Hydrocodone-Ibuprofen

Hydrocodon-Ibuprofen are combination prescription medications used short-term to relieve severe pain.

• Hydrocodon-Ibuprofen are available under various brand names: Ibudone, Reprexain, Vicoprofen, Xylon 10

Common side effects of Hydrocodon-Ibuprofen include:

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

Serious side effects of Hydrocodon-Ibuprofen include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• 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).
• 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.
• 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,
• symptoms of serotonin syndrome, such as agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea

Rare side effects of Hydrocodon-Ibuprofen include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet, oral:

Ibudone:

• 5/200: Hydrocodone bitartrate 5 mg and Ibuprofen 200 mg [DSC]
• 10/200: Hydrocodone bitartrate 10 mg and Ibuprofen 200 mg [DSC]

Reprexain:

• 5/200: Hydrocodone bitartrate 5 mg and Ibuprofen 200 mg [DSC]
• 10/200: Hydrocodone bitartrate 10 mg and Ibuprofen 200 mg [DSC]

Pain management

Adult and pediatric dosage

Aged 16 years and above

• Oral: One tablet (hydrocodone 5 mg to 10 mg/Ibuprofen 200 mg) every 4 to 6 hours as needed; (maximum: 5 tablets [hydrocodone 25 to 50 mg/Ibuprofen 1,000 mg] per 24 hours). Note: Short-term use is recommended (less than 10 days total therapy).

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Hydrocodon-Ibuprofen have severe interactions with the following drug:
  • alvimopan
• Hydrocodon-Ibuprofen have serious interactions with at least 146 other drugs.
• Hydrocodon-Ibuprofen have moderate interactions with at least 369 other drugs.
• Hydrocodon-Ibuprofen have minor interactions with at least 103 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• allergic to hydrocodone or Ibuprofen (Advil, Motrin), 
• severe asthma or breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

Effects of drug abuse

• Addiction
• Overdose 
• Death

Short-Term Effects

• See “What Are Side Effects Associated with Using Hydrocodon-Ibuprofen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Hydrocodon-Ibuprofen?”

Cautions

• 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.
• Do not drink alcohol. Dangerous side effects or death could occur.
• 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.
• 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.
• Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
• 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.

Pregnancy & Lactation

• 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.
• Lactation
  • You should not breastfeed while using this medicine.