Oxycodone hydrochloride and ibuprofen (Tablet)

Oxycodone hydrochloride and ibuprofen (Tablet)

Carefully consider the potential benefits and risks of oxycodone hydrochloride and ibuprofen tablets 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 . After observing the response to initial therapy with oxycodone hydrochloride and ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs.��� For the management of acute moderate to severe pain, the recommended dose of oxycodone hydrochloride and ibuprofen is one tablet given orally. Dosage should not exceed 4 tablets in a 24-hour period and should not exceed 7 days.

Oxycodone hydrochloride component:Oxycodone hydrochloride is a semisynthetic opioid analgesic with multiple actions which involve the central nervous system and smooth muscle. The mechanism of action of oxycodone is not known but is thought to be related to its binding to opiate receptors in the central nervous system. In addition to analgesia, opioids may produce sedation and respiratory depression. Ibuprofen component:Ibuprofen is a nonsteroidal anti-inflammatory agent that possesses analgesic and antipyretic activities. Its mode of action, similar to other NSAIDs, is not completely understood, but is thought to be related to its inhibition of cyclooxygenase activity and prostaglandin synthesis. Ibuprofen is a peripherally acting analgesic. Ibuprofen doesnot have any known effects on opiate receptors.<br/>Pharmacokinetics: Absorption:Oxycodone is rapidly absorbed after single dose administration of oxycodone hydrochloride and ibuprofen tablets. Maximum concentrations (C) of oxycodone, ranging from 9.8 ng/mL to 11.7 ng/mL, are obtained within 1.3 hr to 2.1 hr after administration of oxycodone hydrochloride and ibuprofen tablets. Repeated administration of oxycodone hydrochloride and ibuprofen tablets every 6 hours results in approximately 50-65% increase in C. In the presence of food, the bioavailability of oxycodone is slightly (25%) increased. Ibuprofen is rapidly absorbed after oral administration of oxycodone hydrochloride and ibuprofen tablets. Cvalues range from 18.5 mcg/mL to 34.3 mcg/mL and are reached 1.6 hr to 3.1 hr after oral administration of oxycodone hydrochloride and ibuprofen tablets. Repeated administration of oxycodone hydrochloride and ibuprofen tablets every 6 hours does not result in any accumulation of ibuprofen. The bioavailability of ibuprofen is not altered in the presence of food. Distribution:Oxycodone binding to protein in serum is approximately 45%. Ibuprofen is extensively bound to plasma proteins (99%). Metabolism:Oxycodone is metabolized in the liver by means of N-demethylation and O-demethylation, 6- ketoreduction and glucuronidation. The major circulating metabolite is noroxycodone, which possesses weak analgesic activity. Oxymorphone, the end product of O-demethylation, has analgesic activity but is present in the plasma at low concentrations. Metabolism of oxycodone to oxymorphone occurs via CYP2D6. Ibuprofen is present as a racemate and following absorption, it undergoes interconversion in the plasma from the R-isomer to the S-isomer. Both the R- and S- isomers are metabolized to two primary metabolites: (+)-2-4'-(2-hydroxy- 2-methyl-propyl) phenyl propionic acid and (+)-2-4'-(2-carboxypropyl) phenyl propionic acid, both of which circulate in the plasma at low levels relative to the parent. Elimination:Oxycodone is eliminated from the systemic circulation with half life (T) values ranging from 3.1 hr to 3.7 hr after single dose administration of oxycodone hydrochloride and ibuprofen tablets. Urinary excretion of unchanged oxycodone amounts to approximately 4% of the administered oxycodone dose. Ibuprofen is eliminated from the systemic circulation with half life (T) values ranging from 1.8 hr to 2.6 hr after single dose administration of oxycodone hydrochloride and ibuprofen tablets. Urinary excretion of unchanged ibuprofen is minimal (less than 0.2% of administered ibuprofen dose).<br/>Special Populations:: Gender: There are no gender effects on the pharmacokinetics of oxycodone or ibuprofen after administration of oxycodone hydrochloride and ibuprofen tablets. Age: The effects of age on the pharmacokinetics of oxycodone hydrochloride and ibuprofen tablets after administration of oxycodone hydrochloride and ibuprofen tablets have not been evaluated. When either drug was administered alone, the pharmacokinetics of oxycodone and ibuprofen were similar in elderly subjects, compared to young healthy subjects. Pediatrics: The pharmacokinetics of oxycodone and ibuprofen after administration of oxycodone hydrochloride and ibuprofen tablets have not been evaluated in a pediatric population. Renal Impairment: The effects of renal impairment on the pharmacokinetics of oxycodone and ibuprofen after administration of oxycodone hydrochloride and ibuprofen tablets have not been evaluated. Hepatic Impairment: The effects of hepatic impairment on the pharmacokinetics of oxycodone and ibuprofen after administration of oxycodone hydrochloride and ibuprofen tablets have not been evaluated.

Oxycodone hydrochloride and ibuprofen tablets should not be administered to patients who have previously exhibited hypersensitivity to oxycodone hydrochloride, ibuprofen, or any of oxycodone hydrochloride and ibuprofen tablet's components. Oxycodone hydrochloride and ibuprofen tablets should not be administered in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to oxycodone. Oxycodone hydrochloride and ibuprofen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone hydrochloride and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe anaphylactoid reactions to NSAIDs, some of which were fatal, have been reported in such patients . Oxycodone hydrochloride and ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .

Cardiovascular Risk: Gastrointestinal Risk

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Following an acute overdosage, toxicity may result from oxycodone and/or ibuprofen.<br/>Signs and Symptoms: Acute overdosage with oxycodone may be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, or hypotension. In severe cases death may occur. The toxicity of ibuprofen overdose is dependent on the amount of drug ingested and the time elapsed since ingestion, although individual response may vary, necessitating individual evaluation of each case. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy, and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression, and seizures. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia, and atrial fibrillation, have also been reported.<br/>Treatment: In the treatment of opioid overdosage, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose, as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression, which may result from overdosage or unusual sensitivity to narcotics including oxycodone. An appropriate dose of naloxone hydrochloride should be administered intravenously with simultaneous efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or gastric lavage. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen. Emesis is most effective ifinitiated within 30 minutes of ingestion. Induced emesis is not recommended in patients with impaired consciousness or overdoses greater than 400 mg/kg of the ibuprofen component in children because of the risk for convulsions and the potential for aspiration of gastric contents.

Oxycodone hydrochloride and ibuprofen (Tablet)

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 doseshould 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 . Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke .<br/>Hypertension: NSAIDs, including oxycodone hydrochloride and ibuprofen tablets, 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.<br/>Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking NSAIDs. Oxycodone hydrochloride and ibuprofen tablets should be used with caution in patients with fluid retention or heart failure.<br/>Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including oxycodone hydrochloride and ibuprofen tablets, 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 3-6 months, and in about 2-4% 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 oftherapy. 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.<br/>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 tablets 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 .<br/>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 tablets 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 tablets may decrease respiratory drive to the point of apnea.<br/>Hypotensive Effect: Oxycodone hydrochloride and ibuprofen tablets, 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 tablets may produce orthostatic hypotension in ambulatory patients. Oxycodone hydrochloride and ibuprofen tablets, 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.<br/>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.<br/>Anaphylactoid Reactions: Anaphylactoid reactions may occur in patients without known prior exposure to oxycodone hydrochloride and ibuprofen tablets. Oxycodone hydrochloride and ibuprofen tablets 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 . Emergency help should be sought when anaphylactoid reaction occurs.<br/>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.<br/>Advanced Renal Disease: In patients with advanced kidney disease, treatment with oxycodone hydrochloride and ibuprofen tablets is not recommended. No information is available from controlled clinical studies regarding the use of oxycodone hydrochloride and ibuprofen tablets 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 .<br/>Skin Reactions: NSAIDs, including oxycodone hydrochloride and ibuprofen tablets, 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 firstappearance of skin rash or any other sign of hypersensitivity.<br/>Pregnancy: As with other NSAID-containing products, oxycodone hydrochloride and ibuprofen tablets should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.<br/>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.

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Oxycodone hydrochloride and ibuprofen