially if there is a bone condition, because back and joint pain are more common at this age.
Isotretinoin
Oral retinoid
skin care
Prescription required
Available
How Accutane Works
The exact way isotretinoin works is not known. Improvement in acne goes along with these effects:
- It lowers the amount of oil (sebum) the skin makes
- It shrinks the oil glands in the skin and slows their development
Acne can get worse for a short time at the start. The first signs of healing usually appear after 2 to 3 weeks, and a clear benefit can take 1 to 2 months. Skin may keep improving for several months after a course ends.
Dosage Instructions of Accutane
Your doctor sets your dose based on your body weight, how severe your acne is and how you respond. The usual schedule in the Canadian product monograph is:
- Start: 0.5 mg per kg of body weight per day for 2 to 4 weeks
- Then: adjusted to between 0.1 and 1 mg per kg per day, and in exceptional cases up to 2 mg per kg per day
- Length: a full course is 12 to 16 weeks
- Second course: if needed, it can start 8 or more weeks after the first one ends
Take Accutane with food or just after a meal, once a day or split into two doses. Food helps the body absorb it.
If you could become pregnant, each prescription covers 30 days only and should be filled within 7 days. Treatment starts on the second or third day of your next normal period, after negative pregnancy tests.
Missed dose: you can take it later the same day, but do not take more in one day than prescribed. Do not take a double dose to make up for it.
Storage Instructions
Store Accutane at 15°C to 30°C in the original package, protected from moisture, heat and light. It does not need to be refrigerated. Keep it out of reach of children, and return unused capsules to a pharmacy.
Side Effects of Accutane
Dryness of the lips, skin and nose affects most people. In clinical studies, the most common side effects were:
- Dry, cracked or inflamed lips: 96%
- Redness or rash on the face: 55%
- Dry nose: 51%
- Peeling skin: 50%
- Itching: 30%
- Dry skin: 22%
- Red or inflamed eyes (conjunctivitis): 19%
- Hair thinning and joint pain: about 13% each
Blood tests can change too: triglycerides (a blood fat) rose in about 25% of people and liver enzymes in about 15%. Nosebleeds, tiredness, headache, easier sunburn and dry eyes, which can make contact lenses uncomfortable, can also occur. Use a moisturizer and lip balm from the start. Sexual problems, including erectile dysfunction, have been reported, and in some people they continued after stopping.
Stop taking Accutane and get medical help right away if you have:
- Low mood, loss of interest, unusual irritability or aggression, withdrawing from others, or thoughts of harming yourself
- A bad headache with nausea, vomiting or blurred vision (possible raised pressure in the brain)
- Severe stomach pain, severe diarrhea, bleeding from the rectum, yellow skin or eyes, or dark urine
- Changes in vision, poor night vision, ringing in the ears or changes in hearing
- Muscle weakness or pain, especially after exercise, or bone and back pain that does not go away
- Hives, swelling of the face or mouth, trouble breathing, or a severe rash with blisters, peeling skin, fever or mouth sores
- Chest pain, a racing heartbeat, leg swelling, slurred speech or a seizure
- A missed period, or any reason to think you may be pregnant
Important Safety Information About Accutane
- Pregnancy: Accutane causes severe birth defects in a very high share of babies exposed during pregnancy, even after a short time or a small amount. It can also cause miscarriage, premature birth or death of the baby. Do not take it if you are pregnant, and do not become pregnant during treatment or for 1 month after stopping.
- Pregnancy prevention program: if you could become pregnant, you need two negative pregnancy tests before starting, the second done in a lab within 11 days before you start. You must avoid sex, or use two reliable birth control methods together, from 1 month before treatment until 1 month after it ends. A pregnancy test is needed every month and 1 month after stopping. This applies even if you are not sexually active or have a history of infertility.
- Mental health: some people taking isotretinoin have become depressed, and some have attempted or died by suicide. Psychosis and aggressive behaviour have also been reported. Your doctor should ask about your mental health and family history before and during treatment. Report any change in mood right away.
- Raised pressure in the brain has been reported, some cases in people also taking tetracycline antibiotics.
- Do not take Accutane if you are breastfeeding, have liver or kidney disease, have very high blood fats or too much vitamin A in your body, take a tetracycline antibiotic, or are allergic to isotretinoin or any ingredient, including soybean oil and parabens.
- Breastfeeding: do not breastfeed during treatment or for 1 month after stopping.
- Blood tests: blood fats, liver tests, blood count and blood sugar are checked before treatment and again after 1 month. Liver tests are then repeated at least every 3 months. People with diabetes, obesity or heavy alcohol use may need more frequent checks.
- Exercise and bones: avoid vigorous exercise during treatment. Serious muscle breakdown has been reported, mostly with strenuous activity. Tell your doctor if you have a bone condition or an eating disorder, and tell any provider treating a broken bone that you take Accutane.
- Night vision can drop suddenly. Be careful when driving at night.
- Skin procedures: avoid waxing, dermabrasion and laser treatments during treatment and for at least 6 months after stopping, because of the risk of scarring.
- Sun: avoid tanning beds and strong sunlight, and use a sunscreen of at least SPF 15.
- Blood donation: do not donate blood during treatment or for 1 month after stopping. Never share your capsules with anyone.
Drug Interactions
Tell your doctor and pharmacist about everything you take, including vitamins and herbal products. The main interactions are:
- Tetracycline antibiotics, often used for acne: must not be taken with Accutane because of the risk of raised pressure in the brain
- Vitamin A supplements, including multivitamins with vitamin A: avoid them, because side effects can add up
- Progestin-only birth control pills (the mini-pill): not a suitable birth control method during treatment. An effect on other hormonal birth control has not been fully ruled out.
- St. John's wort: avoid it, because it may make hormonal birth control less effective
- Corticosteroids taken by mouth or injection, and phenytoin: used with caution because of possible effects on bone
- Acne products that peel or exfoliate the skin: avoid them, because irritation can increase
Brands & DIN Number of Accutane
Brand Names
Accutane
DIN (Drug Identification Numbers)
- 00582344
- 00582352
Key Takeaways
- 1Accutane is isotretinoin, a capsule authorized in Canada for severe acne and acne that has not responded to standard treatments.
- 2It causes severe birth defects. Anyone who could become pregnant must use two methods of birth control and have a pregnancy test every month.
- 3The usual starting dose is 0.5 mg per kg per day, taken with food, and a course lasts 12 to 16 weeks.
- 4Dry lips, skin and nose affect most people, and blood fats and liver enzymes can rise, so regular blood tests are needed.
- 5Depression and suicidal thoughts have been reported. Tell your doctor right away about any change in mood.
- 6Tetracycline antibiotics and vitamin A supplements must not be taken with it.
- 7Isotretinoin should be prescribed only by doctors experienced with it, often a dermatologist.
Frequently Asked Questions
Avee Editorial
Avee Editorial Team