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Celebrex 100mg Capsules
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Product ID: **CELEBREX100
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Product Summary

PRESCRIPTION REQUIRED


IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CELECOXIB - ORAL

(sell-eh-COX-ib)

COMMON BRAND NAME(S): Celebrex

WARNING: Rarely, this medication can cause serious (very rarely fatal) stomach/intestinal bleeding. Also, this medication and related drugs have rarely caused blood clots to form, resulting in possibly fatal heart attacks and strokes. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). If you notice any of these rare but very serious side effects, stop taking celecoxib and seek immediate medical attention: coffee-ground vomit, black stools, persistent stomach/abdominal pain, chest pain, weakness on one side of the body, slurred speech, sudden vision changes.

USES: This medication is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, which relieves pain and swelling (inflammation). It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by this medication helps you perform more of your normal daily activities. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using celecoxib and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take by mouth, usually once or twice daily, or as directed by your doctor. To decrease the chance of stomach upset, this drug is best taken with food. Dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used, and only for the prescribed length of time (see also Warning section). Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication. In certain conditions (e.g., arthritis), it may take up to two weeks, taken regularly, before significant benefits of this drug take effect. If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well.

SIDE EFFECTS: See also Warning section. Stomach upset or gas may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, unexplained weight gain, swelling of the hands or feet, pain/swelling/warmth in the groin/calf, change in amount of urine, difficult/painful swallowing, unusual tiredness. This drug may rarely cause serious liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking celecoxib and consult your doctor or pharmacist immediately: yellowing eyes or skin, dark urine, persistent stomach/abdominal pain. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG). Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood flow problem in the brain (e.g., stroke, cerebrovascular disease), kidney problems, liver problems, heart disease (e.g., angina, heart attack, congestive heart failure), high blood pressure, alcohol use, swelling (e.g., edema), blood disorders (e.g., anemia), serious infections, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), bleeding/clotting problems, asthma, growths in the nose (nasal polyps), dehydration, poorly controlled diabetes. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of this medication, especially stomach bleeding and kidney effects. Caution is advised when using this drug in children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Seek immediate medical attention if your child develops sudden bleeding/bruising or bluish skin in the fingers/toes. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medication because very serious interactions may occur: cidofovir. If you are currently using the medication listed above, tell your doctor or pharmacist before starting celecoxib. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: aliskiren, ACE Inhibitors (such as lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (e.g., prednisone), desmopressin, fluconazole, lithium, pemetrexed. This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as naproxen or ibuprofen). These drugs are similar to celecoxib and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, change in amount of urine, slow or shallow breathing, severe headache or loss of consciousness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.

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