This medicine is a narcotic (opioid) pain medicine used to manage moderate to severe pain when continuous (around-the-clock) treatment is needed for an extended period of time. This medicine is not for use right after surgery if you have not already been using narcotic pain medicines, if only occasional or "as-needed" pain relief is needed, or if the pain is mild or is not expected to last for an extended period of 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.
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. TAKE THIS MEDICINE BY MOUTH with or without food. If stomach upset occurs, take with food to reduce stomach irritation. This medicine must only be taken by mouth. Do not inject this medicine. Do not take this medicine through a gastric or nasogastric (NG) tube (stomach tube). SWALLOW THIS MEDICINE WHOLE. Do not break, cut, crush, chew, or dissolve this medicine before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Swallow the mixture right away, followed by a glass of water. Do NOT crush or chew the medicine before swallowing. Do NOT store the mixture for future use. Flush the empty capsule down the toilet right away. 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 room temperature at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. 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 each day. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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 24 hours.
WARNING: THIS MEDICINE IS A NARCOTIC PAIN MEDICINE that may become habit-forming. Do not take more than 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. 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 this medicine. 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, you may open it and sprinkle the contents over a spoonful of applesauce. Swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. ACCIDENTAL SWALLOWING 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. Some medicines or medical conditions may interact with this medicine. 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 mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), 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, scopolamine, oxybutynin), cimetidine, diuretics (eg, furosemide, hydrochlorothiazide), muscle relaxants (eg, cyclobenzaprine), naltrexone, other narcotic pain medicines (eg, hydrocodone, oxycodone), phenothiazines (eg, chlorpromazine), quinidine, or rifamycins (eg, rifampin). TELL YOUR DOCTOR if you have never taken a narcotic pain medicine before. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, bronchitis, emphysema), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), low levels of oxygen in the blood (hypoxia), stomach or bowel problems (eg, blockage, inflammation), liver or kidney problems, gallbladder problems, pancreas problems (eg, pancreatitis), thyroid problems, an enlarged prostate, urinary blockage or trouble urinating, seizures (eg, epilepsy), suicidal thoughts or attempts, allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, poor health, severe drowsiness, increased pressure in the brain, a recent head injury, or growths in the brain (eg, tumors, lesions). TELL YOUR DOCTOR if you are very overweight, have recently had or will be having surgery (eg, stomach or bowel surgery), drink alcohol or have symptoms of alcohol withdrawal, or have a gastric or nasogastric (NG) tube (stomach tube). TELL YOUR DOCTOR if you or a member of your family has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have narrowing of the stomach or bowels; known or suspected stomach or bowel blockage (eg, paralytic ileus); or slow, shallow, or difficult breathing. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe lung problems (eg, severe asthma) or you are having an asthma attack. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while using this medicine include back pain, decreased appetite, diarrhea, dizziness, drowsiness, dry mouth, headache, mild stomach pain, nausea, sweating, tiredness, trouble sleeping, 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; difficult or painful urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizures; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, headache, or lightheadedness; shortness of breath; slow, difficult, or shallow breathing; swelling of the hands, ankles, or feet; tremor; trouble talking, thinking, or walking; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; or vision changes (eg, blurred vision). 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.
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; difficult, shallow, or slow breathing; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or lightheadedness; shortness of breath; or slow or irregular heartbeat.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. IF THIS MEDICINE IS NO LONGER NEEDED, dispose of it as soon as possible. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.