PROTOPIC 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 therapyfor 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.

PROTOPIC Ointment is not indicated for children younger than 2 years of age (see BOXED WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).

Adult

PROTOPIC Ointment 0.03% and 0.1%

• Apply a thin layer of PROTOPIC (tacrolimus) 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 PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been evaluated. PROTOPIC Ointment should not be used with occlusive dressings.

PEDIATRIC – FOR CHILDREN 2-15 YEARS

PROTOPIC Ointment 0.03%

• Apply a thin layer of PROTOPIC (tacrolimus) 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 PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been evaluated. PROTOPIC Ointment should not be used with occlusive dressings.

PROTOPIC® (tacrolimus) Ointment 0.03%

NDC 0469-5201-30 Product Code 520130 30 gram laminate tube
NDC 0469-5201-60 Product Code 520160 60 gram laminate tube
NDC 0469-5201-11 Product Code 520111 100 gram laminate tube

PROTOPIC® (tacrolimus) Ointment 0.1%

NDC 0469-5202-30 Product Code 520230 30 gram laminate tube
NDC 0469-5202-60 Product Code 520260 60 gram laminate tube
NDC 0469-5202-11 Product Code 520211 100 gram laminate tube

Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015-2548. Manufactured by: Astellas Pharma Manufacturing, Inc. Grand Island, NY 14072. Revised: January 2006. FDA revision date: 1/19/2006

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