Indications
Tacrolimus ointment is designed for both short-term and intermittent long-term treatment of moderate to severe atopic dermatitis in patients where alternative conventional therapies are not advisable due to potential risks, or in individuals who do not respond adequately to or cannot tolerate these therapies. Additionally, Tacrolimus ointment is effective for various skin conditions, including chronic cutaneous graft-versus-host disease, hand and foot eczema, allergic contact dermatitis, vitiligo, psoriasis, lichen planus, facial lichen, vulvar lichen sclerosus, pyoderma gangrenosum, leg ulcers related to rheumatoid arthritis, steroid-induced rosacea, alopecia areata, annular erythema, chronic actinic dermatitis, and persistent facial erythema. Consult a registered physician before using this medication.
Pharmacology
Tacrolimus is a macrolide immunomodulator derived from the fungus Streptomyces tsukubaensis. It has been shown to inhibit the activation of T-lymphocytes by binding to an intracellular protein known as FKBP-12. This results in the formation of a complex involving Tacrolimus, FKBP-12, calcium, calmodulin, and calcineurin, which subsequently inhibits calcineurin’s phosphatase activity, leading to a reduced inflammatory response.
Dosage & Administration
For Adults: Apply a thin layer of Tacrolimus ointment to the affected skin areas twice daily, gently rubbing it in until fully absorbed. Continue treatment for one week after the signs and symptoms of atopic dermatitis have resolved. The safety of using Tacrolimus ointment with occlusive dressings, which may enhance systemic absorption, has not been established.
For Children:
- Tacrolimus 0.03% ointment is suitable for pediatric patients aged 2 years and older.
- Tacrolimus 0.1% ointment can be used for children aged 16 years and above.
For Elderly Patients: In phase 3 studies, patients over 65 years old have received Tacrolimus ointment, and the adverse event profile was consistent with that observed in other adult populations. Consult a registered physician before using this medication.
Interactions
No formal studies have been conducted to evaluate drug interactions with Tacrolimus ointment. Caution is advised when using known CYP3A4 inhibitors in patients with extensive or erythrodermic conditions. Examples of such drugs include erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, and cimetidine.
Contraindications
Tacrolimus ointment is contraindicated for individuals with a known hypersensitivity to Tacrolimus or any of its components.
Side Effects
Tacrolimus ointment typically has few and rare side effects. Possible reactions may include skin burning, itching, flu-like symptoms, allergic reactions, skin redness, skin infections, and headaches.
Pregnancy & Lactation
Pregnancy Category C. Adequate and well-controlled studies on the topical use of Tacrolimus in pregnant women are lacking. Although systemic absorption from topical application is minimal compared to systemic administration, Tacrolimus is excreted in human breast milk. Due to potential serious adverse reactions in nursing infants, a decision should be made to either discontinue breastfeeding or to stop the medication, considering the importance of the drug to the mother.
Precautions & Warnings
Caution should be exercised when using Tacrolimus ointment in patients with atopic dermatitis who are prone to superficial skin infections. The safety of Tacrolimus ointment has not been established for patients with generalized erythroderma.
Overdose Effects
Tacrolimus ointment is not intended for oral use. Accidental ingestion may lead to side effects associated with systemic Tacrolimus administration. If oral ingestion occurs, seek medical advice immediately.
Therapeutic Class
Immunomodulatory agents affecting the immune response.
Storage Conditions
Store below 30°C, away from light, and keep out of reach of children.
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