Meclofenamate

Meclofenamate is a nonsteroidal anti-inflammatory drug (NSAID) 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. Meclofenamate sodium is also used alone or with other treatments to reduce pain, swelling, and joint stiffness from rheumatoid arthritis.

• Meclofenamate is available under the following different brand names: Meclomen

Common side effects of Meclofenamate include:

• nausea
• vomiting
• heartburn
• dizziness
• drowsiness
• diarrhea
• headache

Serious side effects of Meclofenamate include:

• blurred vision
• unexplained weight gain
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• yellowing of the skin or eyes
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• nausea
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• pale skin
• fast heartbeat
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Rare side effects of Meclofenamate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 50 mg
• 100 mg

Rheumatoid arthritis

Adult dosage

• 200-400 mg/day orally divided into 3-4 equal doses; initiate at a lower dose, and then increase according to response
• After a satisfactory response is achieved, attempt to reduce the dose for long-term administration
• Not to exceed 400 mg/day

Osteoarthritis

Adult dosage

• 200-400 mg/day orally divided into 3-4 equal doses; initiate at a lower dose, and then increase according to response
• After a satisfactory response is achieved, attempt to reduce the dose for long-term administration
• Not to exceed 400 mg/day

Ankylosing spondylitis

Adult dosage

• 200-400 mg/day orally divided into 3-4 equal doses; initiate at a lower dose, and then increase according to response
• After a satisfactory response is achieved, attempt to reduce the dose for long-term administration
• Not to exceed 400 mg/day

Bursitis/tendinitis

Adult dosage

• 200-400 mg/day orally divided into- 3-4 equal doses; initiate at a lower dose, and then increase the dose according to response
• After a satisfactory response is achieved, attempt to reduce the dose for long-term administration
• Not to exceed 400 mg/day

Gouty arthritis

Adult dosage

• 200-400 mg/day orally divided into 3-4 equal doses; initiate at a lower dose, and then increase the dose according to response
• After a satisfactory response is achieved, attempt to reduce the dose for long-term administration
• Not to exceed 400 mg/day

Juvenile arthritis

Pediatric dosage

• Children younger than 14 years: Safety and efficacy not established
• Children 14 years and older: 200-400 mg/day orally divided into 3-4 equal doses; initiate at a lower dose, and then increase the dose according to response
• After a satisfactory response is achieved, attempt to reduce the dose for long-term administration
• Not to exceed 400 mg/day

Primary dysmenorrhea

Adult dosage

• 100 mg orally three times a day for up to 6 days; initiate at the onset of menstrual flow
• Pediatric dosage
  • Children younger than 14 years: Safety and efficacy not established
  • Children 14 years and older: 100 mg orally three times a day for up to 6 days; initiate at the onset of menstrual flow

Mild-to-moderate pain

Adult dosage

• 50 mg orally every 4-6 hours; may increase the dose
• 100 mg/dose if needed; not to exceed 400 mg/day

Fever

Adult dosage

• 50 mg orally every 4-6 hours; may increase to 100 mg/dose if needed
• Not to exceed 400 mg/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Meclofenamate has severe interactions with no other drugs
• Meclofenamate has serious interactions with at least 21 other drugs
• Meclofenamate has moderate interactions with at least 235 other drugs
• Meclofenamate has minor interactions with at least 75 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• 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
• In the setting of coronary artery bypass graft (CABG) surgery

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Meclofenamate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Meclofenamate?”

Cautions

• Increased risk for serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal 
• Two large, controlled clinical trials of cyclooxygenase (COX)-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of MI and stroke
• Use of NSAIDs in the post-MI period increased the risk for reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment in an observational study; avoid use in patients who have experienced MI recently
• Can lead to new-onset hypertension or worsening of preexisting hypertension; patients taking thiazides or loop diuretics may have impaired response to these treatments while taking an NSAID
• May cause fluid retention and edema; avoid use with severe heart failure
• Can cause serious GI adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal
• Long-term administration has resulted in renal papillary necrosis and other renal injury; patients at greatest risk include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and elderly individuals
• Anaphylactoid reactions reported
• Can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
• Heart failure (HF) risk
  • NSAIDS have the potential to trigger HF by prostaglandin inhibition, which leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDS should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks, or use in LIFE-THREATENING emergencies when no safer drug is available during the third trimester (may cause the premature closure of ductus arteriosus)
• Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks of gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls
• Lactation
  • Drug excreted in breast milk with multiple doses
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or any underlying maternal condition