Drug Notebook

FDA Alerts

Special Alerts:

[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Isotretinoin, http://www.fda.gov/medwatch/safety/2006/accutane_ipledge.pdf, http://www.fda.gov/cder/drug/infopage/accutane/default.htm and http://www.fda.gov/cder/drug/infopage/accutane/FAQ200610.pdf.

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How should I take isotretinoin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Each prescription of isotretinoin must be filled within 7 days of the date it was prescribed by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take isotretinoin with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible. Take isotretinoin with food or milk. Take this medication for the entire length of time prescribed by your doctor. Your acne may seem to get worse at first, but should then begin to improve.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Never share this medicine with another person, even if they have the same symptoms you have. Store isotretinoin at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.

What should I avoid while taking isotretinoin?

Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.

Isotretinoin can weaken bones. Avoid sports or activities that may result in injury or bone fracture.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking isotretinoin and for at least 6 months after you stop taking it. Scarring may result.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Isotretinoin can make your skin more sensitive to sunlight and sunburn may result. Isotretinoin can cause side effects that may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.
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