Marketing Authorization (Malaysia): MAL06081211AZ, indicating approval by the Malaysian National Pharmaceutical Regulatory Agency (NPRA).
Manufacturer: Glenmark Pharmaceuticals Ltd, headquartered in Mumbai, India.
Active Ingredient: Tacrolimus 0.03% w/w (30 mg per 100 g)
Excipients: Polyethylene glycol 400 and polyethylene glycol 3350.
Formulation: Ointment in a white, translucent, water-soluble, polyethylene glycol base.
Pack Size: 30 grams.
Manufacturer: Glenmark Pharmaceuticals Ltd, India.
Tacroz Ointment 0.03% is indicated for:
Topical treatment of moderate to severe atopic dermatitis (eczema) in adults and children aged 2 years and above who have not responded adequately to conventional therapies such as topical corticosteroids.
Maintenance treatment to prolong the period between flare-ups in patients who have responded to initial therapy.
Treatment of facial and flexural areas affected by atopic dermatitis.
Dosage:
Apply a thin layer to the affected or commonly affected areas of the skin.
For flare-ups: Apply twice daily until the lesion is clear or only minor damage remains.
For maintenance: Apply twice weekly (e.g., Tuesday and Friday) after initial clearance.
After 12 months of treatment, a review should be conducted to assess the need for continued therapy.
Application:
Clean and dry the affected area before application.
Gently massage the ointment into the skin.
Avoid contact with eyes, mucous membranes, and areas with cuts or infections.
Do not cover the treated area with bandages or dressings unless instructed by a doctor.
Precautions:
Avoid exposure to sunlight and ultraviolet (UV) light during treatment.
Do not use on areas with active skin infections.
Discontinue use if no improvement is observed within 2 weeks.
Consult a doctor before use if you have a weakened immune system or other skin conditions.
Malaysia
