Neotigason

Neotigason

acitretin

Manufacturer:

Teva Pharma

Distributor:

DKLL
Concise Prescribing Info
Contents
Acitretin
Indications/Uses
Severe forms of psoriasis including erythrodermic psoriasis, local or generalized pustular psoriasis; keratinization disorders eg, congenital ichthyosis, pityriasis rubra pilaris, Darier's disease, other resistant keratinization disorders.
Dosage/Direction for Use
Adult Initially 25 or 30 mg once daily for 2-4 wk. Maintenance: 25-50 mg once daily for 6-8 wk. Max: 75 mg/day. Keratinization disorders Maintenance: Lowest possible dosage (<20 mg daily). Max: 50 mg daily. Childn 0.5 mg/kg daily. Higher doses (up to 1 mg/kg daily) may be given for limited periods, only up to a max of 35 mg daily.
Administration
Should be taken with food: Take w/ main meals or w/ milk.
Contraindications
Hypersensitivity to acitretin or other retinoids. Patients w/ chronic abnormally elevated blood lipid values. Donation of blood is prohibited during & for 1 yr after completion of treatment. Co-administration w/ tetracyclines, MTX, etretinate, vit A or other retinoids. Severe liver or kidney impairment. Women of childbearing potential should practice strict contraception 4 wk before, during & 2 yr after treatment. Pregnancy.
Special Precautions
W/draw if hepatic function deteriorates or fails to return to normal. Not to start the therapy until 2nd or 3rd day of next normal menstrual period. Risk of congenital malformation. Avoid ethanol during & 2 mth after therapy. Decreased night vision. Check hepatic function before, every 1-2 wk for 1st 2 mth & then every 3 mth during treatment; institute wkly checks if results are abnormal. Monitor serum cholesterol & triglycerides (fasting values) in high-risk patients & during long-term treatment; visual problems. Frequently check blood sugar levels. Periodically perform exam in view of possible ossification abnormalities during long-term treatment. May impair ability to drive & operate machines. Women of childbearing potential undergoing treatment must use effective contraception w/o interruption for 4 wk before, during & for 2 yr after discontinuation. Not to be used in pregnant & women planning to become pregnant during or w/in 2 yr of cessation of treatment. Not to be used in lactation. Childn; monitor growth parameters & bone development.
Adverse Reactions
Hypervitaminosis A, nosebleeds, rhinitis, ocular disturbances, cheilitis, mouth rhagades, dry mouth, thirst, stomatitis, gingivitis, taste disturbances, vulvovag candidiasis, skin thinning & scaling, sticky skin, dermatitis, erythema, pruritus, hair loss, nail fragility, paronychia, bullous eruption, abnormal hair texture, blurred vision, impaired night vision, muscle, joint & bone pain, peripheral edema, flushing, elevated transaminases & alkaline phosphatase.
Drug Interactions
Concomitant use w/ vit A & other retinoids; phenytoin; etretinate, ethanol; tetracyclines; MTX & etretinate.
MIMS Class
Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
D05BB02 - acitretin ; Belongs to the class of systemic retinoids used in the treatment of psoriasis.
Presentation/Packing
Form
Neotigason cap 10 mg
Packing/Price
3 × 10's
Form
Neotigason cap 25 mg
Packing/Price
3 × 10's
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