MECLOFENAMATE SODIUM- meclofenamate sodium capsule
Mylan Pharmaceuticals Inc.
Cardiovascular Thrombotic Events
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Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS).
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Meclofenamate sodium capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
Gastrointestinal Risk
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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).
DESCRIPTION
Meclofenamate sodium, USP is N-(2,6-dichloro-m-tolyl) anthranilic acid, sodium salt, monohydrate. It is an anti-inflammatory drug for oral administration. Meclofenamate sodium capsules, USP contain 50 mg or 100 mg meclofenamic acid as the sodium salt and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide.
The imprinting ink contains black iron oxide, D&C yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
Molecular Formula: C14 H10 Cl2 NNaO2 �H2 O
It is a white to creamy white, odorless to almost odorless, crystalline powder with melting point 287� to 291�C, molecular weight 336.15, and it is freely soluble in water.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Meclofenamate sodium is a nonsteroidal agent which has demonstrated anti-inflammatory, analgesic, and antipyretic activity in laboratory animals. The mode of action, like that of other nonsteroidal anti-inflammatory agents, is not known. Therapeutic action does not result from pituitary-adrenal stimulation. In animal studies, meclofenamate sodium was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. In vitro, meclofenamate sodium was found to be an inhibitor of human leukocyte 5-lipoxygenase activity. These properties may be responsible for the anti-inflammatory action of meclofenamate sodium. There is no evidence that meclofenamate sodium alters the course of the underlying disease.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of meclofenamate sodium capsules, USP and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Meclofenamate sodium capsules are indicated:
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For reduction of fever in adults
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For relief of mild to moderate pain in adults
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For relief of signs and symptoms of juvenile arthritis.
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For relief of the signs and symptoms of rheumatoid arthritis
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For relief of the signs and symptoms of osteoarthritis.
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For treatment of primary dysmenorrhea.
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For acute or long-term use in the relief of signs and symptoms of the following:
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Ankylosing spondylitis
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Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)
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Acute gouty arthritis
Meclofenamate sodium capsules are also indicated for the treatment of idiopathic heavy menstrual blood loss (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
As with all nonsteroidal anti-inflammatory drugs, selection of meclofenamate sodium capsules require a careful assessment of the benefit/risk ratio (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).
Meclofenamate sodium capsules are not recommended in children because adequate studies to demonstrate safety and efficacy have not been carried out.