Hydrocodone Bitartrate/Ibuprofen, Oral

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KEY POINTS

• This medicine is taken by mouth to help relieve moderate to severe pain. Take it exactly as directed. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may cause serious or life-threatening breathing problems, ulcers and bleeding in the stomach and intestines or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: narcotic (opioid) pain reliever/nonsteroidal anti-inflammatory drug (NSAID)

Generic and brand names: hydrocodone bitartrate/ibuprofen, oral; Ibudone; Vicoprofen; Reprexain; Xylon

What is this medicine used for?

This medicine is taken by mouth to help relieve moderate to severe short-term pain. It is a strong pain medicine that contains both a narcotic pain reliever (hydrocodone) and an anti-inflammatory (ibuprofen).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A stroke, head injury, or brain tumor
• Addison's disease
• Blood disorders or bleeding problems
• Edema (fluid buildup)
• Heart disease, heart failure, or heart surgery
• High or low blood pressure
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Lupus or other connective tissue disease
• Mental health problems such as depression or bipolar disorder
• Pancreas or gallbladder problems
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble urinating or an enlarged prostate gland
• Ulcers

Tell your provider if you have recently had heart surgery or are scheduled for surgery.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. This medicine should not be used during the third trimester of pregnancy because it may harm the baby. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes.

Check with your healthcare provider before using this medicine in children under the age of 14 years.

Usually you will take this medicine for 7 days or less. You should not take more than 4 tablets in a 24-hour period. Taking the wrong dose could be life-threatening.

Check the labels of all nonprescription and prescription medicines you take. Taking other medicines that contain NSAIDs while you take this medicine may lead to an overdose. Ask your healthcare provider or pharmacist if you have any questions.

You may take this medicine with or without food. Taking it with meals may lessen the chance the medicine will upset your stomach.

What if I miss a dose?

If you are taking this medicine regularly and miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness, pinpoint pupils, vision problems, confusion, trouble breathing or breathing that stops, cold and clammy skin, muscle weakness; irregular or slow heartbeat; seizures, nausea, diarrhea, stomach pain, sweating, vomiting blood, dizziness, ringing in the ears, coma.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine increases your chance of side effects. If you use this medicine regularly for a long time or in high doses, ask your healthcare provider how to reduce your dose gradually. Follow your healthcare provider’s instructions about how to stop taking the medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. You may be at higher risk if you smoke, are over the age of 65 or in poor health, drink alcohol, or take this medicine for a long time.

This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG). Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you use NSAIDs for a long time or have heart disease. Talk with your healthcare provider about this.

If you take this medicine for a long time, you may need to have lab tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine may make you constipated. Drinking lots of water, exercising, or taking more fiber may help. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; seizures; hallucinations (seeing or hearing things that are not there); chest pain; fast, slow, or irregular heartbeat; black tarry or bloody bowel movements; bloody vomit; unusual bruising or bleeding; swelling of your feet, ankles, legs, or hands or any unexplained swelling; neck pain or stiffness; unusual muscle pain; unusual tiredness or weakness; skin rash, peeling or blisters; dark urine; light-colored bowel movements; yellowing of your skin or eyes; decreased or trouble urinating; severe nausea or vomiting; severe or continued stomach pain; severe constipation; severe dizziness or fainting; unusual mood changes; unexplained fever or flushing; trembling; pinpoint pupils; blurred vision.

Other: Dizziness, drowsiness, lightheadedness, nausea, vomiting, constipation, heartburn, diarrhea, headache, dry mouth, sweating, nervousness, ringing in your ears, change in sexual desire or ability, trouble sleeping.

What products might interact with this medicine?

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• ACE inhibitors such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others
• Alcohol
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Angiotensin receptor blockers (ARBs) such as irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), valsartan (Diovan), and others
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), mirtazapine (Remeron), nefazodone, trazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), and others
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Beta blockers such as bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cabergoline
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), verapamil (Calan, Covera, Verelan), and others
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), nilotinib (Tasigna), and others
• Cholesterol-lowering medicines such as cholestyramine (Prevalite) and colestipol (Colestid)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Corticosteroids such as dexamethasone, methylprednisolone (Medrol, Solu-Medrol), prednisone (Prednisone Intensol), and others
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM or dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and others
• Doxepin (Silenor)
• Eluxadoline (Viberzi)
• Flibanserin (Addyi)
• Heart medicines such as digoxin (Lanoxin), dronedarone (Multaq), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Isoniazid
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Lumacaftor/ivacaftor (Orkambi)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Medicines that contain NSAIDs such as allergy, cold, or cough medicines or other pain or fever medicines
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), warfarin (Coumadin), and others
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Methylnaltrexone (Relistor)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), naratriptan (Amerge), sumatriptan (Alsuma, Imitrex, Sumavel), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), tizanidine (Zanaflex), and others
• Naloxegol (Movantik)
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), promethazine/codeine (Phenergan with codeine), and others
• Natural remedies such as garlic, ginger, ginkgo, glucosamine, St. John's wort, tryptophan, and others
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), promethazine, and others
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), ibuprofen (Advil, Motrin), meloxicam (Mobic), naproxen (Aleve, Anaprox, Naprelan), and others
• Osteoporosis medicines such as alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel, Atelvia), and others
• Other pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), and others
• Parkinson's disease medicines such as levodopa/carbidopa (Duopa, Rytary, Sinemet), entacapone (Comtan), pramipexole (Mirapex), rasagiline (Azilect), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentosan polysulfate sodium (Elmiron)
• Probenecid
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Sulfasalazine (Azulfidine)
• Tedizolid (Sivextro)

Do not drink alcohol while you are taking this medicine.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.