Aspirin and oxycodone

You should not take this medicine if you are allergic to aspirin or oxycodone (OxyContin), or if you have:

• a bleeding or blood clotting disorder such as hemophilia;

• ulcer or obstruction in the stomach;

• severe asthma or breathing problems;

• an allergy to any NSAID (nonsteroidal anti-inflammatory drug); or

• if you are taking a blood thinner such as warfarin (Coumadin, Jantoven).

Do not use aspirin and oxycodone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not give this medication to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

To make sure aspirin and oxycodone is safe for you, tell your doctor if you have:

• stomach or intestinal disorder, history of stomach ulcer or bleeding;

• any type of breathing problem or lung disease;

• urination problems;

• liver or kidney disease;

• a history of head injury, brain tumor, or seizures;

• a history of drug abuse, alcohol addiction, or mental illness;

• problems with your gallbladder, pancreas, thyroid, or adrenal gland; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Do not use this medicine if you are pregnant. Use effective birth control to prevent pregnancy while taking aspirin and oxycodone.

• If you use oxycodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

• Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Aspirin and oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using aspirin and oxycodone.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A aspirin and oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Usual Adult Dose for Pain:

Initial dose: 1 tablet (oxycodone 5 mg/aspirin 325 mg) orally every 6 hours as needed for pain
-Adjust dose to a dose that provides adequate analgesia while minimizing adverse reactions
Maximum dose: 12 tablets in 24 hours
Maximum Aspirin dose: 4 g in 24 hours

Comments:
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with aspirin and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Initial dose: 1 tablet (oxycodone 5 mg/aspirin 325 mg) orally every 6 hours as needed for pain
-Adjust dose to a dose that provides adequate analgesia while minimizing adverse reactions
Maximum dose: 12 tablets in 24 hours
Maximum Aspirin dose: 4 g in 24 hours

Comments:
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Mild to moderate hepatic impairment: Use with caution
Severe hepatic impairment: Avoid use

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS:
-Addiction, Abuse, and Misuse: This drug exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
-Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dose increase.
-Accidental Ingestion: Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose of oxycodone.
-Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available.
-CYP450 3A4 Interaction: Concomitant use of CYP450 3A4 inhibitors may result in increased oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP450 3A4 inducer may result in increased oxycodone plasma concentrations. Monitor patients concomitantly receiving any CYP450 3A4 inhibitor or inducer.
-Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for use in patients for whom alternative treatment options are inadequate. If needed, limit dose and duration to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Data not available