Bextra

Generic Name: valdecoxib (Oral route)

val-de-KOX-ib

Oral route(Tablet)

Serious skin reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving valdecoxib, some resulting in death. Patients appear to be at higher risk for these events during the first 2 weeks of treatment, but these may occur at any time. Valdecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity .

Commonly used brand name(s)

In the U.S.

• Bextra

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: Cyclooxygenase-2 Inhibitor

Uses For Bextra

Valdecoxib is a non-steroidal anti-inflammatory drug. Nonsteroidal anti-inflammatory drugs (also called NSAIDs) are used to relieve some symptoms caused by arthritis (rheumatism), 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. It may also be used to treat pain associated with menstrual periods.

This medicine was available only with your doctor's prescription.

Valdecoxib was voluntarily withdrawn from the U.S. market on April 7, 2005 due to safety concerns of increased risk of serious heart problems and skin reactions .

Before Using Bextra

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of valdecoxib in children with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desvenlafaxine


• Duloxetine


• Ethinyl Estradiol


• Fluconazole


• Ketoconazole


• Lithium


• Milnacipran


• Norethindrone


• Venlafaxine


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of ) or


• Bleeding problems or


• Poor general health or


• Stomach ulcer or other stomach or intestinal problems or


• Tobacco use (or recent history of)—The chance of side effects may be increased.

• Allergy to aspirin or other nonsteroidal anti-inflammatory medicines or


• Asthma with inflammation in the nose (with or without polyps) or with spasm in the breathing tubes caused by aspirin or other non-steroidal anti-inflammatory medicines or


• Skin rash after taking aspirin or NSAIDs—Using valdecoxib with these medicines may cause these problems to become much worse.

• Allergy to sulfonamides (sulfamethoxazole and trimethoprim [e.g., Bactrim, Cotrim], sulfisoxazole [e.g., Gantrisin])—May be at greater risk of serious skin reactions.

• Anemia or


• Dehydration or


• Fluid retention (swelling of feet or lower legs) or


• Heart disease or


• High blood pressure or


• Kidney disease or


• Liver disease—Valdecoxib may make these conditions worse.

• Pain after coronary artery bypass graft (CABG) surgery—Higher risk of serious heart complications and infection in these patients. Valdecoxib should not be used.

Proper Use of Bextra

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.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The following section is for information only, since the drug is no longer available.

• Oral dosage form (tablets):
  
  • For dysmenorrhea (pain with your menstrual period)
  
  
  • For osteoarthritis
  
  
  • For rheumatoid arthritis
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Bextra

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, sticky stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Serious skin reactions can occur during treatment with valdecoxib. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness.

Check with your doctor immediately if fever, drowsiness, itching of the skin, tiredness, nausea, or stomach pain occurs; these effects may be the first signs of liver toxicity.

Valdecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin, other nonsteroidal anti-inflammatory drugs, or sulfonamide-type drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

Bextra Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bloating or swelling of face, arms, hands, lower legs, feet


• blood in urine


• bloody, black, or sticky stools


• blurred vision


• chills


• decreased or painful urination


• dizziness


• fever


• muscle aches and pains


• nausea


• nervousness


• pale skin


• pounding in the ears


• rapid weight gain


• severe stomach pain


• tingling of the hands or feet


• trouble breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• yellow eyes or skin

Incidence not known

• Blistering, peeling, loosening of skin


• constipation


• cracks in the skin


• darkened urine


• difficulty swallowing


• fast heartbeat


• hives


• indigestion


• itching


• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue


• joint or muscle pain


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs


• loss of appetite


• loss of heat from the body


• nausea


• pains in stomach, side, or abdomen, possibly radiating to the back


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• shortness of breath


• skin rash


• sores, ulcers, or white spots in mouth or on lips


• tightness in chest


• vomiting


• wheezing


• yellow eyes or skin

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

• Bloody or black tarry stools


• continuing thirst


• dizziness


• drowsiness


• headache, severe or continuing


• nausea and/or vomiting


• shortness of breath


• stomach pain


• sudden decrease in the amount of urine


• swelling of face, fingers, and/or lower legs


• tightness in chest and/or wheezing


• troubled breathing


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• cough


• diarrhea


• ear congestion


• headache


• heartburn


• indigestion


• sore throat

Less common

• Abdominal fullness


• accidental injury


• back pain


• bloating in the abdomen


• excess gas


• rash


• stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Bextra side effects (in more detail)

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More Bextra resources

• Bextra Side Effects (in more detail)
• Bextra Dosage
• Bextra Use in Pregnancy & Breastfeeding
• Drug Images
• Bextra Drug Interactions
• Bextra Support Group
• 9 Reviews for Bextra - Add your own review/rating

• Bextra Prescribing Information (FDA)


• Bextra Consumer Overview

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