Loading…
PMS-MELOXICAM is a brand name for Meloxicam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE......................................................................... 3 CONTRAINDICATIONS............................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................ 5 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
5 and 15 mg meloxicam tablets or capsules. In these clinical trials, the following indications were studied: osteoarthritis and rheumatoid arthritis (approved indications); ankylosing spondylitis, sciatica and low back pain (unapproved indications).
In the overall clinical trial database of 14325 patients, treatment exposure up to 6 weeks was obtained in 14313* patients, while exposure up to 3 months was in 2185 patients. Exposure up to 6 months was in 1642 patients, exposure up to one year was obtained in 1031 patients and 471 patients were exposed for more than one year to meloxicam.
*For 12 patients treated with meloxicam, information is missing to categorize the duration of exposure.
Frequent Adverse Events:
The following adverse events, which may be causally related to the administration of meloxicam, have a frequency of >1%. Gastrointestinal: dyspepsia, nausea, abdominal pain, diarrhea Skin and Appendages: skin rash Central nervous system: light-headedness, headache Serious Adverse Drug Reactions: The following serious adverse drug reactions have been reported in association with meloxicam use: Gastrointestinal ulceration, perforation or bleeding (see WARNINGS AND PRECAUTIONS, Gastrointestinal (GI) and DRUG INTERACTIONS, Drug-Drug Interactions - Selective Serotonin Reuptake Inhibitors (SSRIs); Asthma, bronchospasm (see WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions - Anaphylactoid Reactions and WARNINGS AND PRECAUTIONS, Respiratory); Hypersensitivity reactions including angioedema, skin rash, pruritus (see WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions - Anaphylactoid Reactions and Skin); Renal failure, hematuria (see WARNINGS AND PRECAUTIONS, Genitourinary and Renal, DRUG INTERACTIONS, Drug-Drug Interactions - Anti-hypertensives, Cyclosporine or Tacrolimus, Diuretics and Methotrexate); Visual disturbances including blurred vision (see WARNINGS AND PRECAUTIONS, Neurologic and Ophthalmologic).
Vomiting or persistent dyspepsia, nausea, abdominal pain or diarrhea (see WARNINGS AND PRECAUTIONS, Gastrointestinal (GI) and Infection - Aseptic Meningitis); Micturition disorders; Edema (see WARNINGS AND PRECAUTIONS, Cardiovascular and Renal - Fluid and Electrolyte Balance); Jaundice (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic); pms-MELOXICAM Product Monograph Page 17 of 47 Malaise, fatigue; Aseptic meningitis (see WARNINGS AND PRECAUTIONS, Infection - Aseptic Meningitis); • Confusion, depression, light-headedness (see WARNINGS AND PRECAUTIONS, Neurologic); Tinnitus (see WARNINGS AND PRECAUTIONS, Neurologic).
Risk of Cardiovascular (CV) Adverse Events:
Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (see WARNINGS AND PRECAUTIONS - Cardiovascular). pms-MELOXICAM is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal.
The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing pms-MELOXICAM to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV).
Use of NSAIDs, such as pms-MELOXICAM, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure (see WARNINGS AND PRECAUTIONS -Renal - Fluid and Electrolyte Balance).
Randomized clinical trials with meloxicam have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing pms-MELOXICAM. Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS - Gastrointestinal).
Use of NSAIDs, such as pms-MELOXICAM, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
Risk in Pregnancy:
Caution should be exercised in prescribing pms-MELOXICAM during the first and second trimesters of pregnancy. Use of NSAIDS at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure (see WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Meloxicam in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 181) are presented in Table 1. Diclofenac was used as a comparator in a dose of 100 mg/day. 183) are presented in Table 2.
Diclofenac was used as a comparator in a dose of 150 mg/day (n=182).
Table 2:
Adverse Drug Reactions In A […]
pms-MELOXICAM is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see CONTRAINDICATIONS). General For relevant drug interactions that require particular attention, see DRUG INTERACTIONS section.
pms-MELOXICAM Product Monograph Page 6 of 47 Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration.
As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
pms-MELOXICAM is NOT recommended for use with other NSAIDs, with the exception of low- dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (see DRUG INTERACTIONS - Drug/Drug Interactions - Acetylsalicylic Acid (ASA) or other NSAIDs).
5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine. pms-MELOXICAM tablets 15 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Carcinogenesis and Mutagenesis See TOXICOLOGY section. Cardiovascular pms-MELOXICAM is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal.
The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing pms-MELOXICAM to patients with risk factors for cardiovascular disease, cerebrovascular disease or renal disease, such as any of the following (NOT an exhaustive list): Hypertension Dyslipidemia/Hyperlipidemia Diabetes Mellitus Congestive Heart Failure (NYHA I) Coronary Artery Disease (Atherosclerosis) Peripheral Arterial Disease Smoking Creatinine Clearance (<60 mL/min or 1 mL/sec) Use of NSAIDs, such as pms-MELOXICAM, can lead to new hypertension or can worsen pre- existing hypertension, either of which may increase the risk of cardiovascular events as described pms-MELOXICAM Product Monograph Page 7 of 47 above.
Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing pms-MELOXICAM should hypertension either develop or worsen with its use. Use of NSAIDs, such as pms-MELOXICAM, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renally-mediated mechanism (see WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance).
For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include the use of NSAIDs should be considered first. To minimize the potential risk for an adverse CV event, the lowest effective dose should be used for the shortest possible duration.
Endocrine and Metabolism Corticosteroids: pms-MELOXICAM is NOT a substitute for corticosteroids. It does NOT treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid responsive illness.
Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. (See DRUG INTERACTIONS - Drug- Drug Interactions - […]