صحة وجمال

Tarolimus 0.03% and 0.1% Topical Ointment

74

Tarolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

Tarolimus ointment is not indicated for children younger than 2 years of age.

Qualitative and quantitative composition

Each 1 g of Tarolimus 0.03% Topical Ointment contains:

  • Active Ingredient: 0.3 mg of tacrolimus.
  • Inactive Ingredients: propylene carbonate, white soft paraffin, white beeswax, hard paraffin & liquid paraffin (heavy).

    • Therapeutic Indications

    Tarolimus 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.

    Flare Treatment

    Adults And Adolescents (16 Years Of Age And Above): Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.

    Children (2 years of age and above): Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.

    Maintenance treatment

    Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

    WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established

    Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment.

    Therefore: Continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.

    Tacrolimus ointment is not indicated for use in children less than 2 years of age. Only 0.03% tacrolimus ointment is indicated for use in children 2-15 years of age.

    Dosage And Administration

    Adult; Tarolimus Ointment 0.03% And 0.1%

  • Apply a thin layer of Tarolimus ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
  • If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of topical calcineurin inhibitors, including Tarolimus ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
  • The safety of Tarolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated. Tarolimus ointment should not be used with occlusive dressings.

    • Pediatric: For Children 2-15 Years, Tarolimus Ointment 0.03%

  • Apply a thin layer of Tarolimus ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
  • If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of topical calcineurin inhibitors, including Tarolimus ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
  • The safety of Tarolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated. Tarolimus ointment should not be used with occlusive dressings.

    • تاروليمس TAROLIMUS

    TarolimusOintment Patient Information Leaflet


    السابق
    تانزار لعلاج ضغط الدم المرتفع – لوزارتان
     التالي
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