Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Soriatane

Descriptions


Acitretin is used to treat severe skin disorders, such as psoriasis. It works by allowing normal growth and development of the skin. Acitretin will continue to work after you stop taking it, but after a time, the skin condition returns and you may need to take 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 have 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.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of acitretin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acitretin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving acitretin.

Pregnancy

Information about this acitretin-oral-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Chlortetracycline
  • Demeclocycline
  • Doxycycline
  • Methacycline
  • Minocycline
  • Oxytetracycline
  • Rolitetracycline
  • Tetracycline

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Levonorgestrel

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

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

  • Depression, history of or
  • Eye or vision problems or
  • Heart disease or
  • Hypercholesterolemia (high cholesterol in the blood) or
  • Hyperostosis (bone growth that is not normal) or
  • Hypertriglyceridemia (high triglycerides or fats in the blood) or
  • Hypervitaminosis A (too much vitamin A in the body), or history of or
  • Pancreatitis (inflammation of the pancreas) or
  • Pseudotumor cerebri (brain problem) or
  • Psychosis, history of—Use with caution. May make these conditions worse.
  • Diabetes mellitus, or a family history of or
  • Obesity—Use with caution. May increase risk for side effects.
  • Hyperlipidemia, severe (high fats in the blood) or
  • Kidney disease, severe or
  • Liver disease, severe—Should not be used in patients with these conditions.

Proper Use

It is very important that you take acitretin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Acitretin comes with a patient information form and Medication Guide. It is very important that you read and understand this information. Be sure to follow these instructions carefully and ask your doctor if you have any questions. You will be asked to sign a consent form before you starting taking this medicine to show that you understand the instructions.

You will be given information about the Do Your P.A.R.T. program, which is also called the Pregnancy Prevention Actively Required During and After Treatment program. This is important information about how to prevent pregnancy while you are using this medicine. Ask your doctor about this program if you have any questions.

It is best to take acitretin with a main meal.

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

  • Use two effective forms of birth control (contraception) together for at least 1 month before beginning treatment.
  • Report when your menstrual periods are normal.
  • Take a pregnancy test within 1 week before beginning 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.

Women who are able to bear children must use two effective forms of birth control together for at least 2 to 3 years after they stop taking acitretin to help prevent an unplanned pregnancy. If you do not think this is reasonable or feel like you can not do this, talk to your doctor before you start taking this medicine.

You must not share this medicine with anyone else because of the risk for birth defects and other serious side effects.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

  • For oral dosage form (capsules):
    • For severe psoriasis:
      • Adults—At first, 25 to 50 milligrams (mg) once a day as a single dose. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can cause very serious birth defects. You must use 2 forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated with this medicine, and for 3 years after you take your last dose of this medicine. You will need to have 2 negative pregnancy tests to be sure that you are not pregnant before you start using this medicine. You will also need to have pregnancy tests every month during treatment, and every 3 months for 3 years after you stop taking the medicine. If you think you have become pregnant while using this medicine, stop taking it and call your doctor right away.

Do not use methotrexate (Rheumatrex®, Trexall®) or a tetracycline medicine to treat an infection (such as doxycycline, minocycline, tetracycline, Minocin®, or Vibramycin®) while you are using this medicine. Using these medicines together may cause unwanted side effects.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, prescription or nonprescription (over-the-counter [OTC]) medicines. Some of these medicines or nutritional supplements (eg, St. John's wort) may make your birth control pills not work.

Do not take vitamin A or any supplement containing vitamin A while you are using this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Your skin condition may improve or get worse during the first few 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 doctor if the skin irritation becomes worse or if your skin condition does not improve within 8 to 12 weeks.

Women who are able to bear children must avoid all forms of alcohol while they are taking this medicine and for 2 months after they stop. Do not eat foods, drink beverages, or take medicines that contain alcohol. Drinking alcohol will make the medicine remain in the body for an extended period of time and will increase the chance for side effects. If a woman consumes alcohol during acitretin treatment, she should consider delaying a pregnancy for longer than 2 to 3 years. Talk to your doctor if you have any questions about this.

Do not donate blood during treatment with acitretin, for 3 years following treatment, or as otherwise directed by your doctor. Women who are able to bear children must not receive blood containing the medicine.

Liver problems may occur while you are using this medicine. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Acitretin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may heal more slowly.

Acitretin may cause blurred vision or a decrease in night vision (night blindness). The night blindness may occur suddenly. Do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. Check with your doctor right away if you have vision changes.

Acitretin may cause dry eyes. Wearing contact lenses may become uncomfortable while using this medicine. To help relieve dry eyes, check with your doctor about using a lubricating solution, such as artificial tears. If severe eye irritation or inflammation occurs, check with your doctor.

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 dry mouth continues 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 exposing 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. You should not stop taking this medicine, unless the skin irritation becomes too severe. Do not use a sunlamp or tanning bed. Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.

Unless your doctor tells you otherwise, you should avoid skin products that can irritate the skin. Some examples are:

  • Any topical acne product or skin product containing a peeling agent (eg, 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.

For diabetic patients:

  • This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Acitretin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, check with you doctor right away.

Call your doctor right away if you have a fever, cloudy urine, decrease or increase in the amount of urine, fainting or lightheadedness, nausea, stomach pain, or swelling of hands, ankles, feet, or lower legs. These may be symptoms of a rare but serious condition called capillary leak syndrome.

Side Effects

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

  1. Back pain
  2. bad, unusual, or unpleasant (after) taste
  3. bone or joint pain
  4. change in taste
  5. continuing ringing or buzzing or other unexplained noise in the ears
  6. difficulty with moving or walking
  7. excessive muscle tone
  8. feeling of warmth
  9. headache (severe and continuing)
  10. hearing loss
  11. increased sensitivity to pain
  12. increased sensitivity to touch
  13. muscle stiffness
  14. muscle tension or tightness
  15. nausea or vomiting (severe and continuing)
  16. redness of the face, neck, arms, and occasionally, upper chest
  17. redness of the skin
  18. sleeplessness
  19. stiff, painful muscles
  20. thinning of the skin with easy bruising
  21. tingling in the hands and feet
  22. tongue irritation
  23. trouble sleeping
  24. unable to sleep

Less common

  1. Acid or sour stomach
  2. blurred vision
  3. belching
  4. breast pain
  5. eye pain
  6. eye problems, such as loss of eyebrows or eyelashes, redness or swelling of the eyelid, redness of the eyes, sensitivity of the eyes to light, or watery eyes
  7. general feeling of discomfort or illness
  8. heartburn
  9. increased hair growth on the forehead, back, arms, and legs
  10. indigestion
  11. itching of the vagina or genital area
  12. loosening of the fingernails
  13. pain during sexual intercourse
  14. redness or soreness around the fingernails
  15. sore mouth or tongue
  16. thick, white vaginal discharge with no odor or with a mild odor
  17. white patches in the mouth or on the tongue

Rare

  1. Abdominal or stomach pain
  2. bleeding gums
  3. bleeding time increased
  4. chest pain
  5. coughing, hoarseness, trouble in speaking, or flu-like symptoms
  6. coughing up blood
  7. darkened urine
  8. diarrhea
  9. difficulty in breathing or swallowing
  10. double vision or other problems in seeing, including decreased night vision after sunset and before sunrise
  11. increased menstrual flow or vaginal bleeding
  12. itchy or painful ears
  13. light-colored stools
  14. nosebleeds
  15. pale or cold hands or feet
  16. paralysis
  17. prolonged bleeding from cuts
  18. red or dark brown urine
  19. shortness of breath
  20. skin problems, such as abnormal sensation of burning or stinging, cracking, redness, skin irritation or rash (including a rash that looks like psoriasis), infection, ulcers, unusual odor, or small red spots in the skin
  21. sore on the edge of the eyelid (stye)
  22. thick, white, curd-like vaginal discharge
  23. unpleasant breath odor
  24. unusual tiredness or weakness
  25. vaginal itching or irritation
  26. vomiting of blood
  27. yellowing of the skin or eyes

Incidence not known

  1. Assault
  2. attack
  3. burning, numbness, tingling, or painful sensations
  4. chest pain or discomfort
  5. confusion
  6. difficulty with breathing
  7. difficulty with speaking
  8. doing things to injure oneself
  9. force
  10. inability to move the arms, legs, or facial muscles
  11. inability to speak
  12. pain in the chest, groin, or legs, especially calves
  13. pain or discomfort in the arms, jaw, back, or neck
  14. shortness of breath
  15. slow speech
  16. slurred speech
  17. sudden loss of coordination
  18. sudden, severe weakness or numbness in the arms or legs
  19. sudden, unexplained shortness of breath
  20. sweating
  21. thoughts of killing oneself
  22. unsteadiness or awkwardness
  23. vision changes
  24. weakness in the arms, hands, legs, or feet

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Dizziness or lightheadedness
  2. feeling of constant movement of self or surroundings
  3. sensation of spinning

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Chapped, red, or swollen lips
  2. difficulty in wearing contact lenses
  3. dry or runny nose
  4. dryness of the eyes
  5. increased ability to sunburn
  6. increased amount of ear wax (unusual)
  7. irritation in the mouth or swollen gums
  8. itchy skin
  9. loss of hair (usually reversible)
  10. nosebleeds
  11. scaling and peeling of the eyelids, fingertips, palms, and soles of feet
  12. sticky skin
  13. unusual thirst

Less common

  1. Constipation
  2. diarrhea
  3. increased sweating

Incidence not known

  1. Cracking fingernails or fingernails break easily
  2. muscular pain, tenderness, wasting, or weakness

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.