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Bextra ( valdecoxib )

Bextra is a powerful medication that targets an important source of arthritis pain. It's tough on pain and inflammation. And there's one convenient dose that's powerful enough to tackle both the pain of osteoarthritis and adult rheumatoid arthritis. BEXTRA also delivers relief to the pain associated with moderate to severe menstrual pain (primary dysmenorrhea).

Bextra ( valdecoxib tablets )

(Nonsteroidal Anti-inflammatory Drug - NSAID)

Common uses
Bextra is a nonsteroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor used to relieve the symptoms of arthritis (osteoarthritis, rheumatoid), and menstrual discomfort. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

Before using
Some medicines or medical conditions may interact with Bextra. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking an azole antifungals (e.g., fluconazole, itraconazole, ketoconazole), blood thinners (e.g., warfarin), ACE inhibitors (e.g., captopril, lisinopril), water pills (e.g., furosemide, hydrochlorothiazide), dextromethorphan, or lithium. USE OF Bextra IS NOT RECOMMENDED if you have a history of kidney disease, or severe liver disease. Inform your doctor of any other medical conditions including asthma, nasal polyps, stomach problems (e.g., bleeding, ulcers), liver problems, blood disorders (e.g., anemia), heart disease, high blood pressure, tobacco or alcohol use, swelling problems (fluid retention), dehydration, poorly controlled diabetes, any allergies - especially aspirin/NSAID allergy (e.g., ibuprofen, celecoxib), or sulfa allergy, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking Bextra.

Directions
Follow the directions for using Bextra provided by your doctor. Bextra may be taken on an empty stomach or with food. STORE Bextra at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container, away from heat, moisture, and light. IF YOU MISS A DOSE OF Bextra and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. DO NOT take 2 doses at once.

Cautions
DO NOT TAKE Bextra IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to aspirin or any medicine containing aspirin or to a nonsteroidal anti-inflammatory drug (such as Feldene, Motrin, Naprosyn, Clinoril), or sulfa medicines (e.g., sulfonamide antibiotics). A severe reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to Bextra or if a certain medicine is a nonsteroidal anti-inflammatory drug, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of Bextra unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take Bextra for longer than prescribed without checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using Bextra. ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Bextra or other pain relievers/fever reducers. Bextra may cause stomach bleeding. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes any medicines that contain aspirin, ibuprofen, naproxen, or ketoprofen. Aspirin as prescribed by your doctor for reasons such as heart attack or stroke prevention (i.e., non-arthritis doses) should be continued. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using Bextra during pregnancy. Bextra SHOULD NOT BE USED during the third trimester. IT IS UNKNOWN IF Bextra IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking Bextra.

Possible side effects
SIDE EFFECTS that may occur while taking Bextra include stomach upset, nausea, diarrhea, or headache. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience swelling, unusual tiredness and weakness, or weight gain. CONTACT YOUR DOCTOR IMMEDIATELY if you experience swelling of hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness; flu-like symptoms; sluggishness; yellowing of the skin or eyes; dark urine or pale stools; or unusual fatigue, change in amount of urine, dizziness, or blurred vision. CONTACT YOUR DOCTOR IMMEDIATELY AND STOP TAKING Bextra if you notice any of the following unlikely but very serious side effects: black stools, persistent stomach/abdominal pain, or vomit that looks like coffee grounds. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions

If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include drowsiness, vomiting, or stomach pain.

Additional information
DO NOT SHARE Bextra with others for whom it was not prescribed. DO NOT USE Bextra for other health conditions. KEEP THIS PRODUCT out of the reach of children. IF USING Bextra FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

Bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Bextra works by reducing substances in the body that cause inflammation, pain, and fever.

Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation.

Bextra may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Bextra?

Do not take Bextra without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Bextra.
Bextra should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of Bextra in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking Bextra if you are being treated for pain associated with CABG.
Before taking Bextra, tell your doctor if you
· smoke;
· drink alcohol;
· have an ulcer or bleeding in the stomach;
· have liver disease;
· have kidney disease;
· have asthma;
· have congestive heart failure;
· have fluid retention;
· have heart disease;
· have high blood pressure;
· have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or
· are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.
You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.
Bextra is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Bextra should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Bextra without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether Bextra passes into breast milk. Do not take Bextra without first talking to your doctor if you are breast-feeding a baby.
If you are over the age of 65 years, you may be more likely to experience side effects from Bextra. You may require a lower dosage or special monitoring during your therapy.


How should I take Bextra?

Take Bextra exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Bextra can be taken with or without food or milk. Follow your doctor's instructions.
Store Bextra at room temperature away from moisture and heat.


What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.


What happens if I overdose?

Seek emergency medical attention.
Symptoms of a Bextra overdose include drowsiness, nausea, vomiting, and stomach pain.


What should I avoid while taking Bextra?

There are no restrictions on food, beverages, or activity while taking Bextra unless otherwise directed by your doctor.


What are the possible side effects of Bextra?

Serious skin reactions have occurred in patients taking Bextra. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking Bextra and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.
Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.
Other, less serious side effects may be more likely to occur. Continue to take Bextra and talk to your doctor if you experience
· diarrhea;
· nausea or upset stomach; or
· headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Bextra?

Before taking Bextra, tell your doctor if you are taking any of the following drugs:
· aspirin or another salicylate (form of aspirin) such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others);
· an over-the-counter cough, cold, allergy, or pain medicine that contains dextromethorphan, aspirin, ibuprofen, naproxen, or ketoprofen;
· a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone), and others;
· an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others;
· a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others;
· an anticoagulant (blood thinner) such as warfarin (Coumadin);
· diazepam (Valium);
· phenytoin (Dilantin);
· glyburide (DiaBeta, others);
· an oral contraceptive (Micronor, Triphasil, Levlen, others);
· omeprazole (Prilosec, Zegerid);
· lithium (Eskalith, Lithobid, others); or
· fluconazole (Diflucan) or ketoconazole (Nizoral).
You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with Bextra. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.


Where can I get more information?

Your pharmacist has additional information about Bextra written for health professionals that you may read.

 



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