Protopic Ointment 0.1% (Tacrolimus Hydrate)

Adult use

○ 0.03% 1) Treatment of flare-ups This medicine may be used for short-term treatment and intermittent long-term treatment. This medicine should not be used continuously for a long period. Treatment with this medicine should begin at the first appearance of signs and symptoms. Treat each affected area of skin with this medicine until the lesions resolve, nearly resolve, or become less severe. Restart treatment at the first sign of recurrence (flare-up). Adults and adolescents (16 years of age or older): Adults and adolescents (16 years of age or older) should start with the 0.1% product and apply it to affected areas twice daily until the lesions resolve. If symptoms recur, restart treatment with this medicine, the 0.1% product, twice daily. If the clinical condition allows, attempt to reduce the frequency of administration or use the lower-strength 0.03% product. Improvement generally begins within 1 week of starting treatment. If there are no signs of improvement after 2 weeks of treatment, consider other treatment options. ○ 0.1% 1) Treatment of flare-ups This medicine may be used for short-term treatment and intermittent long-term treatment. This medicine should not be used continuously for a long period. Treatment with this medicine should begin at the first appearance of signs and symptoms. Treat each affected area of skin with this medicine until the lesions resolve, nearly resolve, or become less severe. Restart treatment at the first sign of recurrence (flare-up). Adults and adolescents (16 years of age or older): Adults and adolescents (16 years of age or older) should start with the 0.1% product and apply it to affected areas twice daily until the lesions resolve. If symptoms recur, restart treatment with this medicine, the 0.1% product, twice daily. If the clinical condition allows, attempt to reduce the frequency of administration or use the lower-strength 0.03% product. Improvement generally begins within 1 week of starting treatment. If there are no signs of improvement after 2 weeks of treatment, consider other treatment options. 2) Maintenance therapy Adults and adolescents (16 years of age or older): Suitable for patients who responded to application twice daily for up to 6 weeks (lesions resolved, nearly resolved, or became less severe). To prevent progression to a flare-up, apply once daily on 2 days per week to areas commonly affected by atopic dermatitis. Applications should be 2-3 days apart (for example, every Monday and Thursday). If there are signs of recurrence of a flare-up, restart application twice daily. After 12 months of treatment, the physician should review the patient's condition and decide whether maintenance therapy should continue, given the lack of safety information on maintenance therapy beyond 12 months. ○ Method of application - Apply a thin layer of this medicine only to affected areas or areas where symptoms commonly occur. Use the minimum amount needed to control the patient's symptoms (an amount about the size of a pea squeezed from the tube is sufficient to cover an area approximately 5cm in diameter.). - Avoid occlusive therapy, which may promote systemic absorption. This medicine may be applied to any part of the body, including the face, neck, and flexural areas, except for mucous membranes.

Child use

Children under 2 years of age: This medicine should not be used in children under 2 years of age until further data are available. Children 2 years of age or older: Children (2 years of age or older) should use only the lower-strength 0.03% product. Begin applying it to affected areas twice daily and treat for up to 3 weeks. Thereafter, reduce the frequency of application to once daily until the lesions resolve. Children 2 to 15 years of age: Suitable for patients who responded to application twice daily for up to 6 weeks (lesions resolved, nearly resolved, or became less severe). To prevent progression to a flare-up, apply once daily on 2 days per week to areas commonly affected by atopic dermatitis. Applications should be 2-3 days apart (for example, every Monday and Thursday). If there are signs of recurrence of a flare-up, restart application twice daily. After 12 months of treatment, the physician should review the patient's condition and decide whether maintenance therapy should continue, given the lack of safety information on maintenance therapy beyond 12 months. This medicine should not be used in children under 2 years of age until further data are available.

This medication has an unclear association with the development of malignant tumors with long-term use; however, it should be avoided for long-term, continuous use. This medication should only be applied to areas with atopic dermatitis and should not be used in children under 2 years of age. Patients with impaired immune function should not use this medication. It should not be used in patients with skin wounds or ulcers, those with severely impaired kidney function or hyperkalemia, pregnant or potentially pregnant women, patients allergic to this medication's ingredients, patients receiving UV therapy, or patients with certain skin conditions. When using this medication, skin irritation or itching, headache, cold-like symptoms, or skin infections may occur, and rarely, allergic reactions, skin rashes, or edema may occur. If a skin infection develops while using this medication, it must be continued after treatment, but in the case of a viral infection, treatment should be halted. Do not cover the application area with a bandage or seal it, and wash hands thoroughly after use. It should be applied after the skin has completely dried following bathing or showering, and it is best to avoid water activity immediately after application. Avoid exposure to sunlight or artificial UV light, protect the skin with loose clothing when outdoors, and use appropriate sunscreen if necessary. If pregnant or breastfeeding, consult a doctor to decide whether to use this medication, as it may affect the fetus or newborn and caution is required. It is only for use in children aged 2 years and older, and elderly patients show a similar safety profile to that of adult patients. In case of overdose, consult a physician immediately; this medication is not for oral use and should not be ingested. If starting other medications or changing skin treatments while using this medication, consult a healthcare professional. This medication is for topical use only and should be kept out of the mouth and eyes. While using this medication, the skin may tingle or itch; however, this mostly occurs in the first few days of treatment and gradually improves. When storing this medication, be sure to tightly close the tube cap, keep it out of reach of children, and avoid exposure to extreme temperatures.

• skin irritation
• itching
• cold-like symptoms
• allergic reactions
• skin redness
• headache
• skin infection
• fever
• infection
• increased coughing

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Additionally, it is best to store it at room temperature, avoiding excessive heat or cold.

Appearance

White to pale yellow ointment

Package unit

10g/tube 30g/tube