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Meclofenamate Sodium

Pronunciation: mek-loe-FEN-uh-mate SO-dee-uhm
Class: NSAID

Trade Names

Meclofenamate sodium
- Capsules 50 mg
- Capsules 100 mg

Pharmacology

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

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Pharmacokinetics

Absorption

T max is 0.5 to 2 h and the bioavailability is approximately 100%.

Distribution

Vd is 23 L and the protein binding is greater than 99%.

Elimination

Meclofenamate is excreted renally (70%) and fecally (30%). The t ½ is 1.3 h and Cl is 206 mL/min.

Indications and Usage

Treatment of rheumatoid and osteoarthritis; treatment of primary dysmenorrhea; relief of mild to moderate pain; idiopathic heavy menstrual blood loss.

Unlabeled Uses

Relief of sunburn; pain; migraine (abort acute attacks).

Contraindications

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

Dosage and Administration

Osteoarthritis or Rheumatoid Arthritis; Mild to Moderate Pain
Adults

PO 200 to 400 mg/day in 3 to 4 equally divided doses.

Excessive Menstrual Blood Loss; Primary Dysmenorrhea
Adults

PO 100 mg 3 times daily for up to 6 days.

Storage/Stability

Store at room temperature (59° to 86°F) in tightly closed, light-resistant container.

Drug 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.

Laboratory Test Interactions

May prolong bleeding time.

Adverse Reactions

Cardiovascular

Edema.

CNS

Headache; vertigo; drowsiness; dizziness; tinnitus.

Dermatologic

Rash; urticaria; fascitis.

EENT

Tinnitus.

GI

Diarrhea; vomiting; nausea; abdominal pain; dyspepsia; peptic ulcer; GI bleeding; constipation; flatulence; anorexia; stomatitis; heartburn.

Genitourinary

Acute renal failure; nephrotic syndrome.

Hematologic

Fall in hemoglobin; positive Coombs test; bruising; prolonged bleeding time; thrombocytopenia purpura; anemia.

Hepatic

Abnormal LFT results.

Metabolic

Porphyria; hyponatremia.

Respiratory

Breathing difficulties in aspirin-sensitive individuals.

Precautions

Warnings

NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, inflammation, perforation of the stomach or intestines, and ulceration, which can be fatal. These events can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.


Pregnancy

Safety not established; avoid use, especially during first and last trimester.

Lactation

Undetermined.

Children

Not recommended for children younger than 14 yr of age.

Elderly

Increased risk of adverse reactions.

Hypersensitivity

May occur; use with caution in aspirin-sensitive individuals because of possible cross-sensitivity.

Renal Function

Acute renal insufficiency, interstitial nephritis, hyperkalemia, hyponatremia and renal papillary necrosis may occur. Lower doses may be necessary in patients with renal function impairment.

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.

Overdosage

Symptoms

Sweating, disorientation, vomiting, convulsions, electrolyte imbalance, metabolic acidosis.

Patient Information

  • Explain that therapeutic effects may take up to 1 mo to be noticed.
  • Instruct patient to report the following symptoms to health care provider: 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 health care provider 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 health care provider.
  • Instruct patient to weigh self twice weekly and to notify health care provider if weight gain of more than 3 to 4 lb/wk occurs.
  • Instruct patient not to take OTC medications, including aspirin and ibuprofen, or other prescription medications, without consulting health care provider.
  • 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.

Copyright © 2009 Wolters Kluwer Health.

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