Soriatane

DRUG DESCRIPTION

Soriatane (acitretin), a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is:

SORIATANE® (acitretin)  Structural Formula Illustration

Each capsule contains acitretin, microcrystalline cellulose, sodium ascorbate, gelatin, black monogramming ink and maltodextrin (a mixture of polysaccharides).

Gelatin capsule shells contain gelatin, iron oxide (yellow, black, and red), and titanium dioxide. They may also contain benzyl alcohol, carboxymethylcellulose sodium, edetate calcium disodium.

REFERENCES 1. Berbis Ph, et al.: Arch Dermatol Res (1988) 280:388-389. 2. Maier H, Honigsmann H: Concentration of etretinate in plasma and subcutaneous fat after long-term acitretin. Lancet 348:1107, 1996. 3. Geiger JM, Walker M: Is there a reproductive safety risk in male patients treated with acitretin (Neotigason®/ Soriatane ®)? Dermatology 205:105-107, 2002.

What are the possible side effects of acitretin (Soriatane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acitretin and call your doctor at once if you have any of these serious side effects:

  • blurred vision, headache or pain behind your eyes, sometimes with vomiting;
  • sudden decrease in night vision;
  • depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
  • chest pain or heavy feeling, spreading to...

Read All Potential Side Effects and See Pictures of Soriatane »

What are the precautions when taking acitretin (Soriatane)?

Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 your medical history, especially of: kidney disease, liver disease, heart disease, diabetes, receive phototherapy.

Do not donate blood while taking this drug and for at least 3 years after stopping therapy. This will prevent the...

Read All Potential Precautions of Soriatane »


Soriatane Consumer (continued)

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 persist or worsen, inform your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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.

Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 your medical history, especially of: kidney disease, liver disease, heart disease, diabetes, receive phototherapy.

Do not donate blood while taking this drug and for at least 3 years after stopping therapy. This will prevent the possibility of your blood being given to a pregnant woman.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Acitretin may cause vision changes, including decreased night vision. Do not drive, use machinery, or do any activity that requires clear vision (especially at night) until you are sure you can perform such activities safely.

Avoid drinking alcohol while taking this medication and for 2 months after stopping it.

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 if you are planning to become pregnant during treatment or within 3 years after use has stopped.

Use 2 effective forms of birth control starting 1 month before and during treatment and at least 3 years after use has stopped. If you are unsure which types of birth control are effective, consult your doctor, pharmacist, or Medication Guide.

Semen may pose a risk to a pregnant woman if a 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.


Soriatane Patient Information Including Side Effects

Brand Names: Soriatane

Generic Name: acitretin (Pronunciation: A si TRE tin)

  • What is acitretin (Soriatane)?
  • What are the possible side effects of acitretin (Soriatane)?
  • What is the most important information I should know about acitretin (Soriatane)?
  • What should I discuss with my healthcare provider before taking acitretin (Soriatane)?
  • How should I take acitretin (Soriatane)?
  • What happens if I miss a dose (Soriatane)?
  • What happens if I overdose (Soriatane)?
  • What should I avoid while taking acitretin (Soriatane)?
  • What other drugs will affect acitretin (Soriatane)?
  • Where can I get more information?

What is acitretin (Soriatane)?

Acitretin is a retinoid, which is a form of vitamin A.

Acitretin is used to treat severe psoriasis in adults. It is usually given after other psoriasis medicines have been tried without successful treatment of symptoms.

Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication.

Acitretin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of acitretin (Soriatane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acitretin and call your doctor at once if you have any of these serious side effects:

  • blurred vision, headache or pain behind your eyes, sometimes with vomiting;
  • sudden decrease in night vision;
  • depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
  • chest pain or heavy feeling, spreading to the arm or shoulder, sweating, shortness of breath;
  • sudden headache, confusion, problems with speech or balance, numbness or weakness (especially on one side of the body);
  • sudden cough, wheezing, rapid breathing, fast heart rate;
  • pain or swelling in one or both legs;
  • jaundice (yellowing of the skin or eyes); or
  • loss of feeling in your hands or feet, trouble moving, pain in your back, joints, muscles, or bones.

Less serious side effects may include:

  • dry or irritated eyes, thinning eyebrows or lashes;
  • chapped or peeling skin, hair loss;
  • dry mouth, dry or runny nose, nosebleeds;
  • warmth, redness, or tingly feeling under your skin;
  • nausea, diarrhea, stomach pain, loss of appetite;
  • mouth sores, swollen or bleeding gums;
  • headache;
  • sleep problems (insomnia); or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acitretin (Soriatane)?

This medication can cause birth defects. Do not use if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. You must use 2 forms of birth control together starting at least 1 month before treatment with acitretin, and for at least 3 years after you stop taking this medication.

For women taking acitretin: Before and during treatment, and for 3 years after treatment, you must have negative pregnancy tests at regular intervals to make sure you are not pregnant. No testing is needed if you have had a hysterectomy or have gone completely through menopause.

Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). acitretin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Acitretin is available only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking acitretin and for 2 months after you stop taking it.

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