How Many Ibuprofen Equal One Celebrex

22.08.2023 0 Comments

How Many Ibuprofen Equal One Celebrex

Is Celebrex stronger than 800 mg ibuprofen?

Celebrex and ibuprofen have been compared in numerous studies for specific types of pain. Results indicate that both medications tend to be similarly effective for many types of pain.

What is equal to Celebrex?

Key Points –

Meloxicam (brand name: Mobic ) and celecoxib (brand name: Celebrex ) are both prescription drugs in the group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). They work to reduce prostaglandins in the body, a type of hormone that causes pain and inflammation (swelling). Celebrex is classified as a selective COX-2 inhibitor, while meloxicam is relatively selective for cyclooxygenase (COX)-2 at lower doses, but can inhibit COX-1 at higher doses. Both are used to treat inflammatory conditions like rheumatoid arthritis, osteoarthritis, Juvenile Rheumatoid Arthritis (JRA) and acute pain, but Celebrex is approved by the FDA for additional indications, like menstrual pain and ankylosing spondylitis, a painful spine condition. Both products come as oral medicines. Meloxicam tablet, capsule or liquid is taken once per day, and Celebrex capsule is taken once OR twice a day, based on your medical condition. Both meloxicam tablets and celecoxib capsules are available as a generic option which makes them more affordable than their brand name counterparts. In general, meloxicam will usually be less expensive overall, but he oral liquid and capsule may be more pricey. If you prefer, a $4 copay card from the manufacturer of Celebrex may help to lower your costs for the brand product, if you qualify.

NSAIDs are a large group of prescription and over-the-counter (OTC) medications that also contain common medicines like ibuprofen (Advil, Motrin), naproxen (Aleve) and diclofenac (Cataflam, Voltaren). They are commonly used to treat pain and inflammation, headache and fever.

How many 200 mg Celebrex can you take a day?

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.

For oral dosage form (capsules):

For acute pain or pain during menstruation:

Adults—At first, 400 milligrams (mg). A second dose of 200 mg can be taken if needed on the first day. Then, 200 mg 2 times a day as needed. Children—Use and dose must be determined by your doctor.

For ankylosing spondylitis or osteoarthritis:

Adults—200 milligrams (mg) once a day or 100 mg 2 times a day. Your doctor may increase your dose if needed. Children—Use and dose must be determined by your doctor.

For rheumatoid arthritis or juvenile rheumatoid arthritis:

Adults—100 to 200 milligrams (mg) 2 times a day. Children 2 years of age and older and weighing more than 25 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 100 milligrams (mg) 2 times a day. Children 2 years of age and older and weighing less than 25 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 milligrams (mg) 2 times a day. Children younger than 2 years of age—Use and dose must be determined by your doctor.

For oral dosage form (solution):

For acute migraine with or without aura:

Adults—120 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.

Is Celebrex a strong painkiller?

Descriptions – Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (eg, osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.

However, this medicine 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. This medicine may also be used to treat acute pain and menstrual cramps. Celecoxib is also used to treat acute migraine headaches with or without aura.

However, this medicine is not used to prevent migraines. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms:

  • Capsule
  • Solution

Can you take Celebrex 200 mg with ibuprofen?

Interactions between your drugs – Using celecoxib together with ibuprofen may increase side effects associated with these medications. In particular, there may be an increased risk of serious gastrointestinal toxicity including inflammation, bleeding, ulceration, and perforation.

  • The risk is dependent on both dosage and duration of therapy of each medication.
  • Talk to your doctor if you have any questions or concerns.
  • Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications.

It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor. Switch to professional interaction data

Is 300 mg of Celebrex too much?

How do I take it? – Celecoxib is taken once or twice a day. The pills are100 or 200mg. each. The usual dose is 200 to 400-mg. per day. This drug is used for both rheumatoid arthritis and osteoarthritis. You doctor will tell you how many pills to take and how often.

What is a good substitute for Celebrex?

Abstract – Patients taking celecoxib (Celebrex) because they cannot tolerate the GI effects of nonspecific NSAIDs could continue to do so, but should not exceed recommended dosage. For analgesia and osteoarthritis, acetaminophen (Tylenol, and others) or tramadol (Ultram, and others) are reasonable alternatives to NSAIDS. For rheumatoid arthritis, disease-modifying drugs (DMARDs) can be used.

What is the strongest anti-inflammatory drug?

Frequently Asked Questions –

Is ibuprofen or naproxen better for inflammation? There isn’t much head-to-head research comparing the two. One older study found that both were effective for relieving the symptoms of knee arthritis, but naproxen helped with more symptoms, such as night pain. In general, ibuprofen takes effect and wears off more quickly, while naproxen has a slower onset but lasts longer. Can I take ibuprofen and naproxen together? No. Ibuprofen and naproxen are both NSAIDs. Taking more than one NSAID at a time is not recommended because it can increase the risk of adverse effects like stomach issues and bleeding. What is the strongest anti-inflammatory medication? Research shows diclofenac is the strongest and most effective non-steroidal anti-inflammatory medicine available. Diclofenec is sold under the prescription brand names Cambia, Cataflam, Zipsor, and Zorvolex. It is also available as a topical gel, Voltaren, which is available over the counter. What are the signs of inflammation? Inflammation is the body’s immune response to an injury or illness. Acute inflammation causes redness, swelling, heat, pain, and loss of function in the area that is inflamed. How can I reduce inflammation quickly? Follow the RICE formula for managing inflammation due to an acute injury—rest, ice, compression, and elevation. For systemic inflammation, following an anti-inflammatory diet can help in the long term. NSAIDs and corticosteroids are often recommended for fast relief of pain and inflammation.

Is Celebrex stronger than paracetamol?

Although on average, celecoxib showed better scores than SR paracetamol, 33 of the 41 individual patients (80%) failed to identify the differences between SR paracetamol and celecoxib in terms of overall symptom relief.

Can I take ibuprofen 8 hours after Celebrex?

Key points about celecoxib –

Celecoxib is an anti-inflammatory used to treat pain and inflammation. Celecoxib is also called Celebrex. Find out how to take it safely and the possible side effects.

Celecoxib is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Celecoxib is used to treat different types of pain such as pain from,, and, Read more about In New Zealand celecoxib is available as capsules (100 mg and 200 mg). (RheumInfo, Canada, 2019)Note: this video is from Canada so may have information that differs from New Zealand recommendations.

The usual dose of celecoxib is 200 mg once a day or 100 mg twice a day. Some people may need a higher dose of 200 mg twice a day. Always take your celecoxib exactly as your doctor has told you. The pharmacy label on your medicine will tell you how much to take, how often to take it and any special instructions.

Take celecoxib with a full glass of water. Swallow the capsules whole. Don’t crush or chew them. If celecoxib causes stomach upset, take it with food. Avoid or limit alcohol while you are taking celecoxib. Alcohol can increase the risk of side effects such as stomach upset. Missed dose: If you forget to take a dose, take it when you next need pain relief and then continue as before. Don’t take 2 doses together to make up for a forgotten dose.

For most people taking celecoxib is safe but extra care is needed in some situations, for example if:

you have high blood pressure you have heart or kidney problems or asthma you’re aged 65 years or older you smoke.

It can also be harmful to take celecoxib when you are dehydrated or have been sick with diarrhoea (runny poos) or vomiting (being sick). Read more about the

When you should NOT take celecoxib
Celecoxib should NOT be used in some situations as it can be harmful. For example, if you:

have current or previous stomach problems such as ulcers or bleeding are pregnant have heart failure or chest pain (angina) have had a stroke or heart attack have chronic kidney disease have had an allergic reaction (such as hives or trouble breathing) to ibuprofen, aspirin, or other similar medications (discuss with your healthcare provider) are taking medicines to reduce blood clots (anticoagulants) such as warfarin, dabigatran and rivaroxaban are also taking other anti-inflammatory medicines, eg, diclofenac (Voltaren®), ibuprofen (Brufen) or naproxen (Naprosyn ®, Naprogesic ® ) are taking some blood pressure medicines such as ACE inhibitors, ARBs, diuretics. Always check with your healthcare provider before taking NSAIDs.

Read more about the,

Don’t take other anti-inflammatory medicines such as, or while taking celecoxib. This can increase your risk of side effects. It’s safe to take celecoxib with because they work differently. Celecoxib interacts with some medicines, especially those used for high blood pressure, so check with your doctor or pharmacist before you start taking it. Image credit: University of Otago, NZ Taking NSAIDs together with blood pressure medicines can be harmful to your kidneys. This is called the ‘triple whammy’. If you are taking blood pressure medicines (ACE inhibitors or ARBs and diuretics) tell your doctor or pharmacist before starting celecoxib.

Examples of ACE inhibitors are captopril, cilazapril, enalapril, lisinopril, perindopril and quinapril. Examples of ARBs are candesartan, irbesartan and losartan. Examples of diuretics are furosemide, bumetanide, bendroflumethiazide, chlortalidone, indapamide, spironolactone, eplerenone and metolazone.

Read more about the

Side effects What should I do?

Heartburn Indigestion Stomach discomfort Runny poo (diarrhoea)

These are common and should settle within a few days. Take celecoxib with food. Talk to your doctor if they’re ongoing.

Serious stomach problems such as really bad stomach pain, blood in the stool or black stools, cough or vomit up blood or dark coloured vomit.

Stop taking celecoxib. Tell your doctor immediately or ring Healthline on 0800 611 116.

Chest pain Shortness of breath or trouble breathing Weakness in one part or side of the body Slurred speech

Stop taking celecoxib. Tell your doctor immediately or ring Healthline on 0800 611 116.

Swollen ankles, blood in your pee or not peeing at all – these can be signs of a kidney problem.

Stop taking celecoxib. Tell your doctor immediately or ring Healthline on 0800 611 116.

Signs of an allergic reaction such as skin rash, itching, swelling of your lips, face and mouth or difficulty breathing

Stop taking celecoxib. Tell your doctor immediately or ring Healthline on 0800 611 116.

Did you know that you can report a side effect to a medicine to CARM (Centre for Adverse Reactions Monitoring)?

Credits: Healthify Pharmacists. Healthify is brought to you by Health Navigator Charitable Trust.

Reviewed by: Angela Lambie, Pharmacist, Auckland Last reviewed: 12 Sep 2022 Page last updated: 05 Dec 2022

: Celecoxib

Is 400mg of Celebrex too much?

Does Celebrex have a maximum dose? – Celebrex’s maximum dose per day depends on the condition being treated. In general, the highest dose of Celebrex that doctors prescribe is 400 mg. This can be taken as 400 mg once daily or 200 mg twice daily. However, you should not increase your Celebrex dosage on your own.

Is 200mg of Celebrex a lot?

My Account Area – 1. Name of the medicinal product Celebrex 200 mg hard capsules 2. Qualitative and quantitative composition Each capsule contains 200 mg celecoxib. Excipient with known effect Lactose (each capsule contains 49.8 mg lactose monohydrate; see section 4.4). For the full list of excipients, see section 6.1.3. Pharmaceutical form Hard capsules (capsule). Opaque, white with two gold bands marked 7767 and 200.4. Clinical particulars 4.1 Therapeutic indications Celebrex is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4).4.2 Posology and method of administration Posology As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1). Osteoarthritis The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. Rheumatoid arthritis The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. Ankylosing spondylitis The recommended daily dose is 200 mg taken once daily or in two divided doses. In a few patients, with insufficient relief from symptoms, an increased dose of 400 mg once daily or in two divided doses may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. The maximum recommended daily dose is 400 mg for all indications. Special populations Elderly As in younger adults, 200 mg per day should be used initially. The dose may, if needed, later be increased to 200 mg twice daily. Particular caution should be exercised in elderly with a body weight less than 50 kg (see sections 4.4 and 5.2). Paediatric population Celecoxib is not indicated for use in children. CYP2C9 poor metabolisers Patients who are known, or suspected to be CYP2C9 poor metabolisers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose-dependent adverse effects is increased. Consider reducing the dose to half the lowest recommended dose (see section 5.2). Hepatic impairment Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l. Experience in such patients is limited to cirrhotic patients (see sections 4.3, 4.4 and 5.2). Renal impairment Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2). Method of administration Oral use Celebrex may be taken with or without food. For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of cool or room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with 240 ml of water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2-8 °C). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known hypersensitivity to sulfonamides. Active peptic ulceration or gastrointestinal (GI) bleeding. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors. In pregnancy and in women of childbearing potential unless using an effective method of contraception (see section 4.6). Celecoxib has been shown to cause malformations in the two animal species studied (see sections 4.6 and 5.3). The potential for human risk in pregnancy is unknown, but cannot be excluded. Breast-feeding (see sections 4.6 and 5.3). Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10). Patients with estimated creatinine clearance <30 ml/min. Inflammatory bowel disease. Congestive heart failure (NYHA II-IV). Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.4.4 Special warnings and precautions for use Gastrointestinal (GI) effects Upper and lower gastrointestinal complications (perforations, ulcers or bleedings ), some of them resulting in fatal outcome, have occurred in patients treated with celecoxib. Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or antiplatelet drugs (such as acetylsalicylic acid), or glucocorticoids concomitantly, patients using alcohol, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding. There is further increase in the risk of gastrointestinal adverse effects for celecoxib (gastrointestinal ulceration or other gastrointestinal complications), when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses). A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs, NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1). Concomitant NSAID use The concomitant use of celecoxib and a non-aspirin NSAID should be avoided. Cardiovascular effects Increased number of serious cardiovascular (CV) events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg bis in die (BID) and 400 mg BID compared to placebo (see section 5.1). As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. NSAIDs, including COX-2 selective inhibitors, have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long-term. The exact magnitude of the risk associated with a single-dose has not been determined, nor has the exact duration of therapy associated with increased risk. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.2, 4.3, 4.8 and 5.1). Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see section 5.1). COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects. Therefore, antiplatelet therapies should not be discontinued (see section 5.1). Fluid retention and oedema As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking celecoxib. Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention. Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia. Hypertension As with all NSAIDS, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events. Therefore, blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy. Hepatic and renal effects Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained. NSAIDs, including celecoxib, may cause renal toxicity. Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs. Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, angiotensin converting enzyme (ACE)-inhibitors, angiotensin II receptor antagonists, and the elderly (see section 4.5). Such patients should be carefully monitored while receiving treatment with celecoxib. Some cases of severe hepatic reactions, including fulminant hepatitis (some with fatal outcome), liver necrosis and, hepatic failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Among the cases that reported time to onset, most of the severe adverse hepatic events developed within one month after initiation of celecoxib treatment (see section 4.8). If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered. CYP2D6 inhibition Celecoxib inhibits CYP2D6. Although it is not a strong inhibitor of this enzyme, a dose reduction may be necessary for individually dose-titrated medicinal products that are metabolised by CYP2D6 (see section 4.5). CYP2C9 poor metabolisers Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2). Skin and systemic hypersensitivity reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Serious hypersensitivity reactions (including anaphylaxis, angioedema and drug rash with eosinophilia and systemic symptoms (DRESS), or hypersensitivity syndrome), have been reported in patients receiving celecoxib (see section 4.8). Patients with a history of sulfonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see section 4.3). Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. General Celecoxib may mask fever and other signs of inflammation. Use with oral anticoagulants In patients on concurrent therapy with warfarin, serious bleeding events, some of them fatal, have been reported. Increased prothrombin time (INR) with concurrent therapy has been reported. Therefore, this should be closely monitored in patients receiving warfarin/coumarin-type oral anticoagulants, particularly when therapy with celecoxib is initiated or celecoxib dose is changed (see section 4.5). Concomitant use of anticoagulants with NSAIDS may increase the risk of bleeding. Caution should be exercised when combining celecoxib with warfarin or other oral anticoagulants, including novel anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban). Excipients Celebrex 100 mg and 200 mg capsules contain lactose (149.7 mg and 49.8 mg, respectively). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Celebrex 100 mg and 200 mg contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.4.5 Interaction with other medicinal products and other forms of interaction Pharmacodynamic interactions Anticoagulants Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications. Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with celecoxib is initiated or the dose of celecoxib is changed (see section 4.4). Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal. Anti-hypertensives NSAIDs may reduce the effect of anti-hypertensive medicinal products including ACE-inhibitors, angiotensin II receptor antagonists, diuretics and beta-blockers. As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients, patients on diuretics, or elderly patients) when ACE-inhibitors, angiotensin II receptor antagonists, and/or diuretics are combined with NSAIDs, including celecoxib (see section 4.4). Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring. Among patients treated with celecoxib 200 mg BID, 48 % were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure >90 mmHg or cuff diastolic blood pressure increased >10 % compared to baseline), compared to 27 % of patients treated with placebo; this difference was statistically significant. Ciclosporin and tacrolimus Co-administration of NSAIDs and ciclosporin or tacrolimus may increase the nephrotoxic effect of ciclosporin or tacrolimus, respectively. Renal function should be monitored when celecoxib and any of these medicinal products are combined. Acetylsalicylic acid Celecoxib can be used with low-dose acetylsalicylic acid but is not a substitute for acetylsalicylic acid for CV prophylaxis. In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1). Pharmacokinetic interactions Effects of celecoxib on other medicinal products CYP2D6 inhibition Celecoxib is an inhibitor of CYP2D6. The plasma concentrations of medicinal products that are substrates of this enzyme may be increased when celecoxib is used concomitantly. Examples of medicinal products which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmic medicinal products, etc. The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated. Concomitant administration of celecoxib 200 mg twice daily resulted in 2.6-fold and 1.5-fold increases in plasma concentrations of dextromethorphan and metoprolol (CYP2D6 substrates), respectively. These increases are due to celecoxib inhibition of the CYP2D6 substrate metabolism. CYP2C19 inhibition In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism. The clinical significance of this in vitro finding is unknown. Examples of medicinal products which are metabolised by CYP2C19 are diazepam, citalopram and imipramine. Methotrexate In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses). However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two medicinal products. Lithium In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in C max of 16 % and in area under the curve (AUC) of 18 % of lithium. Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn. Oral contraceptives In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethisterone /35 micrograms ethinylestradiol). Glibenclamide/tolbutamide Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide to a clinically relevant extent. Effects of other medicinal products on celecoxib CYP2C9 poor metabolisers In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors such as fluconazole could result in further increases in celecoxib exposure. Such combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2). CYP2C9 inhibitors and inducers Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole. Concomitant use of 200 mg single-dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib C max of 60% and in AUC of 130%. Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib. Ketoconazole and antacids Ketoconazole or antacids have not been observed to affect the pharmacokinetics of celecoxib. Paediatric population Interaction studies have only been performed in adults.4.6 Fertility, pregnancy and lactation Pregnancy Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see sections 4.3 and 5.3). Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. The potential for human risk in pregnancy is unknown, but cannot be excluded. Celecoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. During the second or third trimester of pregnancy, NSAIDs including celecoxib may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible upon discontinuation. Celecoxib is contraindicated in pregnancy and in women who can become pregnant (see sections 4.3 and 4.4). If a woman becomes pregnant during treatment, celecoxib should be discontinued. Breast-feeding Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma. Administration of celecoxib to a limited number of lactating women has shown a very low transfer of celecoxib into breast milk. Women who take Celebrex should not breastfeed. Fertility Based on the mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.4.7 Effects on ability to drive and use machines Celebrex may have minor influence on the ability to drive and use machines. Patients who experience dizziness, vertigo or somnolence while taking Celebrex should refrain from driving or operating machinery.4.8 Undesirable effects Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources: • Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01 % and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg. In additional studies using non-selective NSAID comparators, approximately 7 400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2 300 patients treated for 1 year or longer. The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 1, • Adverse reactions reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg daily in long-term polyp prevention trials of duration up to 3 years (the Adenoma Prevention with Celecoxib (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials; see section 5.1, Cardiovascular safety – long-term studies involving patients with sporadic adenomatous polyps). • Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications). Even though these were identified as reactions from post-marketing reports, trial data was consulted to estimate frequency. Frequencies are based on a cumulative meta-analysis with pooling of trials representing exposure in 38102 patients. Table 1. Adverse drug reactions in celecoxib clinical trials and surveillance experience (MedDRA preferred terms) 1,2

Adverse Drug Reaction Frequency
System organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data)
Infections and infestations Sinusitis, upper respiratory tract infection, pharyngitis,urinary tract infection
Blood and lymphatic system disorders Anaemia Leukopenia, thrombo-cytopenia Pancytopenia 4
Immune system disorders Hypersensitivity Anaphylactic shock 4, anaphylactic reaction 4
Metabolism and nutrition disorders Hyperkalaemia
Psychiatric disorders Insomnia Anxiety, depression, fatigue Confusional state, hallucinations 4
Nervous system disorders Dizziness, hypertonia, headache 4 Cerebral infarction 1, paraesthesia, somnolence Ataxia, dysgeusia Haemorrhage intracranial (including fatal intracranial haemorrhage) 4, meningitis aseptic 4, epilepsy (including aggravated epilepsy) 4, ageusia 4, anosmia 4
Eye disorders Vision blurred, conjunctivitis 4 Eye haemorrhage 4 Retinal artery occlusion 4, retinal vein occlusion 4
Ear and labyrinth disorders Tinnitus, hypoacusis 1
Cardiac disorders Myocardial infarction 1 Cardiac failure, palpitations, tachycardia Arrhythmia 4
Vascular disorders Hyper-tension 1 (including aggravated hyper-tension) Pulmonary embolism 4, flushing 4 Vasculitis 4
Respiratory, thoracic, and mediastinal disorders Rhinitis, cough, dyspnoea 1 Bronchospasm 4 Pneumonitis 4
Gastrointestinal disorders Nausea 4, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting 1, dysphagia 1 Constipation, gastritis, stomatitis, gastrointestinal inflammation (including aggravation of gastrointestinal inflammation), eructation Gastro-intestinal haemorrhage 4, duodenal ulcer, gastric ulcer, oesophageal ulcer, intestinal ulcer, large intestinal ulcer, intestinal perforation, oesophagitis, melaena, pancreatitis, colitis 4
Hepatobiliary disorders Hepatic function abnormal, hepatic enzyme increased (including increased SGOT and SGPT) Hepatitis 4 Hepatic failure 4 (sometimes fatal or requiring liver transplant), hepatitis fulminant 4 (some with fatal outcome), hepatic necrosis 4, cholestasis 4, hepatitis cholestatic 4, jaundice 4
Skin and subcutaneous tissue disorders Rash, pruritus (includes pruritus generalised) Urticaria, ecchymosis 4 Angioedema 4, alopecia, photo-sensitivity Dermatitis exfoliative 4, erythema multiforme 4, Stevens-Johnson syndrome 4, toxic epidermal necrolysis 4, drug reaction with eosinophilia and systemic symptoms (DRESS) 4, acute generalised exanthematous pustulosis (AGEP) 4, dermatitis bullous 4
Musculoskeletal and connective tissue disorders Arthralgia 4 Muscle spasms (leg cramps) Myositis 4
Renal and urinary disorders Blood creatinine increased, blood urea increased Renal failure acute 4, hypo-natraemia 4 Tubulointerstitial nephritis 4, nephrotic syndrome 4, glomerulonephritis minimal lesion 4
Reproductive system and breast disorders Menstrual disorder 4 Infertility female (female fertility decreased) 3
General disorders and administrative site conditions Influenza-like illness, oedema peripheral/ fluid retention Face oedema, chest pain 4
Injury, poisoning and procedural complications Injury (accidental injury)
SGOT – serum glutamic oxaloacetic transaminase SGPT – serum glutamic pyruvic transaminase 1 Adverse drug reactions that occurred in polyp prevention trials, representing subjects treated with celecoxib 400 mg daily in 2 clinical trials of duration up to 3 years (the APC and PreSAP trials). The adverse drug reactions listed above for the polyp prevention trials are only those that have been previously recognised in the post-marketing surveillance experience, or have occurred more frequently than in the arthritis trials.2 Furthermore, the following previously unknown adverse reactions occurred in polyp prevention trials, representing subjects treated with celecoxib 400 mg daily in 2 clinical trials of duration up to 3 years (the APC and PreSAP trials): Common: angina pectoris, irritable bowel syndrome, nephrolithiasis, blood creatinine increased, benign prostatic hyperplasia, weight increased. Uncommon: helicobacter infection, herpes zoster, erysipelas, bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous floaters, conjunctival haemorrhage, deep vein thrombosis, dysphonia, haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, allergic dermatitis, ganglion, nocturia, vaginal haemorrhage, breast tenderness, lower limb fracture, blood sodium increased.3 Women intending to become pregnant are excluded from all trials, thus consultation of the trial database for the frequency of this event was not reasonable.4 Frequencies are based on cumulative meta-analysis with pooling of trials representing exposure in 38102 patients.

In final data (adjudicated) from the APC and PreSAP trials in patients treated with celecoxib 400 mg daily for up to 3 years (pooled data from both trials; see section 5.1 for results from individual trials), the excess rate over placebo for myocardial infarction was 7.6 events per 1,000 patients (uncommon) and there was no excess rate for stroke (types not differentiated) over placebo. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose There is no clinical experience of overdose. Single-doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects. In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment. Dialysis is unlikely to be an efficient method of medicinal product removal due to high protein binding.5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Non-steroidal anti-inflammatory and antirheumatic drugs, NSAIDs, Coxibs, ATC code: M01AH01. Mechanism of action Celecoxib is an oral, selective, COX-2 inhibitor within the clinical dose range (200-400 mg daily). No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B 2 formation) was observed in this dose range in healthy volunteers. Pharmacodynamic effects Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in humans but its relevance to ulcer healing has not been established. The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions. COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane. Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differs from arylamine sulfonamides (e.g. sulfamethoxizole and other sulfonamide antibiotics). A dose-dependent effect on TxB 2 formation has been observed after high doses of celecoxib. However, in healthy subjects, in small multiple dose studies with 600 mg BID (three times the highest recommended dose) celecoxib had no effect on platelet aggregation and bleeding time compared to placebo. Clinical efficacy and safety Several clinical studies have been performed confirming efficacy and safety in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Celecoxib was evaluated for the treatment of the inflammation and pain of osteoarthritis of the knee and hip in approximately 4200 patients in placebo and active-controlled trials of up to 12 weeks duration. It was also evaluated for treatment of the inflammation and pain of rheumatoid arthritis in approximately 2100 patients in placebo and active-controlled trials of up to 24 weeks duration. Celecoxib at daily doses of 200 mg – 400 mg provided pain relief within 24 hours of dosing. Celecoxib was evaluated for the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo and active-controlled trials of up to 12 weeks duration. Celecoxib at doses of 100 mg BID, 200 mg QD, 200 mg BID and 400 mg QD in these studies demonstrated significant improvement in pain, global disease activity and function in ankylosing spondylitis. Five randomised double-blind controlled studies have been conducted including scheduled upper gastrointestinal endoscopy in approximately 4500 patients free from initial ulceration (celecoxib doses from 50 mg – 400 mg BID). In twelve week endoscopy studies celecoxib (100 – 800 mg per day) was associated with a significantly lower risk of gastroduodenal ulcers compared with naproxen (1000 mg per day) and ibuprofen (2400 mg per day). The data were inconsistent in comparison with diclofenac (150 mg per day). In two of the 12-week studies the percentage of patients with endoscopic gastroduodenal ulceration was not significantly different between placebo and celecoxib 200 mg BID and 400 mg BID. In a prospective long-term safety outcome study (6 to 15 month duration, CLASS study), 5,800 osteoarthritis and 2,200 rheumatoid arthritis patients received celecoxib 400 mg BID (4-fold and 2-fold the recommended osteoarthritis and rheumatoid arthritis doses, respectively), ibuprofen 800 mg ter in die (TID) or diclofenac 75 mg BID (both at therapeutic doses). Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (≤325 mg/day), primarily for CV prophylaxis. For the primary endpoint complicated ulcers (defined as gastrointestinal bleeding, perforation or obstruction) celecoxib was not significantly different than either ibuprofen or diclofenac individually. Also for the combined NSAID group there was no statistically significant difference for complicated ulcers (relative risk 0.77, 95 % CI 0.41-1.46, based on entire study duration). For the combined endpoint, complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group, relative risk 0.66, 95 % CI 0.45-0.97 but not between celecoxib and diclofenac. Those patients on celecoxib and concomitant low-dose acetylsalicylic acid experienced 4-fold higher rates of complicated ulcers as compared to those on celecoxib alone. The incidence of clinically significant decreases in haemoglobin (>2 g/dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95 % CI 0.17- 0.48. The significantly lower incidence of this event with celecoxib was maintained with or without acetylsalicylic acid use. In a prospective randomised 24 week safety study in patients who were aged ≥60 years or had a history of gastroduodenal ulcers, the percentages of patients with decreases in haemoglobin (≥2 g/dL) and/or haematocrit (≥10 %) of defined or presumed GI origin were lower in patients treated with celecoxib 200 mg twice daily (N=2238) compared to patients treated with diclofenac SR 75 mg twice daily plus omeprazole 20 mg once daily (N=2246) (0.2 % vs.1.1 % for defined GI origin, p = 0.004; 0.4 % vs.2.4 % for presumed GI origin, p = 0.0001). The rates of clinically manifest GI complications such as perforation, obstruction or haemorrhage were very low with no differences between the treatment groups (4-5 per group). Cardiovascular safety – long-term studies involving subjects with sporadic adenomatous polyps Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i.e., the APC trial and the PreSAP trial. In the APC trial, there was a dose-related increase in the composite endpoint of CV death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment. The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint. In the APC trial, the relative risks compared to placebo for a composite endpoint (adjudicated) of CV death, myocardial infarction, or stroke were 3.4 (95 % CI 1.4 – 8.5) with celecoxib 400 mg twice daily and 2.8 (95 % CI 1.1 – 7.2) with celecoxib 200 mg twice daily. Cumulative rates for this composite endpoint over 3 years were 3.0 % (20/671 subjects) and 2.5 % (17/685 subjects), respectively, compared to 0.9 % (6/679 subjects) for placebo. The increases for both celecoxib dose groups versus placebo were mainly due to an increased incidence of myocardial infarction. In the PreSAP trial, the relative risk compared to placebo for this same composite endpoint (adjudicated) was 1.2 (95 % CI 0.6 – 2.4) with celecoxib 400 mg once daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 2.3 % (21/933 subjects) and 1.9 % (12/628 subjects), respectively. The incidence of myocardial infarction (adjudicated) was with 1.0 % (9/933 subjects) with celecoxib 400 mg once daily and 0.6 % (4/628 subjects) with placebo. Data from a third long-term study, ADAPT (The Alzheimer’s Disease Anti-inflammatory Prevention Trial), did not show a significantly increased CV risk with celecoxib 200 mg BID compared to placebo. The relative risk compared to placebo for a similar composite endpoint (CV death, myocardial infarction, stroke) was 1.14 (95 % CI 0.61 – 2.15) with celecoxib 200 mg twice daily. The incidence of myocardial infarction was 1.1 % (8/717 patients) with celecoxib 200 mg twice daily and 1.2 % (13/1070 patients) with placebo. Prospective randomised evaluation of celecoxib integrated safety vs. ibuprofen or naproxen (PRECISION) The PRECISION study was a double-blind study of cardiovascular safety in Osteo arthritis (OA) or Rheumatoid arthritis (RA) patients with or at high risk for cardiovascular disease comparing Celecoxib (200-400 mg daily) with Naproxen (750-1 000 mg daily) and Ibuprofen (1 800-2 400 mg daily). The primary endpoint, Antiplatelet Trialists Collaboration (APTC), was an independently adjudicated composite of cardiovascular death (including haemorrhagic death), non-fatal myocardial infarction or non-fatal stroke. The study was planned with 80% power to evaluate non-inferiority. All patients were prescribed open-label esomeprazole (20-40 mg) for gastro protection. Patients who were taking low-dose aspirin were permitted to continue therapy, at baseline nearly half of the subjects were on aspirin. Secondary and tertiary endpoints included cardiovascular, gastrointestinal and renal outcomes. The Average Dose dispensed was 209±37 mg/day for Celecoxib, 2045±246 for Ibuprofen and 852±103 for Naproxen, Regarding the primary endpoint, Celecoxib, as compared with either naproxen or ibuprofen, met all four pre-specified non-inferiority requirements, see Table 2. Other independently adjudicated secondary and tertiary endpoints included cardiovascular, gastrointestinal and renal outcomes. Additionally, there was a 4-month substudy focusing on the effects of the three medicinal products on blood pressure as measured by ambulatory monitoring (ABPM). Table 2. Primary analysis of the adjudicated APTC composite endpoint

Intent-To-Treat Analysis (ITT, through month 30)
Celecoxib 100-200 mg bid Ibuprofen 600-800 mg tid Naproxen 375-500 mg bid
N 8,072 8,040 7,969
Subjects with Events 188 (2.3%) 218 (2.7%) 201 (2.5%)
Pairwise Comparison Celecoxib vs. Naproxen Celecoxib vs. Ibuprofen Ibuprofen vs. Naproxen
HR (95% CI) 0.93 (0.76, 1.13) 0.86 (0.70, 1.04) 1.08 (0.89, 1.31)
Modified Intent-To-Treat Analysis (mITT, on treatment through month 43)
Celecoxib 100-200 mg bid Ibuprofen 600-800 mg tid Naproxen 375-500 mg bid
N 8,030 7,990 7,933
Subjects with Events 134 (1.7%) 155 (1.9%) 144 (1.8%)
Pairwise Comparison Celecoxib vs. Naproxen Celecoxib vs. Ibuprofen Ibuprofen vs. Naproxen
HR (95% CI) 0.90 (0.72, 1.14) 0.81 (0.64, 1.02) 1.12 (0.889, 1.40)

HR – hazard Ratio BID – bis in die TID – ter in die The results were overall numerically similar in the celecoxib and comparator groups for the secondary and tertiary endpoints and there were overall no unexpected safety findings. Taken together the PRECISION study indicates that celecoxib at the lowest approved dose of 100 mg twice daily is non-inferior to ibuprofen dosed in the range of 600 mg-800 mg three times daily or naproxen dosed in the range of 375 mg-500 mg twice daily with respect to cardiovascular adverse effects. The cardiovascular risks of the NSAID class, including coxibs, are dose-dependent, therefore, the results for celecoxib 200 mg daily on the composite cardiovascular endpoint cannot be extrapolated to dosing regimens using the higher doses of celecoxib.5.2 Pharmacokinetic properties Absorption Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours. Dosing with food (high fat meal) delays absorption of celecoxib by about 1 hour resulting in a T max of about 4 hours and increases bioavailability by about 20%. In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in C max, T max or T 1/2 after administration of capsule contents on applesauce. Distribution Plasma protein binding is about 97 % at therapeutic plasma concentrations and the medicinal product is not preferentially bound to erythrocytes. Biotransformation Celecoxib metabolism is primarily mediated via cytochrome P450 2C9. Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i.e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate. Cytochrome P450 2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism. In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median C max and AUC 0-24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes. In three separate single-dose studies, involving a total of 5 subjects genotyped as CYP2C9*3/*3, single-dose AUC 0-24 increased by approximately 3-fold compared to normal metabolisers. It is estimated that the frequency of the homozygous *3/*3 genotype is 0.3-1.0 % among different ethnic groups. Patients who are known, or suspected to be CYP2C9 poor metabolisers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution (see section 4.2). No clinically significant differences were found in Pharmacokinetic parameters of celecoxib between elderly African-Americans and Caucasians. The plasma concentration of celecoxib is approximately 100 % increased in elderly women (>65 years). Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in C max of 53 % and in AUC of 26 % of celecoxib. The corresponding values in patients with moderate hepatic impairment were 41 % and 146 % respectively. The metabolic capacity in patients with mild to moderate impairment was best correlated to their albumin values. Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35 g/l). Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group. There is little experience of celecoxib in renal impairment. The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients. Thus caution is advised when treating patients with renal impairment. Severe renal impairment is contraindicated. Elimination Celecoxib is mainly eliminated by metabolism. Less than 1 % of the dose is excreted unchanged in urine. The inter-subject variability in the exposure of celecoxib is about 10-fold. Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range. Elimination half-life is 8-12 hours. Steady state plasma concentrations are reached within 5 days of treatment.5.3 Preclinical safety data Non-clinical safety data revealed no special hazard for humans based on conventional studies of repeated dose toxicity, mutagenicity or carcinogenicity beyond those addressed in section 4.4, 4.6, and 5.1 of the SmPC. Celecoxib at oral doses ≥150 mg/kg/day (approximately 2-fold human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6-fold human exposure based on the AUC 0-24 at 200 mg twice daily) throughout organogenesis. These effects are expected following inhibition of prostaglandin synthesis. In rats, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses, and reduced embryo/fetal survival. Celecoxib was excreted in rat milk. In a peri-post natal study in rats, pup toxicity was observed. In a 2 year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.6. Pharmaceutical particulars 6.1 List of excipients Capsules content Lactose monohydrate Sodium laurilsulfate Povidone Croscarmellose sodium Magnesium stearate Capsule shells Gelatin Titanium dioxide E171 Sodium laurilsulfate Sorbitan monolaurate Printing ink Iron oxide E172 Shellac Propylene glycol 6.2 Incompatibilities Not applicable.6.3 Shelf life 3 years.6.4 Special precautions for storage Do not store above 30 °C.6.5 Nature and contents of container Clear or opaque PVC/aluminium blisters. Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose, 5x(10x10). Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.7. Marketing authorisation holder Upjohn UK Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom 8. Marketing authorisation number(s) PL 50622/0012 9. Date of first authorisation/renewal of the authorisation 03/05/2011 10. Date of revision of the text

Is Celebrex the best anti-inflammatory?

The bottom line Many studies have shown meloxicam and Celebrex to be as effective as other NSAIDs for pain and inflammation. But some studies show Celebrex might work better than other NSAIDs in some cases. Tell your healthcare provider about other medications you’re taking and other health conditions you have.

Does Celebrex help with pain immediately?

By blocking COX-2, celecoxib reduces inflammation in the body and pain. How long will it take to work? Some people will notice the effects of celecoxib within the first few hours of taking a dose. For others, the effects may not be evident for days and even up to a week or two after the medicine has been started.

How long can you stay on Celebrex?

How long to take it – Depending on your condition, you may need Celebrex for a few days or for longer periods. Celebrex will not cure your condition but should help control pain, swelling and stiffness. Keep taking Celebrex for as long as your doctor advises.

What is stronger than ibuprofen?

Diclofenac vs. ibuprofen: Which is better? – Diclofenac is a more potent NSAID than ibuprofen. Taking diclofenac 2-3 times daily can effectively treat arthritis pain. To treat joint pain with ibuprofen, a higher dose such as a “prescription-strength dose” is usually needed.

Can I have a glass of wine while taking Celebrex?

Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol while taking this medication increases the risk of stomach bleeding.

Can you take Celebrex 200 mg with paracetamol?

Can you take other medicines with celecoxib (Celebrex)? sturti It’s fine to take paracetamol with celecoxib. You can also take opioid-type painkillers such as codeine, co-codamol, tramadol or morphine in combination with celecoxib. However, don’t take the following painkillers while you’re taking celecoxib, as this increases the risk of getting side effects on the stomach and intestines:

painkilling doses of aspirin other related anti-inflammatory painkillers (NSAIDs) like ibuprofen or naproxen.

Remember that many and contain ibuprofen or aspirin and so should be avoided while you’re taking celecoxib. Be sure to check the ingredients of other medicines before taking them with celecoxib, or ask your pharmacist for advice. It is also best to check with your pharmacist if you want to use an anti-inflammatory gel (such as diclofenac, ibuprofen, ketoprofen or piroxicam) alongside celecoxib taken by mouth, because this may not be safe for everyone.

Do you gain weight on Celebrex?

Was Celebrex ever taken off the market? – No, Celebrex has never been taken off the market. Two similar pain relievers, called rofecoxib (Vioxx) and valdecoxib (Bextra), were withdrawn from the market in 2004 and 2005. That’s because these drugs were found to increase the risk of heart attack or stroke.

  • And the FDA considered the risks of these drugs to outweigh their benefits.
  • Vioxx, Bextra, and Celebrex all belong to a class of drugs called COX-2 inhibitors.
  • A class of drugs is a group of medications that act in a similar way.) COX-2 inhibitors are a type of NSAID.
  • So after Vioxx and Bextra were withdrawn from the market, a large clinical study was carried out to check the safety of Celebrex.

Researchers found that the risks of heart attack and stroke with Celebrex were much lower than with Vioxx or Bextra. The study also found that the risks were lower with Celebrex than with high doses of naproxen or ibuprofen. (Naproxen and ibuprofen are widely used and commonly prescribed NSAIDs, but they aren’t COX-2 inhibitors.) Over a 30-month period, 2.3% of people who took Celebrex had a heart attack or stroke.

Can you drink alcohol with Celebrex?

8. Cough Syrup – Such as Robitussin Cough, Robitussin A-C Potential reactions with alcohol: Drowsiness or dizziness. Remember that certain cough medicines contain up to 10 percent alcohol, according to the NIAAA, so imbibing, in addition, could greatly increase those side effects.

“Patients who combine the two should never drive or operate heavy machinery afterward,” says Tiemeier. What’s more, if you’re taking a prescription cough syrup with codeine, it could result in double the trouble because the codeine (a narcotic) and the alcohol have many of the same effects on the brain.

Some related articles:

Why was Celebrex taken off the market?

A U.S. Food and Drug Administration (FDA) advisory panel concluded that prescription pain medication celecoxib ( Celebrex), marketed by Pfizer, is as safe as other common nonsteroidal anti-inflammatory drugs (NSAIDs) when it comes to cardiovascular (CV) risks.

The panel recommended updating the medicine’s safety labeling to reflect that. Celecoxib is a selective COX-2 inhibitor, which means it blocks production of an enzyme associated with inflammation. “Nonselective” NSAIDs, such as naproxen and ibuprofen, block both COX-1 and COX-2; by blocking COX-1, they give rise to gastrointestinal (GI) side effects.

Celecoxib is often prescribed to patients with osteoarthritis (OA) or an inflammatory type of arthritis, such as rheumatoid arthritis (RA), especially those who are at higher risk of GI side effects. But its cardiovascular safety profile has been under a cloud of suspicion for more than a decade, after two other COX-2 inhibitors were pulled from the U.S.

  1. Market. Rofecoxib ( Vioxx ) was removed in 2004 and valdecoxib ( Bextra) in 2005 over concerns they raised the risk of cardiovascular events, such as heart attack and stroke, to unacceptable levels.
  2. All NSAIDs increase the risk of cardiovascular side effects ; risks rise with the dose and length of time used.) Celecoxib was allowed to remain on the market; however, the wording on the label was strengthened to say it had increased risk of heart attacks and strokes.

The FDA ordered Pfizer to conduct a post-market study of its safety. That study, called PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen), compared cardiovascular outcomes of prescription doses of celecoxib, naproxen and ibuprofen in more than 24,000 patients with both arthritis and established cardiovascular disease or risk factors.

  • It found rates of cardiovascular side effects were lowest with celecoxib (2.3 percent) compared to naproxen (2.5 percent) or ibuprofen (2.7 percent).
  • Critics of PRECISION say there were numerous problems with the study, including the facts that more than half of the participants had stopped taking their assigned drug by the end of the study, the allowed doses of the medications were not truly equivalent, and the use of low-dose aspirin, which could throw off the results, was not considered.) After reviewing results of the study, the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in a joint meeting in late April, by a vote of 15 to 5 (with one abstention), in favor of updating the safety labeling on Celebrex to reflect this data.

An FDA spokesperson says the matter is pending before the agency, adding that the committee “provided FDA with important perspectives on the topics discussed. FDA cannot speculate about any outcomes from the advisory committee meeting, including the timing of any possible changes.” The FDA doesn’t have to follow the recommendations of its advisory committees, but it generally does.

  1. A spokesperson for Pfizer, Inc., which had applied for the update, welcomed the vote.
  2. The PRECISION study helped dispel misperceptions about the cardiovascular risk associated with long-term use of Celebrex,
  3. In fact, the totality of evidence supports the use of Celebrex to manage pain and inflammation in people with osteoarthritis or rheumatoid arthritis who also have or are at high risk for cardiovascular disease,” said Milton Pressler, MD, vice president and head of clinical affairs for Pfizer.

But Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, in Fargo, cautions that the dosages in the study may be lower than those that some patients take. The PRECISION trial compared 100 to 200 mg twice a day of celecoxib, 600 to 800 mg three times a day of ibuprofen, and 375 to 500 mg twice a day of naproxen.

The cardiovascular risk with all NSAIDs is dose-related,” says Miller. “The big issue with the PRECISION study is they only allowed a dose of 200 mg of Celebrex, but it can also be used as a 400 mg dose,” If you have concerns, discuss your dosage with your doctor, Miller says. The findings probably will not change how celecoxib is prescribed, he adds, in part because the PRECISION study results were published a year and a half ago.

“From a labeling point of view, this is probably important for Pfizer because it makes the medication less scary,” Miller says. “But rheumatologists are already familiar with this data because the findings of this study were published 18 months ago. So, this decision probably won’t have much effect on practice.” Author: Jennifer Davis for the Arthritis Foundation

What is stronger than 800 mg ibuprofen?

What is ibuprofen? – Ibuprofen is the generic name for Advil or Motrin, It is a widely used and prescribed NSAID that is also available over the counter. The usual dosage is 200mg to 400mg (1 to 2 tablets or capsules) every 4 to 6 hours, with a maximum of 1200mg (6 tablets or capsule) in 24 hours, unless your doctor has told you otherwise.

Is Celebrex the best anti-inflammatory?

The bottom line Many studies have shown meloxicam and Celebrex to be as effective as other NSAIDs for pain and inflammation. But some studies show Celebrex might work better than other NSAIDs in some cases. Tell your healthcare provider about other medications you’re taking and other health conditions you have.

Why is celecoxib better than ibuprofen?

Celecoxib has fewer gastrointestinal adverse effects than the non-selective NSAIDs – Celecoxib is recommended for patients at increased risk of gastrointestinal bleeding who require a NSAID.14 This is because celecoxib is associated with a lower risk of gastrointestinal bleeding than the non-selective NSAIDs.14 However, as some COX-1 inhibition is present, the use of celecoxib in patients with an elevated risk of gastrointestinal bleeding is not entirely without risk.

Age over 65 years A history of gastrointestinal bleeding Previous adverse reactions to NSAIDs The use of other medicines that increase the risk of bleeding, e.g. aspirin, warfarin, dabigatran, selective serotonin reuptake inhibitors and corticosteroids Liver disease Chronic kidney disease Excess alcohol consumption

Patients should be advised to seek immediate medical attention if they vomit blood, pass dark stools or experience symptoms of anaemia. Patients with a high risk of gastrointestinal bleeding should be reviewed within the first month of treatment, including measurement of haemoglobin levels.5

What is the strongest ibuprofen tablet?

How to take tablets, capsules, granules and liquid – Swallow ibuprofen tablets or capsules whole with a drink of water, milk or juice. Do not chew, break, crush or suck them as this could irritate your mouth or throat. For people who find it difficult to swallow tablets or capsules, ibuprofen is available as a tablet that melts in your mouth, granules that you mix with a glass of water to make a drink, and as a liquid.

  1. If you’re taking the tablet that melts in your mouth, put it on your tongue, let it dissolve and then swallow.
  2. You do not need to drink any water.
  3. Take ibuprofen granules by emptying the contents of the sachet into a glass full of water to make an orange flavoured fizzy drink, stir and drink straight away.

If you’re taking liquid, it will come with a plastic syringe or spoon to measure your dose. If you do not have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen spoon, as it will not measure the right amount. Take ibuprofen tablets, capsules, granules or liquid with a meal or snack, or with a drink of milk.