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Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : Oxycodone Hydrochloride

VistaPharm, Inc.

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 VistaPharm, Inc.. 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

Packaging and Delivery

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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.

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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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  • 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 [seeu00a0, ].
  • 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 [see ].
  • 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 [see ]. 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 Oral Solution. Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride Oral Solution or following a dose increase [see ].
  • 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 [see ]n
  • 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 [see ].
  • 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 [see , , ].
  • Arrayn- Array
  • WARNING: n
  • 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. ()
  • 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. ()
  • 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. (,)
  • Dosage and Administration ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a010/2019
  • Warnings and Precautions (, )u00a0 u00a010/2019n
  • 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
  • u00a0n- Array
  • 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]:
  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia
  • No data
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ()n
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ()
  • Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain. ()
  • For control of chronic pain, administer Oxycodone Hydrochloride Oral Solution on a regularly scheduled basis, at the lowest dosage level to achieve adequate analgesia. ()
  • Individually titrate Oxycodone Hydrochloride Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. ()
  • Do not abruptly discontinue Oxycodone Hydrochloride Oral Solution in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide ()
  • Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL)
  • Oral solution 5 mg per 5 mL (1 mg/mL) ()
  • Oxycodone Hydrochloride Oral Solution is contraindicated in patients with:
  • Significant respiratory depression. ()n
  • Acute or severe bronchial asthma in an unmonitored setting or inabsence of resuscitative equipment. ()
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. ()
  • Hypersensitivity to oxycodone. ()
  • 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 deficiencyn- Array
  • Most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. ()
  • To report SUSPECTED ADVERSE REACTIONS,u00a0contact VistaPharm, Inc. at 1-888-655-1505, oru00a0FDA at 1-800-FDA-1088 orn
  • 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
  • Pregnancy: May cause fetal harm. ()
  • No data
  • No data
  • Oxycodone Hydrochloride Oral Solution 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-6one hydrochloride and has the following structural formula:
  • CHNOu2022HCIu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0MW 351.82
  • Oxycodone hydrochloride is a white, odorless 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, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin Natural USP, Sorbitol Solution 70% USP, FD&C Red #40, Raspberry Flavor and Water.
  • 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 presenceu00a0 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, 5 mg per 5 mL (1 mg/mL) is available as follows:
  • NDC 66689-403-16: 500 mL bottle packaged with calibrated measuring cup
  • NDC 66689-401-01: 5 mL unit dose cup
  • NDC 66689-401-50: Case contains 50 unit-dose cups of 5 mL (NDC 66689-401-01), packagedu00a0 in 5 trays of 10 unit-dose cups each
  • Dispense in a tight, light-resistant container as defined in the USP/NF.n
  • Store at controlled room temperature 20u00b0-25u00b0C (68u00b0- 77u00b0F); excursions are permitted to 15u00b0 - 30u00b0C (59u00b0 - 86u00b0F). [See USP Controlled Room Temperature]
  • Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly [].
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Storage and Disposal:n- Array
  • 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 [see ].
  • 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.n
  • 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 [see ]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 [see ]. 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 [see ].
  • Interactions withu00a0 Benzodiazepines and Other CNSu00a0u00a0 Depressants
  • Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone Hydrochloride Oral Solution is used with benzodiazepinesu00a0 oru00a0 otheru00a0 CNSu00a0 depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [see ]n
  • Serotonin Syndrome
  • Inform patients that opioids could cause a rare but potentially life-threatening condition resulting fromu00a0 concomitantu00a0 administrationu00a0 ofu00a0 serotonergicu00a0 drugs.u00a0 Warnu00a0 patientsu00a0 ofu00a0 theu00a0 symptomsu00a0 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. [see ].
  • 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 Solution [see ]
  • 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 [see ].
  • Important Administration Instructions
  • Instruct patients how to properly take Oxycodone Hydrochloride Oral Solution. [see , ]
  • Important Discontinuation Instructions
  • In order to avoid developing withdrawal symptoms, instruct patients not to discontinue Oxycodone Hydrochloride Oral Solution without first discussing a tapering plan with the prescriber [].
  • u00a0n- 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) [see ].
  • 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 [see , ]n
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndrome
  • Inform female patients of reproductive potential that 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 [see , ]n
  • Embryo-Fetal Toxicity
  • Inform female patients of reproductive potential that Oxycodone Hydrochloride Oral Solution can (or may) cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see ]n
  • 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 [see ].
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see ]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 [see ].
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ]n
  • Manufactured by:
  • Largo, FL 33771, USA
  • VP 2013R4
  • 10/19
  • To request medical information contact VistaPharm, Inc. at 1-888-655-1505.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration
  • Manufactured by:
  • Arrayn- Array
  • Largo, FL 33771, USA
  • VP2100R3
  • 10/19
  • Rx Only
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • Oxycodone
  • Hydrochloride Oral Solution, USP CII
  • 5 mg per 5 mL
  • PHARMACIST: Dispense the enclosed Medication Guide to each patient.
  • Delivers 5 mL
  • Store at u00a020u00b0-25u00b0C (68u00b0-77u00b0F); see USP CRT conditions.
  • XACTDOSE
  • Manufactured by:
  • VistaPharmu00ae
  • Largo, FL 33771, USA
  • Rx Only
  • u00a0
  • 06/18
  • NDC 66689-401-01
  • NDC 66689-403-16
  • Oxycodone Hydrochloride Oral Solution, USP CII
  • 5 mg per 5 mL
  • (1 mg/mL)
  • PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT.
  • Each 5 mL Contains:
  • Oxycodone Hydrochloride, USP ........................................... 5 mg
  • DO NOT USE IF SEAL UNDER CAP IS MISSING OR BROKEN.
  • USUAL DOSAGE:u00a0
  • STORAGE:
  • FOR ORAL USE ONLY
  • 500 mL
  • Dispense solution in original container (bottle) with the provided calibrated measuring cup.
  • Keep in secured area and protect from diversion.
  • Manufactured by:
  • Rx Only
  • VistaPharm
  • VP2011R3
  • 08/18
  • NDC 66689-403-16n
  • Oxycodone Hydrochloride Oral Solution, USP CIIn
  • 5 mg per 5 mL
  • u00a0(1 mg/mL)
  • PHARMACIST: DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT.u00a0
  • Each 5 mL Contains:
  • Oxycodone Hydrochloride, USP..............5 mg
  • 500 mL
  • Rx Only
  • VistaPharm

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