Acitretin Oral capsule
What is this medicine?
ACITRETIN (a si TRE tin) is used to treat severe forms of psoriasis.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
taking St. John's Wort
an unusual or allergic reaction to acitretin, etretinate, vitamin A, isotretinoin, tretinoin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, skip the missed dose and resume your normal schedule. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
alcohol, including alcohol that may be in drinks, food, or medicines including over-the-counter medicines
etretinate - tell your doctor if you have ever taken this medicine in the past
multivitamins or nutritional supplements that contain vitamin A
progestin-only birth control pills (mini pill)
st. john's wort
tetracycline type antibiotics like tetracycline, doxycycline or minocycline
vitamin A type medicines like isotretinoin, tretinoin
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your psoriasis may get worse when you first start taking this medicine. You may have to take it for 2 to 3 months before you see the full benefit.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females will need to have 2 negative pregnancy tests before starting this medicine and then monthly pregnancy tests during treatment, even if you are not sexually active. Use 2 reliable forms of birth control together for 1 month before, during, and for at least 3 years after stopping this medicine. Avoid using birth control pills that do not contain estrogen. They may not work while you are taking this medicine. If you become pregnant, miss a menstrual cycle, or stop using birth control, you must immediately stop taking this medicine. Severe birth defects may occur. Do not take this medicine before or during breast-feeding.
Before you receive your prescription review the Do Your P.A.R.T. booklet, which includes the Do Your P.A.R.T. Patient Brochure, The Contraceptive Counseling Referral Form for female patients, the Patient Agreement/Informed Consent Form for female patients, and the Medication Guide. If you did not talk to your doctor about this and sign the consent form, contact your health care provider.
Do not share this medicine with anyone else because of the risk of birth defects and other serious adverse effects.
Do not give blood during your treatment and for 3 years after you stop taking it. This medicine in your blood can harm an unborn baby if the blood is given to a pregnant woman. You can still receive blood transfusions while taking this medicine.
If you wear contact lenses, they may feel uncomfortable.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. If you are receiving light treatment (phototherapy), your doctor may need to change your light dosages to avoid burns.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
This medicine can increase cholesterol and triglyceride levels and decrease HDL (the 'good' cholesterol) levels. Your health care provider will monitor these levels and recommend appropriate therapy, including dietary changes or prescription drugs, if necessary.
This medicine may affect your blood sugar levels. If you are diabetic check with your doctor or health care professional if you notice any change in your blood sugar tests.
During therapy with this medicine and for 2 months after stopping treatment, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol. Avoiding alcohol is important because alcohol changes this medicine into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you take any form of alcohol while taking this medicine or for 2 months after stopping treatment.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
changes in vision
depression and/or aggressive feelings, thoughts of self-harm or suicide
frequent urination, increased thirst or hunger
joint, muscle or bone pain
severe or persistent nausea and vomiting and decreased appetite
swelling in a leg
yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
dry nose, mouth, and eyes
itching and peeling of your fingers, palms, or soles of the feet
ringing in the ears
scaly skin all over
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened. Throw away any unused medicine after the expiration date.
March 21, 2017
U.S. FDA-approved Package Insert