Oxycodone And Acetaminophen (Roxicet)

Trade Name : Roxicet

West-Ward Pharmaceuticals Corp

SOLUTION

Strength 5325 mg/5mLmg/5mL

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

Delivery Process

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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 And Acetaminophen (Roxicet) which is also known as Roxicet and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 5; 325 mg/5mL; mg/5mL per ml. Read more

Oxycodone And Acetaminophen (Roxicet) 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.

Read more
  • No data
  • Rx only
  • Hepatotoxicity
  • Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
  • Each tablet for oral administration contains:
  • Oxycodone Hydrochloride USP.................................................................. 5 mg+
  • (+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
  • Acetaminophen...................................................................................... 325 mg
  • Each 5 mL of oral solution for oral administration contains:
  • Oxycodone Hydrochloride........................................................................ 5 mg+
  • (+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
  • Acetaminophen...................................................................................... 325 mg
  • Alcohol ...................................................................................................... 0.4%
  • The tablets contain colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid.
  • The solution contains alcohol (0.4%), citric acid, disodium edetate, FD&C Red #40, flavors, fructose, polyethylene glycol, potassium sorbate, sodium saccharin and water.
  • ROXICETu2122 contains oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is CHNO u2219 HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:
  • C18H21NO4 u00b7HCl MW 381.82
  • ROXICETu2122 contains acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is CHNO and the molecular weight is 151.17. It may be represented by the following structural formula:
  • C8H9NO2 MW 151.17
  • No data
  • ROXICET is indicated for the relief of moderate to moderately severe pain.
  • ROXICET should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product.
  • Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.
  • No data
  • No data
  • ufeffSerious adverse reactions that may be associated with ROXICET use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see ).
  • The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.
  • Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.
  • Other adverse reactions obtained from postmarketing experiences with ROXICET are listed by organ system and in decreasing order of severity and/or frequency as follows:
  • ROXICET is a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
  • Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with chronic pain but may be more common in individuals who have a past history of alcohol or substance abuse or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.
  • Physical dependence on a prescribed medication does not signify addiction. Physical dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week period will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.
  • The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.
  • u201cDrug-seekingu201d behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated u201clossu201d of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). u201cDoctor Shoppingu201d to obtain additional prescriptions is common among drug abusers and people suffering from untreated infection.
  • Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
  • Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
  • Like other opioid medications, ROXICET is subject to the Federal Controlled Substances Act. After chronic use, ROXICET should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.
  • Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
  • Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
  • Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. ROXICET is given orally.
  • ROXICETu2122 Tablets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg)
  • White, round, scored tablets
  • (Identified 54 543)
  • NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered),
  • 4 cards per shipper.
  • NDC 0054-4650-25: Bottles of 100 tablets.
  • NDC 0054-4650-29: Bottles of 500 tablets.
  • Roxane Laboratories, Inc.
  • NDC 0054-8650-24: Unit Dose
  • Roxane Laboratories, Inc.
  • NDC 0054-4650-25: Bottles of 100
  • u00a0
  • Roxane Laboratories, Inc.
  • NDC 0054-8648-16: Unit Dose Patient Cups
  • Roxane Laboratories, Inc.
  • NDC 0054-3686-63: Bottles of 500 mL

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