{"id":36454,"date":"2022-11-28T07:42:13","date_gmt":"2022-11-28T07:42:13","guid":{"rendered":"https:\/\/zeepedia.com\/?p=36454"},"modified":"2022-11-29T10:16:48","modified_gmt":"2022-11-29T10:16:48","slug":"zoledronic-acid-mylan","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/zoledronic-acid-mylan\/","title":{"rendered":"Zoledronic acid Mylan &#8211; Zoledronic acid uses, dose and side effects"},"content":{"rendered":"\n<p>4 mg\/5 ml\u00a0concentrate for\u00a0infusion\u00a0liquid, solution<br>Zoledronic acid<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Zoledronic acid Mylan is and what it is used for<\/h2>\n\n\n\n<p>The active substance in Zoledronic acid Mylan is zoledronic acid which belongs to a group of substances called bisphosphonates.&nbsp;Zoledronic acid works by binding to bone tissue and reducing the rate of bone turnover.&nbsp;It is used for:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>To prevent bone complications,<\/strong>\u00a0e.g.\u00a0fractures, in adult patients with bone metastases (cancer that has spread from the primary cancer site to bone tissue).<\/li><li>To reduce the amount of\u00a0calcium\u00a0in the blood in adult patients when this is too high due to a\u00a0tumor.\u00a0Tumors\u00a0can accelerate the normal rate of bone turnover in such a way that the\u00a0release\u00a0of\u00a0calcium\u00a0from the bone tissue increases.\u00a0This condition is called tumor-induced\u00a0hypercalcemia\u00a0(TIH).<\/li><\/ul>\n\n\n\n<p><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you receive Zoledronic acid Mylan<\/h2>\n\n\n\n<p>Carefully follow the instructions given to you by your doctor.<\/p>\n\n\n\n<p>Your doctor will take blood tests before you start treatment with Zoledronic acid Mylan and will regularly monitor how you respond to treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">You should not receive Zoledronic acid Mylan:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are breastfeeding.<\/li><li>if you are allergic to zoledronic acid, other bisphosphonates (the group of substances to which zoledronic acid belongs), 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 precautions<\/h2>\n\n\n\n<p>Talk to your doctor before receiving Zoledronic acid Mylan:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have or have had any\u00a0<strong>kidney disease<\/strong>.<\/li><li>if you or have had\u00a0pain, swelling,<strong> or numbness<\/strong>\u00a0in the jaw, a feeling of &#8220;heavy jaw&#8221; or that a tooth has become loose.\u00a0Your doctor may recommend that you undergo a dental examination before starting treatment with Zoledronic acid Mylan.<\/li><li>if you are undergoing\u00a0<strong>dental treatment<\/strong>\u00a0or are going to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Mylan and inform your doctor about your dental treatment.<\/li><\/ul>\n\n\n\n<p>While you are being treated with Zoledronic acid Mylan, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups.<\/p>\n\n\n\n<p>Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or sores that do not heal or drain, as these may be signs of a condition called&nbsp;osteonecrosis&nbsp;of the jaw.<\/p>\n\n\n\n<p>Patients who are undergoing chemotherapy and\/or radiation therapy, who are taking steroids, who are undergoing dental surgery, who do not receive regular dental care, who have gum problems, who are smokers, or who have previously been treated with a bisphosphonate (used to treat or prevent bone disease) may have a higher risk of developing&nbsp;osteonecrosis&nbsp;of the jaw.<\/p>\n\n\n\n<p>Decreased levels of calcium in the blood (hypocalcemia) which can sometimes lead to muscle cramps, dry skin, and a burning sensation have been reported in patients treated with zoledronic acid.\u00a0Irregular heart rhythm (\u00a0cardiac arrhythmia\u00a0), convulsions,\u00a0spasms, and twitching (\u00a0tetany\u00a0) have been reported as a result of severe\u00a0hypocalcemia.\u00a0In some cases,\u00a0hypocalcemia\u00a0can be life-threatening.\u00a0If any of these occur, talk to your doctor immediately.\u00a0If you have pre-existing\u00a0hypocalcemia, it must be corrected before starting the first\u00a0dose\u00a0of zoledronic acid.\u00a0You will be given adequate supplements of\u00a0calcium\u00a0and\u00a0vitamin\u00a0D.<\/p>\n\n\n\n<p><strong>Patients who are 65 years of age and older<\/strong><\/p>\n\n\n\n<p>Zoledronic acid Mylan can be given to people aged 65 and over.&nbsp;There is nothing to suggest that any extra precautions would be necessary.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Zoledronic acid Mylan is not recommended for use in adolescents and children under 18 years of age.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Zoledronic acid Mylan<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.\u00a0You must tell your doctor if you are also taking:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Aminoglycosides\u00a0(medicines used to treat serious\u00a0infections\u00a0), calcitonin (a type of medicine used to treat infertility in postmenopausal women and\u00a0hypercalcemia), loop diuretics (a type of medicine used to treat high\u00a0blood pressure\u00a0or swelling caused by fluid retention (edema) or other medicines that lower calcium levels, as these in combination with bisphosphonates can have the effect of lowering the calcium level in the blood to an excessively low level.<\/li><li>Thalidomide (a medicine used to treat a certain type of blood cancer involving bone tissue) or any other medicine that can damage the kidneys.<\/li><li>Other medicines containing zoledronic acid to treat\u00a0osteoporosis\u00a0and other non-cancerous diseases of bone tissue, or any other bisphosphonate, as the effects of combining these medicines with Zoledronic acid Mylan are unknown.<\/li><li>Anti-angiogenic medicines (used to treat cancer), as combining these with zoledronic acid have been associated with an increased risk of bone damage (\u00a0osteonecrosis\u00a0) of the jaw (ONJ).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>You should not be treated with Zoledronic acid Mylan if you are pregnant.&nbsp;Inform your doctor if you are or think you may become pregnant.<\/p>\n\n\n\n<p>You must not be treated with Zoledronic acid Mylan if you are breastfeeding.<\/p>\n\n\n\n<p>Consult a doctor or pharmacist before taking any medicine during the period that you are pregnant or breastfeeding.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>There have been very rare cases of lethargy and sleepiness associated with the use of zoledronic acid.\u00a0You should therefore be careful when driving a car, using machines, or performing other activities that require your full concentration.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Zoledronic acid Mylan contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0vial, i.e.\u00a0it is almost &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Zoledronic acid Mylan is used<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Zoledronic acid Mylan should only be given by healthcare professionals who have experience in\u00a0administering\u00a0bisphosphonates\u00a0intravenously, i.e. through a vein.<\/li><li>Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.<\/li><li>Follow all other instructions from your doctor, pharmacist, or nurse carefully.<\/li><\/ul>\n\n\n\n<p><strong>The recommended\u00a0dose\u00a0of Zoledronic acid Mylan?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The recommended single dose is 4 mg of zoledronic acid.<\/li><li>If you have impaired kidney function, your doctor will give you a lower\u00a0dose, which depends on the severity of your kidney problems.<\/li><\/ul>\n\n\n\n<p><strong>How often will you be treated with Zoledronic acid Mylan?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are being treated for the prevention of bone tissue complications due to&nbsp;metastases&nbsp;in the bone tissue, you will receive an&nbsp;infusion&nbsp;of Zoledronic acid Mylan every three to four weeks.<\/li><li>If you are being treated to reduce the amount of&nbsp;calcium&nbsp;in your blood, you will normally only receive one&nbsp;infusion&nbsp;of Zoledronic acid Mylan.<\/li><\/ul>\n\n\n\n<p><strong>How is Zoledronic acid Mylan given?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Zoledronic acid Mylan is given as a drip (&nbsp;infusion&nbsp;) into a vein over at least 15 minutes and must be given&nbsp;intravenously&nbsp;as a separate&nbsp;infusion&nbsp;in a special infusion tube.<\/li><\/ul>\n\n\n\n<p>Patients who do not have too much&nbsp;calcium&nbsp;in their blood will also receive a prescription for calcium and&nbsp;vitamin&nbsp;D supplements, which must be taken daily.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you have been given too much Zoledronic acid Mylan<\/h2>\n\n\n\n<p>If you have received\u00a0doses\u00a0higher than those recommended, you must be carefully examined by your doctor.\u00a0This is because you may have abnormal amounts of\u00a0electrolytes\u00a0in your blood (eg abnormal amounts of\u00a0calcium, phosphorus, and\u00a0magnesium\u00a0) and\/or changes in kidney function, including severely impaired kidney function.\u00a0If your level of\u00a0calcium\u00a0is too low, you may need to receive additional\u00a0calcium\u00a0by\u00a0infusion.<\/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.\u00a0The most common of these are usually mild and will most likely disappear after a short time.<\/p>\n\n\n\n<p><strong>Tell your doctor immediately if you experience any of the following serious&nbsp;<\/strong><strong>side effects:<\/strong><\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(affects up to 1 in 10 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Severe kidney impairment (normally determined by your doctor using some specific blood tests).<\/li><li>Low levels of&nbsp;calcium&nbsp;in the blood.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(affects up to 1 in 100 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pain in the mouth, teeth, and\/or jaw, swelling or sores that do not heal on the inside of the mouth or jaw, warts, numbness, or a feeling of the heavy jaw or\u00a0tooth loss.\u00a0These may be signs of bone damage in the jaw (\u00a0osteonecrosis\u00a0).\u00a0Tell your doctor and dentist immediately if you experience such symptoms while you are being treated with Zoledronic acid Mylan or after stopping treatment.<\/li><li>Irregular heart rhythm (\u00a0atrial fibrillation\u00a0) has been observed in patients receiving zoledronic acid for postmenopausal\u00a0osteoporosis.\u00a0It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after receiving zoledronic acid.<\/li><li>Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(affects up to 1 in 1,000 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>As a result of low calcium levels: irregular heart rhythm (cardiac arrhythmia; as a result of&nbsp;hypocalcemia&nbsp;).<\/li><li>A kidney function disorder called Fanconi syndrome (normally diagnosed by your doctor with urine samples).<\/li><\/ul>\n\n\n\n<p><strong>Very rare<\/strong>&nbsp;(&nbsp;<strong>occurs in up to 1 in 10,000 patients<\/strong>&nbsp;):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>As a result of low calcium levels: convulsions, numbness, and twitching (as a result of\u00a0hypocalcemia).<\/li><li>Talk to your doctor if you have ear pain, discharge from the ear, and\/or an ear infection.\u00a0This could be a sign of a bone injury in the ear.<\/li><li>Osteonecrosis\u00a0has, in very rare cases, also been observed in bones other than the jaw, especially in the hip or thigh.\u00a0Tell your doctor immediately if you experience symptoms such as new or worsening aches, pains, or stiffness during treatment with Zoledronic acid Mylan or after stopping treatment.<\/li><\/ul>\n\n\n\n<p><strong>Tell your doctor as soon as possible if you experience any of the following side effects:<\/strong><\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(affects more than 1 in 10 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low level of&nbsp;phosphate&nbsp;in the blood.<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(affects up to 1 in 10 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Headache and a flu-like condition consisting of fever, fatigue, weakness, drowsiness, chills, and aches in bones, joints, and\/or muscles.\u00a0In most cases, no treatment is required and the symptoms disappear after a short time (a few hours or days).<\/li><li>Reactions from the gastrointestinal tract, e.g.\u00a0nausea and vomiting, as well as loss of appetite.<\/li><li>Inflammation\u00a0in the\u00a0conjunctiva\u00a0of the eye.<\/li><li>Low level of\u00a0red blood cells\u00a0(\u00a0anemia\u00a0).<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(affects up to 1 in 100 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Hypersensitivity reaction.<\/li><li>Low\u00a0blood pressure.<\/li><li>Chest pain.<\/li><li>Skin reactions (\u00a0redness\u00a0and swelling) at the infusion site, rash,\u00a0itching.<\/li><li>High\u00a0blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, changes in taste, tremors, tingling or numbness in the hands and feet, diarrhea, constipation, stomach pain,\u00a0and dry mouth.<\/li><li>A low number of\u00a0white blood cells\u00a0and\u00a0platelets.<\/li><li>The low blood level of\u00a0magnesium\u00a0and\u00a0potassium.\u00a0Your doctor will check this and take the necessary measures.<\/li><li>Weight gain.<\/li><li>Increased sweating.<\/li><li>Somnolence.<\/li><li>Blurred vision, watery eyes, eye sensitivity to light.<\/li><li>A sudden feeling of coldness with fainting, weakness, or collapse.<\/li><li>Difficulty breathing with wheezing or coughing.<\/li><li>Hives.<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(affects up to 1 in 1,000 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Slow\u00a0pulse.<\/li><li>Confusion.<\/li><li>Unusual femur fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases.\u00a0Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femur fracture.<\/li><li>Interstitial lung disease (\u00a0inflammation\u00a0of\u00a0the tissue\u00a0around the alveoli).<\/li><li>Flu-like symptoms\u00a0include\u00a0arthritis\u00a0and joint swelling.<\/li><li>Painful red and\/or swollen eyes.<\/li><\/ul>\n\n\n\n<p><strong>Very rare<\/strong>&nbsp;(affects up to 1 in 10,000 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Fainting due to low\u00a0blood pressure.<\/li><li>Severe pain in bones, joints, and\/or muscles, which in some cases can be disabling.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Zoledronic acid Mylan<\/h2>\n\n\n\n<p>Your doctor, pharmacist, or nurse knows how to store Zoledronic acid Mylan correctly (see section 6).<\/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\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is zoledronic acid.\u00a0One\u00a0vial\u00a0contains 4 mg of zoledronic acid (as a monohydrate).<\/li><li>Other ingredients are sodium citrate, sodium hydroxide,\u00a0hydrochloric acid,\u00a0and water for\u00a0injection.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Zoledronic acid Mylan is supplied as a clear, colored concentrate for\u00a0infusion, solution.<\/p>\n\n\n\n<p>The concentrate is supplied in a colored glass&nbsp;vial&nbsp;closed with a bromobutyl stopper and an aluminum cap with a plastic component for opening.<\/p>\n\n\n\n<p>One&nbsp;vial&nbsp;contains 5 ml of concentrate.<\/p>\n\n\n\n<p>Zoledronic acid Mylan is supplied in packs containing 1, 4, or 10 vials or as a multipack containing 4 packs containing 1 vial each.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Mylan Pharmaceuticals Limited<\/p>\n\n\n\n<p>Damastown Industrial Park,<\/p>\n\n\n\n<p>Mulhuddart, Dublin 15,<\/p>\n\n\n\n<p>DUBLIN<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Hikma Farmac\u00eautica SA<\/p>\n\n\n\n<p>Estrada do Rio da M\u00f3, n\u00ba 8, 8-A e 8-B<\/p>\n\n\n\n<p>Ferven\u00e7a, Terrugem SNT, 2705-906<\/p>\n\n\n\n<p>Portugal<\/p>\n\n\n\n<p>VIATRIS SANTE<\/p>\n\n\n\n<p>1 Rue de Turin,<\/p>\n\n\n\n<p>69007 Lyon<\/p>\n\n\n\n<p>France<\/p>\n\n\n\n<p>STERISCIENCE Sp.&nbsp;z o. o<\/p>\n\n\n\n<p>ul.&nbsp;Daniszewska 10<\/p>\n\n\n\n<p>03-230 Warsaw<\/p>\n\n\n\n<p>Poland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The active substance in Zoledronic acid Mylan is zoledronic acid which belongs to a group of substances called bisphosphonates.\u00a0Zoledronic acid works by binding to bone tissue and reducing the rate of bone turnover.<\/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":[2200,22506],"tags":[11834,28540,11832,28537,11833,28538,11831,28536,28539,28406],"class_list":["post-36454","post","type-post","status-publish","format-standard","hentry","category-medicines","category-z","tag-benefits-of-zoledronic-acid","tag-benefits-of-zoledronic-acid-mylan","tag-what-is-zoledronic-acid","tag-what-is-zoledronic-acid-mylan","tag-what-zoledronic-acid-is-used-for","tag-what-zoledronic-acid-mylan-is-used-for","tag-zoledronic-acid","tag-zoledronic-acid-mylan","tag-zoledronic-acid-mylan-side-effects","tag-zoledronic-acid-side-effects"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/36454","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=36454"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/36454\/revisions"}],"predecessor-version":[{"id":36661,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/36454\/revisions\/36661"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=36454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=36454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=36454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}