Agencia Lei Va Hong
Concise Prescribing Info
Severe forms of psoriasis including erythrodermic psoriasis, 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
Adult Initially 25-30 mg/day for 2-4 wk. Maintenance: 25-50 mg/day for a further 6-8 wk. Max: 75 mg/day. Darier's disease Initially 10 mg. Dose should be increased cautiously. Childn 0.5-1 mg/kg/day. Max: 35 mg/day.
Should be taken with food.
Hypersensitivity to acitretin or to other retinoids. Patients w/ severe hepatic or renal impairment; chronic abnormally elevated blood lipid values. Concomitant use w/ tetracyclines, methotrexate, vit A or other retinoids. Rare glucose-galactose malabsorption. Pregnancy & lactation.
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 (fasting values) 1 mth after commencement & then every 3 mth during treatment. Rare reports of benign intracranial HTN. Discontinue in patients w/ severe headache, nausea, vomiting & visual disturbances. Possible ossification abnormalities in adults receving long-term treatment. Closely monitor growth parameters & bone development in childn. Avoid excess exposure to sunlight & unsupervised use of sun lamps. Patients being treated w/ Neotigason is prohibited to donate blood during & for 3 yr after completion of treatment. Reports of decreased night vision; may impair ability to drive or operate vehicle at night. Women of childbearing age must not consume alcohol (in drinks, food or medicines) during treatment & for 2 mth after cessation of therapy. Highly teratogenic. Risk of foetal malformations. Contraceptive measures must be taken 4 wk before, during, & for 3 yr after completion of Neotigason treatment.
Adverse Reactions
Symptoms of hypervitaminosis A (eg, dryness of the lips); nosebleeds, rhinitis, ocular disturbances (xerophthalmia, conjunctivitis); cheilitis, rhagades of the corner of the mouth, dry mouth, thirst; stomatitis, gingivitis, taste disturbances; vulvovaginitis due to Candida albicans; thinning of the skin & scaling, particularly on the palms & soles; sticky skin, dermatitis, erythema, pruritus; increased hair loss, nail fragility, paronychia; bullous eruption, abnormal hair texture; headache; blurred vision & impaired night vision; muscle, joint & bone pain; peripheral edema & flushing; elevation of transaminases, alkaline phosphatase, serum triglycerides & cholesterol.
Drug Interactions
Risk of hypervitaminosis A w/ vit A & other retinoids. Partially reduced protein binding of phenytoin. Additive effect on intracranial pressure w/ tetracyclines. Increased risk of hepatitis w/ methotrexate.
MIMS Class
Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
D05BB02 - acitretin ; Belongs to the class of systemic retinoids used in the treatment of psoriasis.
Neotigason cap 10 mg
Neotigason cap 25 mg
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