Drug information of Meclofenamate

Meclofenamate

Drug group:

Meclofenamate is a nonsteroidal anti-inflammatory drug (NSAID). Meclofenamate works by reducing hormones that cause inflammation and pain in the body.

Meclofenamate is used to treat fever or mild to moderate pain in adults. Meclofenamate is also used to relieve symptoms of osteoarthritis or rheumatoid arthritis in adults, and juvenile arthritis in children who are at least 14 years old.

Meclofenamate is also used to treat menstrual pain or heavy menstrual bleeding.

Meclofenamate is sometimes used long-term to treat symptoms of ankylosing spondylitis, gouty arthritis, or shoulder pain caused by bursitis or tendinitis.

Meclofenamate may also be used for purposes not listed in this medication guide.

Mechanism of effect

known. Therapeutic action does not result from pituitary-adrenal stimulation. In animal studies, meclofenamic acid was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. In vitro meclofenamic acid was found to be an inhibitor of human leukocyte 5-lipoxygenase activity. These properties may be responsible for the anti-inflammatory action of meclofenamic acid. There is no evidence that meclofenamic acid alters the course of the underlying disease.

Pharmacodynamic


Meclofenamic acid is a nonsteroidal agent which has demonstrated anti-inflammatory, analgesic, and antipyretic activity in laboratory animals.

Pharmacokinetics

Absorption

Rapidly absorbed in man following single and multiple oral doses with peak plasma concentrations occurring in 0.5 to 2 hours.

Volume of distribution

  • 1 to 43.2 L

Protein binding

Greater than 99% bound to plasma proteins over a wide drug concentration range.

Metabolism

Hepatic. Meclofenamic acid is extensively metabolized to an active metabolite (Metabolite I; 3-hydroxymethyl metabolite of meclofenamic acid) and at least six other less well characterized minor metabolites. Only Metabolite I has been shown in vitro to inhibit cyclooxygenase activity with approximately one fifth the activity of meclofenamic acid.

Route of elimination

Other metabolites, whose excretion rates are unknown, account for the remaining 35% to 62% of the dose excreted in the urine. The remainder of the administered dose (approximately 30%) is eliminated in the feces (apparently through biliary excretion). Trace amounts of meclofenamate sodium are excreted in human breast milk.

Half-life

In a study in 10 healthy subjects following a single oral dose the apparent elimination half-life ranged from 0.8 to 5.3 hours. Metabolite I (3-hydroxymethyl metabolite of meclofenamic acid) has a mean half-life of approximately 15 hours.

Clearance

  • Oral cl=206 mL/min

Drug indications


Meclofenamate is used for the treatment of mild to moderate pain from various conditions (e.g., dental pain, osteoarthritis) and to decrease pain and blood loss from menstrual periods. It is also used alone or with other treatments to reduce pain, swelling, and joint stiffness from rheumatoid arthritis.

Dosage

  • 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. However, the daily dose should not exceed 400 mg .
·         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 arthritisand osteoarthritis (including acute exacerbations of chronic disease) The dosage is 200 to 400 mg per day, administered in three or four equal doses.

Side effects

  • signs of an allergic reaction:sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
  • signs of a heart attack or stroke:chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
  • the first sign of any skin rash, no matter how mild;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems --little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

 

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Alerts

  • You should not use meclofenamate if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
  • Meclofenamate may increase your risk of heart attack or stroke,especially if you use it long term or have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
  • Meclofenamate may also cause stomach or intestinal bleeding, which can be fatal.These conditions can occur without warning while you are using meclofenamate.
  • Taking meclofenamate during the last 3 months of pregnancy may harm the unborn baby.Tell your doctor if you are pregnant or plan to become pregnant.
  • It is not known whether meclofenamate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
  • Meclofenamate is not approved for use by anyone younger than 14 years old.
 

Points of recommendation

To make sure meclofenamate is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • liver or kidney disease;
  • asthma; or
  • fluid retention.

 

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Do not take more than 400 milligrams (mg) of meclofenamate in one day.

If you use this medicine long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature, away from moisture, heat, and light.

Pregnancy level

Taking meclofenamate during the last 3 months of pregnancy may harm the unborn baby. 

Related drugs

Aceclofenac


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