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Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : Oxycodone Hydrochloride

ANI Pharmaceuticals, Inc.

CAPSULE

Strength 5 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 ANI Pharmaceuticals, Inc.. It is available in strength of 5 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

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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
  • Dosage and Administration ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010/2019Warnings and Precautions (, )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010/2019
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  • WARNING: 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 DEPRESSANTSn
  • See full prescribing information for complete boxed warning.
  • Oxycodone Hydrochloride Capsules expose 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. (n- Arrayn- )
  • Accidental ingestion of Oxycodone Hydrochloride Capsules, especially by children, can result in a fatal overdose of oxycodone. (n- Arrayn- )
  • Prolonged use of Oxycodone Hydrochloride Capsules 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- Arrayn- )
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. (n- Arrayn- , , )
  • 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- Arrayn- , )
  • Oxycodone Hydrochloride Capsules are 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 Usen- [see Warnings and Precautions ()]
  • Oxycodone Hydrochloride Capsules are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ()u00a0
  • Limitations of Use
  • No data
  • Capsules 5 mg: Each capsule has an opaque yellow cap and an opaque white body, imprinted with u2018ANIu2019 on the cap and u2018167u2019 on the body in black ink and contains 5 mg of oxycodone hydrochloride USP.
  • Immediate-release capsules: 5 mg ()
  • Oxycodone Hydrochloride Capsules are 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 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 Capsules 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 Clinical Pharmacology ()]
  • Most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. ()n
  • Table 1 includes clinically significant drug interactions with Oxycodone Hydrochloride Capsules.
  • Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Capsules
  • Serotonergic Drugs:
  • Monoamine Oxidase Inhibitors (MAOIs):
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:
  • Pregnancy:
  • 8.1
  • No data
  • Clinical Presentation
  • Acute overdose with Oxycodone Hydrochloride Capsules 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 re-establishment 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 Capsules, 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 Capsules are an agonist, available as a hard gelatin capsule 5 mg for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82.
  • Its molecular formula is CHNOu2219HCl, and it has the following chemical structure.
  • Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol.
  • The inactive ingredients in Oxycodone Hydrochloride Capsules 5 mg include: colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, FD&C yellow #6, titanium dioxide, yellow iron oxide, shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide.
  • No data
  • Carcinogenesis
  • Long-term studies in animals to evaluate the carcinogenic potential of oxycodone hydrochloride 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 ) and 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 Capsules 5 mg are hard gelatin capsules with an opaque yellow cap and an opaque white body imprinted with u2018ANIu2019 on the cap and u2018167u2019 on the body in black ink available as follows: NDC 62559-167-01: Bottle of 100 Capsules
  • Dispense in a tight, light-resistant container. Protect from moisture and light.Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted at 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Store Oxycodone Hydrochloride Capsules securely and dispose of properly .
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Storage and Disposal:n n- [see Warnings and Precautions (), Drug Abuse and Dependence ()]
  • Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Oxycodone Hydrochloride Capsules should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
  • Addiction, Abuse, and Misusen- [see Warnings and Precautions ()]
  • Life-Threatening Respiratory Depressionn- [see Warnings and Precautions (n- Arrayn- )]
  • Accidental Ingestionn- [see Warnings and Precautions (n- Arrayn- )]
  • Interactions with Benzodiazepines and Other CNS Depressantsn- [see Warnings and Precautions (n- Arrayn- ), Drug Interactions ()]
  • Serotonin Syndromen- [see Drug Interactions ()]
  • MAOI Interactionn- [see Drug Interactions ()]
  • Adrenal Insufficiencyn- [see Warnings and Precautions (n- Arrayn- )]
  • Important Administration Instructionsn- [see Dosage and Administration ()]
  • Important Discontinuation Instructionsn n- [see Dosage and Administration ()]
  • Hypotensionn- [see Warnings and Precautions (n- Arrayn- )]
  • Anaphylaxisn- [see Adverse Reactions ()]
  • Pregnancyn- Neonatal Opioid Withdrawal Syndromen- [see Warnings and Precautions (n- Arrayn- ), Use in Specific Populations ()]
  • Embryo-Fetal Toxicityn- [see Use in Specific Populations ()]
  • Lactationn- [see Use in Specific Populations ()]
  • Infertilityn- [see Use in Specific Populations ()]
  • Driving or Operating Heavy Machineryn- [see Warnings and Precautions (n- Arrayn- )]
  • Constipationn- [see Adverse Reactions (), Clinical Pharmacology ()]
  • Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623n n n 9541 Rev 10/19
  • No data
  • Oxycodone Hydrochloride Capsules, CII5 mgNDC 62559-167-01Rx only100 Capsules

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