Ibudone

This medicine should only be used for short periods of time, usually for a total of less than 10 days. This combination is not used for osteoarthritis or rheumatoid arthritis .

Hydrocodone is a narcotic analgesic that acts on the central nervous system to relieve pain. If hydrocodone is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since hydrocodone and ibuprofen combination is only used for short-term (10 days or less) relief of pain, physical dependence will probably not occur.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and ibuprofen combination in children and teenagers below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and ibuprofen combination in the elderly. However, elderly patients are more likely to develop age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Ardeparin


• Beta Glucan


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Certoparin


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dalteparin


• Danaparoid


• Dantrolene


• Dezocine


• Diazepam


• Enoxaparin


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Fospropofol


• Ginkgo


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Methotrexate


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nadroparin


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Parnaparin


• Pemetrexed


• Pentazocine


• Pentobarbital


• Phenobarbital


• Prazepam


• Propoxyphene


• Quazepam


• Remifentanil


• Reviparin


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tacrolimus


• Tapentadol


• Temazepam


• Thiopental


• Tinzaparin


• Triazolam

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetohexamide


• Alacepril


• Amikacin


• Amiloride


• Aspirin


• Azosemide


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Citalopram


• Clopamide


• Clopidogrel


• Clovoxamine


• Cyclopenthiazide


• Cyclosporine


• Cyclothiazide


• Delapril


• Desipramine


• Desvenlafaxine


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Escitalopram


• Ethacrynic Acid


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Lisinopril


• Lithium


• Losartan


• Methyclothiazide


• Metolazone


• Milnacipran


• Moexipril


• Nefazodone


• Olmesartan Medoxomil


• Paroxetine


• Pentopril


• Perindopril


• Phenytoin


• Piretanide


• Polythiazide


• Quinapril


• Quinethazone


• Ramipril


• Sertraline


• Spirapril


• Spironolactone


• Tacrine


• Tasosartan


• Telmisartan


• Temocapril


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zimeldine


• Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison`s disease (adrenal gland problem) or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Hypothyroidism (underactive thyroid) or


• Kidney disease, severe or


• Liver disease, severe or


• Problems with urination or


• Systemic lupus erythematosus (SLE) or


• Weakened physical conditiona€”Use with caution. May increase risk for more serious side effects.

• Anemia or


• Bleeding problems or


• Breathing problems (e.g., respiratory depression) or


• Edema (fluid retention) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease or


• Lung disease or


• Stomach ulcers or bleeding, history of or


• Stroke, history ofa€”Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history ofa€”Should not be used in patients with these conditions.

• Drug abuse or dependence, or history ofa€”Dependence may be more likely to develop.

• Heart surgery (e.g., coronary artery bypass graft [CABG])a€”Should not be used to relieve pain right before or after the surgery.

Proper Use

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor . Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For pain:
    
    
    
    • Adults and teenagers above 16 years of agea€”One tablet every 4 to 6 hours as needed. However, the dose is usually not more than 5 tablets per day.
    
    
    • Children and teenagers younger than 16 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin . Stop taking this medicine and check with your doctor right away if you notice any of these warning signs .

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs . This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). Call your doctor right away if you have severe stomach pain; black, tarry stools; or are vomiting blood or material that looks like coffee grounds.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin .

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention . Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; a severe skin rash or acne; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Using this medicine during late pregnancy can harm your unborn baby . If you think you have become pregnant while using the medicine, tell your doctor right away.

Hydrocodone and ibuprofen combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, sleeping medicine; or other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If these reactions are especially bothersome, check with your doctor .

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Hydrocodone and ibuprofen combination may cause dry mouth . For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if you take this medicine for a long time and dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting . These could be symptoms of a serious condition called meningitis.

If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment . Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Bloody stools


• Burning feeling in the chest or stomach


• Congestion in the chest


• Changes in facial skin color


• Cough


• Diarrhea


• Difficulty with swallowing


• Fast or irregular breathing


• Fever


• Frequent urge to urinate


• Heartburn


• Inability to urinate


• Irregular heartbeat


• Lightheadedness or dizziness


• Loss of bladder control


• Puffiness or swelling of the eyelids or around the eyes


• Ringing or buzzing in the ears


• Shortness of breath, troubled breathing, tightness in the chest or wheezing


• Skin rash, hives, or itching


• Stomach pain


• Tenderness in the stomach

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision


• Cold or clammy skin


• Confusion


• Difficulty hearing or ringing or buzzing in the ears


• Dizziness


• General feeling of illness


• Headache


• Mood or mental changes


• Nausea or vomiting


• Severe drowsiness


• Severe stomach pain


• Skin rash


• Slow heartbeat


• Slow or troubled breathing


• Stiff neck or back


• Swelling of the face, fingers, feet, or lower legs

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety


• Constipation


• Dry mouth


• Gas


• Increased sweating


• Nervousness


• Pounding heartbeat


• Sleepiness


• Trouble in sleeping


• Unusual tiredness or weakness

Less common or rare

• Decreased appetite


• Decrease in sexual ability


• Depression


• Headache


• Heartburn


• Increased thirst


• Irritability


• Mood or mental changes


• Mouth ulcers


• Pain or burning in the throat


• Runny nose


• Sensation of burning, warmth, heat, numbness, tightness, or tingling


• Slurred speech


• Stomach upset


• Thinking abnormalities


• Trembling or shaking of the hands or feet


• Unexplained weight loss


• Unusual feeling of well-being


• Visual disturbances

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

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