HYDROCODONE /ACETAMINOPHEN 5-325 TB

 
 

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Drug Information For:

HYDROCODONE /ACETAMINOPHEN 5-325 TB

Ingredient Name:

HYDROCODONE (hye-droe-KO-done) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)

Drug Manufacturer:

MALLINCKRODT

Common Uses:

This medicine is a narcotic and analgesic combination used to relieve moderate to moderately severe pain. It may also be used to treat other conditions as determined by your doctor.

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 4,000 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 also taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), buprenorphine, isoniazid, linezolid, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), naltrexone, other narcotic pain medicines (eg, morphine), perampanel, sleep medicines (eg, zolpidem), tricyclic antidepressants (eg, amitriptyline), or medicines that may harm the liver (eg, methotrexate, ketoconazole, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of liver problems (eg, hepatitis), kidney problems, lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease / COPD), drug or alcohol abuse or dependence, heart problems (eg, cor pulmonale, slow or irregular heartbeat), low blood pressure, stomach or bowel problems (eg, blockage, inflammation, paralysis), gallbladder problems, prostate problems (eg, an enlarged prostate), difficulty urinating, seizures, thyroid problems, adrenal gland problems (eg, Addison disease), mental or mood problems, inflammation of the pancreas (pancreatitis), curvature of the spine (scoliosis), suicidal thoughts or actions, allergies, pregnancy, or breast-feeding. Tell your doctor if you have severe drowsiness, or have or recently have had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or infection of the brain or nervous system. Tell your doctor if you have recently had surgery (eg, stomach or bowel surgery) or are scheduled to have surgery. Tell your doctor if you are in very poor health; are very overweight or are dehydrated; have low blood volume, stomach pain, or constipation; drink alcohol; or are going through withdrawal from alcohol or other substances. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have very slow or difficult breathing, or 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. TAKE THIS MEDICINE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. IF YOU HAVE BEEN TAKING THIS MEDICINE REGULARLY or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose. SOME OF THESE PRODUCTS CONTAIN SULFITES. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), 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 TAKE THIS MEDICINE if you are allergic to any ingredient in this medicine. BEFORE USING THIS MEDICINE, check with your doctor if you have had an allergic reaction to other narcotic medicines (eg, codeine, morphine, oxycodone). DO NOT EXCEED THE RECOMMENDED DOSE, take more often than prescribed, or use 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. When using for an extended period, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure that all of your doctors and laboratory personnel know you are taking this medicine. 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 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. THIS MEDICINE MAY ALSO CAUSE DROWSINESS OR BLURRED VISION. 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 while you are using this medicine. CHECK WITH YOUR DOCTOR before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) 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 CONTAINS ACETAMINOPHEN. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. 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. CONTACT YOUR DOCTOR RIGHT AWAY if you take more than 4,000 mg of acetaminophen per day, even if you feel well. 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. FOR WOMEN: IF YOU BECOME 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 fetus or newborn. 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 taking this medicine include dizziness, drowsiness, lightheadedness, nausea, or vomiting. 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. 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 a change in the amount of urine produced; change or loss in hearing; chest pain; confusion; fainting; fever, chills, or persistent sore throat; mental or mood changes (eg, agitation, anxiety, depression); severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or lightheadedness; shortness of breath; slow, shallow, or difficult breathing; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite, unusual or severe stomach pain); trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; 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; or unusual hoarseness. 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; decreased urination; difficult, shallow, or slow breathing; fainting; limp muscles; loss of consciousness; nausea or vomiting; pinpoint pupils; seizures; severe dizziness, drowsiness, or light-headedness; slow heartbeat; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite, unusual or severe stomach pain); unusual bruising or bleeding; or unusual sweating or tiredness.

Additional Information:

If your symptoms do not improve or if they become worse, contact 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.

Disclaimer

- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.