{"id":20800,"date":"2022-04-14T07:56:57","date_gmt":"2022-04-14T07:56:57","guid":{"rendered":"https:\/\/zeepedia.com\/?p=20800"},"modified":"2022-04-15T15:26:20","modified_gmt":"2022-04-15T15:26:20","slug":"pheburane","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/pheburane\/","title":{"rendered":"Pheburane &#8211; Sodium phenylbutyrate uses, dose and side effects"},"content":{"rendered":"\n<p>483 mg \/ g&nbsp;granules<br>sodium phenylbutyrate<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What PHEBURANE is and what it is used for<\/h2>\n\n\n\n<p>PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea metabolic disorders.&nbsp;These rare diseases are due to a deficiency of certain liver enzymes that are necessary to excrete residual nitrogen in the form of ammonia.<\/p>\n\n\n\n<p>Nitrogen is a building block in\u00a0protein, which is an important part of the food we eat.\u00a0When the body breaks down the\u00a0proteins\u00a0we eat, residual nitrogen accumulates in the form of ammonia, because the body cannot excrete it.\u00a0Ammonia is especially toxic to the brain and in severe cases leads to decreased consciousness and\u00a0coma.<\/p>\n\n\n\n<p>PHEBURANE helps the body excrete residual nitrogen and reduces the amount of ammonia in your body.&nbsp;However, PHEBURANE should be combined with a protein-reduced diet that has been specially developed for you by your doctor or dietitian.&nbsp;This diet must be followed carefully.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before taking PHEBURANE<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take PHEBURANE:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6);<\/li><li>if you are pregnant;<\/li><li>if you are breastfeeding.<\/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 taking PHEBURANE if you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>suffer from\u00a0chronic\u00a0heart failure\u00a0(a type of heart disease where the heart is not able to pump enough blood into the body) or a decrease in kidney function;<\/li><li>have impaired kidney or liver function, as PHEBURANE is excreted from the body through the kidneys and liver.<\/li><\/ul>\n\n\n\n<p>PHEBURANE does not prevent the emergence of an\u00a0acute\u00a0excess of ammonia in the blood, a condition that usually requires urgent medical attention.\u00a0If this happens you will have symptoms such as nausea, vomiting, and confusion and will need\u00a0urgent\u00a0medical attention.<\/p>\n\n\n\n<p>If you need to do laboratory tests, it is important to remind your doctor that you are taking PHEBURANE, as sodium phenylbutyrate may affect the results of certain laboratory tests (such as&nbsp;electrolytes&nbsp;or&nbsp;protein&nbsp;in the blood or liver function tests).<\/p>\n\n\n\n<p>If you have any further questions, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and PHEBURANE<\/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 must tell your doctor if you are taking medicines that contain:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>valproate\u00a0(a medicine used to\u00a0treat epilepsy\u00a0),<\/li><li>haloperidol\u00a0(used in certain psychotic disorders),<\/li><li>corticosteroids\u00a0(drugs used to relieve inflamed areas of the body)<\/li><li>probenecid (for the treatment of hyperuricemia, elevated levels of\u00a0uric acid\u00a0in the blood associated with\u00a0gout\u00a0).<\/li><\/ul>\n\n\n\n<p>These medicines may affect the way PHEBURANE works and you may need to do more frequent blood tests.&nbsp;If you are not sure if your medicines contain these substances, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Do not use PHEBURANE if you are pregnant, as this medicine may harm the fetus.<\/p>\n\n\n\n<p>If you are a woman who may become pregnant, you must use a reliable contraceptive during treatment with PHEBURANE.&nbsp;Talk to a doctor for more information.<\/p>\n\n\n\n<p>Do not use PHEBURANE if you are breastfeeding, as this medicine may pass into breast milk and harm your baby.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>PHEBURANE is unlikely to affect the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PHEBURANE contains sodium and sucrose<\/h2>\n\n\n\n<p>This medicine contains 124 mg (5.4 mmol) of\u00a0sodium\u00a0per gram of sodium phenylbutyrate.\u00a0Talk to your doctor or pharmacist if you need 3 grams or more daily for an extended period, especially if you have been prescribed a low-salt diet.<\/p>\n\n\n\n<p>This medicine contains 768 mg of sucrose per gram of sodium phenylbutyrate.\u00a0This should be considered if you have\u00a0diabetes mellitus.\u00a0If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take PHEBURANE<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>The daily\u00a0dose\u00a0of PHEBURANE is based on your body weight or body surface area and is adjusted according to your ability to tolerate\u00a0protein\u00a0and your diet.\u00a0You will need regular blood tests to determine the correct daily\u00a0dosage.\u00a0Your doctor will tell you how many\u00a0granules\u00a0to take.<\/p>\n\n\n\n<p><strong>Method of administration<\/strong><\/p>\n\n\n\n<p>PHEBURANE should be taken by mouth.&nbsp;Because it dissolves slowly, PHEBURANE should not be given through a gastrostomy (gastric fistula, a tube that passes through the abdominal wall to the stomach) or through a gastric tube (a tube that passes through the nose to the stomach).<\/p>\n\n\n\n<p>PHEBURANE must be taken with a special protein-reduced diet.<\/p>\n\n\n\n<p>You should take PHEBURANE with each meal or feeding.&nbsp;In young children, this can be 4 to 6 times a day.<\/p>\n\n\n\n<p>The&nbsp;dose&nbsp;of PHEBURANE prescribed by your doctor is expressed in grams of sodium phenylbutyrate.&nbsp;A calibrated dosing spoon giving up to 3 g of sodium phenylbutyrate at a time is supplied with this medicine.&nbsp;Use only this dosing spoon to measure the&nbsp;dose of&nbsp;a PHEBURANE.&nbsp;The dosing phase must not be used for any other drug.<\/p>\n\n\n\n<p>Measure&nbsp;dose&nbsp;one as follows:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The lines on the spoons indicate the amount of PHEBURANE in grams of sodium phenylbutyrate.\u00a0Take the correct amount according to your doctor&#8217;s\u00a0prescription.<\/li><li>Pour\u00a0granules\u00a0directly into the spoon as shown (on the outer carton and in this leaflet).<\/li><li>Tap the spoons once against a table to make the\u00a0granules\u00a0lie horizontally and continue to refill if necessary.<\/li><\/ul>\n\n\n\n<p>Granules\u00a0can be swallowed directly with a drink (water, fruit juice, protein-free infant formula) or sprinkled on a spoon with solid food (mashed potatoes or apple puree).\u00a0If you mix it with food, you must take it immediately so that the\u00a0granules\u00a0do not develop any taste.<\/p>\n\n\n\n<p>You must take this medicine and eat a special diet for life.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more PHEBURANE than you should<\/h2>\n\n\n\n<p>Patients who have taken very high&nbsp;doses&nbsp;of sodium phenylbutyrate experienced:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>drowsiness, fatigue, dizziness, and on more rare occasions confusion,<\/li><li>headache,<\/li><li>changed taste perception,<\/li><li>impaired hearing,<\/li><li>disorientation,<\/li><li>impaired memory,<\/li><li>deterioration of existing neurological conditions.<\/li><\/ul>\n\n\n\n<p>If you experience any of these symptoms, contact your doctor or nearest emergency department immediately for supportive care.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take PHEBURANE<\/h2>\n\n\n\n<p>Take the next\u00a0dose\u00a0as soon as possible at the next meal.\u00a0Make sure there are at least 3 hours between two\u00a0doses.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/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>If repeated vomiting occurs, contact your doctor immediately.<\/p>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect more than 1 in 10 people):<\/p>\n\n\n\n<p>irregular periods or missed periods in fertile women.<\/p>\n\n\n\n<p>If you are sexually active and your period stops completely, do not take it for granted that this has been caused by PHEBURANE.&nbsp;If this happens, you should discuss it with your doctor, as missed periods can also be due to pregnancy (see the section on pregnancy and breastfeeding above) or menopause.<\/p>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect more than 1 in 100 people):<\/p>\n\n\n\n<p>changes in the number of\u00a0blood cells\u00a0(\u00a0red blood cells,\u00a0white blood cells,\u00a0and\u00a0platelets\u00a0), changes in the amount of\u00a0bicarbonate\u00a0in the blood, decreased appetite, depression, irritability, headache, fainting, fluid retention (swelling), taste changes, abdominal pain, vomiting, nausea, constipation, abnormal skin odor, rash, abnormal kidney function, weight gain, altered laboratory test values.<\/p>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect more than 1 in 1,000 people):<\/p>\n\n\n\n<p>lack of\u00a0red blood cells\u00a0due to bone marrow failure, the appearance of bruises, altered heart rhythm, rectal bleeding, gastritis,\u00a0gastric ulcer,\u00a0and inflammation\u00a0of the pancreas.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store PHEBURANE<\/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 carton and bottle label after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>PHEBURANE can be used within 45 days after opening the package.<\/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 package and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<p>The active substance is sodium phenylbutyrate.<\/p>\n\n\n\n<p>Each gram of&nbsp;granules&nbsp;contains 483 mg of sodium phenylbutyrate.<\/p>\n\n\n\n<p>The other ingredients are sugar balls (sucrose and corn starch, see section 2 PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.<\/p>\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>PHEBURANE&nbsp;granules&nbsp;are white to off-white.<\/p>\n\n\n\n<p>Granules&nbsp;are packaged in a plastic bottle with a child-resistant closure and desiccant.<\/p>\n\n\n\n<p>Each bottle contains 174 g of\u00a0granules.<\/p>\n\n\n\n<p>Each carton contains a bottle.<\/p>\n\n\n\n<p>A calibrated dosing spoon is included.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Eurocept International BV<\/p>\n\n\n\n<p>Trapani 5<\/p>\n\n\n\n<p>1244 RL Ankeveen<\/p>\n\n\n\n<p>NETHERLANDS<\/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>FrostPharma AB<\/p>\n\n\n\n<p>Tel: +46 775 86 80 02<\/p>\n\n\n\n<p>info@frostpharma.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea metabolic disorders. These rare diseases are due to a deficiency of certain liver enzymes that are necessary to excrete residual nitrogen in the form of ammonia.<\/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":[21322,21317,21318,21321,10550,21316,21319,10551,21320,10552],"class_list":["post-20800","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-pheburane","tag-benefits-of-sodium-phenylbutyrate","tag-pheburane","tag-pheburane-side-effects","tag-sodium-phenylbutyrate","tag-sodium-phenylbutyrate-side-effects","tag-what-is-pheburane","tag-what-is-sodium-phenylbutyrate","tag-what-pheburane-is-used-for","tag-what-sodium-phenylbutyrate-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20800","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=20800"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20800\/revisions"}],"predecessor-version":[{"id":20869,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20800\/revisions\/20869"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=20800"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=20800"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=20800"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}