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Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : OXYCODONE HYDROCHLORIDE

Amneal Pharmaceuticals of New York LLC

TABLET, FILM COATED, EXTENDED RELEASE

Strength 10 mg/1

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

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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 Hydrochloride (Oxycodone Hydrochloride) which is also known as OXYCODONE HYDROCHLORIDE and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 10 mg/1 per ml. Read more

Oxycodone Hydrochloride (Oxycodone Hydrochloride) 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.

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  • 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 .
  • See full prescribing information for complete boxed warning.
  • Oxycodone HCl extended-release tablets exposes users to risks of addiction, abuse and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors and conditions. ()
  • 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 Risk Evaluation and Mitigation Strategy (REMS) for these products. ()
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow oxycodone HCl extended-release tablets whole to avoid exposure to a potentially fatal dose of oxycodone. ()
  • Accidental ingestion of oxycodone HCl extended-release tablets, especially by children, can result in a fatal overdose of oxycodone. ()
  • Prolonged use of oxycodone HCl extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ()
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. (, , )
  • 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 for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (, )
  • No data
  • Oxycodone HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
  • Limitations of Use
  • Oxycodone HCl extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
  • Limitations of Use
  • Adults
  • Pediatric Patients 11 Years of Age and Older
  • Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg.
  • Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg. ()
  • Oxycodone HCl extended-release tablets are contraindicated in patients with:
  • Significant respiratory depression. ()
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ()
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. ()
  • Hypersensitivity to oxycodone. ()
  • No data
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (incidence >5%) were constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. ()n
  • Table 4 includes clinically significant drug interactions with oxycodone HCl extended-release tablets.
  • Table 4: Clinically Significant Drug Interactions with Oxycodone HCl Extended-Release Tablets
  • CNS Depressants
  • Serotonergic Drugs
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • Monoamine Oxidase Inhibitors (MAOIs)
  • Pregnancy
  • Lactation
  • No data
  • No data
  • Oxycodone HCl extended-release tablets are an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 CH NO u2219 HCl u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0 MW 351.83
  • The chemical name is 4, 5u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
  • Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.u00a0 Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL).u00a0 It is slightly soluble in alcohol (octanol water partition coefficient 0.7).u00a0
  • The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide.
  • The 10 mg tablets also contain hydroxypropyl cellulose.
  • The 15 mg tablets also contain black iron oxide, yellow iron oxide, and red iron oxide.
  • The 20 mg tablets also contain polysorbate 80 and red iron oxide.
  • The 30 mg tablets also contain polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide.
  • The 40 mg tablets also contain polysorbate 80 and yellow iron oxide.
  • The 60 mg tablets also contain polysorbate 80, red iron oxide and black iron oxide.
  • The 80 mg tablets also contain hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake.
  • No data
  • No data
  • Adult Clinical Study
  • A double-blind, placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with persistent, moderate to severe pain, who were judged as having inadequate pain control with their current therapy. In this study, oxycodone HCl extended-release tablets 20 mg, but not 10 mg, was statistically significant in pain reduction compared with placebo.
  • Pediatric Clinical Study
  • Oxycodone HCl extended-release tablets has been evaluated in an open-label clinical trial of 155 opioid-tolerant pediatric patients with moderate to severe chronic pain.u00a0 The mean duration of therapy was 20.7 days (range 1 to 43 days). The starting total daily doses ranged from 20 mg to 100 mg based on the patientu2019s prior opioid dose. The mean daily dose was 33.30 mg (range 20 to 140 mg/day).u00a0 In an extension study, 23 of the 155 patients were treated beyond four weeks, including 13 for 28 weeks.u00a0 Too few patients less than 11 years were enrolled in the clinical trial to provide meaningful safety data in this age group.
  • Oxycodone HCl Extended-Release Tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Oxycodone HCl Extended-Release Tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Oxycodone HCl Extended-Release Tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Oxycodone HCl Extended-Release Tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Oxycodone HCl Extended-Release Tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Oxycodone HCl Extended-Release Tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Oxycodone HCl Extended-Release Tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 n
  • Store at 25u00b0C (77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Dispense in tight, light-resistant container.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Healthcare professionals can telephone Amneal Pharmaceuticals at 1-877-835-5472 for information on this product.
  • Manufactured by:n Wilson, NC 27893
  • Distributed by:n Bridgewater, NJ 08807
  • U.S. Patent Numbers 7,129,248; 8,309,060; 8,808,741; 8,821,929; 8,894,987; 8,894,988; 9,060,976; 9,073,933; 9,492,389, 9,492,391, 9,492,392, 9,492,393, 9,522,919, 9,675,610; 9,763,886; 9,763,933; 9,770,416; 9,775,808; 9,775,810; 9,775,811; 9,777,011, and 10,130,591
  • Rev. 04-2019-00
  • Oxycodone (n- ) HCl Extended-Release Tablets, CII
  • Oxycodone HCl extended-release tablets are:
  • Important information about oxycodone HCl extended-release tablets:
  • Do not take oxycodone HCl extended-release tablets if you have:
  • Before taking oxycodone HCl extended-release tablets, tell your healthcare provider if you have a history of:
  • Tell your healthcare provider if you are:
  • When taking oxycodone HCl extended-release tablets:
  • While taking oxycodone HCl extended-release tablets DO NOT:
  • The possible side effects of oxycodone HCl extended-release tablets are:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of oxycodone HCl extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. n
  • Manufactured by:n Wilson, NC 27893
  • Distributed by:n Bridgewater, NJ 08807
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Revised: 04-2019-00
  • 305198-0B
  • No data
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