Oxycodone And Acetaminophen

Oxycodone And Acetaminophen

Oxycodone And Acetaminophen Recall

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Questions & Answers

Side Effects & Adverse Reactions

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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious skin reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Oxycodone and Acetaminophen Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Oxycodone and Acetaminophen Tablets, USP for patients with acetaminophen allergy.

Misuse, Abuse and Diversion of Opioids

Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxycodone and acetaminophen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Administration of oxycodone and acetaminophen tablets should be closely monitored for the following potentially serious adverse reactions and complications:

Respiratory Depression

Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in oxycodone and acetaminophen tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE).

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.

Hypotensive Effect

Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients.

Hepatotoxicity

Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.

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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious skin reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Oxycodone and Acetaminophen Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Oxycodone and Acetaminophen Tablets, USP for patients with acetaminophen allergy.

Respiratory Depression

Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in oxycodone and acetaminophen tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE).

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.

Hypotensive Effect

Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients.

Hepatotoxicity

Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Oxycodone and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

Each tablet, for oral administration, contains:

Oxycodone hydrochloride, USP ................................................................. 5 mg
(equivalent to 4.4815 mg of Oxycodone)
Acetaminophen, USP .............................................................................. 325 mg

In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate and stearic acid. May also contain corn starch.

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4∙HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

This is an image of the structural formula of oxycodone.

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 C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula:

This is an image of the structural formula of acetaminophen.

Oxycodone And Acetaminophen Manufacturers


  • Major Pharmaceuticals
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Major Pharmaceuticals]
  • Proficient Rx Lp
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Proficient Rx Lp]
  • Direct Rx
    Oxycodone And Acetaminophen Tablet [Direct Rx]
  • Direct Rx
    Oxycodone And Acetaminophen Tablet [Direct Rx]
  • Mayne Pharma
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Mayne Pharma]
  • Blenheim Pharmacal, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Oxycodone And Acetaminophen Tablet [Blenheim Pharmacal, Inc.]
  • Rebel Distributors Corp
    Oxycodone And Acetaminophen Tablet [Rebel Distributors Corp]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycodone And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Oxycodone And Acetaminophen (Oxycodone And Acetaminophen) Tablet [Bryant Ranch Prepack]
  • Redpharm Drug Inc.
    Oxycodone And Acetaminophen Tablet [Redpharm Drug Inc.]
  • H.j. Harkins Company, Inc.
    Oxycodone And Acetaminophen (Oxycodone And Acetaminophen) Tablet [H.j. Harkins Company, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Dispensing Solutions, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Dispensing Solutions, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Rebel Distributors Corp
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Rebel Distributors Corp]
  • H.j. Harkins Company, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [H.j. Harkins Company, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycodone And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Rebel Distributors Corp
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Rebel Distributors Corp]
  • Stat Rx Usa Llc
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Stat Rx Usa Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycodone And Acetaminophen Tablet [Pd-rx Pharmaceuticals, Inc.]
  • St Marys Medical Park Pharmacy
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride, Acetaminophen) Tablet [St Marys Medical Park Pharmacy]
  • St Marys Medical Park Pharmacy
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride, Acetaminophen) Tablet [St Marys Medical Park Pharmacy]
  • Alvogen, Inc.
    Oxycodone And Acetaminophen Tablet [Alvogen, Inc.]
  • Bryant Ranch Prepack
    Oxycodone And Acetaminophen (Oxycodone And Acetaminophen ) Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Oxycodone And Acetaminophen (Oxycodone And Acetaminophen ) Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Oxycodone And Acetaminophen (Oxycodone And Acetaminophen ) Tablet [Bryant Ranch Prepack]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Product S Llc
    Oxycodone And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Product S Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycodone And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycodone And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Watson Laboratories, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Watson Laboratories, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Qualitest Pharmaceuticals
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Qualitest Pharmaceuticals]
  • Qualitest Pharmaceuticals
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Qualitest Pharmaceuticals]
  • Watson Laboratories, Inc.
    Oxycodone And Acetaminophen Capsule [Watson Laboratories, Inc.]
  • Amneal Pharmaceuticals, Llc
    Oxycodone And Acetaminophen Tablet [Amneal Pharmaceuticals, Llc]
  • Amneal Pharmaceuticals, Llc
    Oxycodone And Acetaminophen Tablet [Amneal Pharmaceuticals, Llc]
  • Amneal Pharmaceuticals, Llc
    Oxycodone And Acetaminophen Tablet [Amneal Pharmaceuticals, Llc]
  • Mallinckrodt, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Capsule, Gelatin Coated [Mallinckrodt, Inc.]
  • Aurolife Pharma Llc
    Oxycodone And Acetaminophen Tablet [Aurolife Pharma Llc]
  • Apotheca, Inc
    Oxycodone And Acetaminophen Tablet [Apotheca, Inc]
  • Physicians Total Care, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Physicians Total Care, Inc.]
  • American Health Packaging
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [American Health Packaging]
  • American Health Packaging
    Oxycodone And Acetaminophen Tablet [American Health Packaging]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Oxycodone And Acetaminophen Tablet [Caraco Pharmaceutical Laboratories, Ltd.]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycodone And Acetaminophen Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Roxane Laboratories, Inc.
    Oxycodone And Acetaminophen Tablet [Roxane Laboratories, Inc.]
  • Unit Dose Services
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Unit Dose Services]
  • Unit Dose Services
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Unit Dose Services]
  • Unit Dose Services
    Oxycodone And Acetaminophen Tablet [Unit Dose Services]
  • Mylan Pharmaceuticals Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Mylan Pharmaceuticals Inc.]
  • Midlothian Laboratories
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Midlothian Laboratories]
  • Mallinckrodt, Inc.
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Mallinckrodt, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycodone And Acetaminophen Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Barr Laboratories Inc.
    Oxycodone And Acetaminophen Capsule [Barr Laboratories Inc.]
  • Alvogen, Inc.
    Oxycodone And Acetaminophen Tablet [Alvogen, Inc.]
  • American Health Packaging
    Oxycodone And Acetaminophen Tablet [American Health Packaging]
  • Qualitest Pharmaceuticals
    Oxycodone And Acetaminophen (Oxycodone Hydrochloride And Acetaminophen) Tablet [Qualitest Pharmaceuticals]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycodone And Acetaminophen Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Amneal Pharmaceuticals Of New York, Llc
    Oxycodone And Acetaminophen Tablet [Amneal Pharmaceuticals Of New York, Llc]
  • Actavis Elizabeth Llc
    Oxycodone And Acetaminophen Tablet [Actavis Elizabeth Llc]
  • Rhodes Pharmaceuticals L.p.
    Oxycodone And Acetaminophen Tablet [Rhodes Pharmaceuticals L.p.]
  • Mikart, Inc.
    Oxycodone And Acetaminophen Tablet [Mikart, Inc.]
  • Medsource Pharmaceuticals
    Oxycodone And Acetaminophen Tablet [Medsource Pharmaceuticals]
  • Directrx
    Oxycodone And Acetaminophen Tablet [Directrx]

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