Accutane

Generic name: Isotretinoin (oral)

Usage of Accutane

Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Accutane is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Accutane is available only from a certified pharmacy under a special program called iPLEDGE.

Accutane side effects

Get emergency medical help if you have signs of an allergic reaction to Accutane (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Accutane and call your doctor at once if you have:

problems with your vision or hearing;

muscle or joint pain, bone pain, back pain;

increased thirst, increased urination;

hallucinations, (see or hearing things that are not real);

symptoms of depression - unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;

signs of liver or pancreas problems - loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);

severe stomach problems - severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or

increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common Accutane side effects may include:

dryness of your skin, lips, eyes, or nose (you may have nosebleeds);

vision problems;

headache, back pain, joint pain, muscle problems;

skin reactions; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Accutane

Accutane can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant or able to become pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be able to get pregnant. You must have 2 negative pregnancy tests before you start taking Accutane, before each prescription is refilled, right after you take your last dose, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking Accutane and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

tubal ligation (tubes tied);

vasectomy of the male sexual partner;

an IUD (intrauterine device);

estrogen-containing birth control pills (not mini-pills); and

hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

a male latex condom with or without spermicide;

a diaphragm plus a spermicide;

a cervical cap plus a spermicide; and

a vaginal sponge containing a spermicide.

Stop using Accutane and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

You should not use Accutane if you are allergic to isotretinoin.

To make sure Accutane is safe for you, tell your doctor if you have ever had:

depression or mental illness;

asthma;

liver disease;

diabetes;

heart disease or high cholesterol;

osteoporosis or low bone mineral density;

an eating disorder such as anorexia;

a food or drug allergy; or

an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

Do not breastfeed.

Not approved for use by anyone younger than 12 years old.

How to use Accutane

Usual Adult Dose for Acne:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day Maximum dose: Up to 2 mg/kg/day Duration of therapy: Up to 20 weeks.

Usual Pediatric Dose for Acne:

12 years or older: -Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day -Maximum dose: 2 mg/kg/day -Duration of therapy: Up to 20 weeks Comments: -Patients should take some formulations of this drug with food. -Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food). -Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing. -Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program. -The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended. Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Warnings

Accutane in just a single dose can cause severe birth defects or death of a baby. Never use this medicine if you are pregnant or able to become pregnant.

You must have a negative pregnancy test before taking Accutane. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine.

Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking Accutane. Stop using Accutane and call your doctor at once if you think you might be pregnant.

Accutane is available only under a special program called iPLEDGE. It is dangerous to try and purchase this medicine on the Internet or from vendors outside of the United States.

Do not take vitamin supplements containing vitamin A while you are taking Accutane. Do not donate blood while taking Accutane and for at least 30 days after you stop taking it.

What other drugs will affect Accutane

Tell your doctor about all your other medicines, especially:

phenytoin;

St. John's wort (may make birth control pills less effective);

vitamin or mineral supplements;

progestin-only birth control pills (mini-pills, may not work as well when taken with isotretinoin);

steroid medicine; or

a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may interact with isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Popular FAQ

No reports of permanent liver damage associated with Accutane (isotretinoin) could be found in the literature but temporary increases in liver test abnormalities are estimated to occur in up to 15% of people taking isotretinoin. Significant increases, such as those more than three times the upper limit of normal (ULN) or increases that require people to stop taking Accutane are exceedingly rare and occur in less than 1% of people taking Accutane. Continue reading

Absorica and Accutane both contain isotretinoin, a medicine used to treat very severe acne, but Absorica is more easily absorbed into your body and, unlike Accutane, does not have to be taken with food. Continue reading

Absorica starts to work within 4 weeks but may take up to 20 weeks (5 months) for the full effects to be seen. Within four weeks of taking Absorica, a more than 33% reduction in the overall number of acne lesions was reported. Over 70% of people with severe nodular acne achieved a 90% reduction in the number of their nodular acne lesions after 20 weeks with Absorica. A single course of Absorica for 20 weeks has been shown to result in complete and prolonged remission of acne in many patients. Continue reading

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