PROTOPIC OINTMENT 0.1%

LEO LABORATORIES LIMITED (IRELAND)🇸🇬 Health Sciences Authority

Approval Date: Mar 8, 2004
Approval ID: 29d72d7feece45b1
Company: LEO LABORATORIES LIMITED (IRELAND)
Type: Therapeutic

Approval Details

Approval Id: 29d72d7feece45b1
Drug Name: PROTOPIC OINTMENT 0.1%
Product Name: PROTOPIC OINTMENT 0.1%
Approval Number: SIN12524P
Approval Date: 2004-03-08
Registrant: DKSH SINGAPORE PTE. LTD.
Licence Holder: DKSH SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: OINTMENT
Dosage: Posology and Method of Administration Protopic® treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Protopic® is available in two strengths, Protopic® 0.03 % and Protopic® 0.1 % ointment. Method of administration Protopic® ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Protopic® ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Protopic® ointment should not be applied under occlusion because this method of administration has not been studied in patients (see Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Posology Flare treament Protopic® can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis. Protopic® treatment should begin at the first appearance of signs and symptoms. Each affected region of the skin should be treated with Protopic® until lesions are cleared, almost cleared or mildly affected. At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. Adult and adolescents (16 years of age and above) Treatment should be started with Protopic® 0.1% twice a day and treatment should be continued until clearance of the lesion. If symptoms recur, twice daily treatment with Protopic® 0.1% should be restarted. An attempt should be made to reduce the frequency of application or to use the lower strength Protopic® 0.03% ointment if the clinical condition allows. Generally, improvement is seen within one week of starting treatment. If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered. Paediatric population Children (2 years of age and above) should use the lower strength Protopic® 0.03% ointment. Treatment should be started twice a day for up to three weeks. Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Protopic® ointment should not be used in children aged below 2 years until further data are available. Elderly patients (65 years of age and above) Specific studies have not been conducted in elderly patients. However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment. Maintenance treatment Patients who are responding to up to 6 weeks treatment using tacrolimus ointment twice daily (lesions cleared, almost cleared or mildly affected) are suitable for maintenance treatment. Adult and adolescents (16 years of age and above) Adult patients should use Protopic® 0.1% ointment. Protopic® ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares. Between applications there should be 2–3 days without Protopic® treatment. After 12 months treatment, a review of the patient’s condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months. If signs of a flare reoccur, twice daily treatment should be re-initiated (see Flare treatment section above). Paediatric population Children (2 years of age and above) should use the lower strength Protopic® 0.03% ointment. Protopic® ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares. Between applications there should be 2-3 days without Protopic® treatment. The review of the child’s condition after 12 months treatment should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease. Protopic® ointment should not be used in children aged below 2 years until further data are available. Elderly patients (65 years of age and above) Specific studies have not been conducted in elderly patients (see Flare treatment section above).
Route Of Administration: TOPICAL
Indication Info: Therapeutic Indications Protopic® 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. Protopic® 0.1 % ointment is indicated in adults and adolescents (16 years of age and above). Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults and adolescents 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 (2 years of age and above) 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).
Contraindications: Contraindications Hypersensitivity to the active substance, macrolides in general or to any of the excipients
Atc Code: D11AH01
Atc Item Name: tacrolimus
Pharma Manufacturer Name: DKSH SINGAPORE PTE. LTD.

Active Ingredients

Tacrolimus monohydrate eqv Tacrolimus

0.10g/100g

TACROLIMUS MONOHYDRATE EQV TACROLIMUS

0.1 G/100 G

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 8, 2004

Approval ID

29d72d7feece45b1

Type

Therapeutic

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