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Meclofenamate (Meclofenamate Sodium) - Indications and Dosage

 
 



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: Ankylosing spondylitis
  • •Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)
  • •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 non-steroidal 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.

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 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, 2 to 3 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 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.


PHARMACIST: Dispense a Medication Guide with each prescription.

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