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Tacrolimus ointment (puterbi)

This product is suitable for patients with moderate to severe atopic dermatitis who are not suitable for traditional therapy due to potential hazards, or do not respond adequately to traditional therapy, or cannot tolerate traditional therapy. It is used as short-term or intermittent long-term treatment. Both 0.03% and 0.1% concentrations can be used for adults, but only 0.03% concentration can be used for children aged 2 years and over. More role
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Common name:
Tacrolimus ointment
Product No.:
C14200011859
Approval No.:
Gyzz j20148 (inquired by the State Drug Administration)
Jianke price:
¥170.00
Product specification:
0.3g:15g 0.1% (10g: 10mg) * 10g / piece 0.03% (10g: 3mg) * 10g / piece 0.1%:10g 10g:3mg(0.03%)+20g 0.1%:10g+20g
Manufacturer:
Astellas Toyama Co., Ltd. Toyama plant (Japan) (sub packaged by anstelai Pharmaceutical (China) Co., Ltd.)

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    Product name Tacrolimus ointment (puterbi)
    Main raw materials The main component of this product is tacrolimus.
    Main role This product is suitable for patients with moderate to severe atopic dermatitis who are not suitable for traditional therapy due to potential hazards, or do not respond adequately to traditional therapy, or cannot tolerate traditional therapy. It is used as short-term or intermittent long-term treatment. Both 0.03% and 0.1% concentrations can be used for adults, but only 0.03% concentration can be used for children aged 2 years and over.
    Product specification 0.1%:10g
    Usage and dosage adult 0.03% and 0.1% tacrolimus ointment Apply a thin layer of this product to the affected skin, gently rub it evenly and completely cover it twice a day. children 0.03% tacrolimus ointment Apply a thin layer of this product to the affected skin, gently rub it evenly and completely cover it twice a day. The product should be used to control the minimum amount of symptoms and signs of atopic dermatitis, and should be stopped when the symptoms and signs of atopic dermatitis disappear. This product should not be used for external use.
    manufacturing enterprise Astellas Toyama Co., Ltd. Toyama plant (Japan) (sub packaged by anstelai Pharmaceutical (China) Co., Ltd.)
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    [drug name] Tacrolimus ointment (puterbi)

    [common name] Tacrolimus ointment

    [specification and model] 0.1%:10g

    [manufacturer] Astellas Toyama Co., Ltd. Toyama plant (Japan) (sub packaged by anstelai Pharmaceutical (China) Co., Ltd.)

    [drug type] Western medicine

    [approval No.] Zzjz j20140148

    [validity period] 30 months

    [functional indications] This product is suitable for patients with moderate to severe atopic dermatitis who are not suitable for traditional therapy, or have insufficient response to traditional therapy or are unable to tolerate traditional therapy due to potential risks, and can be used as short-term or intermittent long-term treatment. Both 0.03% and 0.1% concentrations can be used for adults, but only 0.03% concentration can be used for children aged 2 years and over.

    [usage and dosage] adult 0.03% and 0.1% tacrolimus ointment Apply a thin layer of this product to the affected skin, gently rub it evenly and completely cover it twice a day. children 0.03% tacrolimus ointment Apply a thin layer of this product to the affected skin, gently rub it evenly and completely cover it twice a day. This product should use the minimum amount that can control the symptoms and signs of atopic dermatitis. When the symptoms and signs of atopic dermatitis disappear, it should be stopped. This product should not be used for external use.

    [adverse reactions] In the clinical study of 12 and 216 healthy volunteers, no phototoxicity and photosensitization were found. In the contact sensitization study of 198 healthy volunteers, one case showed signs of contact sensitization. In three 12 week randomized excipient controlled studies and four safety studies, 655 and 9163 patients were treated with puterbi ointment, respectively. The follow-up of adult and child patients in the safety study is shown in the table below: Follow up of patients in four safety studies The following table lists the adjusted incidence of adverse events in the same design, 12 week study, excipient group, tacrolimus ointment 0.03% and 0.1% treatment group, and the unadjusted incidence of adverse events in the four safety studies, regardless of whether these adverse events are related to the study drug. Incidence of adverse events during treatment Other adverse events with an incidence of 0.2% and less than 1% in the clinical trials listed in the above table include abnormal vision, abscess, anaphylactic reaction, anemia, anorexia, anxiety, arthritis, arthropathy, bilirubinemia, blepharitis, bone disorders, benign hyperplasia of breast, mucositis, cataract, chest pain, chills, colitis, conjunctival edema, constipation, cramps Skin candidiasis, cystitis, dehydration, dizziness, dry eyes, dry mouth, dry nose, dyspnea, ear discomfort, blood stasis, edema, epistaxis, eye pain, furuncle, gastritis, gastrointestinal discomfort, hernia, hypercholesterolemia, hyperosmolarity, hypothyroidism, joint discomfort, laryngitis, leukoplakia, lung abnormalities, discomfort, migraine, candidiasis Oral ulcer, nail discomfort, neck pain, benign tumor, oral candidiasis, otitis externa, photosensitive reaction, rectal discomfort, seborrheic dermatitis, skin cancer, skin discoloration, skin overgrowth, skin ulcer, stomatitis, tendon discomfort, abnormal thinking, dental caries, sweating, fainting, tachycardia, abnormal taste, accidental pregnancy, vaginal candidiasis, vaginitis Valvular heart disease, vasodilation, vertigo. Post marketing adverse reactions The following adverse reactions were found after puterbi ointment was approved for marketing. Since these adverse reactions are spontaneous reports from uncertain people, it is not possible to reliably estimate their incidence or establish a causal relationship with the medication. Central nervous system: seizures. Tumors: lymphoma, basal cell carcinoma, squamous cell carcinoma, malignant melanoma. Infection: bullous pustulosis, osteomyelitis, septicemia. Kidney: acute renal failure and renal insufficiency in patients with or without nesseton syndrome (Ichthyoid erythroderma). Skin: erythema and acne. (see the inner packaging manual for details)

    [precautions] In animal studies, continuous systemic use of calcineurin inhibitors to produce sustained immunosuppression and systemic administration to transplant patients can increase the risk of infection, lymphoma and skin malignancy. These risks are related to the intensity and time of immunosuppression. Based on the above information and action mechanism, the potential risk of topical calcineurin inhibitors, including putiper ointment, should be paid attention to. Although the causal relationship has not been established, it has been reported that patients treated with topical calcineurin inhibitors, including putiper ointment, rarely develop skin malignancies and lymphoma. Therefore: ·Puterbi ointment should not be used in adults and children with immune impairment.? ·If the symptoms and signs of atopic dermatitis do not improve within 6 weeks, the patient should be rechecked by the medical service provider and confirm the diagnosis. ·The safety of puterbi ointment for non continuous use for more than one year has not been established. General precautions Puterbi ointment should be avoided for skin diseases and malignant skin diseases that may worsen. Some malignant skin diseases, such as cutaneous T-cell lymphoma, may be very similar to atopic dermatitis. Puterbi ointment is not recommended for patients with skin barrier defects, including but not limited to nesseton syndrome, lamellar ichthyosis, diffuse erythroderma or skin graft-versus-host disease, which may increase the systemic absorption of tacrolimus. Oral administration is also not recommended. In the post marketing adverse reactions, there have been reports of the increase of tacrolimus plasma concentration under the above circumstances. Topical puterbi ointment may cause local symptoms, such as skin burning (burning, tingling, pain) or pruritus. Local symptoms are most common in the first few days of putiper ointment and usually disappear with the improvement of the affected skin of atopic dermatitis.? Apply 0. When treated with 1% puterbi ointment, 90% of the skin burning sensation lasted between 2 minutes and 3 hours (median time: 15 minutes), and 90% of the pruritus symptoms lasted between 3 minutes and 10 hours (median time: 20 minutes). Bacterial and viral skin infections Puterbi ointment has not been evaluated clinically for the safety and efficacy of infectious atopic dermatitis. Before starting the treatment with puterbi ointment, the infection focus at the treatment site should be removed first. Patients with atopic dermatitis are prone to superficial skin infections, including herpetic eczema (Kaposi varicella like rash),. Treatment with puterbi ointment may increase the risk of herpes zoster virus infection (chickenpox or herpes zoster), herpes simplex virus infection or herpetic eczema. Patients with lymphadenopathy In the clinical study, 12 of 13494 patients reported lymphadenopathy (0.8%), usually related to infection (especially skin infection), which was relieved after corresponding antibiotic treatment. Most of the 112 patients had definite etiology or eventually subsided. Organ transplant patients receiving immunosuppressive therapy (e.g. systemic use of tacrolimus) have an increased risk of lymphoma. Therefore, patients treated with puterbi ointment with lymphadenopathy should investigate the etiology of lymphadenopathy. If the cause of lymphadenopathy is not clearly found, or the patient has acute infectious mononucleosis at the same time, consider discontinuing the use of puterbi ointment. Patients with lymphadenopathy should be further monitored to ensure that the lymphadenopathy subsides. Sunlight exposure During treatment, patients should minimize or avoid natural or artificial sunlight exposure, even if there is no putetime on the skin. It is unclear whether puterbi ointment interferes with the skin's response to UV damage. Immunocompromised patients The efficacy and safety of puterbi ointment in immunocompromised patients have not been studied. Renal insufficiency It is reported that there are few cases of acute renal failure in patients treated with puterbi ointment after marketing. Systemic absorption is more likely to occur in patients with damaged epidermal barrier, especially those who apply puterbi ointment on a large area of body surface. Attention should be paid to patients with renal insufficiency. Patient information What is the most important information that patients should know about puterbi ointment?? The safety of long-term application of puterbi ointment is unclear. Very few people developed cancer (such as skin cancer or lymphoma) after applying putiper ointment, but there is no evidence that putiper ointment is related. For this reason, instruct the patient: ·Do not apply putiper ointment continuously for a long time.? ·Apply puterbi ointment only to eczema affected skin areas.? ·Do not use puterbi ointment on children under 2 years old.? Puterbi ointment has 2 specifications:? ·0.03% puterbi ointment is only used for children aged 2 years and over.? ·0.03% or 0.1% putiper ointment can be used in adults. It is recommended that the patient communicate with the doctor for more information.? How should the patient use puterbi ointment? Suggested patient:? ·Use putiper ointment accurately according to the prescription.? ·Use only puterbi ointment on eczema affected skin areas.? ·Short term applications. It can be reused intermittently if necessary.? ·When the symptoms and signs of eczema, such as pruritus, erythema and skin redness, disappear or meet the requirements of the doctor, stop putiper ointment.? ·If eczema symptoms recur after treatment with putiper ointment, please listen From the doctor's advice.? ·The following situations should be reported to the doctor as soon as possible:? 1。 The symptoms worsened after using puterbi ointment;? 2。 Skin infection:? 3。 The symptoms did not improve after six weeks of treatment. Sometimes other skin diseases may look like eczema. Application of puterbi ointment:? Suggested patient:? ·Wash your hands before using Peter.? ·Rub ~ a thin layer of puterbi ointment on eczema affected skin twice a day.? ·Use the minimum amount of puterbi ointment required to control the symptoms and signs of eczema.? ·If the nursing staff applies putiper ointment to the patient, or the patient does not apply it on his own hands, please wash your hands with soap and water after applying putiper ointment, so as to remove the residual drugs on his hands.? ·Don't take a bath, shower or swim after just using puterbi ointment. It may flush the medicine.? ·Moisturizer can be used with putiper ointment. But first consult your doctor if the product is suitable for them. Because the skin of eczema patients may be very dry, it is important to maintain good skin care. If you want to use moisturizer, please use it after using putiper ointment.? What should patients avoid after using puterbi ointment? Suggested patient:? ·Do not use ultraviolet treatment, fluorescent lamp or drying bed during the treatment with puterbi ointment;? ·Limit sun exposure during treatment with putiper ointment, even if there are no drugs on the skin.. If patients need to go outdoors after medication, they can wear loose clothes to cover the treatment area to avoid exposure to the sun. Doctors should advise patients to use appropriate protection from sun exposure.? ·Do not cover the skin in the treatment area with bandages, clothes or binding. Patients can wear normal clothes.? ·Avoid putting putiper ointment into your eyes or mouth. Don't swallow putiper ointment. If the patient swallows putiper ointment, he should seek help from his doctor. Please read the instructions carefully and follow the doctor's advice.

    [taboo] This product is prohibited for patients with a history of allergy to tacrolimus or any other component in the preparation.

    [listing Permit Holder] Astellastoyama Co., Ltd. toyamaplant (Japan) (sub packaged by anstelai Pharmaceutical (China) Co., Ltd.)

    [packaging unit] branch

    [main ingredients] The main component of this product is tacrolimus.

    [character] This product is white to light yellow ointment.

    [applicable population] adult

    [medication for pregnant and lactating women] Teratogenicity: pregnancy medication grade C At present, there has not been enough appropriate controlled research on the local application of this product in pregnant women. The experience of using this product in pregnant women is also very limited, and it is not enough to evaluate the safety of its application during pregnancy. The reproductive toxicity of tacrolimus was studied in rats and rabbits. When the mother was given a toxic dose orally, the fetus had adverse reactions. At the stage of embryonic organ formation, tacrolimus with oral doses of 0.32 and 1.0 mg / kg (in terms of body surface area, equivalent to 0.04 and 0.12 times of the maximum recommended dose for human use, respectively) produced toxic reactions to female rabbits, and the abortion rate increased. Only in the higher dose group, the proportion of fetal malformations and developmental abnormalities increased. Oral administration of tacrolimus at a dose of 3.2mg/kg to rats during embryonic organ formation produced toxic reactions to female rats, resulting in increased late resorption, decreased number of live fetuses, and decreased body weight and developmental ability of young rats. After the embryonic organ formation period and during lactation, oral administration of tacrolimus of 1.0 and 3.2mg/kg (equivalent to 0.04 and 0.12 times of the maximum recommended dose for human use in terms of body surface area) to pregnant rats can lead to weight loss of young rats. There was no decrease in the reproductive capacity of male or female animals. No appropriate controlled study has been conducted on the systemic application of tacrolimus in pregnant women. Tacrolimus can pass through the placenta. Systemic administration of tacrolimus during pregnancy will lead to neonatal hyperkalemia and renal dysfunction. This product can only be used during pregnancy when the benefits of treatment to the mother outweigh the potential harm to the fetus. Although the systemic absorption of tacrolimus after local application is very little compared with systemic application, tacrolimus is known to be secreted into milk. As it may cause serious adverse reactions to lactating infants, it should be decided whether to stop lactation or medication according to the importance of drug treatment to the mother.

    [medication for children] Puterbi ointment is not suitable for children under 2 years old Only a low concentration of 0.03% of puterbi soft high legs and feet are used for short-term or intermittent long-term treatment of children with moderate to severe specific dermatitis aged 2 or over who are not immune impaired, do not respond adequately to other topical treatments, or do not recommend these treatments. The long-term safety and efficacy of puterbi ointment on the developing immune system are unclear. Four studies were conducted on a total of 4400 patients aged 2-15 years: a 12 week randomized excipient controlled study and three one to three-year open safety studies, of which 2500 patients were aged 2-6 years. The most common adverse reactions associated with the application of putiper ointment in these studies were skin burning and itching (see adverse reactions). Compared with the excipient group, the less common adverse events ([5%) in patients treated with puterbi ointment 0.03% were varicella zoster (mostly varicella) and commendatory herpes. In the open safety study, adverse events The incidence of (including infection) did not increase with the extension of medication time or the increase of medication dose. Among 4400 patients treated with putiper ointment, 24 (0.5%) developed herpetic eczema. Because the safety and efficacy of putiper ointment in children under 2 years old have not been established, putiper ointment is not recommended for patients in this age group. In an open study, the immune response of 23 patients with moderate to severe atopic dermatitis aged 2 to 12 years treated with 0.03% tacrolimus ointment after 23 valent pneumococcal polysaccharide vaccine was evaluated. All patients developed protective antibody titers, which was similar to that seen in another seven month, double-blind trial to observe the immune response to meningococcal serum group C The results were similar. Patients with moderate to severe atopic dermatitis aged 2 to 11 were divided into three groups: 0.03% tacrolimus ointment group (121 cases), hydrocortisone excipient group (111 cases) and normal children group (44 cases).

    [medication for elderly patients] In the phase III clinical trial, 25 patients aged 65 and over were treated with this product. The incidence of adverse events in these patients was consistent with that in other adult patients.

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      Tacrolimus ointment (puterbi)

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