acitretin 17.5 mg capsule

Generic name:
Acitretin - oral

Pronunciation
(A-si-TRE-tin)

Brand name(s)
Soriatane

Do not use this medication if you are pregnant or planning to become pregnant within 3 years of stopping this drug because it has caused serious birth defects.

Use 2 effective birth control methods starting 1 month before taking this medication and at least 3 years after treatment has stopped. Do not use "minipills" (non-estrogen-containing pills) for birth control because they may not work as well with this drug. Consult your doctor for more details.

Females who are able to have children must not use this medication unless the following requirements are met: test negative on 2 pregnancy tests (they should be taken 1 week before starting this drug or at least 11 days after the last act of unprotected sexual intercourse); start therapy within 7 days of taking the second pregnancy test; present severe psoriasis and other treatments cannot be used; receive oral and written information on using 2 methods of birth control while taking this drug and for 3 years after stopping it; aware of the dangers of birth control failure and use during pregnancy; understand and correctly follow all birth control requirements and instructions including monthly pregnancy tests during treatment and every 3 months for 3 years after treatment has stopped.

Do not drink alcohol while using acitretin and for 2 months after stopping it because alcohol causes this drug to stay in the body longer.

It is not known if traces of this drug found in semen of male patients pose a risk to the unborn baby during use or after treatment has stopped.

Acitretin may rarely cause serious (possibly fatal) liver disease (hepatitis) and increased fluid pressure on the brain (pseudotumor cerebri). If you notice any of the following unlikely but serious side effects, get medical help right away: headache that is severe or doesn't go away, nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, unusual tiredness, or vision changes (such as blurred/double vision, decreased vision).

Acitretin has also been linked to pancreatitis (inflammation of the pancreas). Tell your doctor right away if you develop lower abdominal pain that doesn't go away.

Rarely, acitretin may cause serious mental/mood changes, even after stopping the medication. Get medical help right away if you have symptoms such as depression, irritability, aggressive or violent behavior, or thoughts of suicide.

This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.

Read the Medication Guide provided by your pharmacist before you start using acitretin and each time you get a refill. Also, read and complete the Patient Agreement and Informed Consent document before taking this drug. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once a day with your main meal.

The dosage is based on your medical condition and response to treatment. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of side effects may increase.

It may take 2 to 3 months before the full benefit of this medication is seen.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

See also Warning section.

You may experience more redness, itching, skin scaling, peeling and dry skin during the first few weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, dry mouth, skin peeling on the fingertips/palms/soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• decreased night vision
• fever
• chills
• dizziness
• bone/joint pain
• muscle pain/tenderness/weakness
• difficulty moving
• swelling
• sudden weight gain
• signs of kidney problems (such as change in the amount of urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease
• heart disease
• diabetes
• personal/family history of mental/mood problems (such as depression)

Do not donate blood while taking this drug and for at least 3 years after stopping therapy. This will prevent the possibility of your blood being given to a pregnant woman.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.

Acitretin may cause vision changes, including decreased night vision. Do not drive, use machinery, or do anything that needs clear vision (especially at night) until you are sure you can perform such activities safely.

Avoid drinking alcohol while taking this medication and for 2 months after stopping it.

This drug must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. This drug should not be used if you are planning to become pregnant during treatment or within 3 years after use has stopped.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Semen may pose a risk to a pregnant woman if a male is using this drug. Consult your doctor.

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for at least three years after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• methotrexate
• St. John's wort
• tetracycline antibiotics
• vitamin A

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include severe headache, nausea, vomiting, drowsiness, irritability, loss of balance, and itching.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, X-rays, cholesterol tests, pregnancy tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of your next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.