ACITRETIN

(A si TRE tin) Brand: Soriatane

What is the most significant information I must know about acitretin?

• Acitretin can harm an unborn child or reason birth defects. Do not use acitretin if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. Till and during treatment, and for 3 years after treatment, you should have negative pregnancy trials at regular intervals to create certain you are not pregnant.

• Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could reason birth defects if the blood contains acitretin.

• Women taking acitretin should not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can reason acitretin to convert to other stuff in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to create certain they do not contain alcohol.

• Acitretin is accessible only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking acitretin and for 2 months after you stop taking it.

What is acitretin?

• 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 medicine guide.

What must I discuss with my healthcare provider till taking acitretin?

• You must not take this medicine if you are allergic to acitretin or similar medications (such as Accutane, Altinac, Avita, Renova, Retin-A, and others), or if you have:

· severe liver or kidney disease;

· tall levels of triglycerides (a type of fat) in your blood;

· if you are pregnant or breast-feeding;

· if you are also using methotrexate (Rheumatrex, Trexall); or

· if you are also using a tetracycline antibiotic, including demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), tetracycline (Brodspec, Panmycin, Sumycin, Tetracap), and others.

• To create certain you can safely take acitretin, speak your doctor if you have any of these another conditions:

· kidney or liver disease;

· heart disease;

· tall cholesterol;

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

· depression;

· if you receive phototherapy;

· if you drink big amounts of alcohol; or

· if you have ever taken etretinate (Tegison or Tigason).

• Acitretin can reason birth defects. Do not use if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. You should use 2 effective forms of birth control starting at least 1 month till treatment with acitretin, and for at least 3 years after you stop taking this medicine. Use both forms of birth control together each time you have sex.

• The first birth control method must include one of the next 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 must include one of the next forms: a latex condom, or a diaphragm or cervical cap used together with a spermicide cream or gel.

• For women taking acitretin: Till using acitretin, you should have 2 negative pregnancy trials. The first test is given when your doctor prescribes acitretin. The second test should be given during the first 5 days of your menstrual period just till you start taking acitretin. No testing is needed if you have had a hysterectomy or have gone completely through menopause.

• You will need monthly pregnancy trials while you are taking acitretin. If you are not menstruating, your pregnancy test must be done at least 11 days after you recent 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.

• You will also need pregnancy trials each 3 months for at least 3 years after you stop taking this medication.

• Call your doctor right away if you think you might be pregnant, if you miss a period, or if you have had sex without using the 2 recommended forms of birth control within 3 years of taking acitretin.

• Acitretin can pass into breast milk and harm a nursing child. Do not take acitretin if you are breast-feeding a baby.

How must I take acitretin?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results.

• Take acitretin with food.

• Your psoriasis may seem to get worse at the start of therapy. For excellent results, hold using the medicine as directed. Conversation with your doctor if your symptoms do not improve after one rate of acitretin treatment.

• To be certain this medicine is not causing deleterious effects, your blood may need to be tested often. Your liver function and cholesterol may also need to be tested. Visit your doctor regularly.

• Never share this medication with other person, even if they have the same symptoms you have.

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

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include headache, dizziness or spinning sensation, and nausea or vomiting.

What must I avoid while taking acitretin?

• Avoid taking vitamin supplements that contain vitamin A. Acitretin is a form of vitamin A, and taking too many can reason side effects similar to overdose symptoms.

• Avoid exposure to sunlight or tanning beds. Acitretin can create 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.

What are the possible side effects of acitretin?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Stop using acitretin and call your doctor at once if you have a serious side effect such as:

· blurred vision, headache or pain behind your eyes, sometimes with nausea and vomiting;

· sudden decrease in night vision;

· depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;

· jaundice (yellowing of the skin or eyes);

· loss of feeling in your hands or foots, trouble moving, pain in your back, joints, muscles, or bones;

· mouth sores, swollen or bleeding gums;

· tall blood sugar (increased thirst, heighten urination, famine, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

· chest pain or hard feeling, spreading to the hand or shoulder, sweating, shortness of breath;

· sudden severe headache, confusion, problems with speech or balance, numbness or weakness (especially on one side of the body);

· sudden cough, wheezing, rapid breathing, quick heart course; or

· pain, swelling, warmth, or redness in one or both legs.

• Smaller serious side effects may include:

· dry eyes, chapped or peeling skin, hair loss;

· itching, scaling, or sticky feeling on your skin;

· weak nails, fragile skin;

· dry mouth, dry or runny nose, nosebleeds;

· mild headache, muscle tightness;

· nausea, stomach pain, diarrhea;

· flushing (warmth, redness, or tingly feeling);

· sleep problems (insomnia); or

· ringing in your ears.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect acitretin?

• Speak your doctor about all another medicines you use, especially:

· hormone replacement therapy or birth control pills (especially "minipills");

· phenytoin (Dilantin); or

· St. John's wort.

• This list is not complete and another drugs may interact with acitretin. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about acitretin.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

(25)