Soriatane

Generic name: Acitretin
Drug class: Antipsoriatics

Usage of Soriatane

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

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

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

Soriatane side effects

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

Soriatane may cause serious side effects. Stop using Soriatane 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 Soriatane 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.

Before taking Soriatane

You should not take this medicine if you are allergic to any retinoid (Soriatane, 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).

Soriatane 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 Soriatane who have not had a hysterectomy or have not gone completely through menopause: Before you start taking this medicine you must have 2 negative pregnancy tests (when your doctor first prescribes this medicine, 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 this medicine, and every 3 months for at least 3 years after your last dose.

Soriatane can cause severe birth defects. Do not use this medicine 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 this medicine 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 Soriatane. Continue using both forms while you are taking this medicine and for at least 3 years after your last dose. Use both forms of birth control together every time you have sex.

While taking Soriatane 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 Soriatane.

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 Soriatane 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).

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How to use Soriatane

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

Take Soriatane with food.

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

While using Soriatane, 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.

Warnings

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

You must use effective birth control to avoid getting pregnant while taking Soriatane 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 Soriatane and for at least 2 months after the last dose. Alcohol can cause this medicine 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 Soriatane and for at least 3 years after the last dose. If donated blood containing this medicine is given to a pregnant woman, it could cause birth defects.

Soriatane 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).

What other drugs will affect Soriatane

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.

Disclaimer

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