Details

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• Marketing Authorization (Malaysia): MAL06081211AZ, indicating approval by the Malaysian National Pharmaceutical Regulatory Agency (NPRA).

• Manufacturer: Glenmark Pharmaceuticals Ltd, headquartered in Mumbai, India.

Content

• 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.

Indications

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.

Instructions for Use

• 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.