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INDICATIONS AND USAGE
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
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.
PROTOPIC Ointment is not indicated for children younger than
2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS:
Pediatric
Use).
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DOSAGE AND ADMINISTRATION
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.
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HOW SUPPLIED
PROTOPIC® (tacrolimus) Ointment
0.1%
NDC54868-5233-1 30 gram laminate tube
NDC 54868-5233-0 100 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 Toyama Co., Ltd. Toyama Plant, 2-178 Kojin-machi, Toyama 930-0809,
Japan
Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK 74146
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