IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
COMMON BRAND NAME(S): Soriatane
WARNING: Because acitretin has caused serious birth defects, do not use this medicine if you are pregnant or plan to become pregnant within 3 years of stopping use of this drug. Use 2 effective methods of birth control starting one month before using this medication and until after a minimum of 3 years has passed from the date this drug was stopped. Do not use "minipills" for birth control (non-estrogen-containing pills), since they may not work as well with acitretin. Females who are able to have children must not use this medication unless all of the following requirements are met: have two negative pregnancy test, the last one, 1 week (and at least 11 days after last act of unprotected sexual intercourse) before starting this drug; will start therapy only on the 2nd or 3rd day of next normal menstrual period; have severe psoriasis and other treatments cannot be used; have received both oral and written information on using 2 methods of birth control while using acitretin and for 3 years after stopping this medication; the dangers of birth control failure; the dangers of using this medication while pregnant; are able to understand and correctly follow the above birth control requirements and instructions. Do not drink alcohol while using acitretin and for 2 months after stopping its use because alcohol causes acitretin to stay in the body longer. It is not known if the traces of acitretin found in semen pose a risk to a fetus while male patients are using this drug or after its use has been stopped. Acitretin use has been linked rarely to serious (possibly fatal) liver problems (hepatitis) and increased fluid pressure on the brain (pseudotumor cerebri). Notify your doctor immediately if you develop any of these symptoms: yellowing eyes or skin, dark urine, stomach pain, unusual fatigue, headache, nausea and vomiting, or vision changes. Your doctor will decide whether to continue using acitretin. Acitretin has also been linked to pancreatitis (inflammation of the pancreas). Notify your doctor immediately if you develop persistent, lower abdominal pain.
USES: This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.
HOW TO USE: Read and complete the Patient Agreement and Informed Consent document. Also be sure to get a Medication Guide from your pharmacist, and then read it carefully. If you have any questions regarding acitretin, consult your doctor or pharmacist before using this medication. Take this medication by mouth exactly as prescribed, usually once a day taken with the main meal. The dosage is based on your medical condition and response to therapy. 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 will be increased. 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. To help you remember, use it at the same time each day.
SIDE EFFECTS: You may experience more redness, itching, skin scaling, peeling and dry skin the first several weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, increased sensitivity to sunlight, dry mouth, peeling of the skin of fingertips, palms or soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects continue or become bothersome, inform your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: decreased night vision, other vision changes, fever, chills. Tell your doctor immediately if any of these unlikely but serious side effects occur: aches and pain in the bones or joints, difficulty moving. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe headache, nausea, vomiting, mood changes (e.g., depression, aggressive or violent behavior, and in rare cases thoughts of suicide), yellowing of the skin or eyes, dark urine, stomach pain. Because this medication causes dry eyes, persons who wear contact lenses may find them uncomfortable while taking this. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease, severe kidney disease. Before using this medication, tell your doctor or pharmacist if you have: kidney disease, liver disease, heart disease, diabetes, receive phototherapy, drug allergies (especially to other retinoids). Do not donate blood while you take acitretin and for at least three years after stopping therapy. This will prevent the possibility of your blood being given to a pregnant woman. This medication increases your sensitivity to the sun. Avoid sun exposure. Wear protective clothing and use a sunscreen when outdoors. Acitretin can affect your night vision. Be cautious when driving or operating machinery after dark. Avoid drinking alcohol while taking this medication and for two months after stopping the drug. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug should not be used in those who intend to become pregnant during treatment or within 3 years after stopping the drug. Use 2 effective forms of birth control together, starting one month before treatment, during and for 3 years after stopping the drug. If you are unsure which types of birth control are effective, consult your doctor, pharmacist, or your Medication Guide. Semen may pose a risk to a pregnant woman if the male is using this drug. Consult your doctor. It is not known if this drug is excreted into breast milk. Breast-feeding is not recommended while using this medication and for at least three years after the medication has been stopped.
DRUG INTERACTIONS: This drug should not be used with the following medication because very serious interactions may occur: tetracycline antibiotics, methotrexate, vitamin A, St John's wort. If you are currently using any of these medications, tell your doctor or pharmacist before starting acitretin Before using this medication, tell your doctor or pharmacist of any over-the-counter or prescription products you may use, especially of: "minipills" (progestin-only contraceptive pills). Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe headache, nausea, vomiting, drowsiness, irritability, loss of balance, and itching.
NOTES: Do not share this medication with others. Laboratory tests (e.g., monthly pregnancy tests, liver function tests, X-rays, and lipid tests) will be done frequently while taking this medication to monitor the effects and to prevent side effects. See your doctor regularly.
MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.
STORAGE: Store this medication at room temperature between 59 and 77 degrees F (15 to 25 degrees C) away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach of children and pets.
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Copyright 2004 by First DataBank, Inc.