How Supplied:
0.03% and 0.1% ointment, 30 g, 60 g, and 100 g
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 these treatments are not available.
Prescribing Instructions:
Prescribing Information Instructions [PDF]
Side Effects and Contraindications:
Rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic. The most common adverse events associated with the use of Protopic included the sensation of skin burning, pruritus, flu-like symptoms, and headache. The use of Protopic should be avoided on known or suspected malignant lesions. The use of Protopic on patients with Netherton’s syndrome or similar skin diseases is not recommended. Patients should minimize or avoid natural or artificial sunlight exposure. Skin infections should be cleared prior to application, and there may be increased risk of certain skin infections. Protopic should not be used with occlusive dressings.
Company:
Astellas Pharma US, Inc.
800-888-7704
www.us.astellas.com
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