DESCRIPTION. celebrex 100 mg CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, mg, mg and mg .

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Celebrex Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. If you think or feel that the effect of Celebrex is too strong or too weak, talk to your doctor or pharmacist. Your doctor will tell you what dose you should take.

As the risk of side effects associated with heart problems may increase with dose and duration of use, it is important that you use the lowest dose that controls your pain and you should not take Celebrex for longer than necessary to control symptoms.

Celebrex is for oral use. The capsules can be taken at any time of the day, with or without food. However, try to take each dose of Celebrex at the same time each day. If you have difficulty swallowing capsules: The entire capsule contents can be sprinkled onto a level teaspoon of semi-solid food such as cool or room temperature applesauce, rice gruel, yogurt or mashed banana and swallowed immediately with a drink approximately ml of water.

To open the capsule, hold upright to contain the granules at the bottom then gently squeeze the top and twist to remove, taking care not to spill the contents. Do not chew or crush the granules. Contact your doctor within two weeks of starting treatment if you do not experience any benefit.

The recommended dose is: For osteoarthritis the recommended dose is mg each day, increased by your doctor to a maximum of mg, if needed. Use of celecoxib may blunt the CV effects of several therapeutic agents used to treat these medical conditions e. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.

Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia , heart failure, liver dysfunction, those taking diuretics, ACE-inhibitors or the ARBs, and the elderly. Hyperkalemia Increases in serum potassium concentration, including hyperkalemia , have been reported with use of NSAIDs, even in some patients without renal impairment.

In patients with normal renal function, these effects have been attributed to a hyporeninemic- hypoadosteronism state. Anaphylactic Reactions Celecoxib has been associated with anaphylactic reactions in patients with and without known hypersensitivity to celecoxib and in patients with aspirin sensitive asthma. Seek emergency help if any anaphylactic reaction occurs. When CELEBREX is used in patients with preexisting asthma without known aspirin sensitivity , monitor patients for changes in the signs and symptoms of asthma.

These serious events may occur without warning and can be fatal. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of CELEBREX at the first appearance of skin rash or any other sign of hypersensitivity.

This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. In controlled clinical trials the incidence of anemia was 0. Patients on long-term treatment with CELEBREX should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.

Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents e. Laboratory Monitoring Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically.

This laboratory abnormality was also seen in patients who received comparator NSAIDs in these studies. The clinical significance of this abnormality has not been established. Disseminated Intravascular Coagulation DIC Because of the risk of disseminated intravascular coagulation with use of CELEBREX in pediatric patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, and inform patients and their caregivers to report symptoms as soon as possible.

Patient Counseling Information Advise the patient to read the FDA-approved patient labeling Medication Guide that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with CELEBREX and periodically during the course of ongoing therapy.

Gastrointestinal Bleeding, Ulceration, And Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia , melena , and hematemesis to their health care provider. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity e.

Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction e. Mutagenesis Celecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary CHO cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow.

Pregnancy category D from 30 weeks of gestation onward. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Discuss their use with your health care provider before taking them. I've been taking Celebrex, and it isn't giving me so much relief anymore. Is there another drug besides Celebrex that I might discuss with my doctor?

The main concern with these medications is that over time, they can cause bleeding in the gastrointestinal GI tract, which includes the esophagus leading into the stomach, the stomach, and the intestines. An alternative is Tylenol acetaminophen , as it works differently, but it does not reduce inflammation. NSAIDs work by reducing the effects of prostaglandins, which cause inflammation, pain, and fever in the body. COX-1 makes prostaglandins that support platelets and protect the stomach lining.

When they are blocked, the platelets cannot cause the blood to clot as easily. COX-2 makes the prostaglandins that cause inflammation, swelling, and as a result, pain.

Celebrex celecoxib is a COX-2 inhibitor that is still on the market and is considered safe, as long as the person taking it does not have any past heart problems or risk factors for them. Patti Brown, PharmD Q: Do you recommend Celebrex for mild arthritis? The treatment of osteoarthritis typically follows a stepwise approach, and mild arthritis may not require drug treatment.

Initially, doctors recommend that patients rest and avoid activities that cause pain, exercise to increase the strength of muscles around the affected joints, and lose weight to decrease pressure on the joints. If medication becomes necessary, it is best to start with those that have the least side effects.

The first treatment is usually acetaminophen Tylenol , which reduces pain, but does not affect inflammation. It is generally well tolerated, but taking more than recommended or having more than three alcoholic drinks per day can increase the risk of liver damage. The next treatments are nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen and naproxen. Some of these drugs are available over the counter without a prescription.

They can cause stomach upset, so it is recommended that they be taken with food. Both acetaminophen and NSAIDs can interfere with blood thinners, so it is important to check with your doctor before taking these medications.

COX-2 inhibitors should be taken only at the lowest dose needed to relieve your pain. When your doctor prescribes a new medication, be sure to discuss all your prescription and over-the-counter drugs, including dietary supplements, vitamins, botanicals, minerals, and herbals, as well as the foods you eat. Always keep a current list of the drugs and supplements you take and review it with your health care providers and your pharmacist.

Is there another medication that I can take that is equally as good as Celebrex. It's very good but so expensive! Celebrex there is no generic but the active ingredient is celecoxib is an expensive NSAID non-steroidal-anti-inflammatory-drug , and there are no alternatives exactly like it, but you may be able to try something similar.

The second one is desirable, as it decreases the inflammation. The first pathway can slowly destroy the stomach lining and over time, cause ulcers or GI bleeding. Celebrex is the only medication that does not go down the COX-1 pathway very much. Others were developed Vioxx and Bextra , but then recalled due to issues with people having heart problems.

Ultimately, you should see what your doctor thinks is best for you. If your doctor insists on Celebrex, you may want to contact the company and see if they have any discount coupons that your pharmacy can process. Many companies do this. The company to contact is Pfizer.

For more information on pain management, please visit our link at: How safe are Geodon and Celebrex? My doctor wants me on Celebrex, but I've read it can cause heart attacks. All prescription medications have side effects or common reactions that are patient specific, and therefore difficult to predict.

Food and Drug Administration is charged with reviewing a drug's safety profile before approving the drug for sales in the United States. Please consult with your physician as to the best prescription medications to treat your health conditions. Lowell Sterler, RPh Q: Does prolonged use of Celebrex hinder your kidneys or liver? Celebrex celecoxib is a nonsteroidal anti-inflammatory drug NSAID similar to ibuprofen, naproxen, diclofenac, and many others. According to the manufacturer, Celebrex has the advantage of causing fewer stomach and intestinal side effects compared to other NSAIDs.

Clinical studies show Celebrex may cause acute renal failure in less than 0. The prescribing information by the manufacturer also states that Celebrex should be used with caution in patients with pre-existing renal impairment. For low-risk patients, it is customary for clinician to order labs for renal function within three months after initiating therapy and repeated every six to 12 months.

For those at high risk for renal failure older than 60 years, pre-existing renal insufficiency , monitoring of renal function should be more frequent. Celebrex has been associated with increasing liver enzymes. According to research data by the manufacturer, elevated liver enzymes were reported in 0. Although liver enzymes were elevated, liver failure is rare.

For patients at low risk, liver enzymes should be monitored within three months of starting treatment and repeated every six to 12 months. In high risk patients, more frequent monitoring is required. Lori Mendoza, PharmD Q: Celebrex is indicated for the symptomatic treatment of pain or inflammation caused by osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in children two years of age and older, ankylosing spondylitis, acute pain, primary dysmenorrhea and as an adjunct to usual care in patients with familial adenomatous polyposis.

Celebrex is contraindicated in patients with documented hypersensitivity to the active ingredient, celecoxib, or sulfonamides or in patients with a medical history of asthma, urticaria, or other allergic-type reactions associated with aspirin or other NSAIDs.

Treatment is Celebrex is also contraindicated during the perioperative period in patients undergoing coronary artery bypass graft CABG surgery. Treatment with Celebrex should be individualized and prescribed at the lowest effective dose and for the shortest duration required to achieve treatment goals for any given indication. Celebrex should be administered with food or milk to decrease stomach upset. Patients are advised to avoid alcohol while being treated with Celebrex as alcohol can increase the risk of stomach bleeding.

The most commonly reported adverse reactions leading to discontinuation of treatment with Celebrex were dyspepsia and abdominal pain. More severe adverse reactions are possible with treatment with Celebrex. Celebrex carries black box warnings regarding the risk of serious cardiovascular and gastrointestinal events associated with treatment.

Celebrex may cause an increased risk of serious cardiovascular thrombotic events, heart attack and stroke, which can be fatal. The risk of cardiovascular events may be increased with duration of use and in those patients with documented cardiovascular disease or risk factors for cardiovascular disease. Patients should be instructed to seek emergency medical attention if they develop any signs or symptoms which may indicate the presence of a cardiovascular event including chest pain, weakness, shortness of breath, slurred speech or vision or balance problems.

Celebrex, like other NSAIDs, may cause an increased risk of serious gastrointestinal events including bleeding, ulceration and perforation of the stomach or intestines, which also may be fatal. Serious gastrointestinal adverse reactions can occur at any time during treatment and without warning symptoms. The risk of developing serious gastrointestinal events is greater in the elderly population.

Contact your health care provider immediately if you experience any signs and symptoms which may indicate the presence of serious gastrointestinal events including black, bloody or tarry stools or coughing up blood or vomit that looks like coffee grinds. When considering treatment with an anti-inflammatory, the patient and health care provider are advised to carefully assess the potential benefits versus risks of Celebrex and other treatment options before deciding upon treatment with Celebrex.

How often should you take Celebrex? How often you should take Celebrex celecoxib depends upon the reason for treatment. Celebrex is approved for the relief of symptoms caused by pain or inflammation associated with several medical conditions, including osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in children ages two and older, ankylosing spondylitis, primary dysmenorrhea, acute pain or familial adenomatous polyposis as an adjunct treatment to usual care.

When prescribed for the symptomatic relief in patients with osteoarthritis, Celebrex is usually taken once or twice daily. As a treatment option for relief of signs and symptoms of rheumatoid arthritis in the adult population, Celebrex is typically taken twice daily.

For the treatment of symptoms of juvenile rheumatoid arthritis in the pediatric population, the usual administration schedule for Celebrex is twice daily. For the relief of signs and symptoms associated with ankylosing spondylitis, Celebrex is typically administered once or twice daily. In adult patients being treated with Celebrex for the management of acute pain or the treatment of primary dysmenorrhea, the usual dose is initially a higher dose, followed by a lower dose if needed on the first day and typically administered twice daily as needed on subsequent days of treatment when required.

Lastly, when Celebrex is used as an adjunct to usual care in patients with familial adenomatous polyposis, the dose is usually taken twice daily with food.

When deciding upon Celebrex as a treatment option, health care providers are urged to carefully consider the risk versus benefit of treatment with Celebrex and use the lowest effective dose for the shortest duration of treatment possible to achieve positive therapeutic outcomes. What is the usual dosage of Celebrex? The usual dosage of Celebrex is dependent upon the indication for treatment. Celebrex is indicated for the symptomatic relief of pain and inflammation associated with osteoarthritis, juvenile rheumatoid arthritis in patients two years of age and older, rheumatoid arthritis in adults, primary dysmenorrhea, acute pain, ankylosing spondylitis and familial adenomatous polyposis as an adjunctive treatment.

The usual dosage of Celebrex recommended for the symptomatic treatment of osteoarthritis is mg daily administered as a single dose or a divided dose of mg administered twice daily. For the relief of the signs and symptoms of juvenile rheumatoid arthritis in the pediatric population, the recommended usual dosage of Celebrex is based on weight.

For those patients greater than 10 kg but weighing less than 25 kg, the usual dosage of Celebrex is 50 mg administered twice daily. For patients weighing greater than 25 kg, the usual dosage of Celebrex is mg administered twice daily. According to the prescribing information, Celebrex capsules can be opened and the contents can be added to applesauce for patients who have difficulty swallowing the capsules.

Furthermore, patients should be instructed to carefully empty the entire capsule contents onto a level teaspoon of cool or room temperature applesauce and ingest immediately with water. However, the sprinkled capsule contents are stable for up to six hours under proper refrigeration at a temperature between 35 and 45 degrees Fahrenheit.

The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint adjudicated: In the APC trial, the hazard ratios compared to placebo for a composite endpoint adjudicated of cardiovascular death, myocardial infarction, or stroke were 3.

The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction. In the PreSAP trial, the hazard ratio for this same composite endpoint adjudicated was 1. Cumulative rates for this composite endpoint over 3 years were 2. Clinical trials of other COX-2 selective and non-selective NSAIDs of up to three-years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

This was a prospective, long-term, safety outcome study conducted post-marketing in approximately 5, OA patients and 2, RA patients. Patients received celecoxib mg twice daily 4-fold and 2-fold the recommended OA and RA doses, respectively , ibuprofen mg three times daily or diclofenac 75 mg twice daily common therapeutic doses.

The primary endpoint of this outcome study was the incidence of complicated ulcers gastrointestinal bleeding, perforation or obstruction. Differences in the incidence of complicated ulcers between celecoxib and the combined group of ibuprofen and diclofenac were not statistically significant.

The Kaplan-Meier rate for complicated ulcers at 9 months was 1. The estimated cumulative rates at 9 months of complicated and symptomatic ulcers for patients treated with celecoxib mg twice daily are described in Table 4. Table 4 also displays results for patients less than or greater than 65 years of age.

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