Description
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. 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 geriatric-specific problems that would limit the usefulness of nabumetone in the elderly. However, elderly patients are more likely to have age-related kidney, stomach, or bowel problems, which may require caution in patients receiving nabumetone.
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
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Abciximab
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amtolmetin Guacil
- Anagrelide
- Apixaban
- Ardeparin
- Argatroban
- Aspirin
- Balsalazide
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Betrixaban
- Bismuth Subsalicylate
- Bivalirudin
- Bromfenac
- Budesonide
- Bufexamac
- Bumetanide
- Cangrelor
- Celecoxib
- Certoparin
- Chlorothiazide
- Chlorthalidone
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Cilostazol
- Citalopram
- Clomipramine
- Clonixin
- Clopamide
- Clopidogrel
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.
- Acebutolol
- Atenolol
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Betaxolol
- Bisoprolol
- Candesartan
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Dicumarol
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Telmisartan
- Timolol
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- 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
- Congestive heart failure or
- Edema (fluid retention or body swelling) or
- Heart attack, history of or
- High blood pressure or
- Kidney disease or
- Liver disease (eg, hepatitis) or
- Stomach or intestinal ulcers or bleeding or
- Stroke, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma, history of or
- Aspirin sensitivity, history of or
- Kidney disease, severe—Should not be used in patients with these conditions.
- Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used for 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.
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:
- Adults—At first, 1000 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2000 mg per day.
- Children—Use and dose must be determined by your doctor.
- For osteoarthritis and rheumatoid arthritis:
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 to make sure 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 or in people who use this medicine for a longer time.
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 (eg, steroid medicine, blood thinner).
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Some possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, unusual bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires medical attention. It may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 rash
- nausea
- stomach pain
- swelling
Less common
- Burning feeling in the chest or stomach
- indigestion
- stomach tenderness or upset
- swelling or inflammation of the mouth
- vomiting
Rare
- Bleeding gums
- blistering, peeling, loosening of the skin
- bloody or black, tarry stools
- bloody or cloudy urine
- burning upper abdominal or stomach pain
- changes in vision
- chest pain or tightness
- chills
- clay-colored stools
- constipation
- cough
- dark-colored urine
- diarrhea
- difficulty swallowing
- dizziness
- dry cough
- dry mouth
- fast heartbeat
- fever
- fluid-filled skin blisters
- greatly decreased frequency of urination or amount of urine
- hives or welts
- increased sensitivity of the skin to sunlight
- increased thirst
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle pain
- pinpoint red spots on the 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 the skin
- severe sunburn
- skin thinness
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach bloating, burning, cramping, or pain
- swelling of the face, fingers, feet or lower legs
- trouble breathing
- 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
- 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 the 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 the ears
- excess air or gas in the stomach or intestines
- hearing loss
- indigestion
- mild diarrhea
- passing gas
Less common
- Increased sweating
- sleepiness or unusual drowsiness
- trouble sleeping
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
- trembling or shaking of the legs, arms, 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.
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