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Drugs reference index «Accutane»



Generic name: IsotretinoinBrand names: Amnesteem, Accutane

Why is Accutane prescribed?

Accutane, a chemical cousin of vitamin A, is prescribed for the treatment of severe, disfiguring cystic acne that has not cleared up in response to milder medications such as antibiotics. It works on the oil glands within the skin, shrinking them and diminishing their output. You take Accutane by mouth every day for several months, then stop. The antiacne effect can last even after you have finished your course of medication.

Most important fact about Accutane

Because Accutane can cause severe birth defects, including mental retardation and malformations of the face, eyes, ears, skull, nervous system, cardiovascular system, and glands, a woman must not become pregnant while taking it. Before starting Accutane therapy, women of childbearing age will be asked to read a pamphlet, watch a video, and sign a detailed consent form regarding the danger of birth defects. You must have two negative pregnancy tests before beginning Accutane therapy, and must take monthly pregnancy tests while using Accutane.

In addition, you must use 2 forms of birth control during Accutane therapy, and for 1 month before and after. Each prescription for Accutane must bear a yellow qualification sticker signifying that you meet these requirements. Scientists have not ruled out the possibility that hormone-based contraceptives (birth control pills and implants) may be less reliable when taken with Accutane, so a second form of birth control should always be used while taking Accutane. If you accidentally become pregnant while taking Accutane, you should immediately consult your doctor.

How should you take Accutane?

Take Accutane two times a day with a meal, unless your doctor tells you otherwise. Swallow the capsule. Don't suck or chew it. Take it with a full glass of water, milk, or other nonalcoholic liquid. Follow your doctor's instructions carefully.

Depending on your reaction to Accutane, your doctor may need to adjust the dosage upward or downward. If you respond quickly and very well, your doctor may take you off Accutane even before the 15 or 20 weeks are up.

After you finish taking Accutane, there should be at least a 2-month "rest period" during which you are off the drug. This is because your acne may continue to get better even though you are no longer taking the medication. Once the 2 months are up, if your acne is still severe, your doctor may want to give you a second course of Accutane. If you are still growing, your doctor may recommend a longer "rest period."

Avoid consumption of alcoholic beverages.

Read the patient information leaflet available with the product.

Do not crush the capsules.

Do not share Accutane with anyone because of the risk of birth defects and other serious side effects.

  • If you miss a dose...Take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
  • Storage instructions...Store at room temperature, away from light.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Accutane.

  • Side effects may include:Back pain, blood disorders, decreased HDL (good) cholesterol, dizziness, dry skin and mucous membranes, hearing problems, high blood sugar, high cholesterol and triglyceride levels, joint pain, mental or mood disorders (such as depression or mood swings), pinkeye, rash, sensitivity to sunlight, vision problems

Why should Accutane not be prescribed?

If Accutane gives you an allergic reaction, you will not be able to use it.

If you are a woman of childbearing age, you should not take Accutane if you are pregnant, if you think there is a possibility you might get pregnant during the treatment, or if you are unable to keep coming back to the doctor for monthly checkups, including pregnancy testing.

Special warnings about Accutane

Stop taking Accutane and notify your doctor immediately at the first sign of a skin rash or any other allergic reaction. Although they are rare, serious and even fatal allergic reactions have been known to occur.

When you first start taking Accutane, it is possible that your acne will get worse before it starts to get better.

Accutane may cause depression or other mental problems such as: mood swings, aggression, sadness, hopelessness, loss of pleasure, fatigue, difficulty concentrating, change in sleep patterns, restlessness, and irritability. In rare cases, it has prompted thoughts of suicide. If you begin to feel depressed or become troubled by suicidal thoughts, contact your doctor immediately.

Before starting Accutane therapy, all patients must sign a consent form noting that they are aware of the possibility of mental side effects, the danger of birth defects, and the need for certain other precautions.

If you are a woman of childbearing age and you are considering taking Accutane, you will be given both spoken and written warnings (the iPLEDGE program) about the importance of avoiding pregnancy during the treatment. You will also be asked to sign a second consent form noting that:

  • You must not take Accutane if you are pregnant, may become pregnant during treatment, or are breastfeeding;
  • If you get pregnant while taking Accutane, your baby will be at high risk for birth defects;
  • If you take Accutane, you must use 2 effective forms of birth control from 1 month before the start of treatment through 1 month after the end of treatment;
  • You must have 2 negative pregnancy tests (one just before starting Accutane therapy), and must be tested every month during therapy;
  • You may participate in a program that includes an initial free pregnancy test and birth control counseling session;
  • If you become pregnant, you must immediately stop taking Accutane and see your doctor;
  • You have read and understood the Accutane patient brochure and asked your doctor any questions you had;
  • You have been invited to participate in a survey of women being treated with Accutane.

Some people taking Accutane, including some who simultaneously took tetracycline, have experienced headache, nausea, and visual disturbances caused by increased pressure within the skull. Avoid taking tetracycline while using Accutane. See a doctor immediately if you have these symptoms; if the doctor finds swelling of the optic nerve at the back of your eye, you must stop taking Accutane at once and see a neurologist for further care.

Be careful driving at night. Some people have experienced a sudden decrease in night vision.

Accutane affects the body's processing of fats and sugars. It should be used cautiously by people with diabetes, excess weight, high triglyceride or cholesterol levels, or a tendency to drink too much alcohol. If you have any of these conditions, your doctor will monitor you closely during Accutane therapy.

You may not be able to tolerate your contact lenses during and after your therapy with Accutane.

You should stop taking Accutane immediately if you have abdominal pain, bleeding from the rectum, or severe diarrhea. You may have an inflammatory disease of the bowel.

You should not donate blood during your therapy with Accutane and for a month after you stop taking it.

You may become more sensitive to light while taking Accutane. Try to stay out of the sun as much as possible.

You should not use wax hair removal treatments or skin resurfacing procedures (dermabrasion, laser treatments) while taking Accutane or for 6 months after completing therapy.

Some people taking Accutane develop vision or hearing problems. If you notice changes in your vision or hearing, stop taking Accutane and contact your doctor.

Possible food and drug interactions when taking Accutane

While taking Accutane, do not take vitamin supplements containing vitamin A. Accutane and vitamin A are chemically related; taking them together is like taking an overdose of vitamin A.

The herb St. John's wort may interact with hormonal contraceptives (taken as part of iPLEDGE). Pregnancies have been reported by those patients who have used St. John's wort in combination with Accutane.

Remember, too, that Accutane should not be combined with tetracycline antibiotics such as doxycycline hyclate and minocycline.

Special information if you are pregnant or breastfeeding

Accutane causes birth defects; do not use it while pregnant. Nursing mothers should not take Accutane because of the possibility of passing the drug on to the baby via breast milk.

Recommended dosage for Accutane

The recommended dosage range for Accutane is 0.5 to 1 milligram per 2.2 pounds of body weight, divided into 2 doses daily, for 15 to 20 weeks. For very severe cases, the doctor may increase the daily dose to as much as 2 milligrams per 2.2 pounds.

If after a period of 2 months or more off therapy, severe cystic acne persists, your doctor may prescribe a second course of therapy.


Any medication taken in excess can have serious consequences. If you suspect an overdose of Accutane, seek medical attention immediately.

  • Overdosage of Accutane, like overdosage of vitamin A, can cause:Abdominal pain, dizziness, dry or cracked lips, facial flushing, incoordination and clumsiness, headache, vomiting
  • Accutane Consumer Overview
  • Accutane Advanced Consumer (Micromedex) - Includes Dosage Information
  • Accutane Prescribing Information (FDA)
  • Accutane MedFacts Consumer Leaflet (Wolters Kluwer)
  • Amnesteem Prescribing Information (FDA)
  • Claravis Prescribing Information (FDA)
  • Sotret Prescribing Information (FDA)

See Also...

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