Novatretin

Novatretin

acitretin

Manufacturer:

Douglas

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Acitretin
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
Should be taken with food.
Contraindications
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).
Special Precautions
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.
Adverse Reactions
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.
Drug Interactions
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.
ATC Classification
D05BB02 - acitretin ; Belongs to the class of systemic retinoids used in the treatment of psoriasis.
Presentation/Packing
Form
Novatretin cap 10 mg
Packing/Price
60's
Form
Novatretin cap 25 mg
Packing/Price
60's
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