Tacrolimus Ointment 0.1% (Tacrolimus Hydrate)

Adult use

1) Treatment of flare-ups This medicine may be used for short-term treatment and intermittent long-term treatment. It should not be used continuously for a prolonged period. Treatment with this medicine should be started at the first appearance of signs and symptoms. Apply this medicine to each affected area of skin until the lesions resolve, nearly resolve, or improve. Restart treatment at the first sign of recurrence (flare-up). Adults and adolescents (16 years of age and older): Adults and adolescents (16 years of age and older) should start with the 0.1% product and apply it to affected areas twice daily, continuing until the lesions resolve. If symptoms recur, restart treatment with this medicine 0.1% product twice daily. If the clinical condition permits, reduce the frequency of application or try using 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, other treatment options should be considered. 2) Maintenance therapy Adults and adolescents (16 years of age and older): Suitable for patients who responded to application for up to 6 weeks twice daily (lesions resolved, nearly resolved, or improved). 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 spaced 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 determine whether maintenance therapy should continue, as safety information for maintenance therapy beyond 12 months is not available. ○ How to apply - Apply a thin layer of this medicine only to the 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 5 cm 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 skin folds, but not to mucous membranes.

This medicine should only be used on areas affected by atopic dermatitis, and prolonged use should be avoided. It is prohibited for use in children under 2 years of age. This medicine should not be used in patients with weakened immune function. Patients with skin wounds or ulcers, severely impaired kidney function, or those with hyperkalemia, as well as pregnant women or those who may become pregnant, should also avoid using this medicine. This medicine is for topical application and should not be ingested or used systemically. Hands should be washed thoroughly after use. The treated area should not be sealed with a bandage or dressing and should be applied only when the skin is completely dry after bathing or showering. Avoid exposure to sunlight or ultraviolet light, and it is recommended to protect the skin with loose clothing when going outdoors. Skin discomfort such as burning, itching, or tingling may occur during use, but this usually subsides after the first few days. If any adverse reactions are severe or persistent, consultation with a doctor is necessary. This medicine may cause skin infections, headaches, fever, or allergic reactions in some patients, so symptoms should be reported to healthcare professionals. If pregnant or breastfeeding, consultation with a doctor is mandatory before using this medicine, and it should be decided whether to stop breastfeeding or medication use. When using this medicine, always consult a doctor or pharmacist if using other topical medications or drugs concurrently. Elderly patients can also use it, but should be monitored closely for adverse reactions. In case of overdose, immediately consult a doctor, and caution should be exercised as this medicine is not for oral use. This medicine should be stored out of reach of children and protected from extreme temperatures.

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

This medicine should be stored in a tightly sealed container to prevent exposure to air and moisture. The storage temperature should be maintained between 1 degree and 30 degrees Celsius. This way of storing ensures the effectiveness of the medicine and prevents deterioration.

Appearance

White to slightly yellow ointment

Package unit

10 grams/tube