Oxycodone Hydrochloride And Ibuprofen

Oxycodone Hydrochloride And Ibuprofen

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Side Effects & Adverse Reactions

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS; Gastrointestinal

Effects - Risk of Ulceration, Bleeding, and Perforation).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, including oxycodone hydrochloride and ibuprofen, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.

Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including oxycodone hydrochloride and ibuprofen, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Oxycodone hydrochloride and ibuprofen should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including oxycodone hydrochloride and ibuprofen, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Misuse, Abuse and Diversion of Opioids

Oxycodone hydrochloride and ibuprofen tablets contain oxycodone, which is an opioid agonist, and a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

Oxycodone hydrochloride and ibuprofen can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxycodone hydrochloride and ibuprofen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

Respiratory Depression

Oxycodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers. Oxycodone hydrochloride also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Oxycodone hydrochloride and ibuprofen should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of oxycodone hydrochloride and ibuprofen may decrease respiratory drive to the point of apnea.

Hypotensive Effect

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

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Anaphylactoid Reactions

Anaphylactoid reactions may occur in patients without known prior exposure to oxycodone hydrochloride and ibuprofen. Oxycodone hydrochloride and ibuprofen should not be given to patients with the aspirin triad or a history of angioedema. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Fatal reactions to NSAIDs have been reported in such patients (see CONTRAINDICATIONS and PRECAUTIONS; Pre-existing Asthma). Emergency help should be sought when anaphylactoid reaction occurs.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

In patients with advanced kidney disease, treatment with oxycodone hydrochloride and ibuprofen is not recommended. No information is available from controlled clinical studies regarding the use of oxycodone hydrochloride and ibuprofen in patients with advanced renal disease. However, if oxycodone hydrochloride and ibuprofen tablets therapy must be initiated, due to the NSAID component, close monitoring of the patient’s kidney function is advisable (see WARNINGS; Renal Effects).

Skin Reactions

NSAIDs, including oxycodone hydrochloride and ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

Starting at 30 weeks gestation, oxycodone hydrochloride and ibuprofen, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus may occur.

Interactions with Alcohol and Drugs of Abuse

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.

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

Carefully consider the potential benefits and risks of oxycodone hydrochloride and ibuprofen and other treatment options before deciding to use oxycodone hydrochloride and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Oxycodone hydrochloride and ibuprofen tablets are indicated for the short term (no more than 7 days) management of acute, moderate to severe pain.

History

There is currently no drug history available for this drug.

Other Information

Each combination tablet contains: Oxycodone hydrochloride, USP 5 mg and ibuprofen, USP 400 mg

Oxycodone hydrochloride and ibuprofen is supplied in a fixed combination tablet form for oral administration and combines the opioid analgesic agent, oxycodone hydrochloride, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.

Oxycodone hydrochloride is a centrally acting semisynthetic opioid analgesic. Its chemical name is 4,5(-Epoxy-14-hydroxy-3-methoxy-methylmorphinan-6-one hydrochloride. Its molecular formula is C18H21NO4HCl and molecular weight is 351.83. Its structural formula is:

36f62898-figure-01

Ibuprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Its chemical name is (±)-2-(p-isobutylphenyl) propionic acid. Its molecular formula is C13H18O2 and molecular weight is 206.29. Its structural formula is:

36f62898-figure-02

Inactive ingredients in oxycodone hydrochloride and ibuprofen tablets include: calcium stearate, croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, pregelatinized starch, and stearic acid. The coloring agents consist of hypromellose, lactose monohydrate, polyethylene glycol, synthetic yellow iron oxide, titanium dioxide, and triacetin.

Oxycodone Hydrochloride And Ibuprofen Manufacturers


  • Actavis Elizabeth Llc
    Oxycodone Hydrochloride And Ibuprofen Tablet, Film Coated [Actavis Elizabeth Llc]
  • Watson Laboratories, Inc.
    Oxycodone Hydrochloride And Ibuprofen Tablet [Watson Laboratories, Inc.]
  • Barr Laboratories Inc.
    Oxycodone Hydrochloride And Ibuprofen Tablet, Film Coated [Barr Laboratories Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycodone Hydrochloride And Ibuprofen Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]

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