{"id":8570,"date":"2021-03-15T07:56:10","date_gmt":"2021-03-15T07:56:10","guid":{"rendered":"https:\/\/zeepedia.com\/?p=8570"},"modified":"2021-04-10T08:26:21","modified_gmt":"2021-04-10T08:26:21","slug":"exparel-liposomal","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/exparel-liposomal\/","title":{"rendered":"Exparel Liposomal &#8211; Bupivacaine uses, dose, and side effects"},"content":{"rendered":"\n<p>\n\n133 mg \/ 10 ml, 266 mg \/ 20 ml&nbsp;solution for injection&nbsp;, prolonged-release dispersion&nbsp;<br>bupivacaine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What EXPAREL liposomal is and what it is used for<\/h2>\n\n\n\n<p>EXPAREL liposomal is a local anesthetic that contains the active substance bupivacaine.<br><\/p>\n\n\n\n<p>EXPAREL liposomal is used in adult patients to reduce pain in a specific part of the body or small to medium-sized surgical wounds after surgery (such as surgery to remove&nbsp;hemorrhoids, hallux valgus, or knee or shoulder surgery).<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you are given EXPAREL liposomal<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">You must NOT be given this medicine:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to bupivacaine (or any other similar local anesthetic) or any of the other ingredients of this medicine (listed in section 6 of this leaflet).<\/li><li>if you are pregnant and need to get local anesthetics injected into the top of your vagina via the cervix.&nbsp;Bupivacaine can cause serious harm to the unborn child if used for this purpose.<\/li><li>in a blood vessel or the joints.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>EXPAREL liposomal should not be used in major surgeries in the abdomen, blood vessels, or chest.<br><\/p>\n\n\n\n<p>Talk to your doctor or nurse before giving EXPAREL liposomal:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have heart problems<\/li><li>if you have liver or kidney problems.<\/li><\/ul>\n\n\n\n<p>EXPAREL liposomal may cause temporary loss of sensation or movement.&nbsp;You may notice a change in your ability to feel things or move normally for up to 5 days after receiving the medicine.<br><\/p>\n\n\n\n<p>The following conditions have sometimes been reported with the use of other local anesthetics:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reactions<br>Allergic reactions may in rare cases occur after you have been given local anesthetics.&nbsp;Signs of allergic reactions you should be aware of:&nbsp;hives&nbsp;or skin rash, swelling around the eyes, face, lips, mouth, or throat, shortness of breath or difficulty breathing, dizziness or fainting, or fever.&nbsp;<strong>Seek medical attention immediately<\/strong>&nbsp;if you notice any of these symptoms after receiving EXPAREL liposomal as these reactions may in rare cases be life-threatening (see also section 4 of this leaflet).<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Neurological conditions<br>Toxicity&nbsp;in the&nbsp;central nervous system&nbsp;may also occur occasionally.&nbsp;Early signs of this include restlessness, anxiety, difficulty speaking, unsteadiness, nausea or vomiting, numbness and tingling in the mouth and lips, metallic taste,&nbsp;tinnitus(ringing in the ears), dizziness, blurred vision, tremors or twitching, depression, drowsiness.&nbsp;<strong>Seek medical attention immediately<\/strong>&nbsp;if you notice any of these symptoms after receiving EXPAREL liposomal.&nbsp;More serious&nbsp;side effects,&nbsp;if you have received too much bupivacaine, include convulsions (convulsions), unconsciousness, and heart attack (see also section 4 of this leaflet).<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Cardiovascular problems<br>Cardiovascular problems can sometimes also occur after the use of local anesthetics.&nbsp;Signs to be aware of are abnormal\/irregular heartbeat, low&nbsp;blood pressure, fainting, dizziness or feeling unsteady, fatigue, shortness of breath, or chest pain.&nbsp;Myocardial infarction can also occur occasionally.&nbsp;<strong>Seek medical attention immediately<\/strong>&nbsp;if you notice any of these symptoms after receiving EXPAREL liposomal (see also section 4 of this leaflet).<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Methemoglobinemia<br>Methemoglobinemia is a disorder of the blood that affects the red&nbsp;blood cells.&nbsp;The condition can occur immediately or a few hours after the use of local anesthetics.&nbsp;Signs and symptoms to be aware of include: pale or gray\/blue skin, shortness of breath, feeling unsteady or fainting, seizures, palpitations, or chest pain.&nbsp;<strong>Seek medical attention immediately<\/strong>&nbsp;if you notice any of these symptoms after receiving EXPAREL liposomal.&nbsp;Occasionally, methemoglobinemia can cause more severe symptoms such as irregular heartbeat, convulsions,&nbsp;coma,&nbsp;and even death (see also section 4 of this leaflet).<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Chondrolysis<br>Controls (degradation of&nbsp;cartilage&nbsp;in the joints) have been noted in patients receiving intra-articular&nbsp;infusions&nbsp;(joint injections) of local anesthetics.&nbsp;EXPAREL liposomal must not be used for&nbsp;intra-articular&nbsp;infusion.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>EXPAREL liposomal should not be used in children and adolescents under 18 years of age.&nbsp;This medicine has not been studied in this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and EXPAREL liposomal<\/h2>\n\n\n\n<p>Tell your doctor if you are taking or have recently taken any other medicines.<br><\/p>\n\n\n\n<p>It can be dangerous to take certain medicines together.&nbsp;This is especially true if you take any of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nitrates\/nitrites &#8211;&nbsp;nitroglycerin, nitroprusside, nitric oxide, nitrous oxide<\/li><li>Local anesthetics &#8211; benzocaine,&nbsp;lidocaine&nbsp;, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articles, ropivacaine<\/li><li>Antiarrhythmics&nbsp;&#8211; medicines used to treat irregular heartbeats (&nbsp;arrhythmias&nbsp;) such as&nbsp;lidocaine&nbsp;and mexiletine<\/li><li>Cytotoxic drugs&nbsp;are &#8211; cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea<\/li><li>Antibiotics&nbsp;&#8211; dapsone,&nbsp;sulfonamides,&nbsp;nitrofurantoin, para-aminosalicylic acid<\/li><li>Antimalarial drugs &#8211; chloroquine, printmaking<\/li><li>Antiepileptics&nbsp;&#8211;&nbsp;phenytoin, sodium valproate, phenobarbital<\/li><li>Other medicines &#8211; acetaminophen (&nbsp;paracetamol&nbsp;), metoclopramide (for stomach problems and nausea), sulfasalazine (for inflammatory diseases), poividonion (local&nbsp;antiseptic&nbsp;)<\/li><\/ul>\n\n\n\n<p>Ask your doctor if you are unsure about any of these medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>EXPAREL liposomal is&nbsp;<strong>NOT<\/strong>&nbsp;recommended&nbsp;for pregnant women and women of&nbsp;childbearing potential&nbsp;not using contraception.&nbsp;If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.<br><\/p>\n\n\n\n<p>EXPAREL liposomal passes into breast milk at very low concentrations and can cause serious&nbsp;side effects&nbsp;in the baby.&nbsp;Consult a doctor before breastfeeding your baby.&nbsp;She\/he decides if you should stop breastfeeding your baby or if you should not be given this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>EXPAREL liposomal may affect your ability to feel things or move normally for up to 5 days after receiving the medicine.&nbsp;You should not drive or use any tools or machines if you experience any of these&nbsp;side effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">EXPAREL liposomal contains sodium<\/h2>\n\n\n\n<p>This product contains 21 mg&nbsp;sodium&nbsp;(the main ingredient in saline\/table salt) per&nbsp;vial&nbsp;by 10 mL and 42 mg per&nbsp;vial&nbsp;by 20 mL.&nbsp;This corresponds to 1.1% and 2.1% respectively of the highest recommended daily intake of&nbsp;sodium&nbsp;for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take EXPAREL liposomal<\/h2>\n\n\n\n<p>You will receive EXPAREL liposomal from your doctor during the operation.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;that you receive will be determined by your doctor.&nbsp;It depends on the type of pain relief you need and in which part of the body the medicine is to be administered.&nbsp;It also depends on the size of the operating area and your physical condition.<br><\/p>\n\n\n\n<p>You will receive EXPAREL liposomal as an&nbsp;injection.&nbsp;Your doctor will inject EXPAREL liposomal at one of the following sites:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The area of \u200b\u200boperation;<\/li><li>close to the nerves that supply the area of \u200b\u200bthe body that has been operated on.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more EXPAREL liposomal than you should<\/h2>\n\n\n\n<p>EXPAREL liposomal is for use by trained doctors who will check&nbsp;your blood pressure, heart rate, respiratory rate, level of consciousness and monitor for any signs that you have been given too much bupivacaine hydrochloride after receiving EXPAREL liposomal.<br><\/p>\n\n\n\n<p><strong>Seek medical attention immediately<\/strong>&nbsp;if you notice any of the&nbsp;side effects&nbsp;listed below after receiving EXPAREL liposomal (see also section 4 of this leaflet).&nbsp;These are signs that you have been given too much bupivacaine.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>convulsions (convulsions);<\/li><li>unconsciousness;<\/li><li>restlessness or anxiety;<\/li><li>speech difficulties;<\/li><li>dizziness or instability;<\/li><li>nausea or vomiting;<\/li><li>numbness and tingling in the mouth and on the lips;<\/li><li>changes in vision, hearing, or taste;<\/li><li>shaking or twitching;<\/li><li>drowsiness, confusion, or not completely alert;<\/li><li>increased or decreased blood pressure;<\/li><li>increased or decreased heart rate.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If you miss a dose of EXPAREL liposomal<\/h2>\n\n\n\n<p>You are not likely to miss a&nbsp;dose.&nbsp;You will only get EXPAREL liposomal once from your doctor (during surgery).<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/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><strong>Seek medical attention immediately<\/strong>&nbsp;if you experience any of the following serious&nbsp;side effects&nbsp;that have been reported with the use of other local anesthetics (see section 2):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>abnormal\/irregular heartbeat, low&nbsp;blood pressure, fainting, dizziness or unsteadiness, fatigue, shortness of breath, chest pain, or cardiac arrest (symptoms of&nbsp;cardiovascular&nbsp;reaction).<br><\/li><li>restlessness, anxiety, difficulty speaking, feeling unsteady, nausea or vomiting, numbness and tingling in the mouth and lips, metallic taste,&nbsp;tinnitus&nbsp;(ie ringing in the ears), dizziness, blurred vision, tremors or twitching, depression, drowsiness, cramps (symptoms of a reaction in the&nbsp;central nervous system&nbsp;).<br><\/li><li>hives&nbsp;or skin rash, swelling around the eyes, face, lips, mouth, or throat, shortness of breath or difficulty breathing, rapid heartbeat, nausea, vomiting, dizziness or fainting, or fever (symptoms of an&nbsp;allergic reaction&nbsp;).<br><\/li><li>pale or gray\/blue skin, shortness of breath, instability or fainting, confusion, palpitations, chest pain, irregular heartbeat, convulsions, or&nbsp;coma&nbsp;(symptoms of methemoglobinemia).<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;may include:<\/strong><br><\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>taste disorders;<\/li><li>constipation;<\/li><li>nausea or vomiting;<\/li><li>lack of sensation in the mouth.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>feeling of warmth;<\/li><li>general bruising or fall;<\/li><li>abnormal blood test results;<\/li><li>joint pain;<\/li><li>impaired mobility or involuntary\/uncontrolled body movements;<\/li><li>injury, pain,&nbsp;spasm, twitching, or weakness in the muscles;<\/li><li>burning sensation;<\/li><li>headache;<\/li><li>loss of sensation;<\/li><li>itchy skin or skin irritation.<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>abdominal discomfort, bloating, or indigestion;<\/li><li>diarrhea;<\/li><li>dry mouth, difficulty swallowing or pain when swallowing;<\/li><li>itching&nbsp;on the inside of the mouth;<\/li><li>excess saliva in the mouth;<\/li><li>overindulge;<\/li><li>pain (in the abdomen, wound area, muscles, groin, hands, or feet);<\/li><li>swelling of the ankles, feet, legs, or joints;<\/li><li>stiffness in the joints;<\/li><li>abnormal ECG;<\/li><li>fresh blood from the rectum, usually with the stool;<\/li><li>feeling tired:<\/li><li>partial paralysis;<\/li><li>difficulty breathing;<\/li><li>redness&nbsp;on the skin or around the wound area;<\/li><li>complications (eg&nbsp;redness, swelling, pain) in the wound area;<\/li><li>heavy sweating;<\/li><li>discoloration of nails.<\/li><\/ul>\n\n\n\n<p><strong>Has been reported<\/strong>&nbsp;(occurs in an unknown number of users)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>inability to urinate (ie empty the bladder completely or partially);<\/li><li>Exparel liposomal does not work.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store EXPAREL liposomal<\/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 vial label after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>EXPAREL liposomal can also be stored at room temperature (maximum 25 \u00b0 C) for up to 30 days in sealed, unopened vials.&nbsp;Vials should not be returned to the refrigerator.<br><\/p>\n\n\n\n<p><strong><em>After the first opening<\/em><\/strong><\/p>\n\n\n\n<p>Chemical and physical in-use stability of EXPAREL liposomal withdrawn from vials and transferred to polypropylene syringes has been demonstrated for 48 hours when stored in a refrigerator (2 \u00b0 C to 8 \u00b0 C) or 6 hours when stored at room temperature (maximum 25 \u00b0 C).<br><\/p>\n\n\n\n<p>From a&nbsp;microbiological&nbsp;point of view, the medicine should be used immediately.&nbsp;If not used immediately, in-use storage times and conditions before use are the responsibility of the user and should not be longer than 24 hours at 2 \u00b0 C to 8 \u00b0 C unless opened under controlled and validated aseptic conditions.<br><\/p>\n\n\n\n<p><strong><em>After dilution<\/em><\/strong><\/p>\n\n\n\n<p>Chemical and physical stability when using the liposomal EXPAREL&nbsp;mixture&nbsp;with other&nbsp;formulation&nbsp;is bupivacaine have been demonstrated for 24 hours at room temperature (above 25 \u00b0 C).&nbsp;When&nbsp;mixed&nbsp;with 9 mg\/ml (0.9%) sodium chloride or lactated Ringer&#8217;s solution, chemical and physical in-use stability have been demonstrated for 4 hours when stored in a refrigerator (2 \u00b0 C to 8 \u00b0 C) or at room temperature (maximum 25 \u00b0 C). ).&nbsp;From a&nbsp;microbiological&nbsp;point of view, unless the dilution method eliminates the risk of&nbsp;microbial&nbsp;contamination, the product should be used immediately.&nbsp;If not used immediately, in-use storage times and conditions before use is the responsibility of the user.<\/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<p>The active substance is bupivacaine.&nbsp;Each ml contains 13.3 mg of liposomal bupivacaine in an&nbsp;injection, depotdispersion.<br><\/p>\n\n\n\n<p>Each&nbsp;vial&nbsp;with 10 ml&nbsp;injection, depotdispersion containing 133 mg and 266 mg bupivacaine free base.<br><\/p>\n\n\n\n<p>Each&nbsp;vial&nbsp;with 20 ml&nbsp;injection, depotdispersion containing 266 mg bupivacaine free base.<br><\/p>\n\n\n\n<p>The other ingredients are dierucoyl phosphatidylcholine(DEPC), dipalmitoyl phosphatidylglycerol (DPPG),&nbsp;cholesterol&nbsp;for&nbsp;parenteral&nbsp;use, tricaprylin, sodium chloride,&nbsp;phosphoric acid,&nbsp;and water for injections.<\/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>EXPAREL liposomal is a white to off-white&nbsp;solution for injection.<br><\/p>\n\n\n\n<p>It is available in 10 ml or 20 ml, disposable glass vials with a gray butyl rubber stopper with a surface of ethylene tetrafluoroethylene and a flip-tear-up seal of aluminum\/polypropylene.<br><\/p>\n\n\n\n<p>Each pack contains 4 or 10 vials.<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 Authorisation Holder<\/h2>\n\n\n\n<p>Pacira Ireland Ltd<\/p>\n\n\n\n<p>Unit 13<\/p>\n\n\n\n<p>Classon House<\/p>\n\n\n\n<p>Dundrum Business Park<\/p>\n\n\n\n<p>Dundrum,<\/p>\n\n\n\n<p>Dublin 14<\/p>\n\n\n\n<p>D14W9Y3<\/p>\n\n\n\n<p>Ireland<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Millmount Healthcare Limited<\/p>\n\n\n\n<p>Block-7, City North Business Campus<\/p>\n\n\n\n<p>Stamullen, Co.&nbsp;Meath<\/p>\n\n\n\n<p>K32 YD60<\/p>\n\n\n\n<p>Ireland<br><\/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><\/p>\n","protected":false},"excerpt":{"rendered":"<p>133 mg \/ 10 ml, 266 mg \/ 20 ml solution for injection , prolonged-release dispersion<br \/>\nbupivacaine<\/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":[2205,2200],"tags":[3310,3312,3313,3311,3314,3316,3317,3315,2215,2212],"class_list":["post-8570","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-bupivacaine","tag-bupivacaine-dose","tag-bupivacaine-side-effects","tag-bupivacaine-uses","tag-exparel-liposomal","tag-exparel-liposomal-dose","tag-exparel-liposomal-side-effects","tag-exparel-liposomal-uses","tag-injection","tag-medicine"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8570","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=8570"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8570\/revisions"}],"predecessor-version":[{"id":9877,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8570\/revisions\/9877"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8570"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8570"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8570"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}