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What is Isotretinoin?

Roaccutane (isotretinoin) is a drug prescribed for severe forms of acne and moderate acne resistant to adequate courses of standard therapy e.g systemic antibiotics and topical therapy. It has been prescribed in Ireland for over 30 years.

It is being prescribed for you only. It is important not to share your medication with friends or family.

 

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How does it work?

Isotretinoin is a retinoid drug which is part of the same family as Vitamin A. It reduces the production of sebum – an oily substance made by the skin. It also reduces the production of keratin – the outer layer of the skin, which can block pores. This leads to less bacterial overgrowth within the pilo-sebaceous unit. It also has powerful anti-inflammatory effect on acne. The drug shrinks down the oil producing glands therefore drying out the skin and mucus membranes.

 

 

How effective is Isotretinoin?

Approximately three quarters 72% of patients who complete a course of oral isotretinoin will never get their acne back again.

Your acne may get worse in the first few weeks taking this medication and it may take 1-2 months for you to start seeing an improvement.

 

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What dose do I take?

You will be advised on your dose by your prescribing doctor. Usually, you will start with a low dose for the first month to avoid a severe flare of acne and to get used to Roaccutane side effects. If tolerating this dose, you will be increased to the full dose after one month. The dose you are given will depend on your body weight. Roaccutane come in 20mg and 10mg capsules.

 

 

When do I take Isotretinoin?

Isotretinoin is taken once a day with food, or the dose can be split and taken twice daily. Swallow the capsules whole. Do not crush or split them.

 

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How long do I take Isotretinoin for?

Your dose and response to treatment will be reviewed at each follow up appointment. Treatment is usually continued until your acne has been cleared and continued for a further 1-2 months to reduce the risk of reoccurrence. A treatment course is generally around 24 weeks (6 months) but may be longer if low doses are used.

 

 

What are the possible side effects?

Isotretinoin may cause serious side effects. While these are rare, it is important that you understand the potential risks in other to make an informed decision about whether to take it.

 

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Common side effects:

 Transient Flare of Acne

• Dry Lips (sometimes chapped or split). Apply lip balm frequently and liberally.

• Dry Skin - especially on exposed skin (face, neck, arms and hands). Apply emollient cream frequently and liberally to dry skin, especially after bathing/showering.

• Dry Eyes – eyes can become dry, irritated and red. Use frequent lubricating eye drops.

• Dry Nose - use petroleum jelly. Do not pick dry scabs. Nosebleeds may occur in those predisposed to them.

• Dry Genital and Anal Mucosa - bleeding at the time of bowel motion may occur from a split anus. Sexual intercourse may be uncomfortable: use plenty of suitable lubrication. Vaseline or oil based degrade condoms. Use water based or silicone based lubricants.

• Increased sensitivity to the sun with the chance of getting sunburnt. SPF is very important.

• Back pain, muscle, and joint aches, especially after exercise.

• Changes in blood tests, which are monitored while you are taking Isotretinoin. These include mildly raised liver enzymes and changes in blood fat levels.

• Headaches

• Tiredness

• Severe birth defects – see pregnancy section.

 

These side effects usually resolve within a few weeks after stopping Isotretinoin.

 

There is an additional leaflet with information on how to help reduce these side effects.

 

 

What other possible side effects can occur?

• Serious immediate allergic reaction with sudden rash, swelling of lips, mouth or throat, and difficulty breathing or swallowing. Call  911 and take an anti-histamine immediately. Do not take any further Isotretinoin.

• Hair Loss. This is usually only mild and temporary. Your hair should return to normal after treatment ends.

• Vision problems, especially decreased night vision. If you develop difficulties seeing in dark conditions, you should avoid driving or operating machinery at nighttime.

• Bowel (gut) problems. This may lead to nausea, vomiting and/or diarrhoea.

• Feeling weak or dizzy.

• Inflammation of the liver. This can show as yellow skin or eyes and feeling tired.

  

 

Isotretinoin and potential Mental Health Problems:

Isotretinoin has been associated with mental health problems in some people. The current published research does not give a clear answer as to whether isotretinoin is the cause of these mental health problems in some people.

 

We know that people with acne are more likely to have anxiety and depression than people without acne. This is because acne may affect self- confidence and make people distressed about the way they look.

Several studies have shown that isotretinoin can improve negative mood changes caused by acne.

 

However, there are some reported experiences of worsening mood or changes in behavior, including anxiety, low mood, depression, or agitation.

 

Extremely rarely, isotretinoin may be associated with people hurting themselves or suicide.

 

If you ever have low mood, suicidal thoughts, or any other mental health issues, stop taking medication and please contact us immediately.

 

 

Blood tests before and during Isotretinoin treatment:

Isotretinoin can occasionally affect blood count, liver function and serum lipids (cholesterol and triglycerides).

 

It is necessary to check these bloods before starting Isotretinoin.

 

Bloods are rechecked 1 month after starting treatment and again at 4 months.

 

More frequent blood monitor is required if the dose of medication is changed or abnormalities occur in the blood results.

 

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For Females:

You must not be pregnant or become pregnant while taking Isotretinoin.

 

You will be required to read and sign a Pregnancy Prevention Protocol.

There is a high risk that an unborn baby could have severe birth defects if you were to get pregnant while taking Isotretinoin.

 

Effective contraception, without interruption, is required for one month before starting treatment, throughout the duration of treatment and one month after the end of treatment.

 

We recommend that you take 2 forms of contraception. For example, the oral contraceptive pill PLUS barrier protection.

 

You will be required to undertake pregnancy tests monthly while taking Isotretinoin. Your last pregnancy test will be 5 weeks after you finish Isotretinoin.

 

If you have unprotected intercourse whilst taking Isotretinoin (or 1 month afterwards, you will need emergency contraception. This may be the ‘morning after pill’ or the emergency copper intrauterine device.

 

If you miss a period, think you may be pregnant or find out you are pregnant. Stop tsking Isotretinoin immediately. Seek medical advice as soon as possible.

 

You cannot breastfeed while taking Isotretinoin.

 

 

For Males:

Isotretinoin does not appear to damage sperm. Very low levels of isotretinoin are present in the semen of men taking Isotretinoin, which is considered too little to harm the unborn baby of your partner. You must remember not to share your medication with anyone, particularly not women.

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Are there any other important precautions while taking Isotretinoin?

• Isotretinoin capsules should never be shared with other people.

• You must not donate blood whilst taking Isotretinoin capsules and for at least 1 month after stopping medication. This is because the blood may be given to a pregnant person.

• Isotretinoin and alcohol can affect the liver so you should not drink much alcohol while taking isotretinoin. Do not drink more than recommended 14 units per week of alcohol.

• Isotretinoin capsules contain highly processed soya. It also contains peanut oil. Therefore, if you have an allergy to soya or peanut you can not take Isotretinoin.

• It is best to avoid treatment such as waxing, epilation, or dermabrasion, as well as tattoos and piercing during treatment and for up to 6 months afterwards. They could cause scarring, skin irritation, or rarely changes in the colour of your skin.

• Avoid exposure to intense sunlight. Wear a sunscreen with a SPF of at least 30. Do not use sunbeds.

• Isotretinoin is a derivative of Vitamin A. Therefore, do not take vitamin supplements that contain Vitamin A as it can increase the possibility of side effects.​