Meclofenamate Sodium

 Action Decreases inflammation, pain and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

 Indications Treatment of rheumatoid and osteoarthritis; treatment of primary dysmenorrhea; elief of mild to moderate pain; idiopathic heavy menstrual blood loss. Unlabeled use(s): Relief of sunburn; pain; migraine (abort acute attacks).

 Contraindications Patients in whom aspirin, iodides or any NSAID has caused allergic-type reactions.

 Route/Dosage

Osteoarthritis or Rheumatoid Arthritis; Mild to Moderate Pain

ADULTS: PO 200–400 mg/day in 3–4 equally divided doses.

Excessive Menstrual Blood Loss; Primary Dysmenorrhea

ADULTS: PO 100 mg tid for up to 6 days.

 Interactions

Anticoagulants: Increased risk of gastric erosion and bleeding. Cyclosporine: Nephrotoxicity of both agents may be increased. Lithium: Serum lithium levels may be increased. Methotrexate: Increased methotrexate levels. Salicylates: Additive GI toxicity.

 Lab Test Interferences May prolong bleeding time.

 Adverse Reactions

CV: Edema. CNS: Headache; vertigo; drowsiness; dizziness; tinnitus. DERM: Rash; urticaria; fasciitis. EENT: Tinnitus. GI: Diarrhea; vomiting; nausea; abdominal pain; dyspepsia; peptic ulcer; GI bleeding; constipation; flatulence; anorexia; stomatitis; heartburn. GU: Acute renal failure; nephrotic syndrome. HEMA: Fall in hemoglobin; positive Coombs' est; bruising; prolonged bleeding time; thrombocytopenia purpura; anemia. HEPA: Abnormal liver function test results. META: Porphyria; hyponatremia. RESP: Breathing difficulties in aspirin-sensitive individuals.

 Precautions

Pregnancy: Safety not established; avoid use, especially during first and last trimester. Lactation: Undetermined. Children: Not recommended for children < 14 yr. Elderly patients: Increased risk of adverse reactions. Diarrhea: If diarrhea occurs, reduce dosage or temporarily discontinue. GI toxicity: Bleeding, ulceration or perforation can occur at any time, with or without warning symptoms. Heavy menstrual flow: It is recommended that meclofenamate sodium treatment not be prescribed for heavy menstrual flow without establishing its idiopathic nature. Hypersensitivity: May occur; use with caution in aspirin-sensitive individuals due to possible cross-sensitivity. Renal effects: Acute renal insufficiency, interstitial nephritis, hyperkalemia, hyponatremia and renal papillary necrosis may occur. Renal impairment: Lower doses may be necessary.

 Administration/Storage

• Administer with meals, followed by full glass of water or milk to reduce GI or esophageal irritation. May be given with antacids if stomach upset occurs.
• Store at room temperature in tightly closed, light-resistant container.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note chronic alcohol use, fluid retention, nasal polyps, bronchospastic disease or hypersensitivity to aspirin or NSAIDs.
• Monitor carefully for hypersensitivity. Note any ecchymosis or rash.
• Notify physician if stomach pain develops or continues.
• Monitor renal and liver function and blood studies throughout treatment.
• Monitor for diarrhea or blood in stools. If diarrhea occurs, notify physician. Dosage may need to be reduced or drug temporarily withheld.
• Weigh patient daily if fluid retention is a concern.

 Patient/Family Education

• Explain that therapeutic effects may take up to 1 mo to be noticed.
• Instruct patient to report these symptoms to physician: Rash, dark stools, persistent headache or stomach pain, unusual bruising or bleeding, decreased urinary output.
• Advise patient to avoid intake of alcoholic beverages.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
• Instruct patient that drug may cause dizziness and to use caution while driving or performing other activities requiring mental alertness until effects of drug are known.
• Tell patient to notify physician if diarrhea occurs. Review symptoms of dehydration. Explain that if diarrhea becomes severe or nausea and vomiting are severe, patient should stop taking medication and contact physician.
• Instruct patient to weigh self twice weekly and to notify physician if weight gain of > 3–4 lb/wk occurs.
• Instruct patient not to take otc medications, including aspirin and ibuprofen, or other prescription medications, without consulting physician.
• Warn patient about potential for bleeding and advise to notify other health care professionals that drug is being taken.
• Advise women who are taking meclofenamate sodium for heavy menstrual flow to consult their doctor if they have spotting or bleeding between cycles or worsening of their menstrual blood flow. These symptoms may be signs of the development of a more serious condition that is not appropriately treated with meclofenamate sodium.