rofecoxib
Vioxx
Pregnancy Risk Category C
How supplied
Tablets: 12.5 mg, 25 mg
Oral suspension: 12.5 mg/5 ml, 25 mg/5 ml
Action
Unknown. Produces anti-inflammatory, analgesic, and antipyretic effects, possibly by inhibiting prostaglandin synthesis.
Indications & dosage
Relief of signs and symptoms of osteoarthritis--
Adults: initially, 12.5 mg P.O. once daily, increased, p.r.n., to maximum of 25 mg P.O. once daily.
Management of acute pain, treatment of primary dysmenorrhea--
Adults: 50 mg P.O. once daily, p.r.n., for up to 5 days.
Adverse reactions
CNS: headache, asthenia, fatigue, dizziness.
CV: hypertension, lower-extremity edema.
EENT: sinusitis.
GI: diarrhea, dyspepsia, epigastric discomfort, heartburn, nausea, abdominal pain.
GU: urinary tract infection.
Musculoskeletal: back pain.
Respiratory: bronchitis, upper respiratory tract infection.
Other: flulike syndrome.
Interactions
Drug-drug. ACE inhibitors: decreased antihypertensive effects of ACE inhibitors. Monitor patient closely.
Aspirin: increased rate of GI ulceration and other complications. Don't use together, if possible. If used together, monitor patient closely for GI bleeding.
Furosemide, thiazide diuretics: potentially reduced efficacy of these drugs. Monitor patient closely.
Lithium: increased plasma lithium levels and decreased lithium clearance. Monitor patient closely for toxic reaction to lithium.
Methotrexate: increased plasma methotrexate levels. Monitor patient closely for toxic reaction to methotrexate.
Rifampin: decreased rofecoxib levels by about 50%. Initiate therapy with a higher dosage of rofecoxib.
Warfarin: increased effects of warfarin. Monitor INR more frequently in the first few days after therapy is initiated or dosage is changed.
Drug-lifestyle. Long-term alcohol use, smoking: increased risk of GI bleeding. Monitor patient closely for such bleeding.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with hypersensitivity to drug or its components and in those who have experienced asthma, urticaria, or allergy-type reactions after taking aspirin or other NSAIDs. Also contraindicated in patients with advanced kidney disease or moderate or severe hepatic insufficiency and in pregnant women because drug may cause ductus arteriosus to close prematurely.
Nursing considerations
- Alert:
NSAIDs may cause serious GI toxicity. Signs and symptoms include bleeding, ulceration, and perforation of the stomach, small intestine, and large intestine. Such toxicity can occur any time, with or without warning. To minimize risk of an adverse GI event, use lowest effective dosage for the shortest possible duration. Monitor patient closely for GI bleeding.
- Use cautiously in patients with history of ulcer disease or GI bleeding and in those taking such drugs as oral corticosteroids and anticoagulants. Also use cautiously in patients with conditions, such as older age, alcoholism, poor general health status, and addiction to smoking, that may increase risk of GI bleeding.
- Use cautiously in patients who are considerably dehydrated. Rehydration is recommended before therapy begins.
- In patients with fluid retention, hypertension, or heart failure, use cautiously and initiate therapy at the lowest recommended dosage. Monitor blood pressure and check patient for fluid retention or worsening heart failure.
- In patients over age 65, initiate therapy at the lowest recommended dosage.
- Patient may be allergic to drug if he has an allergy to aspirin or other NSAIDs.
- Drug may be hepatotoxic. Monitor patient for signs and symptoms of liver toxicity. Drug should be discontinued, as ordered, if signs and symptoms consistent with liver disease develop.
- Oral suspension should be shaken well before it's administered.
- Patients undergoing long-term treatment should have their hemoglobin level and hematocrit checked if they experience signs or symptoms of anemia or blood loss.
Patient teaching
- Warn patient that he may experience signs and symptoms of GI bleeding, including bloody vomitus, blood in urine and stool, and black, tarry stools. Advise patient to call doctor if he experiences these signs or symptoms.
- Advise patient to report rash, unexplained weight gain, or edema.
- Tell patient to avoid aspirin and aspirin-containing products unless doctor has instructed him otherwise.
- Inform patient to avoid OTC anti-inflammatories such as ibuprofen (Advil) unless doctor has instructed him otherwise.
- Tell patient that all NSAIDs, including rofecoxib, may adversely affect the liver. Signs and symptoms of liver toxicity include nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, and flulike syndrome. Advise him to stop therapy and call doctor immediately if he experiences these signs or symptoms.
- Instruct woman to inform doctor if she becomes pregnant or is planning to become pregnant while taking drug.
- Tell patient that drug may be taken without regard to food, although taking it with food may decrease GI upset.
- Tell patient that the most common adverse effects of drug are dyspepsia, epigastric discomfort, heartburn, and nausea. Tell him that taking drug with food may help minimize these effects.
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING