Trade Names:Soriatane- Capsules 10 mg- Capsules 25 mg
Absorption is linear and proportional with increasing doses; approximately 72% is absorbed following a 50 mg dose. C max (mean 416 ng/mL) is achieved in 2 to 5 h.
Plasma protein binding is 99.9%, primarily to albumin.
Undergoes extensive metabolism to cis-acitretin.
Excreted in the feces (34% to 54%) and urine (16% to 53%). Terminal t ½ of acitretin is 49 h; t ½ of cis-acitretin is 63 h.
Higher plasma concentrations are seen; however, no changes occur in the t ½ .Renal failure
Plasma concentrations are lower in end-stage renal failure. Acitretin is not removed by dialysis.
Treatment of severe psoriasis.
Pregnancy; severe liver or kidney function impairment; chronic abnormal elevation in blood lipid values; concurrent use of methotrexate or tetracyclines; hypersensitivity to other retinoids or any component of the product.
PO Start with 25 to 50 mg/day given as a single dose with the main meal. Maintenance doses of 25 to 50 mg/day may be given dependent upon the patient's response to initial treatment.RelapseAdults
PO Relapses may be treated as outlined for initial treatment.PhototherapyAdults
PO When used with phototherapy, the phototherapy dose should be decreased by the prescriber based upon the patient's individual response.
Store capsules at controlled room temperature (59° to 77°F). Protect from light. Avoid exposure to high temperatures and humidity after bottle is opened.
Concurrent use of alcohol and acitretin may lead to the formation of etretinate, which increases the duration of teratogenic potential in women.Glyburide
The glucose-lowering effect of glyburide may be potentiated.Methotrexate
Because the risk of hepatitis may be increased, concurrent use is contraindicated.Phenytoin
Protein binding of phenytoin may be reduced.Progestin “minipill”
Acitretin may interfere with the contraceptive effect.Tetracyclines
Because acitretin and tetracyclines can cause increased intracranial pressure, concurrent use is contraindicated.Vitamin A, oral retinoids
Because the risk of hypervitaminosis A is increased, concurrent use is contraindicated.
None well documented.
Acute MI, thromboembolism, stroke (postmarketing).
Rigors (10% to 25%); headache, pain, depression, insomnia, somnolence (1% to 10%); myopathy with peripheral neuropathy, aggressive feelings and/or suicidal thoughts (postmarketing).
Alopecia, skin peeling (60% to 75%); dry skin, nail disorder, pruritus (25% to 50%); erythematous rash, hyperesthesia, paresthesia, paronychia, skin atrophy, sticky skin (10% to 25%); abnormal skin odor, abnormal hair texture, bullous eruption, cold/clammy skin, dermatitis, increased sweating, psoriasiform rash, purpura, pyogenic granuloma, rash, seborrhea, skin fissures, skin ulceration, sunburn, infection (1% to 10%); skin thinning, skin fragility and scaling (postmarketing).
Rhinitis (25% to 50%); dry eyes (23%); xerophthalmia, epistaxis (10% to 25%); eye irritation (9%); brow and lash loss (5%); Bell palsy, blepharitis, crusting of eye lids, blurred vision, conjunctivitis, corneal epithelial abnormality, cortical cataract, decreased night vision/night blindness, diplopia, itchy eyes or eyelids, nuclear cataract, pannus, papilledema, photophobia, posterior subcapsular cataract, recurrent sties, subepithelial corneal lesions (less than 5%); eye pain, sinusitis, earache, taste perversion, tinnitus (1% to 10%).
Increased phosphorus, potassium, sodium, magnesium, decreased magnesium (10% to 25%); increased calcium, chloride, decreased calcium, chloride, phosphorus, potassium, sodium (1% to 10%).
Cheilitis (greater than 75%); dry mouth (10% to 25%); abdominal pain, diarrhea, nausea, tongue disorder, stomatitis, ulcerative stomatitis (1% to 10%).
White blood cells in urine (25% to 50%); acetonuria, hematuria, red blood cells in urine (10% to 25%); glycosuria, proteinuria (1% to 10%); vulvo-vaginitis from Candida albicans (postmarketing).
Increased reticulocytes (25% to 50%); decreased hematocrit, hemoglobin, WBC (10% to 25%); increased haptoglobin, neutrophils, WBC (10% to 25%); increased bands, basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, platelets, red blood cells, decreased haptoglobin, lymphocytes, neutrophils, reticulocytes, platelets, RBC (1% to 10%).
Increased cholesterol, LDH, AST, ALT, decreased HDL (25% to 50%); increased alkaline phosphatase, direct bilirubin, gamma-glutamyl transpeptidase (10% to 25%); increased globulin, total bilirubin, total protein, serum albumin, decreased serum albumin (1% to 10%).
Arthralgia, spinal hyperostosis (10% to 25%); arthritis, arthrosis, back pain, hypertonia, myalgia, osteodynia, peripheral joint hyperostosis (1% to 10%).
Increased uric acid (10% to 25%); increased BUN, creatinine (1% to 10%).
Increased triglycerides (50% to 75%); increased CPK, fasting blood glucose (25% to 50%); decreased fasting blood sugar, high occult blood (10% to 25%); anorexia, edema, fatigue, hot flashes, increased appetite, gingival bleeding, gingivitis, increased salivation, thirst, infection, decreased and increased iron, flushing (1% to 10%).
Acitretin must not be used by women who are pregnant or intend to become pregnant during therapy or at any time for at least 3 yr following discontinuation of therapy. Acitretin must not be used by women who may not use reliable contraception while undergoing treatment or for at least 3 yr following discontinuation of treatment. Women must sign a Patient Agreement/Information Consent Form that contains warnings about the risk of potential birth defects. An acitretin medication guide must be given to patients each time acitretin is dispensed, as required by law. If pregnancy occurs during therapy or at any time for at least 3 yr after stopping therapy, the prescriber and patient should discuss the possible effects on the pregnancy.Hepatotoxicity
Hepatotoxicity, hepatitis, and hepatitis related deaths may occur.
Category X .
Excreted in breast milk.
Safety and efficacy not established.
May occur; avoid excessive use of sunlamps, exposure to sunlight, and ultraviolet light.
Patients should not donate blood during and for at least 3 yr following completion of acitretin therapy.
Examine patient for possible ossification abnormalities.
Elevation in triglycerides and cholesterol may occur; decreased HDL may occur. CV risk status may be increased.
Pancreatitis (including fatal fulminant pancreatitis) with or without elevated triglyceride levels may occur.
Depression and other psychiatric symptoms such as aggressive feeling or thought of self-harm may occur.
Night vision and tolerance to contact lenses may be decreased.
Identical to acute hypervitaminosis A (headache, vertigo).
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