About Isotretinoin
April 6th, 2008
I thought I would post the patient information leaflet for the particular generic brand of Isotretinoin I am taking. It is made by Beacon Pharmaceuticals.
Also I have posted some further information relating to how the drug works and also some tips that may help while you are taking this drug, these were not written by me but found here http://www.chemocare.com/BIO/accutane.asp
Self-care tips:
• Take this medication at about the same time every day along with a meal that includes some fats.
• Avoid grapefruit juice
• Avoid wearing contact lenses if you have dry or irritated eyes
• Drink at least two to three litres of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.
• When you start taking this drug, you may experience headache, loss of night vision, sleepiness or eyesight changes. Use caution when driving or engaging in tasks requiring alertness until response to drug is known.
• Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
How accutane works:
The inflammation in acne is caused in part by an increased secretion of sebum (oily substance) from glands in the skin (sebaceous glands). The sebum provokes inflammation, and the inflammation resolves (heals) with the formation of a scar (keratinization). Exactly how Accutane works is not known in precise detail; however, it appears that Accutane treats acne by reducing the secretion of sebum. If less sebum is secreted it is likely that there will be less inflammation and keratinization.
Retinoids are drugs that are relatives of vitamin A. Retinoids control normal cell growth, cell differentiation (the normal process of making cells different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors).
There are two major classes of retinoid nuclear receptors: retinoic acid receptors (RAR) and retinoid-X-receptors (RXR). There are also subtypes within each class. Each of these types of receptors has different functions in different tissues. The different retinoid drugs work by binding to different receptors; which, in turn, affect cell growth and differentiation.
Patient Information Leaflet
THE NAME OF THIS MEDICINE IS ISOTRETINOIN CAPSULES.
Each capsule contains either 5 or 20mg of the active substance Isotretinoin.
WHAT TYPE OF MEDICINE IS ISOTRETINOIN CAPSULES?
Isotretinoin belongs to a group of medicines known as retinoids that are normally used to treat skin problems.
WHAT ARE ISOTRETINOIN CAPSULES USED FOR?
This medicine is used to treat severe acne, for patients whose acne has not responded to other treatments. The use of Isotretinoin Capsules must be supervised by a dermatologist (a doctor who specialises in the treatment of skin problems).
Isotretinoin Capsules should not be used to treat acne occurring before the onset of puberty.
In some patients taking Isotretinoin, levels of fat-like substances in the blood may increase. Because of this, it is best that you stop, or reduce the amount of alcoholic drinks you usually drink while you are on treatment. If your doctor finds that you have got high levels of triglycerides while taking this medicine, you may need to reduce the Isotretinoin dosage and go on a low-fat diet.
Do not take more than the recommended daily dietary allowance of vitamin A, (i.e. 4000 to 5000 International Units). If you take vitamins, check the label to see how much vitamin A they contain. If you are not sure, ask your doctor or pharmacist.
If you get severe diarrhoea, stop taking Isotretinoin Capsules straight away and contact your doctor.
Your night vision may be affected by this medicine and you may develop dry eyes or sight problems, but these rarely persist after treatment. If this happens, tell your doctor immediately, so he can monitor your vision. These changes can happen quite suddenly, so always be cautious when driving or operating machinery at night.
You may become more sensitive to sunlight while taking this medicine. Avoid too much sun and do not use a sunlamp or sunbed. Before going out in the sun apply a sun block to exposed skin, particularly in strong sunlight.
Isotretinoin may make your skin more fragile, so vigorous abrasion of the skin and wax epilation during and for at least 6 months after treatment should be avoided as they could cause scarring or irritation of the skin. You should not use any other acne treatments unless told to do so by your doctor.
Are you a blood donor?
Do not donate blood during therapy or for at least one month after treatment with isotretinoin.
IMPORTANT INSTRUCTIONS FOR FEMALE PATIENTS.
Isotretinoin will damage an unborn baby so:
• You must not take Isotretinoin Capsules if you are pregnant or think you may be pregnant.
• You must not take Isotretinoin Capsules if you are breast-feeding.
• You must use an effective method of birth control for one month before Isotretinoin treatment, during treatment and for one month after treatment ends.
• Your doctor will ask you to take a pregnancy test before, during and after your treatment. These must be negative. You should start taking Isotretinoin Capsules on the second or third day of your menstrual cycle.
• You must not become pregnant at any time during treatment or for one month after treatment ends.
• Contact your dermatologist immediately if you do become pregnant or think you may be pregnant during treatment or in the first month after treatment ends.
WHEN WILL MY ACNE CLEAR UP?
For a few patients, the acne may get worse during the first 7 - 10 days of treatment. Your acne should improve with continued treatment. A course of treatment generally lasts for 12 to 16 weeks after which you are likely to remain free of acne for a long time. Repeated courses of therapy are not normally needed, but if your acne does re-occur significantly, your dermatologist may decide on a further course of treatment. However, only if a definite relapse is seen in the post-treatment period should a repeated course be considered.
If your acne has not completely cleared after finishing treatment you can expect it to continue to improve over the next few months. Do not carry on taking this medicine unless your dermatologist tells you to.
DOES THIS MEDICINE CAUSE UNDESIRABLE EFFECTS?
As with all medicines Isotretinoin Capsules may cause some undesirable effects in some patients. These effects often wear off as your treatment continues and your doctor can help you to deal with them.
The most common of these are dryness of the skin, especially of the lips and face and you may get inflamed or chapped lips, a rash, some mild itching and slight peeling. Dryness of the throat may cause hoarseness.
The skin may become more fragile and redder than usual. This dryness can be relieved by the regular use of a good moisturising cream from the start of treatment. Petroleum jelly is particularly good. The inside of the nose may become dry and “crusted”, which may lead to mild nosebleeds. Applying a thin layer of petroleum jelly gently to the inside of the nose will help.
Your eyes may feel dry and slightly irritated. This may especially be a problem if you wear contact lenses. Ask your pharmacist to suggest some suitable eye drops to help.
Some people have muscle aches and pains and occasionally soreness of the tendons when they are on this medicine. This may be more likely to occur if you take vigorous exercise. Also, you may experience some arthritic pain.
You may notice some changes to your hair (either a loss or, rarely, an increase) after taking this medicine for a while. This is usually only temporary and persistent hair thinning is rare. Your hair should return to normal after the treatment ends.
Some people have experienced mood changes (depression or symptoms of mental disorders) and in rare cases suicide and attempts of suicide whilst taking Isotretinoin.
Other less common undesirable effects include headaches, feeling sick, tiredness, sweating, menstrual changes, slight loss of hearing, changes in vision (including colour vision disturbances), jaundice, liver disease, anaemia, seizures, inflammatory bowel disease, inflammation of the pancreas, systemic infections, local bacterial infections such as infection of the tissue around the base of the nail, changes in the nails, increased facial pigmentation, swellings discharging pus, swollen glands, inflammation of blood vessels (sometimes with bruising and red patches), blood in the urine, diabetes, changes in blood glucose levels especially in diabetics and asthma especially in people who have previously suffered from asthma or have allergies to certain substances. Most of the unwanted effects of Isotretinoin will disappear when you stop treatment.
More rarely, the levels of a substance in your blood known as uric acid may increase. If you suffer from gout, this could trigger an attack. Very high levels of uric acid may affect your kidney function.
In a few people, the cells involved with the clotting of your blood may be affected, which means that you may bruise or bleed more easily. Leukocytes, which are cells in your blood involved in fighting infections, may also decrease in number. This makes you more at risk of developing an infection.
If your sight is affected by this medicine tell your doctor straight away and do not drive or operate machinery.
Use of high doses of Isotretinoin for periods in excess of the normal course of treatment may cause bone changes, but these are very unlikely during a normal course of treatment.
If you are concerned about these or any other unwanted effects talk to your doctor.