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Meclofenamate (Meclofenamate Sodium) - Summary


Cardiovascular Risk

  • •NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS and CLINICAL TRIALS).
  • •Meclofenamate sodium capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

  • •NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS).


Meclofenamate sodium is N-(2,6-dichloro-m-tolyl) anthranilic acid, sodium salt, monohydrate. It is an anti-inflammatory drug for oral administration.

Meclofenamate sodium is indicated for the relief of mild to moderate pain.

Meclofenamate sodium is also indicated for the treatment of primary dysmenorrhea and for the treatment of idiopathic heavy menstrual blood loss (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Meclofenamate sodium is also indicated for relief of the signs and symptoms of acute and chronic rheumatoid arthritis and osteoarthritis. As with all non-steroidal anti-inflammatory drugs, selection of meclofenamate sodium requires a careful assessment of the benefit/risk ratio (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).

Meclofenamate sodium is not recommended in children because adequate studies to demonstrate safety and efficacy have not been carried out.

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Published Studies Related to Meclofenamate

Single dose and multidose analgesic study of ibuprofen and meclofenamate sodium after third molar surgery. [1993.12]
The purpose of this study was to compare the analgesic efficacy and safety of meclofenamate sodium with ibuprofen after dental impaction surgery. This study was double-blind and used a unique methodology... The side effect profile of nonsteroidal anti-inflammatory analgesics is best observed with the use of a multidose study design.

Efficacy of meclofenamate sodium (Meclomen) in the treatment of rapidly progressive periodontitis. [1993.10]
This 6-month, double-blind, controlled clinical trial determined the efficacy of the non-steroidal anti-inflammatory drug, meclofenamate sodium (Meclomen), as an adjunct to scaling and root planing in the treatment of rapidly progressive periodontitis (RPP)...

[Analgesic effect of sodium meclofenamate on several painful symptoms] [1993.09]
Three groups of 20 patients, who suffered of acute pain (dental or low back or menorrhalgia) have been randomized and treated, obtained their informed consent, with meclofenamic acid 100 mg or ketoprofene 50 mg by oral route. The study has been completed double blind to assess the powerful antalgic effect between the two drugs, the results underline that the two NSAID have a very good effect on pain of various nature...

Efficacy of meclofenamate sodium versus placebo in headache and craniofacial pain. [1993.01]
Twenty patients were enrolled in a double-blind, placebo-controlled crossover study of meclofenamate sodium in headache and craniofacial pain. There were four observation periods of 15 days each: Period 1 was a wash-out period... Data for pressure threshold, although not significant, were indicative of a possible increase during and after intake of meclofenamate sodium.(ABSTRACT TRUNCATED AT 250 WORDS).

An attempt at real prophylaxis of primary dysmenorrhea: comparison between meclofenamate sodium and naproxen sodium. [1993]
Dysmenorrhea is a widespread phenomenon, affecting mainly young nulliparous women, often inducing difficulties in study or in work... Meclofenamate Sodium in particular led to considerable pain reduction, with very good patient compliance and without significant complications, probably of its additional receptor effect.

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Clinical Trials Related to Meclofenamate

Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary [Recruiting]
Cancer that has spread to the brain, or brain metastasis, is difficult to treat. Meclofenamate is a drug which has been shown to reduce brain metastasis growth in the laboratory. This medicine has been used in the past to treat pain. But, in this study, it will be used to prevent new brain metastasis. This is the first time that meclofenamate will be used in patients with brain metastasis. This is a pilot study which means that the purpose of this study is to determine if a larger clinical trial of meclofenamate is possible in patients with brain metastasis. This study also aims to find out what effects, good and/or bad meclofenamate has on the patient and the cancer that has spread to the brain. The investigators also want to learn more about potential effects that this drug may have in the digestive system.

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Page last updated: 2007-05-03

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