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TEVA-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…
Verbatim from this product's HC label. Tap a section to expand.
g. 5 mg once daily (see WARNINGS AND PRECAUTIONS). The maximum recommended daily dose of TEVA-MELOXICAM tablets is 15 mg. Recommended Dose and Dosage Adjustment Use of TEVA-MELOXICAM is restricted to adults 18 years of age and older and should be limited to the lowest effective dose for the shortest possible duration of treatment (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
5 mg once daily. If necessary, the dose may be increased to 15 mg once daily. Rheumatoid arthritis: 15 mg once daily. 5 mg once daily. TEVA-MELOXICAM may be taken without regard to timing of meals.
Hepatic Impairment:
No dose adjustment is necessary in patients with mild to moderate hepatic insufficiency. TEVA-MELOXICAM is contraindicated in patients with severe liver impairment or active liver disease. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS - Hepatic/Biliary/Pancreatic and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions – Hepatic Insufficiency.
50 mL/s). 5 mL/sec) or deteriorating renal disease (see CONTRAINDICATIONS). 5 mg/day. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS – Renal and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions – Renal Insufficiency.
TEVA-MELOXICAM – Product Monograph Page 29 of 47 Geriatrics (> 65 years of age):
For elderly, frail or debilitated patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS – General and Special Populations - Geriatrics and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions – Geriatrics.
Missed Dose If a dose is missed, the usual schedule must be resumed the following day. An extra dose must not be taken. OVERDOSAGE There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered.
Cholestyramine is known to accelerate the clearance of meloxicam. Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care.
Risk of Cardiovascular (CV) Adverse Events:
Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (see WARNINGS AND PRECAUTIONS – Cardiovascular). TEVA-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 TEVA-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 TEVA-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 TEVA-MELOXICAM. Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS – Gastrointestinal) Use of NSAIDs, such as TEVA-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 TEVA-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).
, WARNINGS AND PRECAUTIONS - Advanced Renal Disease, DOSAGE AND ADMINISTRATION – Renal Impairment). In terminal renal failure, the increase in the volume of distribution may result in higher free meloxicam concentrations. 3% free fraction).
Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Meloxicam is not dialyzable. STORAGE AND STABILITY Store at controlled room temperature (15 - 30°C), safely out of the reach of children.
Store in a dry place. 5 mg meloxicam. 15 mg Tablets: Each pastel yellow, round, scored tablet, engraved with N on one side and 1│5 on the other side, contains 15 mg meloxicam. Each of the above strengths is available in unit dose, (2 x 5) cartons of 30 and HDPE bottles of 100.
Non-medicinal Ingredients: crospovidone, colloidal silica dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium citrate dehydrate. 4 g/mol Structural formula: Physicochemical properties: Meloxicam is a yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases.
It is very slightly soluble in methanol. 2. CLINICAL TRIALS Bioequivalence Study A single-dose, randomized, two-way, comparative bioavailability study was performed on Teva- Meloxicam 15 mg Tablets, and MobicoxTM 15 mg Tablets, in healthy adult male subjects, 19 to 54 years of age (inclusive), under fasting conditions.
66 (45) * Expressed as the arithmetic mean (CV%) only. ); purchased in Canada. Clinical Trials Randomized clinical trials with meloxicam have NOT been designed to detect differences in cardiovascular adverse events in a chronic setting.
Prospective, long-term studies required to compare the incidence of serious clinically significant upper gastrointestinal adverse events among patients taking meloxicam versus other NSAID products have not been performed. 181 The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a double-blind controlled trial involving a total of 774 patients randomized and treated with meloxicam (N=464), placebo (N=157) or diclofenac (N=153) for 12 weeks.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed with symptomatic and supportive care following an NSAID overdose. In cases of acute overdose, gastric lavage followed by activated charcoal is recommended. Gastric lavage performed more than one hour after overdose has little benefit in the treatment of overdose.
Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of meloxicam by 4 gm oral doses of cholestyramine given three times a day was demonstrated in a clinical trial.
Administration of cholestyramine may be useful following an overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For management of a suspected drug overdose, contact your regional poison control centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action TEVA-MELOXICAM – Product Monograph Page 30 of 47 Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in animals.
Meloxicam showed potent anti-inflammatory activity in all standard models of inflammation. NSAIDs are believed to exert their pharmacologic effects primarily through inhibition of the enzyme cyclooxygenase (COX). In turn, inhibition of this enzyme leads to an inhibition of biosynthesis of prostaglandins and other autacoids, substances which are potent biological mediators involved in diverse physiologic functions as well as pathologic conditions.
To date, two isozymes of COX have been identified and characterized, namely, COX- 1 and COX-2 which have different intrinsic properties, expression controls and localization. COX-1, the constitutive form, has been described as a constitutive enzyme occurring in many tissues including the gastrointestinal tract, kidney, lungs, brain and platelets.
COX-1 is found in blood vessels, platelets, stomach and kidney. In contrast, COX-2, the inducible form, is mostly an inducible enzyme, limited in distribution and expressed in high levels in inflamed tissues. COX- 2 is thought to be involved in inflammatory responses.
Recent studies have shown that differential inhibition of these two isozymes is associated with a different biological profile. Meloxicam has shown a selective inhibition of COX-2 in several in vitro test systems, as demonstrated by a greater dose dependent inhibition of COX-2 over COX-1 at levels similar to those seen in plasma at therapeutic steady state concentrations.
The prostaglandins produced by the cyclooxygenases are not the only factors involved in the protection of the gastric mucosa. A human pharmacology […]
TEVA-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.
TEVA-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.
TEVA-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).
4 mg lactose per maximum recommended daily dose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine. 7 mg lactose per maximum recommended daily dose.
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 TEVA-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 TEVA-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) TEVA-MELOXICAM – Product Monograph Page 7 of 47 Use of NSAIDs, such as TEVA-MELOXICAM, can lead to new hypertension or can worsen pre-existing hypertension, either of which may increase the risk of cardiovascular events as described above.
Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing TEVA-MELOXICAM should hypertension either develop or worsen with its use. Use of NSAIDs, such as TEVA-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:
TEVA-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 […]
5 mg and 15 mg daily) was compared to placebo and diclofenac (100 mg) (refer to Table 5). The four primary endpoints were investigator’s global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function and stiffness) (refer to Table 6).
5 mg daily and meloxicam 15 mg daily showed significant improvement in each of these endpoints compared with placebo (refer to Table 6). 5 mg in the treatment of rheumatoid arthritis was also performed to investigate the full dose range of meloxicam in one trial (refer to Table 5).
5 mg, 15 mg, 22 mg) (N=536) or diclofenac (2 x 75 mg) (N=181) (refer to Table 5). Diclofenac 2 x 75 mg was included as active control to assess trial sensitivity. 5 mg were statistically superior to placebo in all primary endpoints, whereas 15 mg was statistically superior in three out of five primary endpoints (refer to Table 6).
Diclofenac was superior to placebo in four of the five primary endpoints. All active treatments were significantly superior to placebo in secondary endpoints such as withdrawal due to lack of efficacy, patient’s and investigator’s final global assessment of efficacy, the patient’s assessment of status with regard to a change in the arthritic condition and after adjustment for baseline also for the modified health assessment questionnaire.
5 mg may be a valuable dose for the treatment of RA but that acute flares might require a higher starting dose.
Study demographics and trial design Table 5:
Summary of Patient Demographics for Clinical Trials in Osteoarthritis and Rheumatoid Arthritis Study # […]