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meloxicam 7.5 mg tablet

In stock Manufacturer UNICHEM PHARMAC 29300012410
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Uses

Meloxicam is used for anti-inflammatory and analgesic effects in the symptomatic treatment of osteoarthritis or rheumatoid arthritis in adults and for the management of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in children 2 years of age or older.

The potential benefits and risks of meloxicam therapy as well as alternative therapies should be considered prior to initiating meloxicam therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.

Osteoarthritis

Meloxicam is used in the symptomatic treatment of osteoarthritis (OA) in adults. Efficacy for the management of the signs and symptoms of OA (e.g., pain, stiffness, quality of life) of the knee or hip has been established in controlled studies of 4 weeks' to 6 months' duration in adults. Efficacy of 7.5 or 15 mg once daily was comparable to that of piroxicam 20 mg daily or 100 mg daily of conventional or extended-release diclofenac. Meloxicam has not been compared with celecoxib in patients with osteoarthritis.

Rheumatoid Arthritis in Adults

Meloxicam is used for the management of the signs and symptoms of rheumatoid arthritis in adults. In the management of rheumatoid arthritis in adults, NSAIAs may be useful for initial symptomatic treatment; however, NSAIAs do not alter the course of the disease or prevent joint destruction.

Efficacy of meloxicam for the management of rheumatoid arthritis was established in a placebo-controlled, double-blind study of 12 weeks' duration; the primary measure of clinical response in this study was the American College of Rheumatology criteria for a 20% improvement (ACR 20 response) in measures of disease activity. An ACR 20 response is achieved if the patient experiences a 20% improvement in the number of tender and swollen joints and a 20% or greater improvement in at least 3 of the following criteria: patient pain assessment, patient global assessment, physician global assessment, patient self-assessed disability, or laboratory measures of disease activity (i.e., erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP] level). In this study, meloxicam 7.5 or 15 mg daily was substantially more effective than placebo as evaluated by ACR 20 response; the 22. 5-mg daily dosage provided no additional benefit compared with 15 mg daily.

Juvenile Arthritis

Meloxicam is used for the management of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in children 2 years of age or older. Efficacy of meloxicam was established in 2 double-blind, active-controlled studies of 12 weeks' duration; response rates were determined according to the American College of Rheumatology pediatric 30% improvement criteria (ACR pediatric 30; a composite of parent and investigator assessments, number of active joints, number of joints with limited range of motion, disability index, and ESR). Results of these studies indicate that meloxicam is as effective as naproxen in the treatment of juvenile rheumatoid arthritis. In one study, response rates (ACR pediatric 30 criteria) of 77, 76, or 74% were achieved at 12 months in children receiving meloxicam 0.125 mg/kg daily, meloxicam 0.25 mg/kg daily, or naproxen 10 mg/kg daily, respectively.

Other Uses

Meloxicam also has been used in the management of ankylosing spondylitis.

Dosage and Administration

General

The potential benefits and risks of meloxicam therapy as well as alternative therapies should be considered prior to initiating meloxicam therapy.

Administration

Meloxicam is administered orally once daily, without regard to meals or antacids. The manufacturer states that commercially available meloxicam tablets and oral suspension are bioequivalent. Meloxicam oral suspension should be shaken well prior to dispensing of each dose.

Dosage

The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed. Dosage of meloxicam must be carefully adjusted according to individual requirements and response, using the lowest possible effective dosage.

The initial and maintenance dosage of meloxicam for the management of osteoarthritis or rheumatoid arthritis in adults is 7.5 mg once daily. Titration to a maximum dosage of 15 mg once daily may provide additional benefit. Higher dosages (e.g., 22.5 mg daily or greater) were associated with increased adverse GI effects, and the manufacturer recommends that the dosage of meloxicam not exceed 15 mg daily.

For the symptomatic management of juvenile rheumatoid arthritis, the recommended dosage of meloxicam is 0.125 mg/kg (maximum 7.5 mg) once daily. Higher dosages evaluated in clinical studies were not associated with additional benefit.To improve dosing accuracy, meloxicam oral suspension preferably should be used in children who weigh less than 60 kg.

Special Populations

No dosage adjustment is necessary in patients with mild-to-moderate hepatic or renal impairment. Use in patients with severe renal impairment is not recommended. Patients with severe hepatic impairment have not been studied.

Cautions

Contraindications

Known hypersensitivity to meloxicam or any ingredient in the formulation. History of urticaria, angioedema, bronchospasm, severe rhinitis, or shock precipitated by aspirin or other nonsteroidal anti-inflammatory agents (NSAIAs). History of aspirin triad (aspirin sensitivity, asthma, and nasal polyps). In the setting of coronary artery bypass graft (CABG) surgery.

Warnings/Precautions

Warnings

Cardiovascular Effects

NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors and prototypical NSAIAs, increase the risk of serious adverse cardiovascular thrombotic events, including myocardial infarction and stroke (which can be fatal), in patients with or without cardiovascular disease or risk factors for cardiovascular disease.

Findings of an FDA review of published observational studies of NSAIAs, a meta-analysis of published and unpublished data from randomized controlled trials of these drugs, and other published information indicate that NSAIAs may increase the risk of serious adverse cardiovascular thrombotic events by 10-50% or more, depending on the drugs and dosages studied. Available data suggest that the increase in risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use. Although the relative increase in cardiovascular risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.

Results from observational studies utilizing Danish national registry data indicated that patients receiving NSAIAs following a myocardial infarction were at increased risk of reinfarction, cardiovascular-related death, and all-cause mortality beginning in the first week of treatment. Patients who received NSAIAs following myocardial infarction had a higher 1-year mortality rate compared with those who did not receive NSAIAs (20 versus 12 deaths per 100 person-years). Although the absolute mortality rate declined somewhat after the first year following the myocardial infarction, the increased relative risk of death in patients who received NSAIAs persisted over at least the next 4 years of follow-up. Some clinicians suggest that it may be prudent to avoid use of NSAIAs whenever possible in patients with cardiovascular disease. Meloxicam should be avoided in patients with recent myocardial infarction unless the benefits of therapy are expected to outweigh the risk of recurrent cardiovascular thrombotic events; if meloxicam is used in such patients, the patient should be monitored for cardiac ischemia.

In 2 large controlled clinical trials of a selective COX-2 inhibitor for the management of pain in the first 10-14 days following CABG surgery, the incidence of myocardial infarction and stroke was increased. Therefore, NSAIAs are contraindicated in the setting of CABG surgery.

Findings from some systematic reviews of controlled observational studies and meta-analyses of data from randomized studies of NSAIAs suggest that naproxen may be associated with a lower risk of cardiovascular thrombotic events compared with other NSAIAs. However, limitations of these observational studies and the indirect comparisons used to assess cardiovascular risk of the prototypical NSAIAs (e.g., variability in patients' risk factors, comorbid conditions, concomitant drug therapy, drug interactions, dosage, and duration of therapy) affect the validity of the comparisons; in addition, these studies were not designed to demonstrate superior safety of one NSAIA compared with another. Therefore, FDA states that definitive conclusions regarding relative risks of NSAIAs are not possible at this time.

To minimize the potential risk of adverse cardiovascular events, NSAIAs should be used at the lowest effective dosage and for the shortest possible duration of therapy. Patients receiving NSAIAs (including those without previous symptoms of cardiovascular disease) should be monitored for the possible development of cardiovascular events throughout therapy.

There is no consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs.

Hypertension

Use of NSAIAs, including meloxicam, can result in the onset of hypertension or worsening of preexisting hypertension; either of these occurrences may contribute to the increased incidence of cardiovascular events. Patients receiving NSAIAs may have an impaired response to diuretics (i.e., thiazide or loop diuretics), angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, or β-adrenergic blocking agents. NSAIAs, including meloxicam, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during initiation of meloxicam therapy and throughout therapy.

Heart Failure and Edema

Data from observational studies indicate that use of NSAIAs in patients with heart failure is associated with increased morbidity and mortality. Results from a retrospective study utilizing Danish national registry data indicated that use of selective COX-2 inhibitors or prototypical NSAIAs in patients with chronic heart failure was associated with a dose-dependent increase in the risk of death and an increased risk of hospitalization for myocardial infarction or heart failure. In addition, findings from a meta-analysis of published and unpublished data from randomized controlled trials of NSAIAs indicated that use of selective COX-2 inhibitors or prototypical NSAIAs was associated with an approximate twofold increase in the risk of hospitalization for heart failure. Fluid retention and edema also have been observed in some patients receiving NSAIAs. Use of NSAIAs may diminish the cardiovascular effects of certain drugs used to treat these conditions (e.g., diuretics, ACE inhibitors, angiotensin II receptor antagonists).(See Drug Interactions.)

The manufacturer states that meloxicam should be avoided in patients with severe heart failure unless the benefits of therapy are expected to outweigh the risk of worsening heart failure; if meloxicam is used in such patients, the patient should be monitored for worsening heart failure. Some experts state that use of NSAIAs should be avoided whenever possible in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.

GI Effects

Risk of serious GI effects (e.g., bleeding, ulceration, perforation), which can occur at any time with or without warning signs or symptoms. Conditions or concomitant therapies that may increase risk include a history of GI bleeding or ulceration, longer duration of NSAIA therapy, treatment with anticoagulants or oral corticosteroids, smoking, alcohol dependence, poor general health, or older age (higher risk of fatal GI complications). Use with extreme caution in these patients. In some clinical studies, meloxicam was associated with a lower incidence of adverse GI effects compared with other NSAIAs (e.g., diclofenac, naproxen, piroxicam).

Renal Effects

Renal papillary necrosis or other renal medullary changes may occur with long-term administration of NSAIAs. Possibility of overt renal decompensation in patients dependent on renal prostaglandins for maintenance of renal perfusion. Patients at particular risk include those with heart failure, hepatic or renal dysfunction, or dehydration; those receiving a diuretic, ACE inhibitor, or angiotensin II antagonist; and geriatric patients. Recovery of renal function to pretreatment levels usually occurs following discontinuance of NSAIA therapy.

Sensitivity Reactions

Sensitivity reactions, including anaphylactoid reactions, possible in patients without prior exposure to meloxicam. Immediate medical intervention and drug discontinuance required. Cross-sensitivity may exist with other NSAIAs.

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur in patients receiving meloxicam. These serious skin reactions may occur without warning. Discontinue meloxicam at the first appearance of rash or any other sign of hypersensitivity.

General Precautions

Provide the medication guide for NSAIAs to the patient each time the drug is dispensed.

Hepatic Effects

Borderline elevations of one or more liver function tests may occur in up to 15% of patients treated with NSAIAs, including meloxicam; meaningful (3 times the upper limit of normal) elevations of serum ALT (SGPT) or AST (SGOT) reported in approximately 1% of patients receiving other NSAIAs. Severe, sometimes fatal, reactions (e.g., jaundice, fulminant hepatitis, liver necrosis, hepatic failure) reported rarely in patients receiving NSAIAs. Discontinue use if clinical signs and symptoms occur.

Hematologic Effects

Anemia has been reported, principally in patients receiving long-term (e.g., 6 months' duration) therapy with meloxicam. Notable effects on platelets or bleeding times do not appear to occur.

Other Precautions

May mask certain signs of infection; cannot be used as a substitute for corticosteroid therapy nor used to treat adrenal insufficiency.

Specific Populations

Pregnancy

Category C. Avoid use in the third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Meloxicam is distributed into milk in rats; discontinue nursing or drug because of potential risk in nursing infants.

Pediatric Use

Safety and efficacy not established in children younger than 2 years of age. Safety and efficacy of meloxicam have been established in pediatric patients 2-17 years of age with juvenile rheumatoid arthritis.

Geriatric Use

As with any NSAIA, use with caution.

Severe Renal Impairment

Use not recommended. If meloxicam must be used in patients with advanced renal disease, closely monitor renal function.

Common Adverse Effects

Adverse effects occurring in 2% or more of adults receiving meloxicam include dyspepsia, headache, nausea, diarrhea, upper respiratory tract infection, abdominal pain, dizziness, edema, flatulence, influenza-like illness, musculoskeletal and connective tissue signs and symptoms (back pain, muscle spasms, musculoskeletal pain), and rash.

The most common adverse effects reported in pediatric patients include abdominal pain, vomiting, diarrhea, headache, and pyrexia.

Drug Interactions

ACE Inhibitors and Angiotensin II Receptor Antagonists

Potential pharmacologic interaction (antagonized antihypertensive effects).

Bile Acid Sequestrants

Pharmacokinetic interaction (increased meloxicam clearance; clinical importance not established) when meloxicam is used with bile acid sequestrants (e.g., cholestyramine).

Cimetidine

Pharmacokinetic interaction unlikely.

Digoxin

Pharmacokinetic interaction unlikely.

Diuretics

Patients receiving diuretics may have an increased risk of developing renal failure secondary to decreased renal blood flow resulting from prostaglandin inhibition by NSAIAs. NSAIAs may reduce the natriuretic effects of furosemide and thiazides. Observe patient for signs of renal failure and for diuretic efficacy.

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP2C9 or 3A4; interaction unlikely.

Lithium

Pharmacokinetic interaction (increased plasma lithium concentration).

Methotrexate

Potential pharmacokinetic interaction (enhanced toxicity of methotrexate resulting from inhibition of methotrexate renal elimination). No interaction was observed in a study of 12 adults with arthritis receiving concomitant methotrexate (weekly) and meloxicam; however, caution advised with concomitant use of NSAIAs and methotrexate.

Aspirin

Concomitant use of aspirin increases serum meloxicam concentrations; clinical importance of this interaction is unknown. Concomitant use of aspirin and an NSAIA increases the risk for serious GI events. Because of the potential for increased adverse effects, concurrent use of meloxicam and aspirin generally is not recommended. Meloxicam is not a substitute for aspirin for cardioprophylaxis. There is no consistent evidence that use of low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs.

Warfarin

The effects of warfarin and NSAIAs on GI bleeding are synergistic. Concomitant use of an NSAIA and warfarin is associated with a higher risk of GI bleeding compared with use of either agent alone. Caution advised if meloxicam is used concomitantly with warfarin.

Potential pharmacologic interaction (increased adverse effects [e.g., bleeding], potential [though less likely] increased prothrombin time/INR).

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