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 usual dosage of Celebrex recommended for the symptomatic treatment of rheumatoid arthritis in adults is mg to mg administered twice daily. For treatment of primary dysmenorrhea and management of acute pain, the dosage and administration recommended for Celebrex is the same.
The usual dosage of Celebrex recommended for these two indications is an initial dose of mg followed by an additional dose of mg if needed on the first day. The recommended dose is mg administered twice daily as needed on subsequent days of treatment. For the management of the signs and symptoms of ankylosing spondylitis, the usual dosage of Celebrex is mg daily administered as a single dose or the dosage may be administered in divided doses twice per day.
According to the prescribing information, if therapeutic effects have not been observed after six weeks of treatment, a trial dosage of Celebrex of mg daily may be beneficial. If a therapeutic response is still not observed after treatment with mg for six weeks, other treatment options should then be considered. Finally, for the adjunctive treatment of familial adenomatous polyposis, to reduce the number of adenomatous colorectal polyps, the usual dosage of Celebrex recommended is mg administered twice daily with food.
Patients should continue to receive usual medical care for familial adenomatous polyposis while being treated with Celebrex.
For all uses of Celebrex, it is recommended that the lowest effective dosage be administered for the shortest duration of treatment possible in order to achieve the desired therapeutic response. I was told by a doctor that the tendon on the underside of my elbow was slipping off the bone. He gave me a shot of Cortisone that did not help and he gave me Lortab.
It is not helping. Would Celebrex help this any or do I need surgery right away? Only your doctor can determine if you need surgery, but these medications will probably not keep the tendon on the bone, unless the problem is from inflammation. Cox-2 makes the prostaglandins that cause inflammation, swelling, and as a result, pain. What over-the-counter medications should not be taken with Celebrex?
People on Celebrex should avoid these products because they contain the same kind of medication. Read labels carefully for the list of ingredients in over-the-counter medicines.
Ask your local pharmacist if you have any questions about whether to take a certain over-the-counter product. Always read and follow the complete directions and warnings on over-the-counter medicines and discuss their use with your doctor before taking them.
Sarah Lewis, PharmD Q: I have pain in my low back and hip because of a mild degeneration of the spine. I do not need hip replacement surgery yet.
My doctor has prescribed Celebrex, but I don't want to take it every day because of the side effects. I do take 4 ibuprofen a day. Is there something else I should be doing? Celebrex works by reducing hormones that cause inflammation and pain. Common side effects of Celebrex include dizziness, constipation, stomach upset, and headache.
Celebrex can be taken any time of the day with food. Advil works by reducing hormones that cause inflammation. Advil is used for pain treatment and inflammation. Common side effects of Advil include upset stomach, bloating, gas, headache, and diarrhea or constipation.
Advil should be taken with food or a glass of milk. Advil can also increase the risk of stomach problems. Also Advil can increase the risk of heart problems such as heart attacks and strokes.
This risk increases the longer that Advil is used. Prescribing information suggests that a individual take more than 6 tablets mg of ibuprofen in 24 hours. Celebrex and Ibuprofen should not be taken together. Coadministration of Celebrex and Ibuprofen may increase the potential for serious gastrointestinal toxicity including inflammation, bleeding, ulceration, and perforation.
The risk is dependent on both dosage and duration of therapy. If your pain from the degeneration of the spine cannot be controlled with the Celebrex, consult with your healthcare provider.
Your doctor may be able to find you an alternative medication to control your pain without causing potential risks and unwanted side effects. Let your doctor know about all the over-the-counter medications you may be taking including herbals, vitamins, and supplements.
Some over-the-counter products can interact with prescription medication or make certain medical conditions worse. I take Celebrex once a day at bedtime? Could if be making me tired? According to prescribing information, fatigue was an infrequent side effect reported. This is not a complete list of the side effects associated with Celebrex. Is there a difference between brand name Celebrex and generic?
What is the name of the generic form? Celebrex is approved for the treatment of osteoarthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, rheumatoid arthritis, treatment of acute pain, primary dysmenorrhea, and for the reduction of intestinal polyps in familial adenomatous polyposis.
In the United States, Celebrex is currently only available as a brand name medication. The drug company that makes Celebrex still has patent rights on the medication. In the future, when the generic becomes approved it will be marketed by the chemical name, celecoxib. Generic medications are less expensive alternatives to brand name medications. Generic medications can look differently and can have a few other minor differences from their brand name counterpart.
However, their labeling and directions must be virtually the same as that of the brand name product. Generic products must contain the same active ingredient as the brand name products. Generics, as well as brand name medications, must follow the same standards of good manufacturing practices. The FDA requires that generic drugs be bioequivalent to the brand name medication. This means that both generic drugs and brand name drugs will work the same way in your body.
Generics are considered by the FDA to be identical to brand name drugs in dose, strength, quality, route of administration, safety, efficacy, and intended use. Generic medications do not need to contain the same inactive ingredients as brand name medications. I have been taking Celebrex for 9 months with no side effects. However, I recently have noticed a skin irritation similar to a bad sunburn where my skin is red and flaking off. I do not want to stop taking Celebrex as it has helped my severely arthritic right hip.
I do not want to have hip replacement surgery now. Can Celebrex be the cause of the skin irritation? Celebrex celecoxib is a COX-2 selective non-steroidal anti-inflammatory drug NSAID which is approved for the treatment of osteoarthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, rheumatoid arthritis, management of acute pain, and treatment of primary dysmenorrhea.
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.
In the general U. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose of mg twice daily. In addition, structural abnormalities e.
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation , and decidualization.
In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post-implantation loss. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition , and increase the incidence of stillbirth.
Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of Celebrex.
A report of two breastfed infants 17 and 22 months of age did not show any adverse events. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin mediated follicular rupture required for ovulation. Safety and efficacy have not been studied beyond six months in children. The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a week open-label extension.
Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg 22 lbs , and in patients with active systemic features. Patients with systemic onset JRA without active systemic features appear to be at risk for the development of abnormal coagulation laboratory tests. In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time APTT but not prothrombin time PT.
When NSAIDs including celecoxib are used in patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, due to the risk of disseminated intravascular coagulation. Patients taking fluconazole should be given the lowest possible Celebrex dose. This effect has been associated to the inhibitory effect of celecoxib in prostanglandin production. There are also several nutritional and herbal supplements that can increase the risk of bleeding.
Some of these supplements include feverfew, garlic, gingko biloba, ginseng, St. This information guide does not contain all medications that can potentially interact with Celebrex. Make sure that you inform your healthcare provider of all the drugs including prescription and over-the-counter medications as well as vitamins, nutritional and herbal supplements that you normally take.
Most prescription medications associated with changes in body weight warfarin the central nervous system. All medications have possible adverse effects associated with them. What is the doe doe of Celebrex? Kidney damage may celebrex result. Your with is best able to guide your treatment choices based on your specific circumstances. I had prostate interact in November In adult patients being treated with Celebrex for the management of acute pain or the treatment of primary dysmenorrhea, the interact 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. I also have rheumatoid arthritis, does celebrex interact with warfarin. There are also several nutritional and herbal supplements that can increase the risk of bleeding, does celebrex interact with warfarin. What are the side effects of Celebrex? Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing with in animal models. Lori Mendoza, PharmD Q: Common side effects of Celebrex include dizziness, constipation, stomach upset, and headache. In patients who have demonstrated allergic-type reactions to sulfonamides. There have been no reports of sulfa-allergic patients reacting to Celebrex. Warfarin, there celebrex no generic available in the United States for Celebrex.
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