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Oxycodone And Acetaminophen (Oxycodone And Acetaminophen)

Trade Name : Oxycodone and Acetaminophen

West-Ward Pharmaceuticals Corp.

TABLET

Strength 5325 mg/1mg/1

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxycodone And Acetaminophen (Oxycodone And Acetaminophen) which is also known as Oxycodone and Acetaminophen and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 5; 325 mg/1; mg/1 per ml. Read more

Oxycodone And Acetaminophen (Oxycodone And Acetaminophen) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Arrayn- Addiction, Abuse, and Misuse
  • Oxycodone Hydrochloride and Acetaminophen Tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing Oxycodone Hydrochloride and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors or conditions [n ].
  • Arrayn- 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 [n ]. 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
  • Arrayn- 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 [n .
  • Arrayn- 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 [].
  • Arrayn- 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 [].
  • Arrayn- Cytochrome P450 3A4 Interaction
  • The concomitant use of Oxycodone Hydrochloride and Acetaminophen 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 [].
  • Arrayn- 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 4,000 mg per day, and often involve more than one acetaminophen-containing product n
  • Arrayn- 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 [].
  • Oxycodone and Acetaminophen Tablets USP are available for oral administration.
  • Each Tablet contains:
  • Oxycodone Hydrochloride USP.................................................................. 5 mg*
  • (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
  • Acetaminophen USP...................................................................................... 325 mg
  • Inactive Ingredients
  • The tablets contain: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid.
  • Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone hydrochloride, 4,5u03b1-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is CHNO u2219 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:
  • Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is CHNO and the molecular weight is 151.16. It may be represented by the following structural formula:
  • No data
  • Oxycodone Hydrochloride and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
  • Limitations of Use:
  • Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [n , reserve Oxycodone Hydrochloride and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
  • Oxycodone Hydrochloride and Acetaminophen Tablets are contraindicated in patients with:
  • No data
  • No data
  • ufeffThe following adverse reactions have been identified during post approval use of Oxycodone Hydrochloride and Acetaminophen Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Serious adverse reactions that may be associated with Oxycodone Hydrochloride and Acetaminophen Tablets use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [].
  • The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.
  • Hypersensitivity reactions may include: skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis have likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.
  • Other adverse reactions obtained from postmarketing experiences with Oxycodone Hydrochloride and Acetaminophen Tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:
  • Body as a Whole:
  • Cardiovascular:
  • Central and Peripheral Nervous System:
  • Fluid and Electrolyte:
  • Gastrointestinal:
  • Hepatic:
  • Hearing and Vestibular:
  • Hematologic:
  • Hypersensitivity:
  • Metabolic and Nutritional:
  • Musculoskeletal:
  • Ocular:
  • Psychiatric:
  • Respiratory System:
  • Skin and Appendages:
  • Urogenital:
  • No data
  • Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
  • No data
  • Oxycodone and Acetaminophen Tablets USP
  • 5 mg/325 mg Tablets are supplied as white biconvex tablets, scored on one side and product identification u201c54u201d over u201c543u201d debossed on the other side.
  • NDC 0054-0551-24: 4 Cards x 25 Unit-Dose Tablets (reverse-numbered)
  • NDC 0054-0551-25: Bottle of 100 Tablets
  • NDC 0054-0551-29: Bottle of 500 Tablets
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.
  • Store Oxycodone and Acetaminophen Tablets USP securely and dispose of properly .
  • DEA Order Form Required.
  • Distr. by: n
  • Eatontown, NJ 07724
  • 10009541/05
  • Revised August 2019
  • 10009541/05
  • Revised August 2019
  • NDC 0054-0551-25
  • Rx only
  • NDC 0054-0551-29
  • Rx only

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Clinical Trials Supply

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STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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