Nabumetone (Oral Route)

This medicine does not cure arthritis and will help you only as long as you continue to take it .

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 nabumetone in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of nabumetone in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving nabumetone .

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

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.

• Ardeparin


• Beta Glucan


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Ginkgo


• Methotrexate


• Nadroparin


• Parnaparin


• Pemetrexed


• Reviparin


• Tacrolimus


• Tinzaparin

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


• Amiloride


• Azosemide


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Citalopram


• Clopamide


• Clopidogrel


• Clovoxamine


• Cyclopenthiazide


• Cyclosporine


• Cyclothiazide


• Delapril


• Desvenlafaxine


• Dicumarol


• 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


• Losartan


• Methyclothiazide


• Metolazone


• Milnacipran


• Moexipril


• Nefazodone


• Olmesartan Medoxomil


• Paroxetine


• Pentopril


• Perindopril


• Phenprocoumon


• Piretanide


• Polythiazide


• Quinapril


• Quinethazone


• Ramipril


• Sertraline


• Spirapril


• Spironolactone


• 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:

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


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


• High blood pressure or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding or


• Stroke, history ofa€”Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history ofa€”This medicine should NOT be used in patients with this condition .

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)a€”This medicine 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, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

You may take this medicine with or without food .

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 osteoarthritis and rheumatoid arthritis:
    
    
    
    • Adultsa€”At first, 1000 milligrams (mg) once a day, in the morning or evening, or 500 mg twice a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 2000 mg a day.
    
    
    • Childrena€”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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs . This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention . The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .

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

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

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:

More common

• Headache


• Itching skin


• Nausea


• Rash


• Stomach pain


• Swelling

Less common

• Burning feeling in chest or stomach


• Indigestion


• Stomach upset


• Swelling or inflammation of the mouth


• Tenderness in stomach area


• Vomiting

Rare

• Bleeding gums


• Blistering, peeling, loosening of skin


• Bloody or black, tarry stools


• Bloody or cloudy urine


• Burning upper abdominal pain


• Changes in vision


• Chest pain


• Chills


• Clay-colored stools


• Constipation


• Cough


• Dark-colored urine


• Diarrhea


• Difficult or labored breathing


• Difficulty swallowing


• Dizziness


• Dry cough


• Dry mouth


• Fast heartbeat


• Fever


• Fluid-filled skin blisters


• General feeling of tiredness or weakness


• Greatly decreased frequency of urination or amount of urine


• High blood pressure


• Hives or welts


• Increased sensitivity of skin to sunlight


• Increased thirst


• Joint pain, stiffness, or swelling


• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs


• Light-colored stools


• Loss of appetite


• Muscle pain


• Pain in lower back or side


• Pinpoint red spots on skin


• Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue


• Rapid breathing


• Red irritated eyes


• Red skin lesions, often with a purple center


• Redness or other discoloration of skin


• Severe or continuing stomach pain


• Severe sunburn


• Shortness of breath


• Skin thinness


• Sore throat


• Sores, ulcers, or white spots in mouth or on lips


• Stomach bloating, burning, or cramping


• Swelling of face, fingers, feet or lower legs


• Tightness in chest


• Unpleasant breath odor


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vaginal bleeding


• Vomiting of blood or material that looks like coffee grounds


• Weight gain or loss


• Wheezing


• Yellow eyes or skin

Symptoms of overdose

• Agitation


• Blurred vision


• Coma


• Confusion


• Depression


• Hostility


• Irregular, fast or slow, or shallow breathing


• Irritability


• Muscle twitching


• Nervousness


• Pain or discomfort in chest, upper stomach, or throat


• Pale or blue lips, fingernails, or skin


• Pounding in the ears


• Seizures


• Severe stomach pain


• Slow heartbeat


• Stupor


• Unusual drowsiness, dullness, or feeling of sluggishness

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

• Acid or sour stomach


• Belching


• Bloated full feeling


• Continuing ringing or buzzing or other unexplained noise in ears


• Excess air or gas in stomach or intestines


• Hearing loss


• Indigestion


• Mild diarrhea


• Passing gas

Less common

• Increased sweating


• Sleepiness or unusual drowsiness


• Sleeplessness


• Trouble sleeping


• Unable to sleep

Rare

• Anxiety


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Feeling of constant movement of self or surroundings


• General feeling of discomfort or illness


• Increased appetite


• Lack or loss of strength


• Lightheadedness


• Sensation of spinning


• Shakiness in legs, arms, hands, feet


• Trembling or shaking of hands or feet

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.