Ibudone

Hydrocodone is a pain medicine from the opioid family. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This combination medicine is used for a short time to help relieve severe pain.

Ibudone may also be used for reasons not mentioned in this medication guide.

Follow the instructions on your prescription label and read all medication guides. Never use Ibudone in larger amounts or for longer than prescribed. Tell your doctor if you feel a stronger desire to take more of this medicine.

Never share this medicine with anyone else, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot reach it. Selling or giving away this medicine is against the law.

Store at room temperature, away from moisture and heat.

Do not keep leftover opioid medication. Just one dose can cause death in someone who accidentally or improperly uses this medicine. Ask your pharmacist where to find a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking Ibudone during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use this medicine if you are allergic to hydrocodone or ibuprofen, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

Ibuprofen can increase your risk of a fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizure;
• liver or kidney disease;
• high blood pressure, heart problems, or a heart attack;
• problems with your gallbladder, pancreas, or thyroid;
• urination problems; or
• drug or alcohol addiction, or mental illness.

If you are pregnant, you should not take this medicine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious problems in the unborn baby and possible complications with your pregnancy. If you take opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.

Ibudone may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing, sighing, slow heartbeat, breathing that stops during sleep;
• swelling, rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• low cortisol levels--vomiting, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are weak or have wasting syndrome or chronic breathing disorders.

Common side effects of Ibudone may include:

• dizziness, drowsiness;
• stomach pain, nausea, vomiting, heartburn, gas;
• constipation, diarrhea; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since Ibudone is used for pain, it is unlikely that you will miss a dose. If you do miss a dose and it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An overdose can be deadly, especially in a child or anyone taking the medicine without a prescription. Signs of an overdose may include black or bloody stools, coughing up blood, extreme drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may suggest that you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person taking care of you can give the naloxone if you stop breathing or do not wake up. Your caregiver must still call for emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help.

Anyone can purchase naloxone from a pharmacy or local health department. Ensure that anyone caring for you knows where you keep naloxone and how to use it.

Avoid driving or doing anything dangerous until you know how Ibudone will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Do not drink alcohol. Dangerous side effects or death could happen.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may have ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids--opioid pain medicine or prescription cough medicine;
• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect Ibudone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.