Description
Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis), including 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
- Capsule
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 oxaprozin tablets in children younger than 16 years of age. Safety and efficacy of oxaprozin in children has not been established.
Appropriate studies have not been performed on the relationship of age to the effects Coxanto® and Daypro® to treat juvenile rheumatoid arthritis in children younger than 6 years of age and to treat osteoarthritis in children. 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 oxaprozin in the elderly. However, elderly patients may be more sensitive to the effects of oxaprozin than younger adults, and are more likely to have age-related heart, stomach, or kidney problems, which may require caution and an adjustment in the dose of patients receiving oxaprozin.
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
- Balsalazide Disodium
- 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
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
- 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
- Trandolapril
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
- Bleeding problems or
- Congestive heart failure or
- Dehydration or
- Edema (fluid retention or swelling) or
- Heart attack, history of or
- Heart or blood vessel disease or
- Hyperkalemia (high potassium in the blood) or
- Hypertension (high blood pressure) or
- Hypovolemia (low amount of blood) or
- Kidney disease or
- Liver disease (eg, hepatitis) or
- Stomach or intestinal ulcers or bleeding, history of or
- Stroke, history of—Use with caution. This medicine may make these conditions worse. .
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of—Should not be used in patients with these conditions.
- Dehydration or
- Hypovolemia—Must be corrected first before using this medicine.
- Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.
Proper Use
Use this medicine exactly as ordered by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than ordered by your doctor. To do so may increase the chance of unwanted effects, especially in elderly patients.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not break, crush, divide, or chew it.
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.
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 juvenile rheumatoid arthritis:
- For oral dosage form (capsules):
- Children 6 to 16 years of age and older—Dose is base on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- Weighing 55 kilograms (kg) or more—1200 milligrams (mg) (four capsules) once a day.
- Weighing 32 to 54 kg—900 mg (three capsules) once a day.
- Weighing 22 to 31 kg—600 mg (two capsules) once a day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Children 6 to 16 years of age and older—Dose is base on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- For oral dosage form (tablets):
- Children 6 to 16 years of age and older—Dose is base on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- Weighing 55 kilograms (kg) or more—1200 milligrams (mg) once a day.
- Weighing 32 to 54 kg—900 mg once a day.
- Weighing 22 to 31 kg—600 mg once a day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Children 6 to 16 years of age and older—Dose is base on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- For oral dosage form (capsules):
- For osteoarthritis and rheumatoid arthritis:
- For oral dosage form (capsules):
- Adults—1200 milligrams (mg) (four-300 mg capsules) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults and children 16 years of age and older—1200 milligrams (mg) (two-600 mg tablets) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (capsules):
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 or your child's progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may increase 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. Check with your doctor right away if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing or speaking, headache, nausea, unusual sweating, or faintness.
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 of age, are in poor health, or are using certain other medicines (eg, steroid or a blood thinner).
Check with your doctor right away if you or your child has 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.
If you are rapidly gaining weight, trouble breathing, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.
Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, fixed drug eruption (FDE), and general bullous fixed drug eruption (GBFDE) 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. .
Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, 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. These may be symptoms of serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).
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 blood in the urine, decrease in the 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 may be symptoms of a serious kidney problem.
This medicine may cause a serious allergic reaction called anaphylaxis, which 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.
Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.
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.
This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
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 using this medicine. It may be necessary for you to stop treatment for a while, or to change to a different medicine 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
- Skin rash
Less common
- Bloating
- bloody or black, tarry stools
- burning upper abdominal or stomach pain
- burning while urinating
- cloudy urine
- constipation
- decrease in urine output or decrease in urine-concentrating ability
- diarrhea
- difficult or painful urination
- frequent urination
- headache
- heartburn
- indigestion
- itching skin
- loss of appetite
- nausea or vomiting
- pale skin
- severe stomach pain, cramping, or burning
- severe and continuing nausea
- swelling
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight loss
Incidence not known
- Agitation
- bleeding gums
- blistering, peeling, or loosening of the skin
- blurred vision
- body aches or pain
- burning feeling in chest or stomach
- changes in blood pressure
- chest pain or tightness
- clay-colored stools
- coma
- confusion
- cough or hoarseness
- cracks in the skin
- dark urine
- depression
- difficult or labored breathing
- difficulty swallowing
- dilated neck veins
- dizziness
- ear congestion
- extreme fatigue
- fainting
- feeling of discomfort
- fever or chills
- fluid-filled skin blisters
- high fever
- hives or welts
- hostility
- increased sensitivity of the skin to sunlight
- increased thirst
- increased volume of pale, dilute urine
- inflammation of the joints
- irregular, fast or slow, or shallow breathing
- joint or muscle pain
- large, flat, blue or purplish patches in the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lethargy
- light-colored stools
- lightheadedness
- loss of heat from the body
- loss of voice
- lower back or side pain
- muscle aches
- muscle twitching
- noisy breathing
- pain or burning in the throat
- pain or tenderness around the eyes and cheekbones
- pale or blue lips, fingernails, or skin
- pinpoint red or purple spots on the skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- redness or other discoloration of the skin
- redness, swelling, or soreness of tongue
- scaly skin
- seizures
- severe sunburn
- skin thinness
- slow, fast, irregular, pounding, or racing heartbeat or pulse
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stuffy or runny nose
- stupor
- swelling of the face, fingers, feet, or lower legs
- swelling or inflammation of the mouth
- swollen lymph glands
- tenderness in the stomach area
- unpleasant breath odor
- upper right abdominal or stomach pain
- yellow eyes or skin
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
- stomach discomfort
Less common
- Continuing ringing or buzzing or other unexplained noise in the ears
- excess air or gas in the stomach or intestines
- hearing loss
- passing gas
- relaxed and calm
- sleepiness or unusual drowsiness
- trouble sleeping
Rare
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, dry, or itching eyes
- change in taste
- decreased hearing
- discharge, excessive tearing
- dry mouth
- feeling of constant movement of self or surroundings
- general feeling of discomfort or illness
- lack or loss of strength
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- sensation of spinning
- shakiness in the legs, arms, hands, feet
- trembling or shaking of the 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.
CON-XXXXXXXX
