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Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : oxycodone hydrochloride

West-Ward Pharmaceuticals Corp.

SOLUTION

Strength 5 mg/5mL

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 West-Ward Pharmaceuticals Corp.. It is available in strength of 5 mg/5mL 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

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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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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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  • No data
  • No data
  • Arrayn- Risk of Medication Errors
  • Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other oxycodone hydrochloride oral solutions of different concentrations can result in accidental overdose and death n n
  • Arrayn- Addiction, Abuse, and Misuse
  • Oxycodone Hydrochloride Oral Solution exposes 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 Oral Solution, and monitor all patients regularly for the development of these behaviors and conditions n n
  • Arrayn- Array
  • Arrayn- Array
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone Hydrochloride Oral Solution. Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride Oral Solution or following a dose increase n n
  • Arrayn- Accidental Ingestion
  • Accidental ingestion (or exposure) of even one dose of Oxycodone Hydrochloride Oral Solution, especially by children, can result in a fatal overdose of oxycodone n n
  • Array
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of Oxycodone Hydrochloride Oral Solution 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 n )].
  • Arrayn- Cytochrome P450 3A4 Interaction
  • The concomitant use of Oxycodone Hydrochloride Oral Solution 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 Oral Solution and any CYP3A4 inhibitor or inducer n 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 n n
  • WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
  • See full prescribing information for complete boxed warning.
  • Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other Oxycodone Hydrochloride Oral Solution of different concentrations can result in accidental overdose and death. (, )
  • Oxycodone Hydrochloride Oral Solution 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. ()
  • Arrayn- Arrayn- 5.3
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. ()
  • Accidental ingestion of Oxycodone Hydrochloride Oral Solution, especially by children, can result in a fatal overdose of oxycodone. ()
  • Prolonged use of Oxycodone Hydrochloride Oral Solution 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. (, )
  • Oxycodone Hydrochloride Oral Solution is 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 reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • Oxycodone Hydrochloride Oral Solution is an opioid agonist 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, reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • No data
  • Oxycodone Hydrochloride Oral Solution USP: 5 mg per 5 mL (1 mg/mL)
  • u2022
  • Oxycodone Hydrochloride Oral Solution is contraindicated in patients with:
  • No data
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients:
  • Adrenal Insufficiency:
  • Severe Hypotension:
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness:
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • The following adverse reactions associated with the use of oxycodone were identified in clinical studies or postmarketing reports. Because some of these reactions were 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 associated with oxycodone use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
  • The common adverse reactions seen on initiation of therapy with oxycodone are dose-related and are typical opioid-related adverse reactions. The most frequent adverse events include nausea, constipation, vomiting, headache, and pruritus. The frequency of these reactions depended on several factors, including clinical setting, the patientu2019s level of opioid tolerance, and host factors specific to the individual.
  • In all patients for whom dosing information was available (n = 191) from the open-label and double-blind studies involving another formulation of immediate-release oxycodone, the following adverse events were recorded in oxycodone treated patients with an incidence u2265 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
  • The other less frequently observed adverse reactions from opioid analgesics, including Oxycodone Hydrochloride Oral Solution included:
  • Body as a Whole:
  • Cardiovascular
  • Digestive
  • Hemic and Lymphatic:
  • Metabolic and Nutritional:
  • Musculoskeletal:
  • Nervous
  • Respiratory
  • Skin and Appendages
  • Special Senses:
  • Urogenital
  • Serotonin Syndrome:
  • Adrenal Insufficiency:
  • Anaphylaxis:
  • Androgen Deficiency:n- [see Clinicaln- Pharmacology ()]
  • To report SUSPECTED ADVERSE REACTIONS, contact
  • West-Ward Pharmaceuticals Corp. at 1-800-962-8364
  • or FDA at 1-800-FDA-1088 or n
  • u2022
  • 6
  • Table 1 includes clinically significant drug interactions with Oxycodone Hydrochloride Oral Solution.
  • Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Oral Solution
  • Serotonergic Drugs:
  • Monoamine Oxidase Inhibitors (MAOIs):
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:
  • No data
  • u00a0
  • 8.1
  • No data
  • Clinical Presentation
  • Acute overdose with Oxycodone Hydrochloride Oral Solution can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
  • Treatment of Overdose
  • In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
  • The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone Hydrochloride Oral Solution, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
  • Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as solution in 5 mg/5 mL (1 mg/mL) strength for oral administration.
  • Chemically, oxycodone hydrochloride is 4, 5u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula:
  • Oxycodone hydrochloride USP is a white to off-white fine crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).
  • Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL, contains equivalent of 4.5 mg of oxycodone free base per 5u00a0mL and contains the following inactive ingredients: anhydrous citric acid, artificial strawberry flavor, disodium edetate, FD&C Red No. 40, purified water, sodium benzoate, sorbitol solution and sucralose.
  • No data
  • Carcinogenesis
  • Long-term studies in animals to evaluate the carcinogenic potential of oxycodone have not been conducted.
  • Mutagenesis
  • Oxycodone hydrochloride was genotoxic in an mouse lymphoma assay in the presence of metabolic activation. There was no evidence of genotoxic potential in an bacterial reverse mutation assay and or in an assay for chromosomal aberrations (mouse bone marrow micronucleus assay).
  • Impairment of Fertility
  • Studies in animals to evaluate the potential impact of oxycodone on fertility have not been conducted.
  • Oxycodone Hydrochloride Oral Solution USP
  • The 5 mg/5 mL (1 mg/mL) solution is supplied as a clear, red solution for oral administration.
  • NDC 0054-0390-41: 15 mL Bottle
  • NDC 0054-0390-63: 500 mL Bottle
  • Dispense in a tight, light-resistant container as defined in the USP/NF.
  • Store 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Advise the patient to read the FDA-approved patient labeling ().
  • Medication Errors
  • Advise patients that oxycodone hydrochloride oral solution, is available in multiple concentrations. Inform patients about which concentration they have been prescribed. Instruct patients how to measure and take the correct dose of Oxycodone Hydrochloride Oral Solution, and to always use the cup when administering Oxycodone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately n
  • If the prescribed concentration is changed, instruct patients on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of Oxycodone Hydrochloride Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death . Instruct patients not to share Oxycodone Hydrochloride Oral Solution with others and to take steps to protect Oxycodone Hydrochloride Oral Solution from theft or misuse.
  • Life-Threatening Respiratory Depression
  • Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Oxycodone Hydrochloride Oral Solution or when the dosage is increased, and that it can occur even at recommended dosages Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
  • Accidental Ingestion
  • Inform patients that accidental ingestion, especially by, children, may result in respiratory depression or death Instruct patients to take steps to store Oxycodone Hydrochloride Oral Solution securely and to dispose of unused Oxycodone Hydrochloride Oral Solution by flushing the solution down the toilet.
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone Hydrochloride Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider n
  • Serotonin Syndrome
  • Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications n
  • MAOI Interaction
  • Inform patients to avoid taking Oxycodone Hydrochloride Oral Solution while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Oxycodone Hydrochloride Oral Solutionn
  • Adrenal Insufficiency
  • Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms n
  • Important Administration Instructions
  • Instruct patients how to properly take Oxycodone Hydrochloride Oral Solution. n
  • If patients have been receiving treatment with Oxycodone Hydrochloride Oral Solution for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication n
  • Hypotension
  • Inform patients that Oxycodone Hydrochloride Oral Solution may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) n
  • Anaphylaxis
  • Inform patients that anaphylaxis has been reported with ingredients contained in Oxycodone Hydrochloride Oral Solution. Advise patients how to recognize such a reaction and when to seek medical attention n
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndromen- [see Warnings and Precautions (), Use in Specific Populations ()].
  • Embryo-Fetal Toxicityn- [see Use in Specific Populations ()].
  • Lactation
  • Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs n
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
  • Driving or Operating Heavy Machinery
  • Inform patients that Oxycodone Hydrochloride Oral Solution may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication n
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention n
  • Disposal of Unused Oxycodone Hydrochloride Oral Solution
  • Advise patients to dispose of unused Oxycodone Hydrochloride Oral Solution by flushing the solution down the toilet or disposing of in accordance with local guidelines and/or regulations.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10009007/04
  • Revised October 2018
  • 10009007/04
  • Revised October 2018
  • No data

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