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Drug Information For:
OXYCONTIN 80MG CONTROLLED REL TABS
Ingredient Name:OXYCODONE (ox-i-KOE-done)
Common Uses:This medicine is a narcotic (opioid) pain medicine used to manage severe pain. This medicine is only for use when continuous (around-the-clock) treatment is needed for a long of time. It is also only for use when other pain treatments do not treat your pain well enough or you cannot take them. It is NOT for use right after surgery if you have not already been using narcotic pain medicines, if you need only occasional or "as-needed" relief, or if the pain is mild or is not expected to last for a long time. CERTAIN STRENGTHS OF THIS MEDICINE should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. The use of these strengths by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.
Before Using This Medicine:WARNING: This medicine is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT exceed the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor. THIS MEDICINE MAY CAUSE severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing. BE SURE TO SWALLOW THIS MEDICINE WHOLE. Do NOT break, crush, cut, dissolve, or chew this medicine before swallowing it. Do NOT inject or snort this medicine. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose. ACCIDENTAL SWALLOWING of even one dose of this medicine may be fatal, especially in children. Keep this medicine out of the reach of children. Seek emergency medical care right away if another person swallows this medicine. Many other medicines interact with this medicine. These medicines can increase the risk of side effects as well as severe and sometimes fatal breathing problems. Talk with your doctor or pharmacist to make sure that it is safe for you to use this medicine with all of your other medicines. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking buprenorphine, a mixed agonist/antagonist pain medicine (eg, butorphanol, nalbuphine, pentazocine), a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or sodium oxybate (GHB), or if you have taken an MAOI within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticholinergics (eg, benztropine), azole antifungals (eg, ketoconazole), carbamazepine, carisoprodol, diuretics (eg, furosemide), macrolide antibiotics (eg, erythromycin), mifepristone, muscle relaxants, naltrexone, other narcotic pain medicines (eg, codeine, morphine), nefazodone, phenothiazines (eg, chlorpromazine), phenytoin, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), or telithromycin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including difficulty swallowing, constipation, low blood pressure, dehydration, low blood volume, poor health, stomach pain, severe drowsiness, a recent head injury, increased pressure in the brain, growths in the brain (eg, tumors, lesions), allergies (especially to other narcotic pain medicines, such as morphine or hydromorphone), pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have a history of lung or breathing problems (eg, asthma, COPD, emphysema, bronchitis); sleep apnea; scoliosis; a certain heart problem (corpulmonale); high blood carbon dioxide levels (hypercapnia or hypercarbia); low blood oxygen levels (hypoxia); seizures; liver, kidney, thyroid, or gallbladder problems; pancreas problems (eg, pancreatitis); urinary blockage or trouble urinating; an enlarged prostate; stomach or bowel problems (eg, blockage, esophageal or colon cancer, inflammation); or suicidal thoughts or attempts. TELL YOUR DOCTOR if you or a family member has a history of mental or mood problems or alcohol or other substance abuse or dependence. TELL YOUR DOCTOR if you drink alcohol or have symptoms of alcohol withdrawal, if you are very overweight, if you have recently had or will be having surgery (eg, stomach or bowel surgery), or if you have never taken a narcotic pain medicine before. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain stomach or bowel problems (eg, narrowing, known or suspected blockage); slow, shallow, or difficult breathing; severe lung problems (eg, severe asthma); or if you are having an asthma attack. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
How to Use This Medicine:Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. If stomach upset occurs, take with food to reduce stomach irritation. This medicine must only be taken by mouth. DO NOT inject or snort this medicine. SWALLOW WHOLE. Do not break, cut, crush, chew, or dissolve the tablet before swallowing. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose. If you cannot swallow this medicine whole, tell your doctor. SOME PATIENTS HAVE REPORTED trouble swallowing this medicine. These reports have included choking, gagging, spitting tablets back up, and getting tablets stuck in the throat. To decrease these risks, take this medicine 1 tablet at a time if your dose calls for more than 1 tablet. Do not pre-soak, lick, or wet the tablet before you place it in your mouth. Take each tablet with enough water to be sure that you swallow it completely. Swallow this medicine immediately after you place it in your mouth. DO NOT SUDDENLY STOP TAKING THIS MEDICINE. You may have an increased risk of withdrawal symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. If you need to stop this medicine, your doctor will gradually lower your dose. STORE THIS MEDICINE at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. THIS MEDICINE works best if it is taken at the same time(s) each day. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible then take your next dose as directed by your doctor. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once. Do not take more than 1 dose in 12 hours.
Cautions:DO NOT TAKE THIS MEDICINE if you are allergic to any ingredient in this medicine. CHECK WITH YOUR DOCTOR BEFORE TAKING THIS MEDICINE if you have had an allergic reaction to any other narcotic pain medicine (eg, morphine, hydromorphone). When used for long periods of time or at high doses, this medicine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if this medicine stops working well. DO NOT EXCEED THE RECOMMENDED DOSE, take for longer than prescribed, or take more often than prescribed without checking with your doctor. Some people who use this medicine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or ADDICTION. If your pain continues or becomes worse of if you have side effects that concern you, contact your doctor. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, emergency care, or surgery, tell the doctor or dentist that you are using this medicine. THIS MEDICINE MAY CAUSE DROWSINESS, dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT DRINK ALCOHOL or take medicines (prescription or nonprescription) that contain alcohol while you are taking this medicine. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol. CHECK WITH YOUR DOCTOR before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking this medicine; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects. SEEK EMERGENCY MEDICAL CARE right away if another person swallows this medicine. Accidental swallowing of this medicine may be fatal, especially in children. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine, especially breathing problems. FOR WOMEN: IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Long-term use of this medicine during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening.Discuss any questions or concerns with your doctor. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.
Possible Side Effects:SIDE EFFECTS that may occur while using this medicine include dizziness, drowsiness, dry mouth, headache, mild itching, mild stomach pain, nausea, sweating, tiredness, vomiting, or weakness. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE CONSTIPATION. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking this medicine, talk with your doctor or pharmacist. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal sighing; burning, numbness, or tingling; chest pain; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; fever or chills; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent stomach pain, constipation, or vomiting; shortness of breath; slow, difficult, or shallow breathing; swelling of the hands, ankles, or feet; tremor; trouble talking, thinking, or walking; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, throat, or tongue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose:IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include bluish skin or nails; cold and clammy skin; coma; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or lightheadedness; shortness of breath; slow or irregular heartbeat; or slow, shallow, or difficult breathing.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.