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Drug monograph for the active ingredient in Soriatane

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

ACITRETIN (Systemic)

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Some commonly used brand names are:

In the U.S.—

• Soriatane

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Some commonly used brand names are:

In Canada—

• Soriatane

Other commonly used names are 13-cis acitretin , etretin , and isoetretin .

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Category

• Antipsoriatic (systemic)
• keratinization stabilizer (systemic)

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Description

Acitretin (a-si-TRE-tin) is used to help relieve and control severe skin disorders, such as severe psoriasis. It works by allowing normal growth and development of the skin. Acitretin may continue to work after you stop taking it, but usually after a time, the skin condition returns and you may need to begin taking it again.

Acitretin must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and failed. Acitretin must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for acitretin .

You must take important precautions while taking acitretin and continue with them for a period of time after you stop taking the medicine . The precautions are:

• Women should not become pregnant and should use two methods of very effective birth control. The birth control methods should begin 1 month before starting the medicine and continue for at least 2 or 3 years after discontinuing the medicine or as directed by your doctor.
• Men and women should not donate blood for transfusion purposes during treatment and for 2 or 3 years after discontinuing the medicine or as directed by your doctor.
• Men and women should not drink alcohol during treatment and for 2 months after discontinuing the medicine.

If you do not think these precautions are reasonable, you should discuss this with your doctor before starting to take this medicine.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Capsules (U.S. and Canada)

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Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For acitretin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual reaction to acitretin, etretinate, isotretinoin, tretinoin, or vitamin A-like preparations, including vitamin A supplements. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Acitretin must not be taken during pregnancy. It has been shown to cause serious birth defects and other problems in humans .

Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Beginning at least 1 month before you start to take acitretin, you should plan on using two effective forms of birth control to prevent pregnancy . In addition, since it is not known how long pregnancy should be avoided after treatment stops, you should plan not to become pregnant for at least 2 or 3 years after you stop taking acitretin or as directed by your doctor. If you become pregnant, stop taking the medicine and tell your doctor .

Breast-feeding—It is not known whether acitretin passes into the breast milk. However, use of acitretin should not be used during breast-feeding because it may cause unwanted effects in nursing babies. You also should plan not to breast-feed for at least 2 or 3 years after you stop taking acitretin.

Children—This medicine has been tested in some children and has been shown not to cause different side effects or problems in children than it does in adults. However, children may be more sensitive to some of the medicine's effect on bones, which may prevent normal bone growth during puberty. This can cause them to grow up to be shorter adults than expected. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, some older patients may have higher levels of the medicine in the blood stream as compared to younger adults, and they may be more sensitive to its effects. This may increase their chance of developing side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together, even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking acitretin, it is especially important that your health care professional know if you are taking any of the following:

• Alcoholic beverages—Drinking alcohol may convert acitretin to a much longer-acting product that can stay in the body 60 times longer than acitretin does. This may result in a greater chance of developing side effects for months or years, depending on how much and how often one drinks. This unusual effect can occur even after you stop taking acitretin, especially for the first 2 months after you stop taking this medicine

• Cyclosporine (e.g., Sandimmune or Neoral) or
• Phenytoin (e.g., Dilantin)—Acitretin may increase the effects of this medicine

• Etretinate (e.g., Tegison) or
• Isotretinoin (e.g., Accutane) or
• Tretinoin (oral) (e.g., Vesanoid) or
• Tretinoin (topical) (e.g., Avita, Renova, or Retin A) or
• Vitamin A, including vitamin supplements—Etretinate, isotretinoin, and tretinoin are not used together with acitretin; problems in skin, vision, and bone may be more likely to occur when they are used at the same time. If vitamin A is taken with acitretin, the dose of vitamin A should not exceed the minimum recommended daily allowance (RDA)

• Methotrexate (e.g., Rheumatrex, Trexall)—Should not be used with acitretin

• Oral contraceptives, progestin-only or “mini pills” (birth control pills) (e.g., Micronor, Nor-QD, Ovrette)—Acitretin may prevent progestin-only oral contraceptives from working properly and may result in an unplanned pregnancy. This does not occur with oral contraceptives containing both estrogens and progestins

• Tetracyclines (demeclocycline [e.g., Declomycin], doxycycline [e.g., Doxycin] minocycline [e.g., Minocin] oxytetracycline [e.g., Terramycin] tetracycline [e.g., Symycin])—Should not be used with acitretin

Other medical problems—The presence of other medical problems may affect the use of acitretin. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes) or
• High cholesterol or triglycerides, uncontrollable (or history of) or
• Inflammation of pancreas (or history of)—Acitretin may make these conditions worse or increase cholesterol or triglyceride problems

• Hypervitaminosis A (or history of)—If you have past or current problems with toxic symptoms from vitamin A, acitretin may increase the chance that they will occur again

• Kidney disease, severe or
• Liver disease, severe—May cause acitretin to stay in the body for a longer period of time and increase the chance of side effects

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Proper Use of This Medicine

Make certain your health care provider knows if you are on any special diet, such as a low-sodium, low-cholesterol, or low-sugar diet. Discuss with your doctor how often you drink alcohol, even if it is only an occasional drink.

Patient information is usually provided with acitretin. Read it carefully before using this medicine .

Take acitretin with a main meal or with a glass of milk.

For women— This medicine may cause birth defects . To make sure you are not pregnant before beginning treatment, your doctor will ask you to:

• Use two effective forms of birth control (contraception) for at least 1 month before beginning treatment .
• Report when your menstrual periods are normal .
• Take a pregnancy test within 1 week before beginning the treatment to make sure you are not pregnant .
• Begin your acitretin treatment on Day 2 or Day 3 of your next menstrual period .
• Sign a paper to show that you understand the importance of not becoming pregnant for at least 2 to 3 years after you stop taking this medicine, according to the advice of your doctor .

Using two effective forms of birth control for at least 2 or 3 years after you stop taking acitretin, according to the advice of your doctor, is very important to help prevent an unplanned pregnancy. If you do not think this is reasonable, you should discuss this with your doctor before you start taking this medicine .

Dosing—Take acitretin with food. Taking with food is important for getting the right amount of medicine out of your stomach.

The dose of acitretin will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of acitretin. If your dose is different, do not change it unless your doctor tells you to do so.

It is important that you do not share this medicine with anyone else because of the risk of birth defects and other serious side effects.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking acitretin .

• For oral dosage form (tablets):
  • For severe psoriasis:
    • Adults—25 to 50 milligrams (mg) a day as a single dose. After four weeks, your doctor may increase your dose depending on how well this medicine is working for you
    • Children—Use and dose must be determined by your doctor.
  • For other severe skin disorders (such as bullous or nonbullous erythroderma, lamellar ichthyoses, and keratosis follicularis):
    • Adults—25 milligrams (mg) a day. After four weeks, a dose of 10 to 75 mg a day is used.
    • Children—Use and dose must be determined by your doctor.

Missed dose—Take the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits while you are taking this medicine. If your condition has improved and you are no longer taking acitretin, your progress must still be checked . This is especially important for children or elderly patients, who may be more sensitive to the effects of this medicine, and for women who want to become pregnant after they stop taking the medicine.

It is important that you check with your doctor before taking any medicines including vitamins, herbal products or over-the-counter (OTC) medicines . Some of these medicines or nutritional supplements (e.g., St. John's wort) may make your birth control pills not work.

Your skin condition may improve or get worse during the first 3 weeks of treatment and you also may notice some skin irritation from the medicine. With continued use, the expected skin irritation will lessen after a few weeks. Check with your health care professional any time skin irritation becomes severe or if your skin condition does not improve within 8 to 12 weeks .

Do not drink alcohol while taking this medicine or for at least 2 months after discontinuing treatment .

• Drinking alcohol can change the medicine in the body to a product that stays in your body for an extended period of time. This can increase your chance of developing side effects for a longer period of time than if you hadn't consumed alcohol.
• If a woman consumes alcohol during acitretin treatment, she should consider delaying a pregnancy for longer than 2 or 3 years or as directed by her doctor.

Do not donate blood during treatment with acitretin, for 2 or 3 years following treatment, or as otherwise directed by your doctor . Although problems resulting from a blood transfusion are not likely, this precaution prevents the possibility that your blood would be used in pregnant women.

Acitretin can cause dryness of the eyes, blur your vision, or cause other vision problems. Be aware that while using acitretin you may see a sudden decrease in your night vision (ability to see before the sun rises or after the sun goes down). Also, acitretin may cause your eyes to be more sensitive to light, including sunlight, than they are normally. These effects can make certain activities dangerous, such as driving or operating machines .

Check with your doctor if you experience any vision or eye problem . Wearing contact lenses may become uncomfortable. Your doctor may suggest using artificial tears to keep your eyes from getting too dry.

Acitretin may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of developing dental disease, including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to wind, cold weather, and sunlight, even on cloudy days. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. However, you should not stop taking this medicine, unless the skin irritation becomes too severe. For best results:

• Wear sunglasses that can block ultraviolet (UV) light. Ordinary sunglasses may not protect your eyes.
• Regularly use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15.
• Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.
• Apply creams, lotions, or moisturizers often. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation.
• Do not use an artificial light, such as a sunlamp, unless directed otherwise by your doctor.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products:

• Any topical acne product or skin product containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur).
• Hair products that are irritating, such as permanents or hair removal products.
• Skin products that cause sensitivity to the sun, such as those containing spices or limes.
• Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

Using these products when taking acitretin may cause mild to severe irritation of the skin.

Do not take doses of vitamin A or any vitamin supplement containing vitamin A that exceeds the minimum recommended allowance (RDA) while you are taking this medicine. To do so may increase the chance of developing side effects.

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Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Headache (severe and continuing); nausea or vomiting (severe and continuing)

Less common

Blurred vision; eye pain

Rare

Abdominal or stomach pain; bleeding gums; bleeding time increased; chest pain; coughing up blood; ; diarrhea; difficulty in breathing or swallowing; double vision or other problems in seeing, including decreased night vision after sunset and before sunrise; darkened urine; increased menstrual flow; or vaginal bleeding; light-colored stools; nosebleeds; pale or cold hands or feet; paralysis; prolonged bleeding from cuts; red or dark brown urine; shortness of breath; unpleasant breath odor; unusual tiredness or weakness; vomiting of blood;yellowing of the skin or eyes

Incidence not known

Assault; attack; burning, numbness, tingling, or painful sensations; chest pain or discomfort; confusion; difficulty breathing; difficulty in speaking; doing things to injure oneself; force; inability to move arms, legs, or facial muscles; inability to speak; pain in chest, groin, or legs, especially calves; pain or discomfort in arms, jaw, back or neck; shortness of breath; slurred speech; slow speech; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; sudden, unexplained shortness of breath; sweating; thoughts of killing oneself; unsteadiness or awkwardness; vision changes; weakness in arms, hands, legs, or feet

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Back pain; bad, unusual or unpleasant (after)taste; bone or joint pain; change in taste; continuing ringing or buzzing or other unexplained noise in ears; degenerative disease of the joint; difficulty in moving or walking; excessive muscle tone; feeling of warmth redness of the face, neck, arms and occasionally, upper chest; headache; hearing loss; increased sensitivity to pain; increased sensitivity to touch; muscle stiffness; muscle tension or tightness; redness of skin; sleeplessness ; stiff, painful muscles; thinning of skin with easy bruising; tingling in the hands and feet; tongue irritation; trouble sleeping ; unable to sleep

Less common

Acid or sour stomach; belching; breast pain; eye problems, such as loss of eyebrows or eyelashes, redness or swelling of the eyelid, redness of the eyes, sensitivity of eyes to light, or watery eyes; general feeling of discomfort or illness; heartburn; increased hair growth on forehead, back, arms, and legs; indigestion; itching of the vagina or genital area; loosening of the fingernails; pain during sexual intercourse; redness or soreness around fingernails; sore mouth or tongue; thick, white vaginal discharge with no odor or with a mild odor; white patches in mouth and/or on tongue

Rare

Coughing, hoarseness, trouble in speaking, or influenza-like symptoms; itchy or painful ears; skin problems, such as abnormal sensation of burning or stinging of skin, cracking of skin, redness of skin, skin irritation or rash (including a rash that looks like psoriasis), skin infection, skin ulcers, skin odor (unusual), or small red spots in skin; sore on the edge of the eyelid (stye); thick, white, curd-like vaginal discharge; vaginal itching or irritation

Symptoms of overdose

Dizziness or lightheadedness; feeling of constant movement of self or surroundings; headache; sensation of spinning; vomiting

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Chapped, red, or swollen lips; difficulty in wearing contact lenses; dryness of eyes; dry or runny nose; increased ability to sunburn; increased amount of ear wax (unusual); itchy skin; nosebleeds; irritation in mouth or swollen gums; loss of hair (usually reversible); scaling and peeling of eyelids, fingertips, palms, and soles of feet; sticky skin; unusual thirst

Less common

Constipation; diarrhea; fatigue; increased sweating

Incidence not known

Cracking fingernails or fingernails break easily; muscular pain, tenderness, wasting or weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

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Developed: 04/24/1998
Revised: 10/26/2004

The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

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