Novatretin

Acitretin

Severe forms of psoriasis including erythrodermic, local or generalized pustular psoriasis. Severe disorders of keratinization eg, congenital ichthyosis; pityriasis rubra pilaris; Darier's disease. Other disorders of keratinization which may be resistant to other therapies.

Individualized dosage. Adult Initially 25 or 30 mg for 2-4 wk. Maintenance: 25-50 mg for 6-8 wk. May be increased to max 75 mg/day. Disorders of keratinization Maintenance therapy is usually needed, though the lowest possible dosage should be given (<20 mg/day). Max: 50 mg/day. Childn 0.5 mg/kg/day. Max: 35 mg/day.

Should be taken with food.

Hypersensitivity to acitretin or to other retinoids. Blood donation by patient being treated is prohibited during & for 2 yr after completion. Patients w/ severely impaired liver or kidney function & chronic abnormally elevated blood lipid values. Combination w/ tetracyclines & methotrexate. Concomitant administration w/ vit A or other retinoids. Women of childbearing potential (unless strict contraception is practiced 4 wk before, during & for 2 yr after treatment). Pregnancy (congenital malformation risk w/ foetal exposure).

Check hepatic function before starting treatment every 1-2 wk for the 1st 2 mth after commencement & then every 3 mth during treatment. Monitor serum cholesterol & triglycerides especially in high-risk patients (disturbances of lipid metabolism, DM, obesity, alcoholism) & during long-term treatment. Frequently check blood sugar levels in early stages of treatment. Periodically perform appropriate exams for possible ossification abnormalities in adults. Monitor growth parameters & bone development in childn. Psychiatric disorders eg, depression, depression aggravated, anxiety & mood alterations. Patients w/ history of depression; monitor for signs of depression. Decreased night vision; patients driving or operating any vehicle at night. Carefully monitor for visual problems. Women of childbearing age must not ingest alcohol; avoid ethanol for 2 mth after cessation of therapy. Low-dose progesterone prep may be an inadequate method of contraception during therapy. Minimal, if any, risk of teratogenic effects for male patients. Not to be given to nursing mothers.

Hypervitaminosis A symptoms (eg, lip dryness); sticky skin, dermatitis, erythema, pruritus; increased hair loss, nail fragility, paronychia. Cheilitis, rhagades of the corner of the mouth, dry mouth, thirst; skin thinning, scaling; transient usually reversible elevation of transaminases & alkaline phosphatases; reversible elevation of serum triglycerides & cholesterol.

Avoid concomitant administration w/ vit A & other retinoids. Partially reduces protein binding of phenytoin. Low-dose progesterone-only products (minipills) may be inadequate method of contraception during therapy. Contraindicated w/ tetracyclines (mutual increase in intracranial pressure), methotrexate (increased risk of hepatitis), & vit A or other retinoids (risk of hypervitaminosis A). Formation of etretinate w/ ethanol; contraceptive measures must be taken for 2 yr after treatment completion.

Psoriasis, Seborrhea & Ichthyosis Preparations

D05BB02 - acitretin ; Belongs to the class of systemic retinoids used in the treatment of psoriasis.

POM