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(roe-feh-cox-ib)>
Vioxx
Tablets: 12.5 mg
Tablets: 25 mg
Tablets: 50 mg
Class: Analgesic
NSAID

 Actions Decreases inflammation, pain, and fever, probably by inhibition of prostaglandin, by way of inhibition of cyclooxygenase-2.

 Indications Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis; treatment of primary dysmenorrhea; management of acute pain in adults.

 Contraindications History of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs.

 Route/Dosage

Osteoarthritis: ADULTS: PO 12.5 to 25 mg once daily. Rheumatoid Arthritis: ADULTS: PO 25 mg once daily (max, 25 mg/day). Primary Dysmenorrhea and Management of Acute Pain: ADULTS: PO 50 mg once daily.

 Interactions

ACE inhibitors: Antihypertensive effects may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Lithium, methotrexate: Rofecoxib may increase plasma levels of these drugs, which may increase activity and adverse effects. Loop diuretics, thiazide diuretics: Diuretic effects may be decreased. Rifampin: May decrease rofecoxib plasma levels, which may cause a decrease in activity. Warfarin: The risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypertension; angina pectoris; irregular heartbeat; bradycardia; premature ventricular contraction; tachycardia; palpitations. CNS: Asthenia; fatigue; dizziness; headache; syncope; hypesthesia; insomnia; migraine; muscular spasm; parethesia; sciatica; somnolence; vertigo; anxiety; depression; decreased mental acuity. DERMATOLOGIC: Alopecia; atopic dermatitis; basal cell carcinoma; blister; cellulitis; contact dermatitis; nail disorder; perspiration; rash; pruritus; erythema; urticaria; xerosis. EENT: Sinusitis; dry mouth; esophagitis; blurred vision; cerumen impaction; conjunctivitis; dry throat; epistaxis; laryngitis; nasal congestion; nasal secretion; ophthalmic injection; otic pain; otitis; otitis media; pharyngitis; tinnitus; tonsillitis. GI: Abdominal pain, tenderness, and distension; GI bleeding; diarrhea; dyspepsia; epigastric discomfort; heartburn; duodenal ulcers; nausea; aphthous stomatitis; constipation; gas symptoms; dysgeusia; flatulence; gastritis; gastroenteritis; bloody stools; hemorrhoids; vomiting. GU: UTI; breast mass; cystitis; dysuria; menopausal symptoms; menstrual disorder; nocturia; urinary retention; vaginitis. METABOLIC: Hypercholesterolemia. RESPIRATORY: Upper respiratory tract infection; bronchitis; asthma; cough; dyspnea; pneumonia; pulmonary congestion. OTHER: Flu-like condition; pain; back pain; chest pain; pelvic pain; flushing; peripheral edema; upper extremity edema; allergy; muscle pain, cramp, stiffness, and weakness; myalgia.

 Precautions

Pregnancy: Category C. Avoid in late pregnancy because rofecoxib may cause premature closure of ductus arteriosus. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Initiate therapy with lowest recommended dose. Asthma: Use with caution in patients with pre-existing asthma. GI effects: Serious GI toxicity (eg, bleeding, ulceration, performation) can occur at any time, with or without warning symptoms. Renal disease: Use with caution. Liver disease: Not recommended in patients with moderate or severe hepatic insufficiency.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Store tablet and suspension at 25°C (77°F); excursions permitted to (59° to 86°F).
  • Shake suspension before use.
  • Administer orally using the lowest effective dose as prescribed for each patient.

 Assessment/Interventions

  • Assess for signs and symptoms of hypersensitivity.
  • Obtain a complete history of prescription and nonprescription drug use and any history of hypersensitivity.
  • Assess for possible drug interactions and potential adverse reactions.
  • Monitor for signs and symptoms of decreased renal function:
    serum creatinine, BUN, unexpected weight gain, edema.

 Patient/Family Education

  • Instruct patient to take the medication as prescribed.
  • Advise patient to inform primary care provider if taking or planning to take any OTC medications.
  • Stress the importance of promptly reporting signs or symptoms of GI ulceration or bleeding, skin rash, unexplained weight gain, or edema to primary caregiver.
  • Inform patients of the warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms) and to stop therapy and contact primary care provider should any of these occur.
  • Instruct patient to seek immediate emergency help in event of an anaphylactoid reaction.
  • Caution patient on prolonged corticosteroid therapy not to stop treatment abruptly but to taper the dosage slowly as directed by health care provider or primary caregiver if the decision has been to discontinue the medication.
  • Instruct women to inform their primary care giver if they are or plan to become pregnant.
  • Warn nursing mothers that a decision to discontinue the drug or nursing should be made in collaboration with their primary health care provider.
  • Instruct patient to report any unusual reaction or concern to primary care provider.

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