Meloxicam
Generic: MELOXICAM
Basic Information
Manufacturer
Exelan Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
dfaac71c-dcc5-4b57-bf3b-616fccab96de
Indications & Usage
1 INDICATIONS AND USAGE Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3) 1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Boxed Warning and Warnings and Precautions (5.1)] GI Bleeding, Ulceration, and Perforation [see Boxed Warning and Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Heart Failure and Edema [see Warnings and Precautions (5.5)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] Anaphylactic Reactions [see Warnings and Precautions (5.7)] Serious Skin Reactions [see Warnings and Precautions (5.9)] Hematologic Toxicity [see Warnings and Precautions (5.11)] 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) To report SUSPECTED ADVERSE REACTIONS, contact Exelan Pharmaceuticals, Inc.
at 1-855-295-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults Osteoarthritis and Rheumatoid Arthritis The Meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Meloxicam 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with Meloxicam 15 mg/day.
Meloxicam at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year.
Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials.
Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Meloxicam trials.
A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Meloxicam with placebo and with an active control.
Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of Meloxicam with placebo.
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.
Pediatrics 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.
These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study.
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.
The adverse events did not demonstrate an age or gender-specific subgroup effect.
The following is a list of adverse drug reactions occurring in <2% of patients receiving Meloxicam in clinical trials involving approximately 16,200 patients.
tab1ab tab2 6.2 Post Marketing Experience The following adverse reactions have been identified during post approval use of Meloxicam.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.
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; toxic epidermal necrolysis, and infertility female.
at 1-855-295-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults Osteoarthritis and Rheumatoid Arthritis The Meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Meloxicam 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with Meloxicam 15 mg/day.
Meloxicam at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year.
Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials.
Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Meloxicam trials.
A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Meloxicam with placebo and with an active control.
Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of Meloxicam with placebo.
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.
Pediatrics 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.
These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study.
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.
The adverse events did not demonstrate an age or gender-specific subgroup effect.
The following is a list of adverse drug reactions occurring in <2% of patients receiving Meloxicam in clinical trials involving approximately 16,200 patients.
tab1ab tab2 6.2 Post Marketing Experience The following adverse reactions have been identified during post approval use of Meloxicam.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.
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; toxic epidermal necrolysis, and infertility female.