Accutane

Generic name: Isotretinoin

What is Accutane?

Accutane is a medication taken by mouth to clear up the most severe form of acne, nodular acne. Accutane should only be used if other forms of treatment have not worked, including antibiotics. Accutane can only be prescribed by doctors that are registered in the iPLEDGE program, dispensed by a pharmacy that is registered with the iPLEDGE program, and given to patients who are registered in the iPLEDGE program, who understand and agree to do everything required in the program.

What is the most important information I should know about Accutane?

Accutane may cause birth defects, miscarriage, death of a baby, and early births; therefore, it can only be used by patients enrolled in the iPLEDGE program. Females should not become pregnant if they or their partners are taking Accutane. Pregnancy should be avoided 1 month before taking this drug, while taking it, and 1 month after therapy has ended.

If you get pregnant while taking Accutane, stop taking it immediately and call your doctor right away. Doctors and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088, and the iPLEDGE pregnancy registry at 1-866-495-0654.

This drug may also cause serious mental health problems such as depression, psychosis, and suicidal thoughts. If you or a family member notices signs and symptoms of depression or psychosis, stop Accutane and call your doctor right away. You may also need follow-up mental healthcare if you had any symptoms of depression or psychosis after stopping Accutane.

Who should not take Accutane?

Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during therapy. Also, talk to your doctor about the ingredients of this drug to make sure you are not allergic to anything in it.

What should I tell my doctor before I take the first dose of Accutane?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Accutane. Also, talk to your doctor about your complete medical history, especially if you have asthma, bone loss/weak bones (osteoporosis), diabetes, an eating disorder (anorexia), heart problems, liver disease, mental problems, and allergies to foods or medications.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

The usual dosage of Accutane is between 0.5 to 1 milligram (mg) per kilogram (kg) per day, taken twice a day, depending on what your doctor prescribes.

How should I take Accutane?

Accutane should be taken 2 times a day with a meal, unless told otherwise by your doctor. Swallow Accutane capsules whole with a full glass of water; do not chew or suck on the capsules.

What should I avoid while taking Accutane?

While being treated with Accutane, do not breastfeed, drive at night, get pregnant, give blood, have waxing, dermabrasion, or laser procedures performed on your face, stay in sunlight and under ultraviolet light (tanning beds), take other medicines or herbal products, or share Accutane with other people.

What are possible food and drug interactions associated with Accutane?

Consult with your doctor before taking antibiotics, corticosteroids, Dilantin (phenytoin), progestin-only birth control pills (mini pills), St. John's wort, and vitamin A supplements.

What are the possible side effects of Accutane?

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

Side effects may include: back pain, birth defects in babies, blood sugar changes, blurred vision, broken bones, chapped lips, dark urine, diarrhea, dizziness, decreased red and while blood cells, dry eyes, dry nose leading to nosebleeds, dry skin, headache, heartburn, hearing problems, joint pain, painful swallowing, lipid (fats and cholesterol in blood) problems, muscle weakness/damage, nausea/vomiting, rectal bleeding, seizures, serious mental health problems, severe stomach/chest/bowel pain, stroke, yellowing of skin/eyes, vision problems, serious allergic reactions

Can I receive Accutane if I am pregnant or breastfeeding?

Do not take Accutane if you are pregnant. Do not become pregnant if you are receiving treatment with Accutane. This drug causes severe developmental problems during pregnancy, and may result in loss of the child. Also, do not nurse while on Accutane, as the drug may pass into breast milk.

What should I do if I miss a dose of Accutane?

If you miss a dose of Accutane, skip it and continue on your regular schedule. Do not take 2 doses at the same time.

How should I store Accutane?

Store at room temperature, away from light.