Accutane

Generic Name: isotretinoin (oral) (EYE so TRET i noyn)
Brand Names: Accutane, Amnesteem, Claravis, Sotret

Accutane (also known as Isotretinoin), or Roaccutane as is also known in parts of the world, was discovered in 1979 when it was first given to patients with severe acne, most of whom reacted with dramatic and permanent clearing of their acne symptoms.

It is a drug in the form of a vitamin A derivative (13-cis-retinoic acid). It is administered orally in pill form, normally for 15-20 weeks (3.5-4.5 months). It was originally prescribed for people with severe acne that did not respond to other treatments, but has gained in popularity in the past 25 years and is prescribed more and more frequently for less severe acne.

Accutane is a serious medication which must be taken under close doctor's supervision. Blood tests are required and side effects can be as devastating as they are widespread.

Exactly how Accutane works on a cellular level is unknown, but we do know that it affects the way that acne develops.

1. It dramatically reduces the size of the skin's oil glands (35%-58%) and even more dramatically reduces the amount of oil the skin produces (around 80%).
2. Acne bacteria (P. Acnes) lives in skin oil. Since oil is so dramatically reduced, so is the amount of acne bacteria in the skin.
3. It also slows down how fast the skin produces skin cells inside the pore which helps pores from becoming clogged in the first place.
4. It displays anti-inflammatory properties.

Although acne may get worse within the first month on a cycle of Accutane, the ultimate results are usually dramatic. Accutane works to achieve complete or partial clearance of acne in about 95% of people who complete a cycle, regardless of whether they have inflammatory or non-inflammatory acne.

The majority of people who take it see their acne effectively cured, experiencing long term remission of acne symptoms. Studies show an average relapse rate of 25%, and in these cases sometimes a second course is given. This relapse rate is dose dependent. Patients who receive a cumulative dose of 100-120mg/kg see the best results and lowest relapse rates. Patients who receive a lower dose relapse more frequently. Depending on how much the patient weighs, .5mg - 2mg/kg is usually prescribed per day.

Accutane need not be paired with other medications. For people who have problems handling Accutane, intermittent dosage is potentially an option and is being studied for effectiveness. Generic forms of Accutane may or may not be as therapeutic or safe. This is based on only one study which was performed in the UK in 2006. Out of the 14 generic brands studied, 13 failed to match Roaccutane (as it is called in the UK) in one or more tests and 11 failed in three or more tests. More studies like this one are needed to present better data on this subject.

Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms.

Accutane may also be used for other purposes not listed in this medication guide.

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

Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant.

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. Unless you have had a total hysterectomy or have been in menopause for at least a year, you are considered to be of child-bearing potential.

Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign agreements to use birth control and undergo pregnancy testing as required by the program. Read all program brochures and agreements carefully.

It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
What should I discuss with my healthcare provider before taking Accutane?

Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Read all of the iPLEDGE program brochures and agreements carefully. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.

It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are pregnant or may become pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking Accutane, tell your doctor if you are allergic to any foods or drugs, or if you have:

* a personal or family history of depression or mental illness;
* heart disease, high cholesterol or triglycerides;
* osteoporosis or other bone disorders;
* diabetes;
* asthma;
* an eating disorder (anorexia nervosa); or
* liver disease.

Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are 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 of child-bearing potential.

Even women who have had their tubes tied are required to use birth control while taking Accutane.

You must have a negative pregnancy test 30 days before you start taking Accutane. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Accutane, 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 you stop taking it. 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 plus spermicidal foam or gel;
* a diaphragm plus spermicidal foam or gel;
* a cervical cap plus spermicidal foam or gel; and
* a vaginal sponge containing spermicide.

Do not take St. John's wort, an herbal supplement, if you are using any type of hormonal birth control, including pills, patches, implants, injections, or a vaginal ring. Breakthrough bleeding may occur.

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 Accutane, call the iPLEDGE pregnancy registry at 1-866-495-0654.

It is not known whether isotretinoin passes into breast milk. Do not take Accutane without first talking to your doctor if you are breast-feeding a baby.

How should I take Accutane?

Take Accutane 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 Accutane 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 Accutane at one time.

Always take Accutane 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 Accutane 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 Accutane 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 Accutane?

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

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

Do not donate blood while taking Accutane 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 Accutane.

Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking Accutane 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). Accutane can make your skin more sensitive to sunlight and sunburn may result. Accutane 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.
Accutane side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Accutane and call your doctor at once if you have any of these serious side effects:

* depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
* sudden numbness or weakness, especially on one side of the body;
* blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
* hearing problems, hearing loss, or ringing in your ears;
* seizure (convulsions);
* severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
* loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
* severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
* fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; or
* joint stiffness, bone pain or fracture.

Less serious Accutane side effects may include:

* discomfort with contact lenses;
* joint pain, back pain;
* feeling dizzy, drowsy, or nervous;
* dryness of the lips, mouth, nose, or skin; or
* cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

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.

What other drugs will affect Accutane?

Before taking Accutane, tell your doctor if you are also taking:

* steroids (prednisone and others);
* seizure medication such phenytoin (Dilantin); or
* a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap).

This list is not complete and there may be other drugs that can interact with Accutane. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Accutane.

Acne scarring can be treated while on Accutane.

Destroyed collagen and damage to elastin fibers and to the microvascular system caused by acne can be regenerated so that normal functional tissue (skin) is not replaced by connective tissue (scarring).

Acne scarring can be prevented and healed while you are on Accutane, and Accutane's side effects can be relieved.

Acne produces multiple skin injuries (inflammatory infections) that place heavy demands upon the skin's components. Areas with recurrent acne infections caused by moderate or severe acne frequently develop deficiencies of essential ingredients, impairing the skin's ability to defend itself and heal efficiently.

Acne infections destroy collagen and elastin fibers, sever the microvascular system and damage and kill cells. When healing occurs, normally after a long time if acne injuries are not properly treated, a scar is left in the skin. The normal functional tissue (skin) is replaced by connective tissue (scar).

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