Vioxx (Rofecoxib) Overdose information: News Wise: "No overdoses of VIOXX were reported during clinical trials. Administration of single doses of VIOXX 1000 mg to 6 healthy volunteers and multiple doses of 250 mg/day for 14 days to 75 healthy volunteers did not result in serious toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. Rofecoxib is not removed by hemodialysis; it is not known whether rofecoxib is removed by peritoneal dialysis."
http://www.newswise.com/articles/1999/5/VIOXX-14.MCK.html

******************************************************

Physician prescribing information for Vioxx (Rofecoxib): Merck: "Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been demonstrated that upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk."
http://www.merck.com/product/usa/vioxx/hcp/prescribing_info/full_pi/full_pi.html

******************************************************

General Precautions while taking Vioxx (Rofecoxib): FDA Consumer Information: "Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you: retain fluids have high blood pressure have heart failure If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive patients.The safety and effectiveness of Vioxx in patients below the age of 18 years has not been determined."
http://www.fda.gov/cder/consumerinfo/druginfo/vioxx.htm

******************************************************

Drugs that are contraindicated while taking Vioxx, (Rofecoxib): Chemist: "Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.Some medicines and Vioxx may interfere with each other. These include:warfarin, a medicine used to prevent blood clots rifampicin, an antibiotic used to treat tuberculosis and other infections methotrexate, a medicine used to treat arthritis and some types of cancer ACE inhibitor medicines used to lower high blood pressure or treat heart failureThese medicines may be affected by Vioxx or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Vioxx. Vioxx can be taken with low dose aspirin (less than or equal to 325mg daily).Vioxx is not a substitute for aspirin for prevention of heart attack or stroke."
http://www.chemist.co.nz/pm/Vioxx.cfm

******************************************************

Vioxx (Rofecoxib) What is being said about this drug and it's effectiveness?: Global Change: " Vioxx is much safer with ulceration rate similar to what you would expect in an untreated population.The results were even more striking after 24 weeks: Brufen ulcer rates rising to 46% compared to 10% and 15% for those taking 25mg or 50mg Vioxx. With results as spectacular as this some would argue that it becomes unethical to continue comparison studies, because of the risk of harm to those on placebo who need relief and the needless risk to health of those denied Vioxx. Vioxx seems to work as well as naproxen for menstrual pain, according to a new study comparing 550mg naproxen to 50mg Vioxx every 12 hours. The double-blind controlled trial included 127 women for over four months.Health service chiefs and insurance companies are worried about budgets being wiped - Vioxx and Celebrex are far more expensive - but perhaps not when you add in treatment of side effects and of course lives saved"
http://www.globalchange.com/vioxx.htm

******************************************************

What is Vioxx (Rofecoxib) and why is it prescribed?: Health Square: "Vioxx is a new kind of painkiller used in the treatment of osteoarthritis, painful menstruation (dysmenorrhea), and other types of acute pain. It is part of a class of nonsteroidal anti-inflammatory drugs (NSAIDs) called "COX-2 inhibitors." Currently, the only other drug in this class is the new arthritis medication called Celebrex. Like older NSAIDs such as aspirin, Motrin, and Naprosyn, Vioxx and Celebrex are believed to fight pain and inflammation by inhibiting the effect of a natural enzyme called COX-2. Unlike the older medications, however, these newer drugs do not interfere with a similar substance, called COX-1, which exerts a protective effect on the lining of the stomach. Vioxx and Celebrex are therefore less likely to cause the bleeding and ulcers that sometimes accompany sustained use of the older NSAIDs. Although COX-2 inhibitors offer many of the same benefits as aspirin, they do not share its blood-thinning effects. If you're taking low-dose aspirin to reduce the risk of a heart attack, you'll need to continue taking it in addition to Vioxx."
"http://www.healthsquare.com/newrx/VIO1533.HTM"

******************************************************

Absorptions rate of Vioxx (Rofecoxib): Health and Age: "The mean oral bioavailability of Vioxx at therapeutically recommended doses of 12.5, 25, and 50 mg is approximately 93%. The area under the curve (AUC) and peak plasma level (C max ) following a single 25-mg dose were 3286 (±843) ng·hr/mL and 207 (±111) ng/mL, respectively. Both C max and AUC are roughly dose proportional across the clinical dose range. At doses greater than 50 mg, there is a less than proportional increase in C max and AUC, which is thought to be due to the low solubility of the drug in aqueous media. The plasma concentration-time profile exhibited multiple peaks. The median time to maximal concentration (T max ), as assessed in nine pharmacokinetic studies, is 2 to 3 hours. Individual T max values in these studies ranged between 2 to 9 hours. This may not reflect rate of absorption as T max may occur as a secondary peak in some individuals. With multiple dosing, steady-state conditions are reached by Day 4. The AUC 0-24hr and C max at steady state after multiple doses of 25 mg rofecoxib was 4018 (±1140) ng·hr/mL and 321 (±104) ng/mL, respectively. The accumulation factor based on geometric means was 1.67. Vioxx Tablets 12.5 mg and 25 mg are bioequivalent to VIOXX Oral Suspension 12.5 mg/5 mL and 25 mg/5 mL, respectively."
http://www.healthandage.com/html/res/com/ConsDrugs/Tolmetincd.html

******************************************************

Patient information for the use of Vioxx (Rofecoxib): Rx List: "VIOXX can cause discomfort and rarely, more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be apprised of the importance of this follow- up (see WARNINGS, Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation).Patients should promptly report signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, unexplained weight gain, or edema to their physicians. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e. g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu- like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should also be instructed to seek immediate emergency help in the case of an anaphylactoid reaction (see WARNINGS). In late pregnancy VIOXX should be avoided because it may cause premature closure of the ductus arteriosus."
http://www.rxlist.com/cgi/generic/rofecox_pi.htm