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ratio-Oxycodan

(ASA - oxycodone)



How does this medication work? What will it do for me?

This combination product contains two medications: oxycodone and acetylsalicylic acid (ASA). ASA belongs to the group of medications called analgesics (pain relievers), anti-inflammatories, and antipyretics (fever reducers). Oxycodone belongs to the group of medications called narcotic analgesics. This medication is used to relieve moderate to moderately severe pain, including conditions associated with fever or inflammation.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The dosage varies according to each individual and can be affected by the severity of the pain as well as each person's response to the medication.

The recommended adult dose is 1 full-strength tablet every 6 hours as needed. The total amount of ASA taken during a 24-hour period should not exceed 4 g.

The dosage for children and adolescents 6 years and older is calculated by the doctor based on body weight. The recommended dose is 0.1 mg to 0.2 mg of oxycodone per kilogram of body weight per dose.

This medication is not recommended for children under 6 years of age.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

This medication may be habit-forming if taken for long periods of time. Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to lessen the severity of withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each yellow tablet, imprinted with "TEC" on one side and a single score on the other, contains oxycodone 5 mg and ASA 325 mg. Nonmedicinal ingredients: colloidal silicon dioxide, FD&C Yellow No. 5 Aluminum Lake, lactose, microcrystalline cellulose, sodium starch glycolate, and stearic acid.

Who should NOT take this medication?

ASA - oxycodone HCl should not be taken by anyone who:

  • is allergic to oxycodone, to ASA, or to any of the ingredients of the medication
  • is allergic to nonsteroidal anti-inflammatory medications
  • is in the last 3 months of pregnancy or is breast-feeding
  • is taking warfarin
  • is under 19 years of age and is experiencing fever
  • has a history of blood clotting problems
  • has a history of stomach ulcers or duodenal ulcers
  • has a seizure disorder
  • has asthma, rhinitis (runny nose), and nasal polyps
  • has preexisting respiratory depression
  • has severe anemia
  • has status asthmaticus (unresponsive asthma)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • dizziness
  • drowsiness
  • heartburn or indigestion
  • itching
  • lightheadedness or feeling faint
  • mood changes
  • nausea
  • vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • agitation
  • blurred or double-vision or other changes in vision
  • confusion
  • difficulty sleeping
  • dizziness when rising from a lying or sitting position
  • dry mouth
  • false sense of well-being
  • general feeling of discomfort or illness
  • hallucinations
  • headache
  • increased sweating
  • irregular breathing
  • loss of appetite
  • muscle twitching
  • nervousness
  • nightmares or unusual dreams
  • pain in lower back or side
  • redness or flushing of face
  • ringing or buzzing in the ears
  • signs of allergic reaction (e.g., hives, itching, or skin rash)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of unusual bleeding (e.g., bloody or black, tarry stools, vomiting of blood or material that looks like coffee grounds, unusual bruising or bleeding, nosebleeds)
  • sore throat and fever
  • stomach pain (severe)
  • swelling of face
  • tightness in chest or wheezing
  • trembling or uncontrolled muscle movements
  • unusual excitement (especially in children)
  • unusual tiredness or weakness
  • urinating changes such as difficulty urinating, frequent urge to urinate, decrease in amount of urine

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • any loss of hearing
  • bloody urine
  • confusion (severe)
  • convulsions (seizures)
  • diarrhea (severe or continuing)
  • dizziness (severe)
  • drowsiness (severe)
  • excitement, nervousness, or restlessness (severe)
  • headache (severe or continuing)
  • increased sweating
  • increased thirst
  • low blood pressure
  • drowsiness
  • nausea or vomiting (severe or continuing)
  • nervousness or restlessness
  • signs of breathing problems (e.g., shallow, irregular breathing, or slow or troubled breathing)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • stomach pain (severe or continuing)
  • symptoms of overdose (e.g., cold, clammy skin, abnormally slow or weak breathing, severe dizziness, confusion, slow heartbeat, or extreme uncontrollable flapping movements of the hands - especially in elderly patients)
  • weakness (severe)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

October 17, 2013

Health Canada has issued new restrictions concerning the use of ratio-Oxycodan (ASA-oxycodone). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abdominal conditions: Oxycodone may make the diagnosis of abdominal conditions more difficult, or it may worsen these conditions. People with abdominal conditions such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bleeding disorders: ASA may increase bruising and bleeding from cuts that may take longer to stop. People with bleeding disorders or a history of bleeding problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breathing: Oxycodone can suppress breathing. People at risk for breathing difficulties such as asthma should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains oxycodone. Physical dependence, psychological dependence, and abuse have occurred with the use of oxycodone. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Gout: ASA may cause or worsen attacks of gout. Symptoms of an acute gout attack include sudden pain, swelling, and stiffness in the affected joint, often the big toe. You may also experience a fever. If this is your first attack, seek medical attention as soon as possible. If you have had gout attacks before, follow your doctor's instructions for dealing with the attack.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. These people should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Taking ASA - oxycodone for a long period of time may increase the risk of developing kidney disease. People with kidney disease or reduced kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: People with liver disease or reduced liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other medical conditions: People about to undergo surgery of the biliary tract should use caution while taking oxycodone as it may worsen their condition. Oxycodone will worsen the effects of acute alcohol intoxication and delirium tremens.

As well, people with low thyroid (hypothyroidism), Addison's disease, benign prostatic hypertrophy (enlarged prostate), urethral stricture, decreased function of the adrenal glands, or porphyria should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: This medication may cause seizures, especially when higher doses are used or when taken with other medications that may increase the risk of seizures such as:

  • cyclobenzaprine
  • monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, tranylcypromine)
  • neuroleptics (e.g., haloperidol, quetiapine, olanzapine, resperidone)
  • opioids (e.g., morphine, codeine, oxycodone)
  • promethazine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)

The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma).

Stomach problems: ASA may cause stomach problems such as ulcers or bleeding. People with stomach problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using ASA at the same time as other anti-inflammatory medications increases the risk of stomach ulcers and bleeding.

Surgery: Do not take this medicine for 1 to 2 weeks before any surgery, including dental surgery, unless otherwise directed by your doctor or dentist. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking ASA - oxycodone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 6 years of age. The use of ASA may be associated with the development of Reye's syndrome in children and teenagers who have illnesses accompanied by fever, especially influenza and chickenpox. ASA should not be given to or used by children or teenagers who have chickenpox or flu symptoms, unless a doctor is consulted.

Seniors: Seniors may be more susceptible to the harmful effects of ASA, possibly because of decreased kidney function.

What other drugs could interact with this medication?

There may be an interaction between ASA - oxycodone and any of the following:

  • acetazolamide
  • alcohol
  • alendronate
  • anesthetics
  • angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, ramipril)
  • antidiabetic medications (e.g., insulin, glyburide)
  • antihistamines (e.g., cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine)
  • antipsychotics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
  • "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
  • baclofen
  • barbiturates (e.g., butalbital, phenobarbital, secobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • bosentan
  • bupropion
  • buspirone
  • butorphanol
  • calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
  • carbamazepine
  • cefamandole
  • cefoperazone
  • cefotetan
  • chloral hydrate
  • cholestyramine
  • cimetidine
  • corticosteroids (e.g., dexamethasone, prednisone, methylprednisolone)
  • dasatanib
  • dexamethasone
  • dextroamphetamine
  • disulfiram
  • divalproex
  • fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin, moxifloxacin)
  • furosemide
  • ginkgo biloba
  • glucosamine
  • heparin
  • imatinib
  • isoniazid
  • ketorolac
  • lamotrigine
  • macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin)
  • methocarbamol
  • methotrexate
  • monoamine oxidase inhibitors (e.g., tranylcypromine, phenelzine, moclobemide)
  • moxalactam
  • naltrexone
  • non-steroidal anti-inflammaotry medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • other narcotic analgesics (e.g., codeine, morphine)
  • pentazocine
  • pentoxiphylline
  • phenytoin
  • phenothiazines (e.g., perphenazine, thioridazine)
  • phenylbutazone
  • primidone
  • probenacid
  • protease inhibitors (e.g., daraunavir, indinavir, lopinavir, ritonavir saquinavir)
  • quinidine
  • rifabutin
  • rifampin
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
  • spironolactone
  • St. John's wort
  • sulfinpyrazone
  • tetracycline antibiotics (e.g., doxycycline, minocycline, tetracycline)
  • thiazide diuretics (e.g., hydrochlorothiazide, indapamide)
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
  • valproic acid
  • vancomycin
  • warfarin
  • zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material © 1996-2014 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

Mackenzie Health / 10 Trench St. Richmond Hill, On. L4C 4Z3 / Main Hospital Site: (905) 883-1212 / TTY Service: (905) 883-2123