{"id":18918,"date":"2022-02-25T16:36:00","date_gmt":"2022-02-25T16:36:00","guid":{"rendered":"https:\/\/zeepedia.com\/?p=18918"},"modified":"2022-02-26T09:57:20","modified_gmt":"2022-02-26T09:57:20","slug":"nexodal","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/nexodal\/","title":{"rendered":"Nexodal &#8211; Naloxone hydrochloride uses, dose and side effects"},"content":{"rendered":"\n<p>0.4 mg \/ ml&nbsp;solution for injection \/ infusion<br>naloxone hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Nexodal is and what it is used for<\/h2>\n\n\n\n<p>Nexodal 0.4 mg\/ml is a medicine used to counteract the effects of opioid overdose, e.g.\u00a0overdose with morphine.<\/p>\n\n\n\n<p>Nexodal 0.4 mg\/ml is used to eliminate the side effects of\u00a0opioids, to counteract life-threatening paralysis of the\u00a0central nervous system\u00a0and respiratory tract (difficulty breathing).<\/p>\n\n\n\n<p>Nexodal 0.4 mg\/ml is also used to diagnose\u00a0acute\u00a0opioid overdose or poisoning.<\/p>\n\n\n\n<p>Naloxone hydrochloride contained in Nexodal may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Nexodal<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Nexodal<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Take special care with Nexodal<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are physically addicted to morphine or similar drugs, or if you have been given high&nbsp;doses&nbsp;of these drugs.&nbsp;You may experience withdrawal symptoms such as high&nbsp;blood pressure&nbsp;, palpitations, severe difficulty breathing or cardiac arrest.<\/li><li>if Nexodal must be given to your newborn baby, as acute withdrawal symptoms may occur.<\/li><li>if you have heart or circulation problems (as&nbsp;side effects&nbsp;such as high or low&nbsp;blood pressure&nbsp;, palpitations or severe breathing difficulties are likely to occur more quickly)<\/li><li>if you are taking the painkiller buprenorphine, as naloxone has only a limited effect (see also section \u201cOther medicines and Nexodal\u201d).<\/li><\/ul>\n\n\n\n<p><em>Consult a doctor even if any of the above has previously applied to you.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Nexodal<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n<p>Please note that this may also apply to medicines that you have used before or that you may use in the future.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are taking painkillers, such as buprenorphine.&nbsp;The analgesic effect can be stronger if you are treated with Nexodal.<\/li><li>Severe&nbsp;hypertension&nbsp;has been reported when Nexodal has been used in&nbsp;coma&nbsp;due to&nbsp;clonidine overdose&nbsp;.&nbsp;Clone&nbsp;idin is a medicine used to treat withdrawal symptoms that occur when treatment with&nbsp;opioids&nbsp;has ended.&nbsp;It can also be used for high&nbsp;blood pressure&nbsp;,&nbsp;migraines&nbsp;and hot flashes in menopause.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Nexodal with food and drink<\/h2>\n\n\n\n<p>Tell your doctor if you have been drinking alcohol.&nbsp;In patients with mixed poisoning (with&nbsp;opioids&nbsp;and sedatives or alcohol), the effect of Nexodal may be slower.<\/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 for advice before using this medicine.<\/p>\n\n\n\n<p>There are no adequate data from the use of Nexodal in pregnant women.&nbsp;During pregnancy, your doctor will consider the benefits of Nexodal against the possible risks to the fetus.<\/p>\n\n\n\n<p>Nexodal may cause withdrawal symptoms in the infant (see section \u201cTake special care with Nexodal\u201d).<\/p>\n\n\n\n<p>It is not known whether Nexodal 0.4 mg\/ml passes into breast milk and it has not been established whether breastfed infants are affected by Nexodal 0.4 mg\/ml.\u00a0Breast-feeding should therefore be avoided for 24 hours after treatment.<\/p>\n\n\n\n<p><em>Ask your doctor or pharmacist for advice before taking any medicine.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>After receiving Nexodal 0.4 mg\/ml to eliminate the effects of\u00a0opioids, do not drive, use machines or perform other physically or mentally demanding activities for at least 24 hours, as the effects of the\u00a0opioids\u00a0may recur&#8230;<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Nexodal contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0dose, ie it is essentially &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Nexodal<\/h2>\n\n\n\n<p><strong>Dose<\/strong><\/p>\n\n\n\n<p>Your doctor will adjust the&nbsp;dose&nbsp;individually for you.<\/p>\n\n\n\n<p><strong>Adults<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Intravenous&nbsp;injection: 0.1 to 0.2 mg naloxone hydrochloride.&nbsp;If needed, additional 0.1 mg&nbsp;intravenous&nbsp;injections may be administered at 2-3 minute intervals.&nbsp;An additional&nbsp;injection&nbsp;may be needed within 1 to 2 hours.<\/li><\/ul>\n\n\n\n<p><strong>Children and young people<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Initially&nbsp;an&nbsp;intravenous&nbsp;injection&nbsp;of 0.01-0.02 mg naloxone hydrochloride per kg body weight at 2-3 minute intervals.&nbsp;Additional&nbsp;doses&nbsp;may be needed at 1 to 2 hour intervals.&nbsp;Doses&nbsp;may differ depending on local recommendations.<\/li><\/ul>\n\n\n\n<p><strong>Older<\/strong><\/p>\n\n\n\n<p>In elderly patients with pre-existing heart disease or in patients receiving medicinal products that may be cardiotoxic (toxic to the heart), naloxone hydrochloride should be used with caution.<\/p>\n\n\n\n<p><strong>Diagnosis of suspected&nbsp;acute&nbsp;opioid overdose or poisoning<\/strong><\/p>\n\n\n\n<p><em>Adults<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The starting dose is 0.4-2 mg naloxone hydrochloride&nbsp;intravenously&nbsp;.&nbsp;If necessary, a&nbsp;dose&nbsp;can be repeated at 2-3 minute intervals.<\/li><\/ul>\n\n\n\n<p><em>Children and young people<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The starting dose is 0.01 mg \/ kg body weight&nbsp;intravenously&nbsp;.&nbsp;If a satisfactory response is not obtained, a further increased&nbsp;dose&nbsp;of 0.1 mg \/ kg may be administered<\/li><li>Dose&nbsp;one for children and adolescents may differ due to local recommendations.<\/li><\/ul>\n\n\n\n<p>Newborns whose mothers have received opioids:<\/p>\n\n\n\n<p>The usual\u00a0dose\u00a0is 0.01 mg\/kg body weight\u00a0intravenously.\u00a0If necessary, a\u00a0dose\u00a0can be repeated at 2-3 minute intervals.\u00a0Dose\u00a0one to newborns may differ due to local recommendations.<\/p>\n\n\n\n<p><strong>Method of administration<\/strong><\/p>\n\n\n\n<p>Nexodal can be given as an&nbsp;injection&nbsp;and injected into a vein (= intravenous) or into a muscle (=&nbsp;intramuscularly&nbsp;) or can be given as an&nbsp;intravenous&nbsp;infusion&nbsp;by a doctor or nurse.&nbsp;The intramuscular&nbsp;administration&nbsp;of naloxone hydrochloride should only be used if&nbsp;intravenous&nbsp;administration&nbsp;is&nbsp;not possible.<\/p>\n\n\n\n<p>Nexodal can be given as an&nbsp;intravenous&nbsp;infusion&nbsp;(drip) after dilution with<\/p>\n\n\n\n<p>0.9% sodium chloride solution or 5% glucose solution.<\/p>\n\n\n\n<p><strong>Duration of treatment<\/strong><\/p>\n\n\n\n<p>The doctor will decide how long the treatment should last.<\/p>\n\n\n\n<p><em>If you have the impression that the effect of Nexodal is too strong or too weak, talk to your doctor or pharmacist.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Nexodal than you should &nbsp;<\/h2>\n\n\n\n<p>If you receive more Nexodal than you should, contact a doctor or nurse immediately.\u00a0He\/she will take action if necessary.<\/p>\n\n\n\n<p><em>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/em><\/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>The following&nbsp;side effects&nbsp;may occur:<\/p>\n\n\n\n<p><em>Very common (affects more than 1 user in 10):<\/em>&nbsp;nausea, malaise<\/p>\n\n\n\n<p><em>Common (affects 1 to 10 users in 100):<\/em>\u00a0dizziness, headache, palpitations, low\u00a0blood pressure, high\u00a0blood pressure, vomiting, postoperative pain<\/p>\n\n\n\n<p><em>Uncommon (affects 1 to 10 users in 1,000):<\/em>\u00a0tremors, sweating, changes in heart rate, slow heartbeat, diarrhea,\u00a0dry mouth, rapid and deep breathing (hyperventilation), irritation of the vessel wall (after\u00a0intravenous\u00a0administration\u00a0)<\/p>\n\n\n\n<p><em>Rare (affects 1 to 10 users in 10,000):<\/em>&nbsp;seizures, nervous tension<\/p>\n\n\n\n<p><em>Very rare (affects less than 1 user in 10,000):<\/em>\u00a0rapid and irregular heartbeat, cardiac arrest, fluid accumulation in the lungs, allergic reactions (\u00a0hives, runny nose, difficulty breathing,\u00a0Quincke&#8217;s edema\u00a0), allergic\u00a0shock, erythema multiforme<\/p>\n\n\n\n<p>When Nexodal is given to people who are addicted to morphine or similar drugs, acute withdrawal symptoms may occur (eg high\u00a0blood pressure\u00a0and heart symptoms).\u00a0This can also occur in infants whose mothers are addicted to\u00a0opioids.<\/p>\n\n\n\n<p>If an overdose of&nbsp;Nexodal&nbsp;is given after surgery, you may become agitated and feel pain (because the effects of the painkiller you have been given have been counteracted, as well as the effects on your breathing).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Nexodal<\/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&nbsp;ampoule&nbsp;after \u201cEXP\u201d.&nbsp;respectively &#8220;EXP&#8221;.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Do not store above 25 \u00b0 C.&nbsp;Store the&nbsp;ampoules&nbsp;in the outer carton.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>The drug should be used immediately after opening.<\/p>\n\n\n\n<p>After dilution, the product should be used immediately.\u00a0If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 \u00b0 C, unless dilution has taken place under controlled and validated aseptic conditions.<\/p>\n\n\n\n<p>This medicine is for single use only.\u00a0Discard unused solutions.<\/p>\n\n\n\n<p>Do not use Nexodal if the solution is discolored, cloudy, or contains particles.<\/p>\n\n\n\n<p>For&nbsp;intravenous&nbsp;infusion&nbsp;, Nexodal&nbsp;0.4 mg \/ ml should be diluted with sodium chloride 0.9% w \/ v or&nbsp;glucose&nbsp;5% w \/ v.<\/p>\n\n\n\n<p>5&nbsp;ampoules&nbsp;of Nexodal 0.4 mg \/ ml (2 mg) diluted to 500 ml give a final concentration of 4 micrograms \/ ml.<\/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 pack 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 naloxone hydrochloride.<\/p>\n\n\n\n<p>Each\u00a0ampoule\u00a0of 1 ml solution for injection\/infusion contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate).<\/p>\n\n\n\n<p>The other ingredients are sodium chloride,\u00a0hydrochloric acid\u00a0(diluted), and water for injections.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Nexodal is a clear and colorless solution for injection\/infusion.<\/p>\n\n\n\n<p>Nexodal is available in packs of 10\u00a0ampoules\u00a0of 1 ml solution for injection\/infusion.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Orpha-Devel Handels und Vertriebs GmbH<\/p>\n\n\n\n<p>Wintergasse 85 \/ 1B<\/p>\n\n\n\n<p>A-3002 Purkersdorf, Austria<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Hikma Italia SPA<\/p>\n\n\n\n<p>Viale Certosa<\/p>\n\n\n\n<p>10 Pavia (PV) 27100, Italy<\/p>\n\n\n\n<p>GL Pharma GmbH<\/p>\n\n\n\n<p>A-1160 Vienna, Austria<\/p>\n\n\n\n<p>AOP Orphan Pharmaceuticals GmbH<\/p>\n\n\n\n<p>A-1190 Vienna, Austria<\/p>\n\n\n\n<p>This medicinal product is authorized under the European Economic Area under the names:<\/p>\n\n\n\n<p>Denmark: Nexodal 0.4 mg \/ ml solution for injection or infusion<\/p>\n\n\n\n<p>Estonia: Nexodal 0.4 mg \/ ml s\u00fcste- \/ infusioonilahus<\/p>\n\n\n\n<p>Finland: Nexodal 0.4 mg \/ ml injection \/ infusion test, liuos<\/p>\n\n\n\n<p>Ireland: Naloxone 400 micrograms \/ ml solution for&nbsp;injection&nbsp;or&nbsp;infusion<\/p>\n\n\n\n<p>Italy: Nexodal 0.4 mg \/ ml inoperable or infusion solution<\/p>\n\n\n\n<p>Netherlands: Naloxone Orpha 0.4 mg \/ ml solution for injection or infusion<\/p>\n\n\n\n<p>Romania: Nexodal 0.4 mg \/ ml injectable solution for perfusion<\/p>\n\n\n\n<p>Slovenia: Nexodal 0.4 mg \/ ml injected with infusion or infusion<\/p>\n\n\n\n<p>United Kingdom: Naloxone 400 micrograms \/ ml solution for\u00a0injection\u00a0or\u00a0infusion<\/p>\n\n\n\n<p>Hungary: Nexodal 0.4 mg \/ ml injectable vaginal infusion<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nexodal 0.4 mg \/ ml is a medicine used to counteract the effects of opioid overdose, e.g. overdose with morphine.<\/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":[2200,15581],"tags":[18368,18828,18364,18367,18824,18827,18365,18825,18366,18826],"class_list":["post-18918","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-naloxone-hydrochloride","tag-benefits-of-nexodal","tag-naloxone-hydrochloride","tag-naloxone-hydrochloride-side-effects","tag-nexodal","tag-nexodal-side-effects","tag-what-is-naloxone-hydrochloride","tag-what-is-nexodal","tag-what-naloxone-hydrochloride-is-used-for","tag-what-nexodal-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18918","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=18918"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18918\/revisions"}],"predecessor-version":[{"id":18969,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18918\/revisions\/18969"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18918"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18918"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}