Posted on April 28th, 2009 by
Generic Name: Isotretinoin (eye-soe-TRE-ti-noyn), 13-cis-retinoic acid
Trade Name: Accutane®
For which conditions is this drug approved? Isotretinoin is FDA approved for the treatment of acne that is unresponsive to standard therapies. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Isotretinoin is classified as a retinoid. Isotretinoin binds to a protein forming a complex which then binds to a retinoid-dependant receptor. Binding of the complex to DNA then occurs, resulting in changes involved with cell growth, replication, and differentiation. The precise mechanism has not been fully defined.
How is isotretinoin typically given (administered)? Isotretinoin is taken orally, in the form of a capsule and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with isotretinoin. Patients may have blood tests to monitor lipid levels, liver function, sugar (glucose), and CPK. Patients may also have their levels of blood cells monitored. Female patients may also take pregnancy tests every month while on isotretinoin, as this drug may cause severe birth defects.
What are the most common side effects of treatment with isotretinoin?
• Dryness of the skin, eyes, mouth, lips and nose
• Peeling of palms and soles
• Vision changes
• Cataracts, corneal opacities, eye irritation
• Hearing changes
• Skin abnormalities, rash, photosensitivity, itching, skin fragility
• Changes in menstrual cycles
• Emotional instability, depression
• Dizziness, drowsiness, headache, fatigue, weakness
• Back pain, joint pain, muscle pain
• Gastrointestinal disturbances, abdominal pain, diarrhea, nausea, vomiting, lack of appetite
• Changes in levels of blood cells
• Changes in lipid blood levels
• Increase in blood glucose
• Changes in liver function levels
• Abnormalities of cardiac (heart) rate or rhythm
• Increase or decrease in blood pressure
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
Are there any special precautions patients should be aware of before starting treatment?
• Female patients of childbearing age are advised to use two sources of contraception, or abstain from sexual intercourse, while being treated with isotretinoin, as well as one month prior to treatment and one month following the completion of treatment with isotretinoin, as isotretinoin is associated with severe birth defects.
• Male patients should always use a condom if engaging in sexual intercourse, or should abstain from sexual intercourse while being treated with isotretinoin and one month following the completion of treatment with isotretinoin, as isotretinoin is associated with severe birth defects.
• Caution should be taken while driving or operating heavy machinery, as isotretinoin may cause visual disturbances that occur suddenly.
• Patients may experience decreased tolerance to contact lenses.
• Patients should speak with their physician prior to taking vitamin A supplements or the antibiotic tetracycline while being treated with isotretinoin.
• If an oral dose is missed, do not double up on doses. Patients should contact their physician in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Severe depression, or thoughts of suicide, psychosis, emotional instability
• Changes in hearing
• Changes in vision
• Yellowing of skin or eyes
• Right upper quadrant pain in the abdomen
• Abdominal pain, rectal bleeding, diarrhea
• Chest pain or noticeable changes in heart rate or rhythm
• Severe headache
• Dizziness, drowsiness, nervousness, seizure, fatigue
• Signs of an allergic reaction – difficulty breathing, hives, closing of throat, changes in heart rate, bruising, red patches on skin
• Difficulty or pain when urinating
• Frequent urination
• Swelling, pain or redness of one extremity and not the other
• Sudden onset of severe headache, visual disturbances and/or difficulty speaking
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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