The American Academy of Pediatrics makes the following recommendations for Accutane:

  • Isotretinoin should be prescribed only for patients with severe cystic acne who are unresponsive to standard therapies.
  • Etretinate should not be prescribed for women of childbearing potential.
  • Isotretinoin and etretinate should be prescribed only by those physicians with experience in treating severe acne.
  • Consideration of other alternatives in patients with a history of depression. Depression, psychosis, and suicidal thoughts and actions have been reported in patients using Accutane. Some patients who reported depression also reported that the depression subsided when they stopped taking the Accutane and came back when they resumed taking the Accutane.

Isotretinoin should not be given to women of childbearing potential unless the following conditions are met:

  1. the patient visits a health professional for contraceptive counseling, with which the patient must be able to comply, before beginning the drug;
  2. results of serum pregnancy test are negative within 2 weeks of beginning the drug and every month during treatment;
  3. the drug is started on the third day of a normal menstrual period; and
  4. the patient has received oral and written warning of the reproductive hazards of isotretinoin and etretinate during pregnancy and has acknowledged in writing her understanding of those warnings. It must be emphasized that one third of the affected infants were born to mothers using contraception. The manufacturer recommends that two contraceptive measures be used simultaneously.

What To Expect:

It may take a month or two before the full benefits of this medication are observed. Acne may worsen during the first few days of therapy.

How To Take This Medication:

  • Read the information leaflet available with the medication.
  • Complete a patient consent form.
  • Take with meals.
  • Swallow capsules whole (do not crush or chew them).

Side Effects:

  • May cause dry lips and mouth, inflammation of the eyelids or lips, crusty skin, nosebleeds, indigestion, headache, or thinning of hair.These effects should subside as your body adjusts to the medication. If they persist or become bothersome, inform your doctor.Notify your doctor immediately for any changes in vision, hives, rash, stomach pain, rectal bleeding, severe diarrhea, tingling skin sensation, sun sensitivity or mood changes (depression).In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include rash, itching, swelling, dizziness or trouble breathing.If you notice other side effects not listed above, inform your doctor.


  • Before using this drug, tell your doctor your medical history, including diabetes, family history of high blood fats (triglycerides), depression or any drug allergies.
  • Do not donate blood while you take isotretinoin and for at least one month after you stop taking it.
  • Avoid exposure to the sun and sunlamps. Use a sunscreen and wear protective clothing when you are exposed to direct sunlight.
  • Isotretinoin can affect your night vision. Be cautious when driving or operating any machinery after dark.
  • If you wear contact lenses, you may not tolerate them as well as usual while using this medication.
  • Avoid the use of alcohol while taking this medication.
  • This drug should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug should not be used by those who may become pregnant during treatment. Consult your doctor.
  • It is not known if this drug is excreted into breast milk. Breast-feeding is not recommended while using this medication.
  • Use two reliable forms of birth control together, starting one month before treatment, during and at least one month after stopping the drug.
  • Semen may pose a risk to a pregnant woman if the male is using this drug. Consult your doctor.

Drug Interactions:

Tell your doctor of all prescription and nonprescription drugs you may use, especially of vitamin A-type drugs (including etretinate and vitamin A itself), minocycline and tetracycline.

Do not start or stop any medicine without doctor approval.

Missed Dose:

If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule.

Do not "double-up" the dose to catch up.


Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight.

Do not store in the bathroom.

Notes: Do not allow anyone else to take this medication.


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