Topical Tacrolimus Ointment 0.03% (Tacrolimus Monohydrate)

Adult use

Adults and adolescents (aged 16 years and older): Adults and adolescents (aged 16 years and older) should start with the 0.1% product and apply it to the affected areas twice daily until the lesions resolve. If symptoms recur, restart treatment with this 0.1% product twice daily. If the clinical condition allows, reduce the frequency of application or try using the lower-dose 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. 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 increase systemic absorption. This medicine may be applied to any part of the body, including the face, neck, and flexural areas, except mucous membranes.

Child use

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

This medication is used for the treatment of atopic dermatitis and should be limited to use on the skin. Long-term use may have an unclear association with malignant tumors; however, prolonged use across all age groups should be avoided. It is prohibited for use in children under the age of 2 years, and patients with reduced immune function should not use this medication. Patients with skin erosion or ulcers, severe renal impairment, or hyperkalemia, as well as pregnant women or those who may become pregnant, should not use this medication. Furthermore, individuals allergic to tacrolimus or its additives, patients undergoing ultraviolet therapy, and patients with certain skin disorders should also avoid use. During use, local symptoms such as burning sensation, itching, and pain may occur, typically appearing in the first few days of use and gradually diminishing. This medication may increase the risk of viral infections, such as skin infections and herpes dermatitis; if an infection is suspected, treatment should be discontinued and a physician consulted. Avoid sunlight or ultraviolet exposure, do not cover the area where the medication is applied, and wash hands thoroughly after use. If pregnant or nursing, the risks and benefits of using this medication should be carefully considered, and the decision to use it during breastfeeding should be made in consultation with a physician. This medication is not for oral intake; if ingested accidentally, medical attention should be sought immediately. When using this medication, it is important to consult a physician or pharmacist if using other topical medications or prescription/non-prescription drugs. Store out of reach of children and do not keep in excessively cold or hot locations. This medication has very low systemic absorption, but absorption may vary depending on skin condition, so caution is needed during use. Reported adverse reactions include skin irritation, itching, skin redness, headaches, cold-like symptoms, etc. If symptoms are severe or persist, inform a physician.

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

Store this medication in a tightly sealed container to prevent exposure to air or moisture, maintaining a storage temperature between 1 to 30 degrees Celsius. This way, the efficacy of the medication can be safely maintained.

Appearance

White to yellowish ointment

Package unit

10g/tube, 30g/tube