| 1-Roaccutane
Roaccutane is one of the most important drugs used in the treatment of moderate, severe, or sometimes mild types of acne vulgaris. Its introduction into the market in the late seventies and early eighties has caused a revolution in dermatology; the repercussions of which can be felt till now.
2-Why is Roaccutane considered to be a revolution in the field of dermatology?
It is so because:
• It is the only drug which can get rid of acne vulgaris for good, or at least subdue it's activity significantly.
• It has become possible to treat some types of acne, which were considered before to be unmanageable because of their severity.
• The drug and its derivatives have opened the door for several research studies that used the drug in the treatment of diseases even in many fields other than dermatology.
• The drug has a high safety profile if the necessary precautions are followed, which was proven in more than twenty years of usage in the market.
3-What is Roaccutane composed of?
The drug is a Vitamin A derivative, a natural element which is found in the body in small amounts. It is available in the form of capsules that are taken orally.
4-Who is Roaccutane used for?
The drug has been in the market for twenty years, and so with time, was used in the treatment of millions of patients, where its safety and efficacy was proved. It is now accepted by most scientific authorities as an early treatment for acne vulgaris. The drug is used for most types of acne, but especially in the following cases:
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Cystic types of acne vulgaris.
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Types of acne that cause scars even if mild.
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Types of acne that do not respond to treatment by other drugs.
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Relapsing acne that returns after treatment by other drugs.
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For patients who want to get rid of acne permanently.
5-How does Roaccutane work:
It works through several ways, the most important of which are:
• It decreases the production of oil by the oil glands.
• It breaks down the epidermal plugs opening the ducts of the sebaceous glands.
• It loosens up the epidermal cells and weakens their bonds to each other thus decreasing the formation of plugs.
• It has an anti-inflammatory effect that decreases the skin inflammation accompanying acne due to colonization by the bacteria.
6-Before you take ROACCUTANE
When you must not take it
Do not take ROACCUTANE if:
1. You are pregnant, or for at least one month before you plan to fall pregnant. If you fall pregnant while taking ROACCUTANE there is an extremely high risk of having a baby that is severely deformed. You must use effective contraception for one month before, during and one month after treatment.
2.You are breastfeeding Breastfeeding must stop before treatment begins. Do not breastfeed while taking ROACCUTANE.
3.You have had an allergic reaction to ROACCUTANE, vitamin A, other retinoids or any ingredients listed at the end of this leaflet
4.You are taking tetracycline antibiotics (such as Vibramycin®, Tetrex®, Doryx®, Achromycin®, Rondomycin®, Minomycin®)
5.You have kidney or liver disease
6.You have very high fat levels (cholesterol, triglycerides) in your blood
7.You have hypervitaminosis A
This is a condition caused by an excessive amount of vitamin A in the diet.
8.The packaging is torn or shows signs of tampering
9.The expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should start taking ROACCUTANE, contact your doctor.
Before you start to take it
You must tell your doctor if:
1. you have any allergies to any other substances, such as foods, preservatives or dyes
2. you have any other health problems or issues including:
diabetes, or a history of diabetes in your family
depression or a history of depression
3. you drink large amounts of alcohol.
If you have not told your doctor about any of the above, tell them before you start taking ROACCUTANE
7-Are there any side-effects for using Roaccutane?
There are some possible side-effects which your doctor will explain to you and tell you how frequently they occur. Generally, they are rare and accepted if compared to the benefits of the drug, as well as the permanent problems that acne might cause. They are divided into several categories:
• Side effects that happen to all patients and these include:
• Skin Dryness: Which starts a few days after the initial use of the drug and increases with its usage, but disappears after treatment is stopped. The patient is advised to use skin moisturizers.
• Dryness of the mucous membranes: This includes:
a- Lip dryness: which may cause painful lip cracks and even bleeding. This is best managed by frequent wetting using lipsticks.
b- Nose dryness: Can be managed by the use of Vaseline inside the nose.
c- Eye dryness: This too can be managed by the frequent application of eye drops known as artificial tears. Contact lenses should not be worn while your under treatment because they may cause corneal ulcers that might lead to serious complications like corneal opacity.
• Side effects that happen only to some patients:
• A rise in the level of serum lipids: These include triglycerides and cholesterol and it usually affects patients who already suffer from increased lipid levels. Checking the lipid level in the serum monthly is advised and if it rises, the doctor usually advises the patient to decrease his intake of fat, or rarely, may discontinue the drug temporarily till the lipid level falls down again.
• Elevated levels of liver enzymes: This happens only very rarely. An initial check of the liver enzymes and a monthly follow-up is recommended. The elevated enzymes though, fall back to normal once the drug intake is stopped.
• Muscle and joint pains: This usually affects patients who engage in sports. Though it may rarely be severe enough to warrant discontinuation of the drug. You can take analgesic after doctor's advice.
• Headache: It is usually mild and transient and responds to regular analgesics. Consult your doctor if the headache persists inspite of analgesics.
• Side-effects that occur rarely in some patients:
• Hair loss: It is rare and the hair regrows again after the treatment is stopped.
• Slow healing of wounds: It is not recommended to perform any elective plastic surgeries in the face or neck even for several months after the treatment is finished.
• Psychological disturbances: There is no proven correlation between the drug and the occurrence of depression, though it might occur in patients who have a previous history of depression. In fact, a noticeable improvement in most patients' moods occurs because of the improvement of their acne.
• Photosensitivity: The skin may become sensitive to the sun and so it is advised to avoid excess exposure to the sun.
• Teratogenecity :
It is by far the most serious side-effect of all, and its incidence once the patient is exposed to the drug is 30-40% which is really a very high incidence. Donation of blood should never be done while taking Roaccutane to protect other people from such a problem.
When is it safe to allow pregnancy after treatment is stopped? The drug is stored in the fat tissues of the body and thus remains in the body for some time after intake is stopped. It's concentration drops with time till it returns to the normal level (the drug is normally found in the body in small amounts) within a month from the last dose. It is thus advised to postpone pregnancy for one month, though some doctors recommend two or three months, especially if the patient is anxious about the problem, though this long time has no scientific basis.
What are the necessary precautions to prevent pregnancy? It is recommended to use two different types of contraception concurrently to make double sure that pregnancy will not occur. This must include the use of contraceptive pills or intrauterine devices (IUD). Natural methods of contraception such as early withdrawal, or the safe-period method are not allowed because of their high rates of failure. The use of contraception must be started one month (or a menstrual cycle) before the initiation of treatment with Roaccutane and should be continued for one month (or a menstrual cycle) only after treatment is stopped. A pregnancy test in the blood should be done before treatment and done on a monthly basis with the other routine follow-up investigations while under treatment.
8-Who is the drug given to?
The drug is given to patients suffering from one of the following types of acne vulgaris:
• Cystic acne.
• Scarring acne.
• Resistant acne.
• Relapsing acne.
The doctor must be aware of the uses and the side-effects of the drug and the patient must be responsible for the correct usage of the drug. As for married women, they should be aware of the risks of becoming pregnant under treatment with the drug and must take full responsibility to protect themselves, their families, and foetus from exposure to these risks.
9-How is the drug used?
The drug is available in the form of capsules taken daily in different doses according to the body weight to reach a cumulative dose not less than 120 mg/kg body weight. If a patient for example is 60 kgs, then the cumulative dose should be 60*120=7200mg. This is taken in divided doses over the day according to the doctor's advice and the patient's tolerance to the possible side-effects. Doctors frequently start with a low dose that is increased gradually over several weeks to reach the desired dose. The cumulative dose is just a guide, and the doctor may increase or decrease the dose according to the patient's individual case.
10-How is the treatment started?
If the doctor decides to prescribe Roaccutane, he must first ask for blood, liver and lipid tests as well as a pregnancy test for married women. Such tests should be repeated whenever the doctor sees fitting.
11-Misconcepts about Roaccutane:
1-It can be taken without medical supervision:
False: Because of the above mentioned reasons, the drug should be taken only under strict medical supervision.
2-The drug is "too strong" and "too dangerous":
False: The term "too strong" is a relative term and the decision to use any drug is taken when the overall benefits of treatment outweigh the side-effects –in absence of any contraindications-. This drug is thus considered to be a safe and highly effective drug if the necessary precautions are followed.
3-The drug destroys the liver:
False: Elevated levels of liver enzymes do not always necessitate stoppage of the drug, and their level falls back to normal once it has been stopped.
4-Natural methods of contraception are enough when using this drug:
False: This is a very common but big mistake because for every type of contraception, there is an expected failure rate. The lowest failure rate (and so the highest rate for the success of contraception) is for both contraceptive pills or intrauterine devices where it is only 1-2%, so they are the only types of contraception with an acceptable level of safety especially if condoms are used at the same time. On the contrary, natural methods like withdrawal before ejaculation or the safe period have high failure rates and are thus unacceptable.
5-Roaccutane affects the future fertility of women:
False: This drug has no effect whatsoever on the fertility of men or women.
6-Roaccutane is stored in the body for years:
False: After one month, there is no trace of the drug in the body except for its original normal concentration.
7-It is dangerous to give the drug to patients before puberty:
False: The safety and efficacy of the drug in adolescents suffering from acne has been established and it is not fair to deprive adolescent patients from the benefits of treatment on such false grounds.
8-It is wrong to repeat the drug course:
False: The drug course can be repeated safely several times provided it is done under medical supervision.
9-All patients receiving treatment with Roaccutane will be fully cured from acne:
False: Almost all patients improve after the administration of Roaccutane, though only 70 to 90% are the ones who are permenantly cured. There is however, a minimal chance of recurrence inspite of improvement in the problem.
The above information edited with the cooperation of ADAMA Hospital |
