hydrocodone and ibuprofen (Ibudone, Reprexain, Vicoprofen)

Brand Names: Ibudone, Reprexain, Vicoprofen, Xylon 10

Generic Name: hydrocodone and ibuprofen

• What is hydrocodone and ibuprofen?
• What are the possible side effects of hydrocodone and ibuprofen?
• What is the most important information I should know about hydrocodone and ibuprofen?
• What should I discuss with my healthcare provider before taking hydrocodone and ibuprofen?
• How should I take hydrocodone and ibuprofen?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking hydrocodone and ibuprofen?
• What other drugs will affect hydrocodone and ibuprofen?
• Where can I get more information?

Hydrocodone is an opioid pain medication, sometimes called a narcotic. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID).

Hydrocodone and ibuprofen is a combination medicine that is used short-term to relieve severe pain.

Hydrocodone and ibuprofen may also be used for purposes not listed in this medication guide.

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round, white, imprinted with 3585, V

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oblong, white, imprinted with IP 116

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round, yellow, imprinted with IP 117

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round, white, imprinted with LOGO 524

Hydrocodone-Ibuprofen 7.5 mg-200 mg-AMN

round, white, imprinted with IP 145

Hydrocodone-Ibuprofen 7.5 mg-200 mg-TEV

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Hydrocodone-Ibuprofen 7.5-200 mg-WAT

round, white, imprinted with IP 145

Reprexain 5 mg-200 mg

oval, white, imprinted with IP 146

Vicoprofen

round, white, imprinted with VP LOGO

Get emergency medical help if you have signs of an allergic reaction (hives, difficult 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.

Stop using this medicine and 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; or
• low cortisol levels--vomiting, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects 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.

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

Taking this medicine 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.

Ibuprofen can increase your risk of fatal heart attack or stroke. Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

Ibuprofen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. 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. These conditions can occur without warning while you are using this medicine, especially in older adults.

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

• severe asthma or breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizure;
• long QT syndrome (in you or a family member);
• liver or kidney disease;
• high blood pressure;
• problems with your gallbladder, pancreas, or thyroid;
• urination problems; or
• drug or alcohol addiction, or mental illness.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with hydrocodone and cause a serious condition called serotonin syndrome.

If you use 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 opioids may need medical treatment for several weeks. Taking ibuprofen during late pregnancy may cause bleeding in the mother or the baby during delivery.

You should not breastfeed while using this medicine.

Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Use the lowest dose that is effective in treating your condition. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share opioid medicine with another person, 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 get to it. Selling or giving away opioid medicine is against the law.

If you need surgery, tell the surgeon ahead of time that you are using hydrocodone and ibuprofen.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

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

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer

Since hydrocodone and ibuprofen is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal.

Overdose symptoms may include vomiting, black or bloody stools, coughing up blood, slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint or dilated pupils, or coma.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain 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 narcotic medications--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 hydrocodone and ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Your pharmacist can provide more information about hydrocodone and ibuprofen.

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