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Generic Name: acitretin with moisturizer (A-si-TRE-tin)
Brand Name: Soriatane CK
Soriatane CK causes severe birth defects. Do not take Soriatane CK if you are pregnant or if you may become pregnant during therapy or at any time within 3 years after you stop Soriatane CK. Women who are able to become pregnant should use Soriatane CK only if they are unable to use other medicines to treat psoriasis or if they have severe psoriasis that is not helped by other medicines.
The Do Your P.A.R.T. (Pregnancy Prevention Actively Required During and After Treatment) program provides information about the serious risks associated with Soriatane CK. It also provides information about preventing pregnancy during therapy and for at least 3 years after you stop Soriatane CK. Ask your doctor or pharmacist any questions that you may have about the information, the program, or Soriatane CK. Do not take Soriatane CK if there is anything you do not understand.
You must have at least 2 negative pregnancy tests before you start Soriatane CK. You must also have monthly pregnancy tests while you take Soriatane CK. You must also have a pregnancy test every 3 months for at least 3 years after you stop taking Soriatane CK. Contact your doctor immediately if you think you may be pregnant.
The risk of birth defects lasts for at least 3 years after you stop Soriatane CK. Do not become pregnant while you take Soriatane CK and for at least 3 years after you stop taking it. You must use 2 effective forms of birth control for at least 1 month before you start Soriatane CK, while you take it, and for at least 3 years after you stop treatment.
Do not drink alcohol or take medicines that contain alcohol while you take Soriatane CK and for 2 months after you stop treatment. The risk of birth defects may last longer after you stop treatment if you drink alcohol or take any product that contains alcohol.
Women must sign a Patient Agreement/Informed Consent for Female Patients form before they start to take Soriatane CK. This form contains information on the risk of birth defects, birth control failure, and the need to avoid alcohol. Contact your doctor before you take Soriatane CK if you have any questions or if you have not signed this form.
Small amounts of Soriatane CK are found in semen. It is not known if this poses any risk to the fetus. Discuss any questions that you may have with your doctor.
Patients must not donate blood during treatment and for at least 3 years after treatment is stopped.
Serious liver problems have occurred in some patients taking Soriatane CK. Contact your doctor right away if you develop dark urine, pale stools, severe or persistent stomach pain, or yellowing of the skin or eyes.
Soriatane CK comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soriatane CK refilled.
Soriatane CK is used for:
Treating severe psoriasis.
Soriatane CK is a kit that contains a vitamin A derivative (retinoid) and moisturizing foam. Exactly how the retinoid works is not known. The moisturizing foam relieves dry and chapped skin.
Do NOT use Soriatane CK if:
- you are allergic to any ingredient in Soriatane CK or to another retinoid (eg, tretinoin)
- you are pregnant, planning to become pregnant, or are breast-feeding
- you have severe liver or kidney problems
- you have persistent high blood lipid levels
- you are taking methotrexate, a tetracycline, or vitamin A
Contact your doctor or health care provider right away if any of these apply to you.
Before using Soriatane CK:
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have diabetes or high blood lipid levels, are very overweight, or have a family member with any of these problems
- if you have a history of liver or kidney problems, bone problems, pancreas problems (eg, pancreatitis), heart disease, or mental or mood problems (eg, depression, suicidal thoughts or actions)
- if you receive phototherapy or drink alcohol
- if you take St. John's wort; it may decrease the effectiveness of hormonal contraceptives (eg, birth control pills)
- if you take a progestin-only birth control pill (mini-pill); your doctor may need to prescribe a different form of hormonal birth control
Some MEDICINES MAY INTERACT with Soriatane CK. Tell your health care provider if you are taking any of the following medicines.
- Certain medicines for diabetes (eg, glyburide) because the risk of low blood sugar may be increased
- Methotrexate or tetracyclines (eg, doxycycline) because liver damage or increased pressure in the brain may occur
- Vitamin A because it may increase the risk of Soriatane CK's side effects
- Phenytoin because the risk of its side effects may be increased by Soriatane CK
- Certain hormonal contraceptives (eg, low-dose progestin-only birth control pill, mini-pill) because their effectiveness may be decreased by Soriatane CK
This may not be a complete list of all interactions that may occur. Ask your health care provider if Soriatane CK may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Soriatane CK:
Use Soriatane CK as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Soriatane CK comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soriatane CK refilled.
- Take the capsule(s) by mouth with a meal at about the same time each day, or as directed by your doctor.
- To use the foam, shake well before each use. Point the canister down and dispense a small amount onto the affected area as needed. Gently message the area until the foam disappears. Repeat as needed.
- Continue to use Soriatane CK even if your condition does not improve right away. Your condition may become worse for a short time before it improves. It may take 2 to 3 months before you see the full benefits of Soriatane CK.
- If you miss a dose of Soriatane CK, you may take it later the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Soriatane CK.
Important safety information:
- Soriatane CK may cause drowsiness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Soriatane CK with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Soriatane CK may cause decreased night vision. Use caution or avoid driving at night if you experience this effect.
- Do not drink alcohol while you are taking Soriatane CK without first checking with your doctor.
- Your condition may return after you stop treatment with Soriatane CK. Check with your doctor if this occurs. Do not use any leftover medicine to treat your skin condition.
- Soriatane CK is similar to vitamin A. Before you start any new medicine, check the label to see if it has vitamin A in it too. Do not take other medicines that contain vitamin A without checking with your doctor.
- Soriatane CK may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Soriatane CK. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Dental problems (eg, mouth sores, gum bleeding) may occur while you take Soriatane CK. Contact your doctor or dentist if these problems persist or become bothersome.
- If you wear contact lenses, you may notice increased irritation with them while you are taking Soriatane CK. If these effects continue, check with your doctor.
- The foam is for external use only. Do not get it into your eyes, nose, mouth, lips, or near your genital area. If you get the foam in one of these areas, rinse the area right away with water.
- The foam is flammable. Do not store or use near and open flame, or while you are smoking.
- Women who are able to become pregnant must use 2 effective forms of birth control for at least 1 month before they start Soriatane CK, while they take it, and for at least 3 years after they stop treatment.
- Diabetes patients - Soriatane CK may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including monthly pregnancy tests, liver function tests, x-rays, and lipid tests, may be performed while you use Soriatane CK. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Soriatane CK with caution in the ELDERLY; they may be more sensitive to its effects.
- Soriatane CK is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Soriatane CK if you are pregnant. If you think that you may be pregnant, contact your doctor right away. Women of childbearing age should either abstain from sexual intercourse or use 2 effective methods of birth control for at least 1 month before, while taking, and for 3 years after taking Soriatane CK. Do not breast-feed while you are using Soriatane CK and for at least 3 years after stopping treatment.
Possible side effects of Soriatane CK:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dry mouth, lips, or nose; dry or irritated eyes; hair loss; runny nose; thinning of the eyebrows or eyelashes; thinning, peeling, or scaling of the skin; weak nails.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or joint pain or stiffness; blurred vision or other vision changes; bone pain; calf or leg pain or swelling; chest pain; dark urine; eye pain; loss of appetite; mental or mood changes (eg, aggressiveness, depression); muscle pain, stiffness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; pale stools; red, blistered, swollen skin; severe dizziness; severe or persistent headache; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; signs of high blood sugar (eg, frequent hunger, thirst, or urination); slurred speech; suicidal thoughts or actions; vaginal itching, odor, or discharge; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or persistent headache or dizziness.Proper storage of Soriatane CK:
Store Soriatane CK at room temperature, between 59 and 77 degrees F (15 and 25 degrees C) in a tightly closed container. Avoid temperatures above 120 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Soriatane CK out of the reach of children and away from pets.
- If you have any questions about Soriatane CK, please talk with your doctor, pharmacist, or other health care provider.
- Soriatane CK is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Soriatane CK. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.