Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three 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 development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent ev >see Warnings and Precautions (5.2) ].
Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSA >see Contraindications (4) ].
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next
four years of follow-up.
Avoid the use of Mexolan in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Mexolan is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Rated Mexolan for Osteoarthritis Report
It really works! So much better than taking 800 mg ibuprofen daily!
Generally speaking, the daily recommended dose of Mexolan is 7.5 mg.
Your doctor may increase the dosage to 15 mg.
Mexolan should be taken exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed.
Take Mexolan with a glass of water. Swallow the pill whole; don't chew it or let it melt/dissolve in your mouth.
Take Mexolan with or without food. Taking it with food can help prevent an upset stomach.
Also, wait at least 30 minutes after taking Mexolan before lying down to help prevent an upset stomach.
What Are NSAIDs and Mexolan?
Nonsteroidal anti-inflammatory drugs have many other drugs under their umbrella: ibuprofen, nabumetone, and indomethacin, to name a few. They address problems caused by prostaglandins, chemical compounds in the body that contribute to inflammation in bone joints. The inflammation leads to the recognizable symptoms of pain, such as the swelling and tenderness that sufferers of arthritis are familiar with.
When a patient takes Mexolan, the chemicals in the drug block the enzymes that produce prostaglandins and reduce the overall level of those chemical compounds. This results in a decrease in inflammation and the pain symptoms they cause.
For this reason, Mexolan is prescribed for the treatment of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. The brand-name formulation of Mexolan is Mobic. The drug is administered in capsule, tablet, or liquid forms. The average dose is 5-7.5 mg once a day, with room for adjustment.
Rated Mexolan for Moderate Pain Report
I took Mexolan for RC tendonitis and it was worthless. After ten days I went back to Ibuprofen which seemed to work much better.
Mexolan is used to treat tenderness, swelling, and pain caused by the inflammation of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis in patients 2 years of age or older.
Rated Mexolan for Osteoarthritis Report
Began taking 7.5 mg/day, but no help with symptoms/pain. Rx written to take 1 or 2 per day, so I began taking 2 per day. After about 2 weeks of taking the 2 per day dosage with no issues, the past 3 days I began having moderate and constant heartburn, feeling nauseous, a "knot" feeling in my stomach, and increased belching. I stopped taking the Mobic when the symptoms began and began a bland diet. No relief yet. Waiting for PCP recommendation about symptoms. Glad it helps some people, but this is not a good choice for me.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered Mexolan at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5-and 2.6-times, respectively, the maximum recommended human dose of 15 mg/day Mexolan based on body surface area comparison).
Mexolan was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.
Impairment of Fertility
Mexolan did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-times greater, respectively, than the MRHD based on BSA comparison).
1 MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)
2 MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS
No . of Patients 469 481 477 Gastrointestinal Disorders 14.1 18.9 16.8 Abdominal pain NOS 2 0.6 2.9 2.3 Dyspeptic signs and symptoms 1 3.8 5.8 4.0 Nausea 2 2.6 3.3 3.8 General Disorders and Administration Site Conditions Influenza-like illness 2 2.1 2.9 2.3 Infection and Infestations Upper respiratory tract infections-pathogen >1 4.1 7.0 6.5 Musculoskeletal and Connective Tissue Disorders Joint related signs and symptoms 1 1.9 1.5 2.3 Nervous System Disorders Headaches NOS 2 6.4 6.4 5.5 Skin and Subcutaneous Tissue Disorders Rash NOS 2 1.7 1.0 2.1
The adverse events that occurred with Mexolan in ≥2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2
What is Mexolan?
Mexolan is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Mexolan is used to treat pain or inflammation caused by rheumatoid arthritis and osteoarthritis in adults.
Mexolan is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.
Mexolan may also be used for purposes not listed in this medication guide.