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Oxycodone 80mg

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Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.

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Oxycodone 80mg

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY, AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Oxycodone Hydrochloride and Acetaminophen Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Oxycodone Hydrochloride and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors and conditions .

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone Hydrochloride and Acetaminophen Tablets. Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride and Acetaminophen Tablets or following a dose increase

Accidental Ingestion

Accidental ingestion of Oxycodone Hydrochloride and Acetaminophen Tablets, especially by children, can result in a fatal overdose of Oxycodone Hydrochloride and Acetaminophen Tablets 

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Oxycodone Hydrochloride and Acetaminophen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

Cytochrome P450 3A4 Interaction

The concomitant use of Oxycodone Hydrochloride Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone Hydrochloride and Acetaminophen Tablets and any CYP3A4 inhibitor or inducer [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; DRUG INTERACTIONS].

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death

  • Reserve concomitant prescribing of Oxycodone Hydrochloride and Acetaminophen Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.
Weight 250 g
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Oxycodone is a medicine processed from thebaine, of Opium. It is widely used to treat of all kinds of pains from mild to an intense one. It is composed as a single constituent products as well as compounded products. The most popular uses of compounding are oxycodone with acetaminophen or paracetamol or ibuprofens.

Oxycodone is rendered to be very effective in relieving all kinds of pains, from a mild one to intense acute chronic pains. It has been providing promising effects by improving the lifestyle and day to day activities of the patients who have been battling with these pains. Oral oxycodone may also be used as an alternative medicine to treat pains of cancer to oral which is usually treated with morphine. Though oxycodone is not more effective than Morphine, the later one has a lot of adverse effects too. Morphine cause respiratory depression, sedation, pruritus, and nausea among the patients. But, oxycodone is less harmful in this respect from Morphine, thus it is can be used for all the patients.

However, regular and constant use of oxycodone results into adverse effects. These side effects are loss of memory, anxiety, fatigue, dry mouth quite often, restlessness, headaches, abdominal pain, constipation, nausea, pruritus, diaphoresis and blurred vision. Appetite-loss, nervousness, and hiccups have also occurred in a few patients. Teenagers often tend to designate the pains or ache as chronic one use these medicines at regular interval of time. If the patient turn out to be intolerant to opium or overdosed, it may result into, respiratory problems, pupil constriction clammy skin, apnoea, circulatory collapses, impotence, hypotension or hypertension, and other problems which may even lead to death. Though rarely people are affected by this drug severely, it is recommended to use oxycodone only on recommendation of physicians after proper diagnosis.

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