{"id":21416,"date":"2022-05-23T06:52:32","date_gmt":"2022-05-23T06:52:32","guid":{"rendered":"https:\/\/zeepedia.com\/?p=21416"},"modified":"2022-05-23T15:00:57","modified_gmt":"2022-05-23T15:00:57","slug":"protopic","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/protopic\/","title":{"rendered":"Protopic &#8211; Tacrolimus monohydrate uses, dose and side effects"},"content":{"rendered":"\n<p>0.03%&nbsp;ointment<br>tacrolimus monohydrate<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">WHAT PROTOPIC IS AND WHAT IT IS USED FOR<\/h2>\n\n\n\n<p>The active substance in Protopic, tacrolimus monohydrate, is an immunomodulatory agent.<\/p>\n\n\n\n<p>Protopic 0.03% ointment is used to treat moderate to severe atopic\u00a0dermatitis\u00a0(\u00a0eczema\u00a0) in adults who have not had enough effect or can not tolerate conventional treatment such as\u00a0topical\u00a0corticosteroids\u00a0and in children (2 years and older) who have not had enough effect of conventional treatment such as\u00a0topical\u00a0corticosteroids\u00a0are.<\/p>\n\n\n\n<p>When moderate to severe atopic&nbsp;dermatitis&nbsp;is completely or almost healed, after up to 6 weeks of treatment for an eczema outbreak, and if you usually have eczema outbreaks frequently (4 times a year or more), it may be possible to prevent the recurrence of eczema outbreaks or that extend the time when you have no outbreak, by using Protopic 0.03% ointment twice a week.<\/p>\n\n\n\n<p>In atopic\u00a0dermatitis, an overreaction of the skin&#8217;s immune system causes\u00a0inflammation\u00a0of the skin (\u00a0itching,\u00a0redness, dryness).\u00a0Protopic alters the abnormal immune response and relieves\u00a0inflammation\u00a0and itching of the skin.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">BEFORE YOU USE PROTOPIC<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Protopic<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (eg azithromycin, clarithromycin, erythromycin).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before using Protopic:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you have\u00a0<strong>liver failure<\/strong>.<\/li><li>If you have any form of\u00a0skin cancer\u00a0(\u00a0tumors\u00a0) or if you have a\u00a0weakened immune system\u00a0(immune deficiency), for whatever reason.<\/li><li>If you have a\u00a0hereditary skin barrier disease\u00a0such as Netherton&#8217;s syndrome,\u00a0lamellar\u00a0ichthyosis\u00a0(skin that scales heavily, due to the thickening of the outer layer of skin), or if you have\u00a0general\u00a0erythroderma\u00a0(red, inflamed, flaky skin on the whole body).<\/li><li>If you have\u00a0cutaneous\u00a0Graft versus Host disease (an immune reaction in the skin that is a common complication in patients who have had a bone marrow transplant)<\/li><li>If you have\u00a0swollen\u00a0lymph nodes\u00a0at the beginning of treatment.\u00a0If your\u00a0lymph nodes\u00a0swell during treatment with Protopic, consult your doctor.<\/li><li>If you have\u00a0infected\u00a0eczema.\u00a0Do not use the ointment on infected\u00a0eczema.<\/li><li>If you notice any\u00a0change in the appearance of your skin, consult your doctor.<\/li><li>Based on the results of long-term studies and experience, no association between treatment with Protopic ointment and the development of\u00a0malignancy\u00a0has been confirmed, but no definitive conclusions can be drawn.<\/li><li>Avoid\u00a0exposing\u00a0the skin to sunlight for extended periods and artificial sunlight such as tanning beds.\u00a0If you spend a lot of time outdoors after using Protopic, you should wear sunscreen and wear loose-fitting clothing that protects your skin from sunlight.\u00a0Ask your doctor for advice on other suitable ways to protect yourself from the sun.\u00a0If you have been prescribed light therapy, tell your doctor that you are using Protopic, as concomitant treatment with Protopic, and light therapy is not recommended.<\/li><li>If your doctor prescribes treatment with Protopic twice a week, to keep\u00a0eczema\u00a0away, your condition should be evaluated by a doctor at least once a year, even if the disease is under control.\u00a0For children, a break must be made in the maintenance treatment after 12 months, to be able to assess whether further treatment is needed.<\/li><li>It is recommended to use the Protopic ointment with the lowest possible strength and the lowest frequency for the shortest possible time.\u00a0This decision should be based on your doctor&#8217;s assessment of how your\u00a0eczema\u00a0responds to the Protopic ointment.<\/li><\/ul>\n\n\n\n<p><strong>Children<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Protopic ointment\u00a0<strong>is not approved for the treatment of children under 2 years<\/strong>.\u00a0The ointment should therefore not be used on this age group.\u00a0Consult your doctor.<\/li><li>The effect of treatment with Protopic on a developing immune system in children, especially young children, have not been studied.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines, cosmetics, and Protopic<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>You can use emollient&nbsp;creams&nbsp;and skin lotions during treatment with Protopic, but these products should not be used within two hours before and after using Protopic.<\/p>\n\n\n\n<p>The use of Protopic with other topical medicinal products&nbsp;or&nbsp;with concomitant treatment with oral&nbsp;corticosteroids&nbsp;(eg&nbsp;cortisone&nbsp;) or medicines affecting the immune system has not been studied.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Protopic with food and alcohol<\/h2>\n\n\n\n<p>When using Protopic, alcohol consumption can cause swelling or&nbsp;redness&nbsp;and a feeling of warmth in the skin or face.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Protopic contains butylhydroxytoluene (E321)<\/h2>\n\n\n\n<p>Protopic contains butylhydroxytoluene (E321) which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">HOW TO USE PROTOPIC<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Apply a thin layer of Protopic on the affected skin areas.<\/li><li>Protopic can be used on most body parts, including the face and neck and in the elbow and knee creases.<\/li><li>Avoid using the ointment on the inside of the nose or mouth or in the eyes.\u00a0If the ointment comes in contact with any of these areas, wipe it off thoroughly and\/or rinse with water.<\/li><li>Do not cover skin areas treated with the ointment with a bandage or similar.<\/li><li>Wash your hands after using Protopic, unless your hands are also treated.<\/li><li>Before using Protopic after showering or bathing, the skin should be completely dry.<\/li><\/ul>\n\n\n\n<p><em>Children (2 years and older)<\/em><\/p>\n\n\n\n<p>Use Protopic 0.03% ointment twice daily for up to three weeks, once in the morning and once in the evening.&nbsp;Thereafter, the ointment is applied once daily on the affected skin areas until the&nbsp;eczema&nbsp;is gone.<\/p>\n\n\n\n<p><em>Adults (16 years and older)<\/em><\/p>\n\n\n\n<p>For adult patients (16 years and older) there are two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment).&nbsp;Your doctor will decide which strength is best for you.<\/p>\n\n\n\n<p>Treatment is usually started with Protopic 0.1% ointment twice daily, once in the morning and once in the evening until eczema\u00a0has healed.\u00a0Depending on the effect on your\u00a0eczema, your doctor will decide if you can use the ointment less often or if the lower strength, Protopic 0.03% ointment, can be used.<\/p>\n\n\n\n<p>Treat any affected skin area until the&nbsp;eczema&nbsp;is gone.&nbsp;Improvement usually occurs within a week.&nbsp;If you do not notice any improvement within two weeks, talk to your doctor about other possible treatments.<\/p>\n\n\n\n<p>Your doctor may\u00a0prescribe\u00a0you to use Protopic ointment twice a week, when\u00a0the eczema\u00a0is completely or almost healed (Protopic 0.03% for children and Protopic 0.1% for adults).\u00a0The Protopic ointment should then be used once a day two days a week (eg Monday and Thursday) on the skin areas where you usually get\u00a0eczema.\u00a0It should take 2-3 days without Protopic treatment between each treatment session.<\/p>\n\n\n\n<p>If symptoms recur, you should use Protopic twice daily, as described above, and consult your doctor to review treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you happen to swallow ointment<\/h2>\n\n\n\n<p>If you accidentally swallow the ointment, talk to your doctor or pharmacist as soon as possible.&nbsp;Do not try to induce vomiting.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Protopic<\/h2>\n\n\n\n<p>If you forget to apply the ointment at the time you should do it, do it as soon as you remember and then continue as before.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">POSSIBLE SIDE EFFECTS<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>Very common (may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>burning sensation and&nbsp;itching<\/li><\/ul>\n\n\n\n<p>These symptoms are usually mild to moderate and usually go away within a week of starting treatment.<\/p>\n\n\n\n<p>Common (may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>redness<\/li><li>feeling of warmth<\/li><li>pain<\/li><li>increased sensitivity of the skin (especially to heat and cold)<\/li><li>creeps in the skin<\/li><li>rash<\/li><li>local skin reactions regardless of cause;&nbsp;a reaction can be inflamed or infected hair follicles<\/li><li>herpes virus infections (eg cold sores, generalized&nbsp;herpes&nbsp;simplex&nbsp;infections&nbsp;)<\/li><li>redness&nbsp;of the face or skin irritation after consuming alcohol<\/li><\/ul>\n\n\n\n<p>Uncommon (may affect less than 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>acne<\/li><\/ul>\n\n\n\n<p>After treatment twice a week,&nbsp;infection&nbsp;at the treatment site has been reported in children and adults.&nbsp;Impetigo, a superficial bacterial skin infection that normally causes blisters or sores on the skin, has been reported in children.<\/p>\n\n\n\n<p>Rosacea&nbsp;(&nbsp;redness&nbsp;of the face), rosacea-like skin inflammation, lentigo (flat brown spots on the skin),&nbsp;edema&nbsp;(fluid accumulation) at the site where the ointment has been used, and herpes infection of the eye have been reported after the product was introduced to the market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">HOW TO STORE PROTOPIC<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the tube and the carton after \u201cEXP\u201d.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Do not store above 25 \u00b0 C.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CONTENTS OF THE PACKAGING AND OTHER INFORMATION<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is tacrolimus monohydrate.\u00a01 g Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).<\/li><li>The other ingredients are white petrolatum, liquid paraffin, propylene carbonate, white beeswax, solid paraffin, butylhydroxytoluene (E321), and all\u00a0<em>-rac<\/em>\u00a0-\u03b1-tocopherol.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Protopic is a white to slightly yellowish ointment.\u00a0It is provided in tubes containing 10, 30, or 60 grams of ointment.\u00a0Not all pack sizes may be marketed.\u00a0Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorization Holder:<\/strong><br>LEO Pharma A \/ S, Industriparken 55, 2750 Ballerup, Denmark.<\/p>\n\n\n\n<p><strong>Manufacturer:<\/strong><br>Astellas Ireland Co.&nbsp;Ltd., Killorglin, County Kerry, Ireland.<br>LEO Laboratories Ltd.&nbsp;285 Cashel Road, Crumlin, Dublin 12, Ireland<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n<p>LEO Pharma AB<\/p>\n\n\n\n<p>Tel: +46 40 3522 00<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The active substance in Protopic, tacrolimus monohydrate, is an immunomodulatory agent.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18527],"tags":[22107,22102,22103,22106,22098,22101,22104,22099,22105,22100],"class_list":["post-21416","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-protopic","tag-benefits-of-tacrolimus-monohydrate","tag-protopic","tag-protopic-side-effects","tag-tacrolimus-monohydrate","tag-tacrolimus-monohydrate-side-effects","tag-what-is-protopic","tag-what-is-tacrolimus-monohydrate","tag-what-protopic-is-used-for","tag-what-tacrolimus-monohydrate-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21416","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=21416"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21416\/revisions"}],"predecessor-version":[{"id":21461,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21416\/revisions\/21461"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21416"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21416"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}