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Retinoid / acne · PFB-03

Isotretinoin (Accutane): iPLEDGE Rules and Course Length

Isotretinoin, once sold as Accutane, stays behind iPLEDGE: two negative pregnancy tests before the first fill, then a monthly test and counseling before each refill. A usual course is 15 to 20 weeks at 0.5 to 1 mg/kg/day, set by current weight, not a fixed 20 mg for everyone. Take the capsule with a meal that has some fat. Do not use it in pregnancy.

  • Retinoid capsule
  • 0.5-1 mg/kg/day
  • iPLEDGE required in the U.S.
  • Not during pregnancy
Pregnancy test, two contraceptive packs, and one brown 20 mg capsule on a tray

What isotretinoin treats

Isotretinoin is approved for severe acne that has not responded to other treatments.

The drug comes in capsule form and is taken once per day for approximately four months. It's usually given only after other treatments have failed because isotretinoin has many side effects, including serious birth defects and mental health issues. It should never be used during pregnancy.

Isotretinoin dosage by weight

The daily dose is set by body weight, using the formula: 0.5-1 mg/kg/day.

The usual duration of treatment is 15 to 20 weeks or longer if necessary.

The total dose may be divided into two doses, one taken in the morning and the other at night.

Taking isotretinoin with food

Isotretinoin capsules should be taken with a meal that contains some fat, such as a burger or pizza. This may help your body absorb the medicine better.

Swallow capsules whole. Do not chew, suck or bite into capsules.

IPLEDGE: pregnancy tests and prescription rules

The iPLEDGE program ties every fill to a patient's pregnancy prevention method (PPM) and monthly counseling to make sure they understand their PPM and that it is still working for them.

Females who are able to get pregnant must have two negative pregnancy tests before starting isotretinoin capsules. You will need to take monthly pregnancy tests.

Isotretinoin side effects

The most common side effect of isotretinoin is dry skin. Dryness can occur in the eyes and mouth as well as on the face and body.

Dry, cracked lips are the most common side effect of isotretinoin and is also referred to as cheilitis.

Isotretinoin, mood and depression

The drug is highly effective, but it has serious side effects and can cause birth defects if taken by pregnant women.

Accutane has been linked to depression and suicidal thoughts in some patients.

Isotretinoin interactions, alcohol and blood donation

No. The label warns against combining isotretinoin with tetracyclines like doxycycline as it is associated with an increase in intracranial hypertension.

Wait at least one month after the last dose of oral isotretinoin before donating blood.

Sources

  1. DailyMed: isotretinoin capsule
  2. FDA: iPLEDGE risk evaluation and mitigation strategy
  3. FDA BeSafeRx: Considering an online pharmacy?
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