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Drug Information For:
TRAMADOL/APAP 37.5MG/325MG TABS
Ingredient Name:TRAMADOL (TRA-ma-doll) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)
Drug Manufacturer:AMNEAL PHARMACEUTICALS
Common Uses:This medicine is an analgesic combination used to treat pain in certain patients.
Before Using This Medicine:WARNING: THIS MEDICINE CONTAINS ACETAMINOPHEN. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor. 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 taking sodium oxybate (GHB), or any other medicine containing tramadol or acetaminophen. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking alpha-2 receptor blockers (eg, yohimbine), anorexiants (eg, phentermine), anticoagulants (eg, warfarin), azole antifungals (eg, ketoconazole), butyrophenones (eg, haloperidol), carbamazepine, cyclobenzaprine, digoxin, isoniazid, linezolid, lithium, loxapine, macrolide antibiotics (eg, erythromycin), certain medicines for mental or mood disorders (eg, olanzapine), molindone, nefazodone, opioid pain medicines (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), quinidine, rifampin, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), sleeping medicines (eg, zolpidem), St. John's wort, thioxanthenes (eg, thiothixene), tiagabine, tricyclic antidepressants (eg, amitriptyline), or "triptans" (eg, sumatriptan). Tell your doctor if you are taking furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) or if you have taken one of these medicines within the last 14 days. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including heart problems (eg, cor pulmonale), liver problems (eg, hepatitis), pancreas problems, kidney problems, thyroid problems, prostate problems (eg, enlargement of the prostate gland), a blockage in the bladder, diabetes, high blood pressure, metabolism problems, allergies, pregnancy, or breast-feeding. Tell your doctor if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system. Tell your doctor if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease / COPD); seizures (eg, epilepsy); recent stomach or bowel surgery, or any other stomach or bowel problem (eg, pain, inflammation, ulcers); mood or mental problems (eg, depression); or suicidal thoughts or actions. Tell your doctor if you drink alcohol or if you are going through withdrawal from alcohol or other substances. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe or persistent diarrhea due to taking an antibiotic; liver problems; suicidal thoughts or actions; or a history of alcohol or other substance abuse or addiction. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are intoxicated with alcohol or certain medicines, including opioids or narcotics (eg, morphine, codeine), or sedatives or sleeping medicines (eg, temazepam, zolpidem). Use of this medicine in CHILDREN is not recommended; safety and effectiveness in children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine:Follow the directions for taking this medicine provided by your doctor. Take this medicine by mouth with or without food. DO NOT TAKE THIS MEDICINE FOR LONGER THAN PRESCRIBED without checking with your doctor. Do NOT take more than 8 tablets per day. Do not take more than 4 tablets per day if you have kidney problems. CONTACT YOUR DOCTOR RIGHT AWAY if you take more than 4000 mg of acetaminophen in a 24 hour period, even if you feel well. 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. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE of this medicine and you are taking it regularly, take it as soon as possible. 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.
Cautions:DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine or to any other codeine-or morphine-related medicine (eg, oxycodone, hydrocodone, dihydrocodeine, hydromorphone). DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. Your dose may need to be slowly lowered to avoid side effects. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. 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 or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. ALCOHOL, HOT WEATHER, EXERCISE, OR FEVER MAY INCREASE DIZZINESS. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect. DO NOT DRINK ALCOHOL while you are using this medicine. THIS MEDICINE MAY HARM YOUR LIVER. Your risk may be greater if you drink alcohol while you are using this medicine. Talk to your doctor before you take this medicine or other fever reducers if you drink alcohol. CHECK WITH YOUR DOCTOR BEFORE you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. THIS MEDICINE MAY increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking this medicine. SEROTONIN SYNDROME is a possibly fatal syndrome that can be caused by this medicine. Your risk may be greater if you take this medicine with certain other medicines (eg, "triptans," MAOIs, antidepressants). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes other medicines containing acetaminophen (check labels closely). Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects. FOR WOMEN: This medicine may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. This medicine is found in breast milk. Do not breast-feed while taking this medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; mildly increased sweating; nausea; tiredness; trouble sleeping; or vomiting. If they continue or are bothersome, check with your doctor. A VERY BAD SKIN REACTION (Stevens-Johnson syndrome / toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; confusion; difficult or painful urination; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mental or mood changes (eg, agitation, depression); severe nausea, vomiting, or diarrhea; severe or persistent headache or dizziness; seizures (convulsions); slow or shallow breathing; suicidal thoughts or behaviors; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, stomach pain); tremor; unusual tiredness or weakness; unusually pale skin; 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; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; or wheezing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care 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 may include bluish skin; cold, clammy skin; decreased urination; difficult, shallow, or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; nausea and vomiting; pinpoint pupils; seizure (convulsions); slow or irregular heartbeat; stomach or bowel pain; symptoms of liver damage (eg, yellowing of the eyes or skin, pale stools, dark urine, loss of appetite); or unusual bruising or bleeding.
Additional Information:IF YOUR SYMPTOMS DO NOT IMPROVE or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.