• Severe psoriasis unresponsive to other therapies.

Contraindicated in:

• Hypersensitivity to retinoids or parabens
• Concurrent use of alcohol, in any form
• Concurrent methotrexate or tetracycline therapy
• Chronically elevated blood lipids
• Severe hepatic or renal impairment
• OB: Pregnancy
• Lactation: Lactation
• Pedi: Safety and effectiveness not established in children.

Use Cautiously in:

• Concurrent phototherapy (intensity of treatment may need to be altered).

Exercise Extreme Caution in:

• Rep: Women of reproductive potential.

CV: capillary leak syndrome, edema, hypotension.

Derm: alopecia, dry skin, nail disorder, peeling, pruritus, rash, dermatitis, erythroderma, exfoliative dermatitis, sunburn, sweating.

EENT: dry eyes, epistaxis, irritation, ↓ night vision/night blindness, blurred vision, dry mouth, intolerance to contact lenses, loss of eyelashes and brows, photophobia, tinnitus,.

Endo: hyperglycemia, hypoglycemia.

F and E: hyperkalemia, hypermagnesemia, hypernatremia, hyperphosphatemia, hypomagnesemia.

GI: cheilitis, abdominal pain, anorexia, diarrhea, gingivitis, HEPATOTOXICITY, hypoalbuminemia, nausea, PANCREATITIS, stomatitis, taste disturbances, vomiting.

GU: hematuria.

Hemat: ↑ hematocrit, anemia, neutrophilia.

Metab: hyperlipidemia (↑ triglycerides, ↑ total cholesterol, ↓ HDL), hyperuricemia, weight gain.

MS: arthralgia, hyperostosis, myalgia.

Neuro: paresthesia, rigors, depression, fatigue, headache, pseudotumor cerebri (benign intracranial hypertension), RHABDOMYOLYSIS, sleep disorders.

Misc: fever, hot flashes, HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA AND URTICARIA) .

Drug-Drug:

• Methotrexate ↑ risk of hepatotoxicity; concurrent use contraindicated.
• Tetracyclines may ↑ intracranial pressure; concurrent use contraindicated.
• May ↓ effectiveness of hormonal contraceptives (especially microdosed progestin preparations).
• May ↑ hypoglycemic effects of sulfonylureas.
• Alcohol ↑ conversion to a very long-acting compound (avoid use of alcohol during acitretin therapy and for 2 mo after discontinuation).
• Concurrent use with high doses of vitamin A ↑ risk of hypervitaminosis A.

Drug-Food:

• Food ↑ absorption.

(Generic available)

• Capsules: 10 mg; 17.5 mg; 25 mg;

• PO (Adults): 25 mg or 50 mg once daily with a meal.

• Mechanism of action is not known.

• Improvement in psoriatic lesions.

Therapeutic Classification: antipsoriatics

Pharmacologic Classification: retinoids

Absorption: Well absorbed (72%) following oral administration.

Distribution: Crosses the placenta; remainder of distribution unknown.

Protein Binding: Highly protein bound (99.9%).

Metabolism/Excretion: Mostly metabolized by the liver; metabolites excreted in feces (34–54%) and urine (16–53%).

Half-life: 49–63 hr.

Soriatane

(antipsoriatic effect)

• Instruct patient to take medication as directed. If a dose is missed, skip dose and return to regular schedule. Do not double doses. Inform patient that condition may appear to worsen during initial therapy. Caution patient not to share this medication with others; may be dangerous.
• Explain the EPPA Program program to female patient.
• Caution patient not to take vitamin A supplements while taking acitretin. Hypervitaminosis A may result.
• Instruct patient to immediately report decreased vision in the dark, mood disturbances, suicidal thoughts, or signs and symptoms of severe liver damage (yellowing of skin or whites of eyes, nausea and vomiting, loss of appetite, dark urine) or allergic reactions (hives, itching, swelling of face, mouth, or tongue, breathing problems).
• Instruct patient to use caution when driving at night.
• Instruct patients with diabetes to closely follow blood glucose levels while taking acitretin. and to report significant changes in blood glucose levels to a health care provider.
• Inform patient that dry skin and chapped lips will occur and to apply lubricant to lips. Health care professional should be notified if these symptoms become bothersome.
• Advise patient that oral rinses, sugarless gum or candy, and frequent oral hygiene may help relieve dry mouth.
• Discuss possibility of excessively dry eyes with patient who wears contact lenses. Patient may need to wear glasses during therapy.
• Caution females of reproductive potential not to ingest beverages or products containing alcohol during or for 2 mo after discontinuation of acitretin; may lengthen the time of effects on pregnancy.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's Wort.
• Caution patient not to donate blood while taking acitretin and for 3 yr after discontinuation to prevent the possibility of a pregnant patient receiving the blood.
• Caution patient to minimize exposure to sunlight, to wear sunscreen, and to avoid sunlamps to prevent photosensitivity reactions.
• Rep: May cause fetal harm. Acitretin is contraindicated during pregnancy and breastfeeding. Teratogenic effects may persist for years. Caution female patients to use two reliable forms of contraception for 1 mo prior to, during, and for at least 3 yr after discontinuation of therapy. Patients who have undergone a tubal ligation should also use a second form of contraception. Patient should discuss past use of acitretin with health care professional before attempting pregnancy. Information on the Do your P.A.R.T. program is available at doyour-part-Program.html or by calling 1-888-784-3335. Patients that become pregnant during or within 3 yr of taking acitretin should report the pregnancy to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088.
• Inform patient of need for follow-up. Periodic ophthalmic exams and bone x-rays may be required.
• Emphasize the importance of regular blood tests to check lipids and hepatic function.

a-si-TRE-tin

NDC Code^*

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-1135- Acitretin
    • 0093-1135-56- 30 CAPSULE in 1 BOTTLE (0093-1135-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-1136- Acitretin
    • 0093-1136-56- 30 CAPSULE in 1 BOTTLE (0093-1136-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-1138- Acitretin
    • 0093-1138-56- 30 CAPSULE in 1 BOTTLE (0093-1138-56)

• 0115- Impax Generics
  • 0115-1698- Acitretin
    • 0115-1698-08- 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1698-08)

• 0115- Amneal Pharmaceuticals of New York LLC
  • 0115-1750- Acitretin
    • 0115-1750-08- 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1750-08)

• 0115- Amneal Pharmaceuticals of New York LLC
  • 0115-1751- Acitretin
    • 0115-1751-08- 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1751-08)

• 0115- Amneal Pharmaceuticals of New York LLC
  • 0115-1752- Acitretin
    • 0115-1752-08- 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1752-08)

• 0115- Amneal Pharmaceuticals of New York LLC
  • 0115-1753- Acitretin
    • 0115-1753-08- 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1753-08)

• 0145- Stiefel Laboratories Inc
  • 0145-0090- SORIATANE
    • 0145-0090-25- 30 CAPSULE in 1 BOTTLE (0145-0090-25)

• 0145- Stiefel Laboratories Inc
  • 0145-0091- SORIATANE
    • 0145-0091-25- 30 CAPSULE in 1 BOTTLE (0145-0091-25)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-7020- Acitretin
    • 0378-7020-93- 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7020-93)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-7023- Acitretin
    • 0378-7023-93- 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93)

• 42291- AvKARE, Inc.
  • 42291-086- ACITRETIN
    • 42291-086-30- 30 CAPSULE in 1 BOTTLE (42291-086-30)

• 42291- AvKARE, Inc.
  • 42291-087- ACITRETIN
    • 42291-087-30- 30 CAPSULE in 1 BOTTLE (42291-087-30)

• 42291- AvKARE, Inc.
  • 42291-088- ACITRETIN
    • 42291-088-30- 30 CAPSULE in 1 BOTTLE (42291-088-30)

• 42794- Sigmapharm Laboratories, LLC
  • 42794-080- ACITRETIN
    • 42794-080-08- 30 CAPSULE in 1 BOTTLE (42794-080-08)

• 42794- Sigmapharm Laboratories, LLC
  • 42794-081- ACITRETIN
    • 42794-081-08- 30 CAPSULE in 1 BOTTLE (42794-081-08)

• 42794- Sigmapharm Laboratories, LLC
  • 42794-083- ACITRETIN
    • 42794-083-08- 30 CAPSULE in 1 BOTTLE (42794-083-08)

• 66993- Prasco Laboratories
  • 66993-894- ACITRETIN
    • 66993-894-30- 30 CAPSULE in 1 BOTTLE (66993-894-30)

• 66993- Prasco Laboratories
  • 66993-896- ACITRETIN
    • 66993-896-30- 30 CAPSULE in 1 BOTTLE (66993-896-30)