Meclofenamate Sodium 100 mg/1
meclofenamate sodium · CAPSULE · Mylan Pharmaceuticals Inc.
Meclofenamate Sodium is a capsule containing meclofenamate sodium at 100 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Meclofenamate Sodium
- Generic Name
- meclofenamate sodium
- NDC Code (Product)
0378-3000- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA071081
- Marketing Start
- 09/03/1986
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of meclofenamate sodium capsules 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: • For reduction of fever in adults • For relief of mild to moderate pain in adults • For relief of signs and symptoms of juvenile arthritis. • For relief of the signs and symptoms of rheumatoid arthritis • For relief of the signs and symptoms of osteoarthritis. • For treatment of primary dysmenorrhea. • For acute or long-term use in the relief of signs and symptoms of the following: 1. Ankylosing spondylitis 2. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 3. 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 , PRECAUT…
Dosage & Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of meclofenamate sodium capsules 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 ). After observing the response to initial therapy with meclofenamate sodium capsules, the dose and frequency should be adjusted to suit an individual patient's needs. Usual Dosage For Mild to Moderate Pain The recommended dose is 50 mg every 4 to 6 hours. Doses of 100 mg may be needed in some patients for optimal pain relief (see CLINICAL PHARMACOLOGY ). However, the daily dose should not exceed 400 mg (see ADVERSE REACTIONS ). For excessive menstrual blood loss and primary dysmenorrheal The recommended dose of meclofenamate sodium is 100 mg 3 times a day, for up to 6 days, starting at the onset of menstrual flow. For rheumatoid arthritis and osteoarthritis (including acute exacerbations of chronic disease) The dosage is 200 mg to 400 mg per day, administered in three or four equal doses. Therapy should be initiated at the lower dosage, then increased as necessary to impro…
Warnings
WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the developme…
Contraindications
CONTRAINDICATIONS Meclofenamate sodium capsules are contraindicated in patients with known hypersensitivity to meclofenamate sodium. Meclofenamate sodium capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma ). Meclofenamate sodium capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Drug Interactions
Drug Interactions ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Aspirin When meclofenamate sodium in administered with aspirin, its protein binding is reduced, although the clearance of free meclofenamate sodium is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of meclofenamate sodium capsules and aspirin is not generally recommended because of the potential of increased adverse effects. Furosemide Clinical studies, as well as post-marketing observations, have shown that meclofenamate sodium can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see PRECAUTIONS: Renal Effects ), as well as to assure diuretic efficacy. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. …
Adverse Reactions
ADVERSE REACTIONS Incidence Greater Than 1% The following adverse reactions were observed in clinical trials and included observations from more than 2,700 patients, 594 of whom were treated for one year and 248 for at least 2 years. Gastrointestinal The most frequently reported adverse reactions associated with meclofenamate sodium involve the gastrointestinal system. In controlled studies of up to 6 months duration, these disturbances occurred in the following decreasing order of frequency with the approximate incidences in parentheses: diarrhea (10% to 33%), nausea with or without vomiting (11%), other gastrointestinal disorders (10%), and abdominal pain * . In long-term uncontrolled studies of up to 4 years duration, one third of the patients had at least one episode of diarrhea some time during meclofenamate sodium therapy. In approximately 4% of the patients in controlled studies, diarrhea was severe enough to require discontinuation of meclofenamate sodium. The occurrence of diarrhea is dose related, generally subsides with dose reduction, and clears with termination of therapy. The incidence of diarrhea in patients with osteoarthritis is generally lower than that reported i…
Frequently Asked Questions
What is Meclofenamate Sodium used for?
Meclofenamate Sodium contains meclofenamate sodium. It is a capsule taken oral. Consult your doctor for specific uses.
Is Meclofenamate Sodium a controlled substance?
Meclofenamate Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Meclofenamate Sodium?
The generic name for Meclofenamate Sodium is meclofenamate sodium. There are no other listed brand versions of meclofenamate sodium.
What is the NDC code for Meclofenamate Sodium 100 mg/1?
The NDC (National Drug Code) for Meclofenamate Sodium 100 mg/1 is 0378-3000, listed by Mylan Pharmaceuticals Inc..
Other Meclofenamate Sodium Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)