{"id":7481,"date":"2021-02-23T09:25:44","date_gmt":"2021-02-23T09:25:44","guid":{"rendered":"https:\/\/zeepedia.com\/?p=7481"},"modified":"2021-05-24T11:13:53","modified_gmt":"2021-05-24T11:13:53","slug":"dificlir","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/dificlir\/","title":{"rendered":"Dificlir &#8211; Fidaxomicin uses, dose and side effects"},"content":{"rendered":"\n<p> 200 mg\u00a0film-coated tablets\u00a0<br>fidaxomicin<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What DIFICLIR is and what it is used for<\/h2>\n\n\n\n<p>DIFICLIR is an&nbsp;antibiotic&nbsp;that contains the active substance fidaxomicin.<br><\/p>\n\n\n\n<p>DIFICLIR film-coated tablets are used in adults, adolescents, and children who weigh at least 12.5 kg to treat the&nbsp;infection&nbsp;in the colonic&nbsp;mucosa, caused by bacteria called&nbsp;<em>Clostridioides difficile<\/em>.&nbsp;This serious illness can cause painful, severe diarrhea.&nbsp;DIFICLIR works by killing the bacteria that cause&nbsp;infection&nbsp;and helps reduce diarrhea associated with&nbsp;infection.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using DIFICLIR<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use DIFICLIR<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to fidaxomicin or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before using DIFICLIR.<br><\/p>\n\n\n\n<p>If you think you may have a severe&nbsp;allergic reaction&nbsp;such as difficulty breathing (&nbsp;dyspnoea&nbsp;), swelling of the face or throat (&nbsp;angioedema&nbsp;), severe skin rash, severe&nbsp;itching,&nbsp;or severe&nbsp;hives&nbsp;(&nbsp;urticaria&nbsp;), stop taking DIFICLIR and contact a doctor, pharmacist immediately or the nearest emergency department (see section 4).<br><\/p>\n\n\n\n<p>If you are allergic to&nbsp;macrolides&nbsp;(a type of&nbsp;antibiotic&nbsp;), ask your doctor before using this medicine.&nbsp;Your doctor will inform you if this medicine is suitable for you.<\/p>\n\n\n\n<p>If you have kidney or liver problems, ask your doctor for advice before using this medicine.&nbsp;Your doctor will tell you if this medicine is suitable for you.<br><\/p>\n\n\n\n<p>There are only limited data from the use of fidaxomicin in severe cases of the disease (eg pseudomembranous&nbsp;colitis&nbsp;).&nbsp;Your doctor knows if your disease belongs to the difficult categories and will tell you if this medicine is suitable for you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Do not give this medicine to children weighing less than 12.5 kg as these children need a lower&nbsp;dose.&nbsp;For an appropriate&nbsp;dosage&nbsp;for these patients, DIFICLIR&nbsp;granules for&nbsp;oral&nbsp;suspension&nbsp;may be used.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and DIFICLIR<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<br><\/p>\n\n\n\n<p>Blood levels of DIFICLIR may be affected by other medicines you are taking, and blood levels of other medicines may be affected by your taking DIFICLIR.&nbsp;Such drugs are, for example:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ciclosporin (a medicine used to suppress the body&#8217;s immune reactions. It is used eg after an organ or bone marrow transplant, for&nbsp;psoriasis&nbsp;or&nbsp;eczema,&nbsp;rheumatoid arthritis,&nbsp;or&nbsp;nephrotic syndrome&nbsp;)<\/li><li>ketoconazole&nbsp;(a medicine used to treat fungal infections)<\/li><li>erythromycin (a medicine used to treat&nbsp;infections&nbsp;of the ears, nose, throat, chest, and skin)<\/li><li>clarithromycin (a drug used to treat&nbsp;infection&nbsp;slower respiratory tract&nbsp;infection&nbsp;s throat and sinuses,&nbsp;infection&nbsp;s skin and&nbsp;tissue&nbsp;s and&nbsp;infection&nbsp;s with&nbsp;<em>Helicobacter pylori<\/em>&nbsp;in gastric ulcers and&nbsp;duodenal&nbsp;a)<\/li><li>verapamil (a medicine used to treat high&nbsp;blood pressure&nbsp;or to prevent angina) It can also be used after a heart attack to prevent a new heart attack)<\/li><li>dronedarone and&nbsp;amiodarone&nbsp;(medicines used to regulate heart rhythm)<\/li><li>dabigatran etexilate (a medicine used to prevent the formation of blood clots after hip or knee surgery)<\/li><\/ul>\n\n\n\n<p>You should not use DIFICLIR in combination with any of these medicines unless your doctor tells you to.&nbsp;If you are taking any of these medicines, ask your doctor for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>You should not take DIFICLIR if you are pregnant unless your doctor tells you to.<\/p>\n\n\n\n<p>The reason is that it is not known if fidaxomicin can harm your baby.<\/p>\n\n\n\n<p>If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.<br><\/p>\n\n\n\n<p>It is not known if fidaxomicin passes into breast milk, but it is not expected to do so.<\/p>\n\n\n\n<p>If you are breast-feeding, talk to your doctor or pharmacist before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>DIFICLIR is not expected to affect your ability to drive, use tools or operate machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">DIFICLIR contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)&nbsp;sodium&nbsp;per tablet, ie it is essentially &#8216;sodium-free&#8217;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use DIFICLIR<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;for patients weighing at least 12.5 kg is one tablet (200 mg), twice daily (one tablet every 12 hours) for 10 days.&nbsp;Swallow the tablets whole with a glass of water.&nbsp;You can take DIFICLIR before, during, or after a meal.<br><\/p>\n\n\n\n<p>DIFICLIR&nbsp;granules&nbsp;for&nbsp;oral&nbsp;suspension&nbsp;should be used in patients weighing less than 12.5 kg.&nbsp;This form of medicine (&nbsp;oral&nbsp;suspension&nbsp;) may also be more suitable for patients over 12.5 kg, consult a doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more DIFICLIR than you should&nbsp;<\/h2>\n\n\n\n<p>If you take more tablets than you should, talk to a doctor.&nbsp;Take the medicine pack with you so that the doctor knows what you have taken.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use DIFICLIR<\/h2>\n\n\n\n<p>Take the tablet as soon as you remember, unless it is time for the next&nbsp;dose.&nbsp;In that case, skip the missed&nbsp;dose&nbsp;one.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using DIFICLIR<\/h2>\n\n\n\n<p>Do not stop taking DIFICLIR unless your doctor has advised you to do so.<\/p>\n\n\n\n<p>Continue to take this medicine until the end of the treatment, even if you feel better.<\/p>\n\n\n\n<p>If you stop taking the medicine too soon, an&nbsp;infection&nbsp;may come back.<br><\/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\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p>A severe&nbsp;allergic reaction&nbsp;may occur, including difficulty breathing (&nbsp;dyspnoea&nbsp;), swelling of the face or throat (&nbsp;angioedema&nbsp;), severe rash, or severe&nbsp;itching&nbsp;(&nbsp;pruritus&nbsp;) (see section 2).&nbsp;If any of these reactions occur, stop taking DIFICLIR and contact a doctor, pharmacist, or nearest emergency department immediately.<br><\/p>\n\n\n\n<p><strong>The&nbsp;<\/strong>&nbsp;<strong>most common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people)<\/strong>&nbsp;are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>vomiting<\/li><li>nausea<\/li><li>constipation<\/li><\/ul>\n\n\n\n<p>Other possible&nbsp;side effects&nbsp;are:<\/p>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>decreased appetite<\/li><li>dizziness, headache<\/li><li>dry mouth&nbsp;changed taste (&nbsp;dysgeusia&nbsp;)<\/li><li>bloating, gas production (&nbsp;flatulence&nbsp;)<\/li><li>skin rash,&nbsp;itching&nbsp;(&nbsp;pruritus&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Unknown&nbsp;side effects&nbsp;(frequency cannot be calculated from the available data)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swelling of the face and throat (&nbsp;angioedema&nbsp;), difficulty breathing (&nbsp;dyspnoea&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Additional&nbsp;side effects&nbsp;are in children and adolescents<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>hives<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store DIFICLIR<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<br><\/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\">6. 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 fidaxomicin.&nbsp;1 film-coated tablet contains 200 mg fidaxomicin.<\/li><li>Other ingredients are Tablet core: microcrystalline cellulose, pregelatinized&nbsp;starch, hydroxypropyl cellulose, butylhydroxytoluene, sodium starch glycolate, and magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol, and lecithin (soy).<\/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>DIFICLIR 200 mg film-coated tablets are white to off-white, capsule-shaped tablets, marked with &#8220;FDX&#8221; on one side and &#8220;200&#8221; on the other side.<br><\/p>\n\n\n\n<p>DIFICLIR is available in:<\/p>\n\n\n\n<p>100 x 1 film-coated tablets in perforated aluminum \/ aluminum single-dose blisters.<\/p>\n\n\n\n<p>20 x 1 film-coated tablets in perforated alu \/ alu unit dose blisters.<br><\/p>\n\n\n\n<p>DIFCLIR is also available as&nbsp;granules&nbsp;for&nbsp;oral&nbsp;suspension.<br><\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Astellas Pharma Europe BV<\/p>\n\n\n\n<p>Sylviusweg 62<\/p>\n\n\n\n<p>2333 BE Leiden<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>DIFICLIR is an antibiotic that contains the active substance fidaxomicin.<\/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":[2204,2200],"tags":[5622,5624,5625,5618,5620,5621,2212,2211,5623,5619],"class_list":["post-7481","post","type-post","status-publish","format-standard","hentry","category-d","category-medicines","tag-dificlir","tag-dificlir-side-effects","tag-dificlir-tablet","tag-fidaxomicin","tag-fidaxomicin-side-effects","tag-fidaxomicin-tablet","tag-medicine","tag-tablets","tag-what-is-dificlir","tag-what-is-fidaxomicin"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7481","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=7481"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7481\/revisions"}],"predecessor-version":[{"id":11013,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7481\/revisions\/11013"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=7481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=7481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=7481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}