PO: IV: Treatment of: Mild to moderate pain, Fever. PO: Treatment of: Inflammatory disorders including rheumatoid arthritis (including juvenile) and osteoarthritis, Dysmenorrhea. IV: Moderate to severe pain with opioid analgesics.
Inhibits prostaglandin synthesis. Therapeutic Effects: Decreased pain and inflammation. Reduction of fever.
Absorption: Oral formulation is well absorbed (80%) from the GI tract; IV administration results in complete bioavailability.
Distribution: Does not enter breast milk in significant amounts.
Protein Binding: 99%.
Metabolism and Excretion: Mostly metabolized by the liver; small amounts (1%) excreted unchanged by the kidneys.
Half-life: Children: 1–2 hr; Adults: 2–4 hr.
Contraindicated in: Hypersensitivity (cross-sensitivity may exist with other NSAIDs, including aspirin); Active GI bleeding or ulcer disease; Chewable tablets contain aspartame and should not be used in patients with phenylketonuria; Peri-operative pain from coronary artery bypass graft (CABG) surgery; OB: Avoid after 30 wk gestation (may cause premature closure of fetal ductus arteriosus).
Use Cautiously in: Cardiovascular disease (may ↑ risk of cardiovascular events); Renal or hepatic disease, dehydration, or patients on nephrotoxic drugs (may ↑ risk of renal toxicity); Aspirin triad patients (asthma, nasal polyps, and aspirin intolerance); can cause fatal anaphylactoid reactions; Geri: ↑ risk of adverse reactions secondary to age-related ↓ in renal and hepatic function, concurrent illnesses, and medications; Chronic alcohol use/abuse; Coagulation disorders; OB: Use cautiously up to 30 wk gestation; avoid after that; Lactation: Use cautiously; Pedi: Safety not established for infants <6 mo (oral) and children <17 yr (IV).
Exercise Extreme Caution in: History of GI bleeding or GI ulcer disease.
ADVERSE REACTIONS AND SIDE EFFECTS
CNS: headache, dizziness, drowsiness, psychic disturbances. EENT: amblyopia, blurred vision, tinnitus. CV: arrhythmias, edema, hypertension. GI: GI BLEEDING, HEPATITIS, constipation, dyspepsia, nausea, vomiting, abdominal discomfort. GU: cystitis, hematuria, renal failure. Derm: EXFOLIATIVE DERMATITIS, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, rashes. Hemat: anemia, blood dyscrasias, prolonged bleeding time. Misc: allergic reactions including anaphylaxis.
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