Celecoxib may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Celecoxib is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Celecoxib can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: Cyclooxygenase-2 Inhibitor
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, celecoxib does not cure arthritis and will help you only as long as you continue to take it.
Celecoxib is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. celecoxib may be used to treat acute pain and menstrual cramps. Celecoxib is used together with certain medical procedures (e.g., endoscopy, surgery) to help reduce the number of polyps in the intestine for patients with familial adenomatous polyposis (FAP).
celecoxib is available only with your doctor's prescription.
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 celecoxib, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to celecoxib 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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of celecoxib in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of celecoxib in the elderly. However, elderly patients are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving celecoxib.
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.
Using celecoxib 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.
Using celecoxib 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.
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.
The presence of other medical problems may affect the use of celecoxib. Make sure you tell your doctor if you have any other medical problems, especially:
For safe and effective use of celecoxib, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of celecoxib may increase the chance of unwanted effects.
celecoxib should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you cannot swallow the capsule, you may open it and pour the medicine onto a teaspoon of cool or room temperature applesauce. This mixture must be swallowed right away without chewing and followed with a glass of water to make sure all of the mixture is swallowed.
Any medicine that has been mixed with applesauce may be stored in a refrigerator and used within 6 hours.
The dose of celecoxib 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 celecoxib. 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.
If you miss a dose of celecoxib, 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.
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.
It is very important that your doctor check your progress or your child's 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.
celecoxib 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 celecoxib for a long time might also have a higher risk.
celecoxib 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, are over 60 years of age, are in poor health, or using certain other medicines (such as steroids or a blood thinner).
Serious skin reactions can occur with celecoxib. Check with your doctor right away if you or your child have any of the following symptoms while taking celecoxib: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.
Taking two or more of the nonsteroidal anti-inflammatory drugs (NSAIDs) together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with celecoxib for more than a few days, and do not take any ketorolac (e.g., Toradol) while you are taking celecoxib, unless your doctor has directed you to do so and is following your progress.
Some possible warning signs of serious side effects that can occur during treatment with celecoxib may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow eyes and skin. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Stop taking celecoxib and check with your doctor immediately if you notice any of these warning signs.
Celecoxib may 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, other nonsteroidal anti-inflammatory drugs (NSAIDs), or sulfonamide-type drugs. Anaphylaxis can be life-threatening and 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. Ask someone to drive you to the nearest hospital emergency room. If this is not possible, do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.
Using celecoxib late in pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Do not use celecoxib during the later part of a pregnancy unless your doctor tells you to.
Before having any kind of surgery or medical tests, tell your doctor that you are taking celecoxib. 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.
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
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
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
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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