Drugs & Vitamins

Vioxx Active Ingredients: Rofecoxib   Representative Names: Vioxx, Withdrawn from the market Available Product Images: What are rofecoxib tablets? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with rofecoxib? What side effects may I notice from taking rofecoxib? What should I watch for while taking rofecoxib? Where can I keep my medicine? What are rofecoxib tablets? (Back to top) ROFECOXIB (Vioxx®) is a drug used to reduce inflammation and ease mild to moderate pain for such conditions as arthritis, painful menstrual cycles, or pain after dental or surgical procedures. Generic rofecoxib tablets are not available. NOTE: This drug is discontinued in the United States. Patients currently taking Rofecoxib should contact their prescriber regarding discontinuation and alternative therapies. If you have unused tablets, you may return the product to NNC Group, Merck Returns, 2670 Executive Drive, Indianapolis, IN 46241 for a refund. Send any unused product in its original pharmacy packaging, the pharmacy receipt for the product you are returning, and your name, address, and phone number by regular, first-class U.S. mail. You will receive a full refund of the price paid, as reflected on your pharmacy receipt. You will also receive a refund of the cost of shipping via regular U.S. mail. If you have questions about the discontinuation of Rofecoxib or about the refund, you may call 1—800—805—9542 or 1—888—368—4699. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •anemia •asthma •cigarette smoker •coronary artery bypass graft (CABG) surgery within the past 2 weeks •dehydrated •drink more than 3 alcohol-containing beverages a day •heart or circulation problems such as heart failure, angina, blocked artery in heart, or leg edema •high blood pressure •history of a heart attack •kidney disease •liver disease •nasal polyps •stomach bleeding or ulcers •taking blood thinners •taking hormones such as prednisone (steroids) •pregnant or trying to get pregnant •an unusual or allergic reaction to aspirin, other salicylates, rofecoxib, other NSAIDs, foods, dyes or preservatives •breast-feeding How should I take this medicine? (Back to top) Take rofecoxib 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 laying down. If rofecoxib 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? (Back to top) 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 rofecoxib? (Back to top) •alcohol •alendronate •aspirin and aspirin-like medicines •cidofovir •cyclosporine •drospirenone; ethinyl estradiol (Yasmin®) •entecavir •herbal products that contain feverfew, garlic, ginger, or ginkgo biloba •lithium •medicines for high blood pressure •methotrexate •other antiinflammatory drugs (such as ibuprofen or prednisone) •pemetrexed •probenecid •theophylline •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 side effects may I notice from taking rofecoxib? (Back to top) Patients should seek immediate emergency help in the case of a serious allergic reaction. Side effects that you should report to your prescriber or health care professional as soon as possible: •black, tarry stools •blurred vision •decrease in the amount of urine passed •difficulty breathing •fainting or passing out •fast heartbeat •fatigue, weakness, or sleepiness •skin rash, hives, redness, blistering, peeling or itching •stomach tenderness, pain, bleeding, or cramps •swelling of eyelids, throat, lips, legs, ankles, or feet •unexplained weight gain or edema •unusual headache with stiff neck •severe nausea or vomiting •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): •constipation or diarrhea •difficulty swallowing •dizziness •gas or heartburn •minor upset stomach •nausea or vomiting What should I watch for while taking rofecoxib? (Back to top) 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 rofecoxib 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 rofecoxib. 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 rofecoxib. Side effects including stomach upset, heartburn, nausea, vomiting or serious side effects such as ulcers are more likely if rofecoxib is given with other NSAIDs. Many non-prescription products contain NSAIDs; closely read labels before taking any medicines with rofecoxib. Rofecoxib 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 rofecoxib during the last 3 months of pregnancy unless specifically directed to do so by your health care provider. Rofecoxib may cause problems in the unborn child or complications during delivery. Where can I keep my medicine? (Back to top) 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. Last Updated:09/06/2006 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.