March 21, 2017

Valdecoxib tablets

What are valdecoxib tablets?

VALDECOXIB (Bextra®) is a drug used to reduce inflammation and ease mild to moderate pain for such conditions as arthritis or painful menstrual cycles. Generic valdecoxib tablets are not available.

NOTE: This drug is discontinued in the United States. Patients taking Valdecoxib should contact their prescriber regarding discontinuation and alternative therapies. If you have questions about Bextra®, you may call 1—866—6—BEXTRA or 1—866—623—9872.

What should my health care professional know before I take valdecoxib?

They need to know if you have any of these conditions:

  • anemia

  • asthma, especially aspirin sensitive asthma

  • cigarette smoker

  • dehydrated

  • drink more than 3 alcohol-containing beverages a day

  • heart or circulation problems such as heart failure or leg edema (fluid retention)

  • high blood pressure

  • kidney disease

  • liver disease

  • recent surgery, especially coronary artery bypass graft surgery (CABG)

  • stomach bleeding or ulcers

  • taking blood thinners

  • taking hormones such as prednisone (steroids)

  • an unusual or allergic reaction to valdecoxib, aspirin, other salicylates, other NSAIDs, sulfonamides, other drugs, foods, dyes or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I take this medicine?

Take valdecoxib tablets by mouth. Follow the directions on the prescription label. Swallow tablets whole with a full glass of water; take tablets in an upright or sitting position. Taking a sip of water first, before taking the tablets, may help you swallow them. If possible, take bedtime doses at least 10 minutes before lying down. If valdecoxib upsets your stomach, take it with food or milk. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with valdecoxib?

  • alcohol

  • alendronate

  • cyclosporine

  • cidofovir

  • drospirenone; ethinyl estradiol (Yasmin®)

  • entecavir

  • fluconazole

  • herbal products that contain feverfew, garlic, ginger, or ginkgo biloba

  • ketoconazole (products taken by mouth only)

  • lithium

  • medicines for high blood pressure

  • methotrexate

  • other antiinflammatory drugs (such as ibuprofen or prednisone)

  • pemetrexed

  • warfarin

  • water pills (diuretics)

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking valdecoxib?

Let your prescriber or health care professional know if your pain continues; do not take with other pain-killers without advice. If you get flu-like symptoms (fever, chills, muscle aches and pains), call your prescriber or health care professional; do not treat yourself.

To reduce unpleasant effects on your stomach, take valdecoxib with a full glass of water. Do not smoke cigarettes or drink alcohol; these increase irritation to your stomach and can make it more susceptible to damage from valdecoxib. If you notice black, tarry stools or experience severe stomach pain and/or vomit blood or what looks like coffee grounds, notify your health care prescriber immediately.

Avoid taking other prescription or over-the-counter non steroidal anti-inflammatory drugs (NSIADs), such as ibuprofen (Advil®), naprosyn (Aleve®), or ketoprofen (Orudis® KT), while taking valdecoxib. Side effects including stomach upset, heartburn, nausea, vomiting or serious side effects such as ulcers are more likely if valdecoxib is given with other NSAIDs. Many non-prescription products contain NSAIDs; closely read labels before taking any medicines with valdecoxib.

Valdexocib cannot take the place of aspirin for the prevention of heartattack or stroke. If you are currently taking aspirin for this purpose, you should not discontinue taking aspirin without checking with your prescriber or health care professional.

It is especially important not to use valdecoxib during the last 3 months of pregnancy unless specifically directed to do so by your health care provider. Valdecoxib may cause problems in the unborn child or complications during delivery.

What side effects may I notice from taking valdecoxib?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • chest pain or pressure

  • signs of bleeding from the stomach - black tarry stools, blood in the urine, unusual tiredness or weakness, vomiting blood or vomit that looks like coffee grounds

  • signs of an allergic reaction - difficulty breathing, pain while breathing, or wheezing, skin rash, redness, mouth sores, blistering or peeling skin, hives, or itching, swelling of eyelids, throat, lips

  • decrease in the amount of urine passed

  • difficulty swallowing, severe heartburn or burning, pain in throat

  • inability or problems seeing, speaking, or standing

  • pain or swelling in an arm or leg

  • stomach tenderness, pain, bleeding, or cramps

  • swelling of feet or ankles

  • unexplained weight gain or edema

  • yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • diarrhea

  • dizziness

  • gas

  • headache

  • heartburn

  • minor upset stomach

  • nausea or vomiting

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature below 15—30 degrees C (59—86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.


March 21, 2017


U.S. FDA-approved Package Insert