Oxycodone and aspirin tablets are contraindicated in patients with known hypersensitivity to oxycodone or aspirin, and in any situation where opioids or aspirin are contraindicated.
Aspirin is contraindicated for patients with hemophilia.Reye’s Syndrome: Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses.Allergy: Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products and in patients with the syndrome of asthma, rhinitis, and nasal polyps.
Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma).Oxycodone is contraindicated in patients with known hypersensitivity to oxycodone.
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.
Misuse, Abuse and Diversion of OpioidsOxycodone 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 aspirin 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 aspirin tablets should be closely monitored for the following potentially serious adverse reactions and complications:Respiratory DepressionRespiratory depression is a hazard with the use of oxycodone, one of the active ingredients in oxycodone and aspirin 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 PressureThe 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 pre-existing 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 EffectOxycodone 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.Alcohol WarningPatients who consume three or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.Coagulation AbnormalitiesEven low doses of aspirin can inhibit platelet function leading to an increase in bleeding time.
This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders.GI Side EffectsGI side effects include stomach pain, heartburn, nausea, vomiting, and gross GI bleeding.
Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms.Physicians should inform patients about the signs and symptoms of GI side effects and what steps to take if they occur.Peptic Ulcer DiseasePatients with a history of active peptic ulcer disease should avoid using aspirin, which can cause gastric mucosal irritation and bleeding.