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Meclofenamate

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Meclofenamate

Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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 three times a day, for up to six days, starting at the onset of menstrual flow.

For rheumatoid arthritis and osteoarthritis (including acute exacerbations of chronic disease) The dosage is 200 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 improve clinical response. The dosage should be individually adjusted for each patient, depending on the severity of the symptoms and the clinical response. The daily dosage should not exceed 400 mg per day. The smallest dosage of meclofenamate sodium that yields clinical control should be employed.

Although improvement may be seen in some patients in a few days, two to three weeks of treatment may be required to obtain the optimum therapeutic benefit.

After a satisfactory response has been achieved, the dosage should be adjusted as required. A lower dosage may suffice for long-term administration.

If gastrointestinal complaints occur (see WARNINGS and PRECAUTIONS), meclofenamate sodium may be administered with meals or with milk (see CLINICAL PHARMACOLOGY for a description of food effects). If intolerance occurs, the dosage may need to be reduced. Therapy should be terminated if any severe adverse reactions occur.

HOW SUPPLIED

Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt. The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with MYLAN over 2150 in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:

NDC 0378-2150-01 - bottles of 100 capsules

The 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with MYLAN over 3000 in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:

NDC 0378-3000-01 - bottles of 100 capsules
NDC 0378-3000-05 - bottles of 500 capsules

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505. MAY 2006.

Last reviewed on RxList: 4/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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