ACITRETIN – Drug Information

Generic Name: Acitretin

Therapeutic Classification: Antipsoriatics

Description:

Acitretin is a synthetic retinoid, prescribed for severe psoriasis (abnormal growth of skin cells that causes red, thickened, or scaly skin). It regulates the growth of epidermal cells. It is an oral retinoid of choice used in the treatment of severe resistant psoriasis.

Mechanism of Action:

The mechanism of action of Acitretin is unknown, however it is believed to work by targeting specific retinoid receptors (RXR and RAR) in the skin which help to normalize the growth cycle of skin cells.

Pharmacokinetics:

  • Half-Life: 49 hours.
  • Peak Plasma Time: 2-5 hour.
  • Protein Bound: >99.9% (primarily albumin).
  • Excretion: 34-54% feces; 16-53% urine.

Contraindications for Acitretin:

  • Hypersensitivity to retinoids (eg, angioedema, urticaria), parabens.
  • Contraindicated in patient’s history with liver, kidney impairment.
  • During pregnancy (before the start, during and at least 2-3 year after cessation of therapy), lactation, increased level of lipids in blood.

Pregnancy Category:

Category X

Animal and/or human studies have demonstrated fetal injury and potential risks outweigh the benefits of the drug in pregnancy. These drugs are found to be harmful when taken during pregnancy, and should not be used.

Warnings and Precautions for Acitretin:

  • Acitretin is noted for the possibility of severe birth defects and should not be used by pregnant women or women planning to get pregnant within 3 years following the use of this medication.
  • Sexually active women of childbearing age who use Acitretin should also use at least 2 forms of birth control concurrently.
  • Avoid blood donation during therapy or at least 1-3 years after stopping therapy.
  • It may cause drowsiness or vision changes. Do not drive a car or operate machinery while taking this medication.
  • It may cause capillary leak syndrome
  • It may make your skin sensitive to light, so avoid sunlight.
  • Alcohol is contraindicated during treatment with acitretin and for 2 months after stopping therapy as ethanol promotes the formation of etretinate, which has prolonged half-life and teratogenic risk.
  • Remove contact lenses while using this medication otherwise it will increase irritation.
  • Monitor liver function, plasma lipid and glucose levels (especially in diabetic patients) regularly.

Adverse Reaction / Side Effects of Acitretin:

  • Central Nervous System: Headache, shakiness, sleeplessness, aggressive feelings and / or suicidal thoughts and depression.
  • Heart: Heart attack, clots in blood vessels and stroke.
  • Gastrointestinal: Dry mouth, increased thirst, taste changes, nausea, vomiting, inflammation of the pancreas and lower stomach pain.
  • Skin: Rash, sweating, itching, dryness, thinning, dry or chapped lips, damage of skin, abnormal skin odor, hair loss and nail damage.
  • Genitourinary: Vulvo-vaginal infection due to fungal infection.
  • Hypersensitivity: Allergic reaction includes: rash, itching / swelling (especially of the face/tongue/throat), dizziness and breathing problem.
  • Potentially Fatal: Sunburn, jaundice and liver toxicity.
  • Miscellaneous: Fever, chills, oedema, dark urine and peeling of skin.

Dosage of Acitretin:

  • Adult: PO- The recommended dose is 25 to 50 mg per day, given as a single dose with the main meal.
  • Acitretin comes as with capsule form to take by mouth. It is usually taken once a day with the main meal.

Storage Conditions of Acitretin:

Store between 15° and 25°C (59° and 77°F) in an airtight container. Protect from light.

Trade Names/Brand Names of Acitretin:

India:

Acitrin | Acetec | Aceret | Acrotac (10 mg) | Aceret | Acetec (25 mg) | Acrotac (25 mg) | Aceret (25 mg) | Zoratame (25 mg) | Acitrin (25 mg) | Aceret (10 mg)

International:

Neotigason, Soriatane, Soriatane CK

 

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