Regulatory Information
GOLDPLUS UNIVERSAL PTE LTD
GOLDPLUS UNIVERSAL PTE LTD
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**Dosage and administration** Because there are differences in the absorption and rate of metabolism of acitretin, the dosage must be individually adjusted. The capsules should preferably be taken once daily with a meal, or with milk. The following will serve as guidelines. _Adults_ _The initial daily dosage_, 25 mg (i.e. 1 capsule 25 mg) or 30 mg (i.e. 3 capsules 10 mg) for about 2–4 weeks may give satisfactory therapeutic results. The maintenance dose must be based on clinical efficacy and tolerability. In general, a daily dosage of 25–50 mg taken for a further 6–8 weeks achieves optimal therapeutic results. It may be necessary in some cases to increase the dose up to a maximum of 75 mg/day (i.e. 3 capsules 25 mg). Therapy can be terminated in patients with psoriasis whose lesions have resolved sufficiently. Relapses should be treated as described above. In _disorders of keratinization_, maintenance therapy is usually needed, though the lowest possible dosage should be given. This may be less than 20 mg/day and should not exceed 50 mg/day. _Children_ In view of possible severe side effects associated with long-term treatment, the risk should be carefully weighed against the therapeutic benefit. Acitretin should be used only when all alternative therapies have proved inadequate. The dosage should be established according to bodyweight. The _daily dosage_ is about 0.5 mg/kg. Higher doses (up to 1 mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day. The _maintenance dose_ should be kept as low as possible in view of possible long-term side effects. _Combination treatment_ When Acitretin Capsule is used in combination with other types of therapy, it may be possible depending on the patient’s individual response to reduce the dosage of Acitretin Capsule. Standard topical treatments can generally be continued and do not interfere with Acitretin Capsule.
ORAL
Medical Information
**Indications** _Severe forms of psoriasis including_ - erythrodermic psoriasis - local or generalized pustular psoriasis _Severe disorders of keratinization, such as_ - congenital ichthyosis; - pityriasis rubra pilaris; - Darier’s disease; - other disorders of keratinization which may be resistant to other therapies.
**Contraindications** Acitretin Capsule is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practised 4 weeks before, during and for 3 years after treatment (see below). Women of childbearing potential must not receive blood from patients being treated with Acitretin Capsule. Donation of blood by a patient being treated with Acitretin Capsule is prohibited during and for 3 years after completion of treatment with Acitretin Capsule. Acitretin Capsule is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values. Since both Acitretin Capsule and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated. An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with Acitretin Capsule is also contraindicated. Concomitant administration of Acitretin Capsule and vitamin A or other retinoids is contraindicated due to the risk of hypervitaminosis A. Acitretin Capsule is contraindicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids.
D05BB02
acitretin
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
USV Private Limited