Meloxicam

2.5 Renal Impairment
The use of meloxicam tablets in subjects with severe renal impairment is not recommended.

In patients on hemodialysis, the maximum dosage of meloxicam tablets is 7.5 mg per day [see Clinical Pharmacology (12.3)].

8.7 Renal Impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been studied. The use of meloxicam in subjects with severe renal impairment is not recommended. In patients on hemodialysis, meloxicam should not exceed 7.5 mg per day. Meloxicam is not dialyzable [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].

8.6 Hepatic Impairment
No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment have not been adequately studied. Since meloxicam is significantly metabolized in the liver and hepatotoxicity may occur, use meloxicam with caution in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

8.5 Geriatric Use
Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1, 5.2, 5.3,5.6, 5.14)].

2.6 Non-Interchangeability with Other Formulations of Meloxicam
Meloxicam tablets have not shown equivalent systemic exposure to other approved formulations of oral meloxicam. Therefore, meloxicam tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Do not substitute similar dose strengths of meloxicam tablets with other formulations of oral meloxicam product.

Highlights: Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms (6.1)
Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience (6.1)

6.1 Clinical Trials Experience (Adults, Osteoarthritis and Rheumatoid Arthritis)
Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across meloxicam trials.

Table 1a depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Higher doses of meloxicam (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of meloxicam should not exceed 15 mg.

NOTE: Tables 1a, 1b and 2 (the actual adverse event percentages) are NOT CAPTURED VERBATIM: they did not appear in the printer-friendly label text returned by get_page_text.

6.1 (Tables 1a, 1b and 2 list events occurring in ≥2% of meloxicam groups): NOT CAPTURED VERBATIM (tables absent from the text returned).

6.2 Postmarketing Experience
Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome; fixed drug eruption (FDE); toxic epidermal necrolysis, and infertility female.

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)
Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to meloxicam with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. The adverse events observed in these pediatric studies with meloxicam were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven (<2%) patients receiving meloxicam. No unexpected adverse events were identified during the course of the trials.

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs; with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use; without warning symptoms; that may cause death
The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs; taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”; increasing doses of NSAIDs; longer use of NSAIDs; smoking; drinking alcohol; older age; poor health; advanced liver disease; bleeding problems
NSAIDs should only be used: exactly as prescribed; at the lowest dose possible for your treatment; for the shortest time needed

Who should not take NSAIDs?
Do not take NSAIDs:

if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
right before or after heart bypass surgery.

What are the possible side effects of NSAIDs?
NSAIDs can cause serious side effects, including: new or worse high blood pressure; heart failure; liver problems including liver failure; kidney problems including kidney failure; low red blood cells (anemia); life-threatening skin reactions; life-threatening allergic reactions
Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing; chest pain; weakness in one part or side of your body; slurred speech; swelling of the face or throat
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea; more tired or weaker than usual; diarrhea; itching; your skin or eyes look yellow; indigestion or stomach pain; flu-like symptoms; vomit blood; there is blood in your bowel movement or it is black and sticky like tar; unusual weight gain; skin rash or blisters with fever; swelling of the arms, legs, hands and feet

Meloxicam comes as a tablet and suspension (liquid) to take by mouth. It is usually taken once a day with or without food. Take meloxicam at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take meloxicam exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as meloxicam may have a higher risk of having a heart attack, or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as meloxicam if you have recently had a heart attack, unless directed to do so by your doctor.

Meloxicam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
diarrhea
constipation
gas
sore throat