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    Home > Active Ingredient News > Drugs Articles > All roads lead to Rome: hysingla Er, a single hydrocodone sustained-release tablet against abuse, has been approved by the US FDA for listing

    All roads lead to Rome: hysingla Er, a single hydrocodone sustained-release tablet against abuse, has been approved by the US FDA for listing

    • Last Update: 2014-11-21
    • Source: Internet
    • Author: User
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    Source: U.S - China drug source November 21, 2014 [news event] on November 20, the U.S FDA approved the listing of hysingla Er, a powerful opioid analgesic of Purdue pharmaceutical company Hysingla Er is a single component hydrocodone sustained-release tablet, which is used for nursing severe chronic pain that needs long-term use without other treatment options Hysingla ER was prepared by the resistec? Sustained-release oral solid preparation process of Purdue pharmaceutical, which can effectively prevent the extraction of its effective component hydrocone Hysingla Er conforms to the guiding principle of "evaluation and labeling of anti abuse opioid drugs" issued by FDA in 2013, so the label approved by FDA this time contains the feature of "anti abuse" [source analysis] hydrocodone is the most widely used opioid prescription analgesic in the United States In 2011 alone, 131 million prescriptions were issued Hydrocortisone is a kind of analogues of codeine and has similar anesthetic, analgesic and antitussive effects Most of these effects are related to the central nervous system and smooth muscle The commonly used preparation is hydrocone tartrate, which is often combined with paracetamol to relieve moderate and severe pain Hydrocortisone is as easy to be abused as other opioid analgesics, which not only causes addiction, but also causes side effects caused by excessive use According to a study released by the Centers for Disease Control and prevention, 15000 people in the United States have died from the abuse of opioid analgesics Opium, the predecessor of opium, is also an indispensable painkiller in clinic It has quick effect on dull pain, sharp pain and visceral pain caused by various reasons But at the same time, opioid abuse is a worldwide problem In response to the increasing abuse of opioid analgesics, the United States anti drug administration (DEA) reclassified "hydrocodone combination drugs" (HCP) from category III to category II controlled drugs in October 2014 It means that doctors can't prescribe more than 3 months' dosage, and must provide written prescription In October 2013, the U.S FDA approved the ultra-strong opioid analgesic zohydro, which has been criticized Zohydro is a hydrocortisone sustained-release tablet taken orally twice a day Hysingla Er, which is prepared by the resistec? Sustained release oral solid dosage form platform, makes it difficult to extract the main effective component hydrocone by common means such as crushing, decomposition or dissolution, so as to use it in other similar drugs such as elephant nose inhalation or injection Hysingla Er contains high polymer, which is processed by a unique technology The tablets produced by this process are not only very high in hardness, but also form a thick hydrogel at most after dissolution, which is not easy to be used intravenously Even so, these properties of hysingla Er cannot completely eliminate abuse, such as addiction or death hazards caused by large-scale use Because hysingla Er still has the risk of abuse, misuse or addiction, it has not been approved by FDA as "as needed pain relief" Only for those patients who are intolerant or ineffective with alternative pain relief Hysingla Er is expected to ship to us pharmacies in early 2015 Hysingla Er only needs to be taken orally once a day, and the tablet specifications are 20, 30, 40, 60, 80, 100 and 120 mg tablets However, a dose of more than 80 mg should not be used in patients who have not previously used opioid painkillers Although the resistec? Process adopted by hysingla Er is not omnipotent and can not completely eliminate the abuse through intravenous, nasal and oral routes, it is the first and only hydrocortisone drug approved by FDA to prevent misuse or abuse through chewing, inhalation and injection According to the drug source, the development of Purdue's sustained-release and anti abuse hydrocortisone products is like a road to Rome Although this kind of new drug is not a great scientific breakthrough, it is a very practical technology, which effectively improves the quality of life of patients.
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