Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : OXYCODONE HYDROCHLORIDE

Pharmaceutical Associates, Inc.

SOLUTION

Strength 5 mg/5mL

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

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 Hydrochloride (Oxycodone Hydrochloride) which is also known as OXYCODONE HYDROCHLORIDE and Manufactured by Pharmaceutical Associates, 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

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.

Inquire directly from our website and get 5% off on any medicine!

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

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
  • 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. (n n n , n n n )n n n
  • Oxycodone Hydrochloride Oral Solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (n n n )n n n
  • 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. (n n n )n n n
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (n n n )n n n
  • Accidental ingestion of Oxycodone Hydrochloride Oral Solution, especially by children, can result in a fatal overdose of oxycodone. (n n n )n n n
  • 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. (n n n )n n n
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. (n n n , n n n , n n n )n n n
  • 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. (n n n , n n n )n n n
  • No data
  • 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 [see n n n ], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:n nn
  • 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. (n n n )n nn
  • Limitations of Use (n n n )n n n
  • 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 n n )n n n
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (n n n )n n n
  • Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain. (n n n )n n n
  • For control of chronic pain, administer Oxycodone Hydrochloride Oral Solution on a regularly scheduled basis, at the lowest dosage level to achieve adequate analgesia. (n n n )n n n
  • Individually titrate Oxycodone Hydrochloride Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. (n n n )n n n
  • 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. (n n n )n n n
  • Oxycodone Hydrochloride Oral Solution, USP
  • 5 mg per 5 mL (1 mg/mL)
  • Oral solution 5 mg per 5 mL (1 mg/mL) (n n n )n nn
  • Oxycodone Hydrochloride Oral Solution is contraindicated in patients with:
  • Significant respiratory depression. (n n n )n n n
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (n n n )n n n
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. (n n n )n n n
  • Hypersensitivity to oxycodone. (n n n )n n n
  • 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 patient's 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. (n n n )n nn
  • Table 1 includes 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. (n n n )n nn
  • 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:
  • 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: artificial raspberry flavor, citric acid, FD&C Red #40, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol solution.
  • No data
  • No data
  • Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (1 mg/mL) is available as a red colored, raspberry flavor and supplied in the following oral dosage forms:
  • Dispense in a tight, light-resistant container as defined in the USP/NF.
  • STORAGE
  • Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature]
  • Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly [see n n n ].n nn
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • MANUFACTURED BY
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n
  • R10/19
  • Revn n n 10/2019n nn
  • MANUFACTURED BY
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n
  • NDC 0121-0827-04
  • Oxycodone Hydrochloriden n n Oral Solution USPn n n CIIn nn
  • 5 mg per 5 mLn n n (1 mg/mL)n nn
  • Rx ONLY
  • Pharmacist: Dispense the enclosedn n n Medication Guide to each patient.n nn
  • 4 fl oz (118 mL)
  • Pharmaceuticaln n n Associates, Inc.n n n Greenville, SC 29605n nn
  • Delivers 5 mLn n n NDC 0121-4827-05n nn
  • Oxycodone Hydrochloriden n n Oral Solution USPn n n CIIn n n 5 mg/5 mLn nn
  • Rx ONLYn n n FOR INSTITUTIONAL USE ONLYn nn
  • PHARMACEUTICAL ASSOCIATES, INC.n n n GREENVILLE, SC 29605n n n SEE INSERTn nn
  • A4827050617

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

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

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.