Acitretin (a-si-TRE-tin)

Treats severe psoriasis.

Brand Name(s):

Soriatane

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food, at your main meal of the day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also taking methotrexate or a tetracycline antibiotic, including doxycycline, minocycline, or tetracycline.
• Some medicines can affect how acitretin works. Tell your doctor if you are also taking any of the following:
  • Glyburide, phenytoin
  • Birth control pills, including progestin only "minipills"
  • Multivitamins or vitamin A supplements
  • Retinoid medicine, including isotretinoin
• Do not drink alcohol while you are using this medicine. Do not drink alcohol for at least 2 months after your last dose.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy because it can cause very serious birth defects. You must use 2 forms of birth control for 1 month before you start taking acitretin, for the entire time you are being treated, and for 3 years after you take your last dose. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have kidney disease, liver disease, bone or muscle problems, diabetes, eye or vision problems, heart disease, high cholesterol or triglyceride levels, or a history of depression. Tell your doctor if you are also receiving light therapy (phototherapy).
• This medicine may cause the following problems:
  • Liver problems
  • Bone or muscle problems
  • Pancreatitis (swelling of the pancreas)
  • Benign intracranial hypertension (increased pressure in the brain)
  • Capillary leak syndrome (blood vessel problem)
  • Depression or changes in mood or behavior
• Do not donate blood during the time you are being treated with this medicine and for at least 3 years after you take your last dose.
• This medicine may cause blurred vision or a decrease in night vision (night blindness). Do not drive or do anything else that could be dangerous if you are not able to see well.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your psoriasis may get worse for a short time before it starts to improve. It may take 8 weeks or longer before your skin starts to look and feel better.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Changes in vision (especially at night), eye pain or irritation, blurred vision
• Chest pain, trouble breathing, unusual sweating, faintness, severe headache
• Cloudy urine, lightheadedness, fever, swelling of your hands, ankles, feet, or lower legs
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Feeling depressed, thoughts of hurting yourself or others, unusual mood or behavior
• Increased hunger or thirst, increase in how much or how often you urinate
• Joint pain or stiffness

If you notice these less serious side effects, talk with your doctor:

• Dry eyes or mouth, chapped lips, stuffy or runny nose
• Hair loss
• Mild skin dryness, peeling, scaling, redness, or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088