ACITRETIN 10MG 30CAP; acitretin, retinoids, vitamin a, dermatological agents .
ACTIVE-INGREDIENT OF ACITRETIN 10MG 30CAP
Each capsule contains acitretin 10 mg.
INDICATION OF ACITRETIN 10MG 30CAP
ACITRETIN Capsule is indicated for the treatment of severe pasoriasis in adults. ACITRETIN Capsule should be prescribed only by those knowledgable in the systemic use of retinoids. In females of reproductive potential, ACITRETIN Capsule should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments. Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficiacy results similar to the initial course of therapy.
DOSAGE OF ACITRETIN 10MG 30CAP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. ACITRETIN Capsule therapy should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient’s response to initial treatment. Relapses may be treated as outlined for initial therapy, when ACITRETIN Capsule is used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient’s individual response.
OVER-DOSAGE OF ACITRETIN 10MG 30CAP
In the event of acute overdosage, ACITRETIN Capsule must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A, ie, headache and vertigo. The acute oral toxicity (LD50) of acitretin in both mice and rats was greater than 4000 mg/kg.
CONTRA-INDICATION OF ACITRETIN 10MG 30CAP
Pregnancy Category ₓ ACITRETIN Capsule is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values. 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. Since both ACITRETIN Capsule and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated. ACITRETIN Capsule is contraindicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids.
STORAGE OF ACITRETIN 10MG 30CAP
Store at 30 °C. Protect from light. Avoid exposure to high temperature and hunidity.
PACK OF ACITRETIN 10MG 30CAP
Carton box of 3 blisters each of 10 capsules (total of 30 capsules/box).
ACITRETIN 10MG 30CAP MANUFACTURED BY
Sabaa International Company for pharmaceutical and chemical industries S.A.E.