Acitretin is a retinoid, which is a form of vitamin A.

Acitretin is used to treat severe psoriasis in adults. Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication.

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

Acitretin can cause severe birth defects. Do not use acitretin if you are pregnant or if you might become pregnant within 3 years after you stop taking acitretin.

You must use effective birth control to avoid getting pregnant while taking acitretin and for at least 3 years after your last dose. You will need pregnancy tests at regular intervals to make sure you are not pregnant.

Women who are able to get pregnant must not drink alcohol while taking acitretin and for at least 2 months after the last dose. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body.

Men or women should not donate blood while taking acitretin and for at least 3 years after the last dose. If donated blood containing acitretin is given to a pregnant woman, it could cause birth defects.

Acitretin can cause serious liver problems. Stop taking this medicine and call your doctor right away if you have symptoms such as nausea, vomiting, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes).

Follow all directions on your prescription label. Do not take acitretin in larger or smaller amounts or for longer than recommended.

Take acitretin with food.

It may take 2 to 3 months before your symptoms improve, and your psoriasis may even get worse when you start taking acitretin. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

While using acitretin, you may need frequent blood tests. If you use this medicine long-term, you may need additional medical tests, including x-rays.

NEVER SHARE THIS MEDICINE WITH ANOTHER PERSON, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Psoriasis:

Initial dose: 25 to 50 mg orally once a day, administered as a single dose with main meal
Maintenance dose: 25 to 50 mg orally once a day, administered upon an individual patient's response to initial treatment

Comments: When used with phototherapy, the healthcare provider should decrease the phototherapy dose, dependent on the patient's individual response.

Use: Treatment of severe psoriasis in adults

You should not take this medicine if you are allergic to any retinoid (acitretin, isotretinoin, tretinoin, Accutane, Claravis, Myorisan, Refissa, Renova, Retin-A, and others), or if:

• you have severe liver disease or severe kidney disease;

• you have high levels of triglycerides (a type of fat) in your blood;

• you are pregnant or breast-feeding;

• you are also using methotrexate; or

• you also use a tetracycline antibiotic (such as demeclocycline, doxycycline, minocycline, tetracycline, and others).

Acitretin is available to women only under an agreement that you will use approved birth control methods and undergo required pregnancy testing while taking this medicine and for at least 3 years after your last dose.

For women taking acitretin who have not had a hysterectomy or have not gone completely through menopause: Before you start taking acitretin you must have 2 negative pregnancy tests (when your doctor first prescribes acitretin, and again during the first 5 days of your menstrual period just before you start taking this medicine). You will also need pregnancy tests every month while you are taking acitretin, and every 3 months for at least 3 years after your last dose.

Acitretin can cause severe birth defects. Do not use acitretin if you are pregnant or if you might become pregnant within 3 years after you stop taking this medicine. You must use 2 effective forms of birth control to avoid getting pregnant while taking acitretin and for at least 3 years after your last dose.

The first birth control method should include one of the following forms:

• birth control pills (but not the "mini-pill");

• an intrauterine device (IUD);

• birth control shots, inserts, skin patches, or implants;

• a tubal ligation; or

• your male partner's vasectomy.

The second birth control method should include one of the following forms:

• a diaphragm or cervical cap used with a spermicide;

• a latex condom used with or without a spermicide; or

• a vaginal sponge that contains a spermicide.

Start using both forms of birth control at least 1 month before you start taking acitretin. Continue using both forms while you are taking acitretin and for at least 3 years after your last dose. Use both forms of birth control together every time you have sex.

While taking acitretin and for at least 3 years after your last dose: Call your doctor right away if you think you might be pregnant, if you miss a period, or if you have sex without using both forms of birth control. You may also call the MedWatch program at 1-800-FDA-1088. Consider using emergency contraception ("morning-after pill") if you have sex without using both of the 2 recommended birth control methods.

If you are not menstruating, you should have a pregnancy test at least 11 days after you last had sex without using 2 effective forms of birth control.

Do not miss a scheduled pregnancy test or you may not be able to continue taking acitretin.

Acitretin can pass into breast milk and may cause serious side effects in the nursing baby. Do not breast-feed while using this medicine.

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

• phototherapy;

• kidney or liver disease;

• heart disease;

• high cholesterol or triglycerides (a type of fat in the blood);

• diabetes (you may need to check your blood sugar more often);

• a habit of drinking large amounts of alcohol;

• depression; or

• if you have ever used a medicine called etretinate (Tegison, Tigason).

Skip the missed dose and take the next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause headaches or severe dizziness.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Women who are able to get pregnant must not drink alcohol while taking acitretin and for at least 2 months after the last dose. Any alcohol swallowed during this time can cause acitretin to convert to another substance in your body that could take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Both men and women should not donate blood while taking acitretin and for at least 3 years after the last dose. If donated blood containing acitretin is given to a pregnant woman, it could cause birth defects.

Avoid taking more than the minimum recommended daily allowance of vitamin A. Acitretin is a form of vitamin A, and many multivitamin products or dietary supplements contain vitamin A. Taking certain products together can cause you to get too much vitamin A.

Avoid exposure to sunlight or tanning beds. Acitretin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Acitretin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Acitretin may cause serious side effects. Stop using acitretin and call your doctor at once if you have:

• mood changes--depression, aggression, unusual thoughts or behavior, thoughts of hurting yourself;

• heart attack or stroke symptoms--chest pain, dizziness, nausea, feeling short of breath, sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or balance, swelling or warmth in one or both legs;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision;

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

• liver problems--nausea, vomiting, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes);

• problems with your bones or muscles--loss of feeling in your hands or feet, trouble moving, pain in your back, joints, muscles, or bones;

• serious skin problems--itching, redness, pain, swelling or peeling of your skin; or

• signs of a blood vessel problem--sudden swelling, rapid weight gain, fever, muscle pain, feeling light-headed.

Common side effects of acitretin may include:

• chapped lips, dry mouth;

• itchy or scaly skin;

• weak nails, fragile skin;

• peeling skin on your hands and feet;

• hair loss;

• dry eyes, discomfort while wearing contact lenses;

• dry or runny nose, nosebleeds; or

• joint pain, tight muscles.

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.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• glyburide;

• phenytoin;

• St. John's wort; or

• hormone replacement therapy or birth control pills (especially "minipills").

This list is not complete. Other drugs may interact with acitretin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to acitretin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.