Hydrocodone Bitartrate (hye-droe-KOE-done bye-TAR-trate), Ibuprofen (eye-bue-PROE-fen)

Treats pain. This medicine contains an opioid and an NSAID.

Brand Name(s):

Ibudone, Xylon 10

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• An overdose can be life-threatening. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days or any other NSAID medicine (including aspirin, diclofenac, diflunisal, ibuprofen, or salsalate) unless your doctor tells you otherwise.
• Some medicines can affect how ibuprofen/hydrocodone works. Tell your doctor if you are using any of the following:
  • Aspirin, carbamazepine, cyclosporine, diflunisal, digoxin, erythromycin, ketoconazole, lithium, methotrexate, mirtazapine, pemetrexed, phenytoin, rifampin, ritonavir, salsalate, tramadol, or trazodone
  • Benzodiazepine medicine
  • Blood pressure medicine (including ACE inhibitors, ARBs, beta blockers)
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Medicine to treat depression, anxiety, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Phenothiazine medicine
  • Steroid medicine
  • Triptan medicine to treat migraine headaches
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of your pregnancy, unless your doctor tells you to.
• Tell your doctor if you have kidney disease, liver disease, anemia, lung disease, bleeding problems, high blood pressure, heart attack, heart failure, adrenal problems, gallbladder problems, pancreas problems, trouble urinating, prostate disorder, or a history of head injury, brain tumor, seizures, stomach or bowel problems (including ulcers, bleeding), or drug or alcohol use disorder.
• This medicine might cause the following problems:
  • High risk of overdose, which can be life-threatening
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems, including sleep apnea, sleep-related hypoxemia
  • Serotonin syndrome (when used with certain medicines)
  • Worsening of pain
  • Increased risk of heart attack, heart failure, or stroke
  • Increased risk of stomach or bowel problems, including bleeding, ulcers, or perforation
  • Adrenal gland problems
  • Low blood pressure
  • High blood pressure
  • Kidney problem
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Liver problems
  • Seizures
  • Aseptic meningitis
  • Serotonin syndrome, when used with certain medicines
• Check with your doctor immediately if blurred vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, bloody or cloudy urine
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Chest pain that may spread, trouble breathing, nausea, unusual sweating, fainting
• Chest pain, trouble breathing, or coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Fever, neck pain or stiff neck
• Lightheadedness, dizziness, fainting
• Numbness or weakness in one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe constipation, stomach pain, vomiting blood, bloody or black, tarry stools
• Unusual bleeding, bruising, or weakness
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Blurred vision, changes in vision
• Drowsiness and sleepiness
• Mild constipation, diarrhea, heartburn, stomach upset

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088