MECLOFENAMATE SODIUM

MECLOFENAMATE SODIUM (me-kloe-fen-am'ate) Classifications: analgesic, nonsteroidal antiinflammatory drug (nsaid); antipyretic; Therapeutic: nsaid, analgesic; antipyretic Prototype: Ibuprofen Pregnancy Category: C first and second trimester; D third trimester

Availability

50 mg, 100 mg capsules

Action

Inhibits prostaglandin synthesis by inhibiting both the COX-1 and COX-2 enzymes necessary for its synthesis and competes for binding at prostaglandin receptor sites. Does not appear to alter course of arthritis.

Therapeutic Effect

Palliative antiinflammatory, analgesic, and antipyretic activity.

Uses

Symptomatic treatment of acute or chronic rheumatoid arthritis and osteoarthritis. Also in combination with gold salts or corticosteroids in treatment of rheumatoid arthritis.

Unlabeled Uses

Management of psoriatic arthritis, mild to moderate postoperative pain, dysmenorrhea.

Contraindications

Patient in whom bronchospasm, urticaria, and allergic rhinitis are induced by aspirin or other NSAIDs; active peptic ulcer, ulcerative colitis; perioperative pain related to CABG surgery; renal disease; pregnancy (category C first and second trimester, category D third trimester), lactation, children <14 y, patient designated as functional class IV rheumatoid arthritis (incapacitated, bedridden, or confined to wheelchair, little or no self-care).

Cautious Use

History of upper GI tract disease; coronary artery disease; acute MI, cardiac arrhythmias; CVA; diabetes mellitus; SLE; compromised cardiac and kidney function, or other conditions predisposing to fluid retention.

Route & Dosage

Inflammatory Disease Adult: PO 200–400 mg/d in 3–4 divided doses (max: 400 mg/d)

Administration

Oral

• Give with food or milk if patient complains of GI distress. An aluminum and magnesium hydroxide antacid (Maalox) also may be prescribed. Consult physician if symptoms persist.
• Withhold dose and report to physician if significant diarrhea occurs.
• Store at 15°–30° C (59°–86° F) in airtight, light-resistant container.

Adverse Effects (≥1%)

CNS: Dizziness, vertigo, lack of concentration, confusion, headache, tinnitus. CV: Edema. GI: Severe diarrhea (dose-related), peptic ulceration, GI bleeding, dyspepsia, abdominal pain, nausea, vomiting (may be severe), flatulence, eructation, pyrosis, anorexia, constipation. GI: Abnormal liver function tests, cholestatic jaundice. Special Senses: Blurred vision. Urogenital: Elevated BUN and creatinine, kidney failure. Skin: Rash, pruritus, urticaria.

Interactions

Drug: oral anticoagulants, heparin may prolong bleeding time; may increase lithium toxicity; increases pharmacologic and toxic activity of phenytoin, sulfonylureas, sulfonamides, warfarin through protein-binding displacement. Herbal: Feverfew, garlic, ginger, ginkgo increase bleeding potential.

Pharmacokinetics

Absorption: Rapidly and completely from GI tract. Peak: 1–2 h. Duration: 2–4 h. Distribution: Crosses placenta. Metabolism: In liver. Elimination: 60% in urine, 30% in feces. Half-Life: 2–3.3 h.

Nursing Implications

Assessment & Drug Effects

• Expect clinical improvement in the rheumatoid patient within 2–3 wk with reduction in number of tender joints, severity of tenderness, and duration of morning stiffness.
• Observe improvement in the osteoarthritic patient as reflected by reduced night pain, pain on walking, starting pain, and pain with passive motion and improved joint function.
• Report diarrhea promptly. It is the most frequent adverse effect and usually dose related.
• Lab tests: Monitor kidney function where incidence of adverse reactions is potentially high because drug is excreted primarily by the kidneys. Monitor PT, PTT, and INR frequently with concurrent anticoagulant therapy.
• Monitor I&O ratio. Encourage fluid intake of at least 8 glasses of liquid a day.
• Consider sodium content of meclofenamate tablets if patient is on restricted sodium intake.

Patient & Family Education

• Stop taking drug and promptly notify the physician if nausea, vomiting, severe diarrhea, and abdominal pain occur. Generally dose reduction or temporary withdrawal will control symptoms.
• Report to physician without delay: Blurred vision, tinnitus, or taste disturbances.
• Schedule ophthalmic examinations before and periodically during treatment and whenever you experience visual disturbances.
• Notify physician if you become pregnant.
• Weigh under standard conditions (similar clothing, same time of day) twice weekly. Report weight gain of more than 2.5 to 3.5 kg (3–4 lb)/wk as well as signs of edema: Swollen ankles, tibiae, hands, feet.
• Do not use OTC drugs without approval of physician.
• Dizziness, a troublesome early side effect, frequently disappears in time. Avoid driving a car or potentially hazardous activities until response to drug is known.
• Report immediately to physician any sign of bleeding (e.g., melena, epistaxis, ecchymosis) when taking concomitant oral anticoagulant.

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Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug