Tacrolimus ointment

The mechanism of action of tacrolimus in the treatment of atopic dermatitis is still unclear. Although the mechanism of action of tacrolimus is somewhat understood, the clinical relevance of these findings to atopic dermatitis is unclear. Tacrolimus has been shown to inhibit T lymphocyte activation by first binding to the intracellular protein FKBP-12 to form a complex composed of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin, thereby inhibiting the phosphatase activity of calcineurin and preventing the dephosphorylation and translocation of nuclear factor of activated T cells (NF-AT), a nuclear component that initiates gene transcription to form lymphokines (e.g., IL-2, interferon). Tacrolimus can also inhibit the transcription of genes encoding IL-3, IL-4, IL-5, GM-CSF, and TNF-?, all of which are involved in the early stages of T cell activation. In addition, tacrolimus can inhibit the release of synthesized mediators in skin mast cells and basophils and downregulate the expression of FCRI on the surface of Langerhans cells.

Each gram of this product contains 0.03% or 0.1% (w/w) tacrolimus, and the ointment base is mineral oil, paraffin, propylene carbonate, white vaseline and white wax.

This product is a white to light yellow ointment.

No data yet

Adults: 0.03% and 0.1% Tacrolimus Ointment: Apply a thin layer of this product to the affected skin, rub it in gently, and cover it completely, twice a day, until one week after the symptoms and signs of atopic dermatitis disappear. Occlusive therapy may promote systemic absorption, and its safety has not been evaluated. This product should not be applied externally with occlusive dressings. Children: 0.03% Tacrolimus Ointment: Apply a thin layer of this product to the affected skin, rub it in gently, and cover it completely, twice a day, until one week after the symptoms and signs of atopic dermatitis disappear. Occlusive therapy may promote systemic absorption, and its safety has not been evaluated. This product should not be applied externally with occlusive dressings.

In clinical studies with 12 and 216 healthy volunteers, respectively, the drug was not found to be phototoxic and photosensitizing. In a contact sensitization study of 198 healthy volunteers, one case showed signs of contact sensitization. In three randomized vehicle-controlled studies and two long-term safety studies, 655 and 571 patients were treated with this product, respectively. The following table lists the adjusted adverse event rates in the vehicle group, 0.03% and 0.1% concentration of this product in three identically designed 12-week studies, and the unadjusted adverse event rates in two one-year safety studies, regardless of whether these adverse events are related to the study drug. It may be related to the use of this product. A total of 4 cases of varicella occurred in the 12-week study in children; 1 case of herpes zoster on the labialis in the 12-week study in adults; 7 cases of varicella and 1 case of herpes zoster occurred in the open-label study in children; 2 cases of herpes zoster occurred in the open-label study in adults. Usually warts. Other adverse events with an incidence of greater than or equal to 1% in various clinical trials included alopecia, ALT or AST increased, anaphylactic reaction, angina pectoris, angioedema, anorexia, anxiety, arrhythmia, arthralgia, arthritis, bilirubinemia, breast pain, cellulitis, cerebrovascular accident, cheilitis, chills, constipation, creatinine increased, dehydration, depression, dizziness, dyspnea, ear pain, skin ecchymosis, edema, epistaxis, exacerbation of untreated areas, eye discomfort, eye pain, furunculosis, gastritis, hernia, hyperglycemia, hypertension, hypoglycemia, hypoxia, laryngitis, leukocytosis, leukopenia, abnormal liver function tests, pulmonary disorder, malaise, migraine, neck pain, neuritis, palpitations, paresthesia, peripheral vascular abnormality, photosensitivity reaction, complications of treatment procedures, skin depigmentation, sweating, taste disturbances, dental disorders, unintended pregnancy, vaginal candidiasis, vasodilation, and vertigo.

This product is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the formulation.

Precautions for children: 1. For children, it is usually necessary to use 1.5 to 2 times the recommended adult dose to achieve the same blood drug concentration as adults (except for patients with impaired liver and kidney function). 2. Patients under 2 years old should undergo serological tests for EBV virus before using this product. 3. If the physician decides that children should take this product, they must take it under adult supervision. Precautions for pregnancy and lactation: Contraindicated. Precautions for the elderly: In the Phase III clinical trial, 25 patients aged 65 and above were treated with this product. The adverse events in these patients were consistent with those in other adult patients.

The drug interaction of this product for topical application has not been studied. Due to the extremely small amount of absorption, this product is unlikely to interact with systemically administered drugs, but it cannot be completely ruled out. Patients with more extensive dermatitis and/or erythroderma should be cautious when taking known CYP3A4 inhibitors. Examples of these drugs include erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

seal.

10g:3mg(0.03%)

30 months

Zhejiang Sansheng Mandi Pharmaceutical Co., Ltd.

• Founded in:

  1997-10-27

• Address:

  No. 1, Wangjiashan Road, Qingshanhu Street, Lin'an District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330185253932420N

• Registered Funds:

  56.5 million yuan

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