Soriatane (Acitretin)

(℞) Prescription Required - Soriatane is also marketed as Neotigason

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Acitretin 10mg

Product of United Kingdom
Manufactured by: UK Various Generics
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Acitretin 10mg
Product of United Kingdom
Manufactured by UK Various Generics
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Acitretin 25mg

Product of United Kingdom
Manufactured by: UK Various Generics
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Acitretin 25mg
Product of United Kingdom
Manufactured by UK Various Generics
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Neotigason 10mg

Product of United Kingdom
Manufactured by: Actavis
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Neotigason 10mg
Product of United Kingdom
Manufactured by Actavis
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Soriatane 10mg

Product of Canada
Manufactured by: Tribute Pharmaceuticals Canada
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Soriatane 10mg
Product of Canada
Manufactured by Tribute Pharmaceuticals Canada
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Soriatane 25mg

Product of Canada
Manufactured by: Tribute Pharmaceuticals Canada
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Soriatane 25mg
Product of Canada
Manufactured by Tribute Pharmaceuticals Canada
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Soriatane (Acitretin) Dosage and Side Effects

SORIATANE (acitretin) is used in the treatment of severe psoriasis and other disorders of keratinization in adult patients who have not responded to standard treatments.

*Soriatane can cause severe birth defects* - Discuss this with your doctor.

Proper Use of this medication

You should take SORIATANE as told by your doctor.

Usual dose:

For Severe psoriasis: starting dose of 25 mg once daily; maintenance daily dose from 25 mg to 50 mg; maximum daily dose of 75 mg.

For Other disorders of keratinization: 10 mg once daily; maximum daily dose of 50 mg.

Take SORIATANE once daily with food or after a meal.

Overdose:

In case of drug overdose, contact your doctor, or a Poison Control Centre, or go to Emergency room of the hospital near you immediately.

Missed dose:

If you miss a dose, take it as soon as you remember on the same day. Skip that dose if you do not remember until the next day.

Side Effects

The first few weeks before you begin to see any healing, you may begin to have some side effects.

Side effects of SORIATANE include the following:

Very common:

Dry eyes, particularly if you wear contact lenses;

Dry mouth, chapped lips, runny or dry nose;

Dry skin, peeling of fingertips and/or palms and soles, itchiness, rash, sticky skin, brittle nails;

Chills, joint pain, increased sensitivity to touch.

Most patients experience some degree of hair loss or abnormal hair texture but the condition varies among patients. The extent of hair loss that you may experience and whether or not all your hair will return to normal after treatment cannot be predicted.

Common:

Nosebleeds;

Ear problems such as pain, wax build-up, or buzzing in the ear;

Eye problems such as blurred vision, light sensitivity, pain, impaired vision;

Inflammation along the edge of the eyelid (blepharitis), inflammation or infection of the membrane lining the eyelids (conjunctivitis);

Tiredness, pain, thirst;

Swelling of leg, foot, ankle (oedema);

Bleeding or inflammation of the gums, or inflammation of the mucous lining of the mouth;

Nausea or abdominal pain;

Infections, including skin around the fingernail;

Decreased or increased appetite;

Back pain, bone pain or muscle pain;

Headache, trouble sleeping;

Skin problems such as cold sweat, excessive sweating, sensitivity to sunlight, inflamed, ulcerated, and oily or cracked skin.

Uncommon:

Decrease in night vision, or other eye problems, impaired hearing.

These are not all the possible side effects of SORIATANE. For more information, ask your prescriber or pharmacist.

Serious Side Effects:

Seek emergency treatment, if you experience any of the following symptoms:

  • Shortness of breath, dizziness, nausea, chest pain, weakness or trouble speaking as these can be signs of a heart attack, or stroke.
  • Swelling of a leg, foot, ankle or arm as these can be signs of a blood clot.
  • Worsening depression, suicidal thoughts or thoughts of self-harm.

Other Serious Side Effects:

  • Headaches, abdominal pain, diarrhea, rectal bleeding, nausea, vomiting, blurred vision, other visual problems.
  • Decrease in night vision.
  • Persistent feeling of dry eyes.
  • Yellowing of the skin or eyes and/or dark urine, flu-like symptoms.

Aches or pains in bones or joints, or difficulty in moving. Bone changes have been detected by X-ray examination in patients taking SORIATANE. The extent of any harm from these changes is not presently known.

Warnings and Precautions

Serious Warnings and Precautions

You must avoid becoming pregnant while you are taking SORIATANE and until at least 3 years after you stop taking SORIATANE (discuss this with your doctor).

You must discuss effective birth control with your doctor before beginning treatment and you must use effective birth control without interruption as follows:

  • for at least one month before you start SORIATANE;
  • while you are taking SORIATANE; and
  • for at least 3 years after you stop taking SORIATANE (discuss this with your doctor); and
  • bearing in mind that any method of birth control can fail,
  • it is recommended that you either abstain from sexual intercourse or use two effective methods of birth control at the same time (discuss this with your doctor);
  • Low dose progesterone-only (Micronor 28) may not be an effective method to prevent pregnancy during treatment with SORIATANE and is not recommended for use.

Do not take SORIATANE until you are sure that you are not pregnant:

  • You must have 2 negative pregnancy tests before you start SORIATANE. The first test (with a negative result) is obtained at screening when SORIATANE treatment is under consideration. A second (confirmatory) test (with a negative result) must be obtained not older than 3 days before the first dose.
  • You must wait until the second or third day of your next menstrual period before you start SORIATANE.
  • During treatment, you must have a pregnancy test at 28-day intervals. A negative pregnancy test, from a licensed laboratory, not older than 3 days is mandatory before you can receive another prescription for SORIATANE.
  • After stopping treatment, you must have pregnancy tests every 1-3 months for at least 3 years after your last dose.

Every time you start a new course of treatment with SORIATANE, however long the intervening period may have been, you must use effective and uninterrupted birth control, during treatment and for at least 3 years after you stop taking SORIATANE.

Contact your doctor immediately if you do become pregnant while taking SORIATANE or after treatment has stopped. You should discuss the serious risk of having a baby with severe birth deformities because you are taking or have taken SORIATANE, as well as available options, with your doctor.

Do not breastfeed while taking SORIATANE and until at least 3 years after the treatment has stopped.

Male and female patients should avoid consuming alcohol while taking SORIATANE and until least 2 months after the treatment has stopped.

Male and female patients should not donate blood while taking SORIATANE and until at least 3 years after the treatment has stopped.

Before taking SORIATANE, talk to your doctor if you have any of the following conditions:

  • high cholesterol or triglycerides
  • high blood sugar
  • liver or kidney problems
  • mood changes
  • skin problems
  • high pressure in the brain (intracranial hypertension)
  • eye problems or wear contact lenses. SORIATANE may cause dry eyes, light sensitivity, or other eyes problems.

While taking SORIATANE you should avoid prolonged exposure to sunlight or sun lamps. Use protective clothing or hat or sunscreen with SPF 30 or more.

SORIATANE is not recommended for use in children.

Interactions with this medication

Before taking SORIATANE tell your doctor or pharmacist about all other medications you take including medications that you bought without prescription, vitamins, and natural products. Particularly if you are taking the following:

  • Vitamin A
  • Methotrexate
  • Tetracyclines, phenytoin
  • Glyburide, or a sulfonylurea
  • St. John's wort
  • Alcohol because it can convert SORIATANE to etretinate, a chemical that also causes birth defects and stays in the body longer.
  • Low dose of progesterone-only contraceptive (Micronor 28)

Other related products

The above 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.

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