Instructions for use MELOXICAM-MAXPHARMA


Meloxicam STADA (tablets)

Meloxicam is intended for symptomatic therapy and should not be taken to prevent exacerbation of diseases.

Caution should be exercised when treating patients with a history of gastrointestinal diseases and in patients receiving anticoagulants. Patients experiencing gastrointestinal symptoms should be monitored regularly. Periodic monitoring of blood clotting parameters is necessary. If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, meloxicam should be discontinued.

If allergic reactions (itching, urticaria, skin rash, photosensitivity) occur during treatment, you should consult a doctor to decide whether to stop taking the drug.

The use of NSAIDs in patients with reduced renal blood flow or reduced circulating blood volume may lead to decompensation of latent renal failure. After discontinuation of NSAIDs, renal function usually returns to baseline levels. Elderly patients are most at risk of developing this reaction; patients who experience dehydration; patients with congestive heart failure, liver cirrhosis, nephrotic syndrome or kidney disease; patients receiving diuretics, ACE inhibitors, angiotensin II receptor antagonists; as well as patients who have undergone major surgical procedures leading to hypovolemia. In such patients, diuresis and renal function should be carefully monitored when initiating therapy.

The increase in transaminase activity is usually transient and insignificant. If there is a significant and persistent increase in transaminase activity, meloxicam should be discontinued and liver function monitored.

Weakened or malnourished patients may be less able to tolerate adverse events and such patients should be monitored closely. Caution should be used when treating elderly patients who are more likely to have impaired renal, hepatic and cardiac function.

The use of NSAIDs in combination with diuretics can lead to sodium, potassium and water retention, and affect the natriuretic effect of diuretics. As a result, predisposed patients may experience increased signs of heart failure or hypertension.

Meloxicam, like other NSAIDs, can mask the symptoms of an infectious disease.

The use of meloxicam, like other drugs that block prostaglandin synthesis, can affect fertility, so the drug is not recommended for women wishing to become pregnant.

Revmart, 15 mg, tablets, 20 pcs.

Risk of developing hyperkalemia.

Drugs of the following pharmacological groups can cause hyperkalemia when used together with meloxicam: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARA II), NSAIDs, unfractionated and low molecular weight heparin, cyclosporines, tacrolimus and trimethoprim.

Pharmacodynamic interactions:

When meloxicam is used simultaneously with other NSAIDs, including salicylates (acetylsalicylic acid), and glucocorticoids, the risk of erosive and ulcerative lesions of the gastrointestinal tract and gastrointestinal bleeding increases due to the synergistic action (inhibition of prostaglandin synthesis). The simultaneous use of meloxicam and other NSAIDs is not recommended. Anticoagulants for oral administration, heparin for systemic use, and thrombolytic agents when used simultaneously with meloxicam increase the risk of bleeding. In case of simultaneous use, careful monitoring of blood coagulation parameters is necessary. Antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs) when used concomitantly with meloxicam increase the risk of bleeding due to inhibition of platelet function. In case of simultaneous use, careful monitoring of blood coagulation parameters is necessary. Meloxicam reduces the effect of antihypertensive drugs (beta-blockers, ACE inhibitors, vasodilators, diuretics) due to inhibition of the synthesis of prostaglandins, which have vasodilating properties. The use of NSAIDs (including meloxicam) while taking diuretics in case of dehydration of patients is accompanied by a risk of developing acute renal failure. Adequate hydration should be maintained in patients receiving meloxicam and diuretics. Before starting treatment, a kidney function test is necessary. The combined use of NSAIDs and ARA II, as well as ACE inhibitors, enhances the effect of reducing glomerular filtration. This may lead to the development of acute renal failure, especially in patients with impaired renal function. Meloxicam, by exerting an inhibitory effect on the synthesis of renal prostaglandins, may enhance the nephrotoxicity of cyclosporine. In case of combination therapy, renal function should be regularly monitored, especially in elderly patients. In patients with a creatinine clearance of 45 to 79 mL/min, meloxicam should be discontinued 5 days before starting pemetrexed and possibly restarted 2 days after stopping pemetrexed. If there is a need for concomitant use of meloxicam and pemetrexed, patients should be carefully monitored, especially for myelosuppression and the occurrence of gastrointestinal side effects. In patients with creatinine clearance <45 ml/min, the use of meloxicam with pemetrexed is not recommended. NSAIDs should be started no earlier than 8-12 days after taking mefiprestone, as NSAIDs may reduce the effectiveness of mefiprestone.

Pharmacokinetic interactions:

NSAIDs increase plasma lithium concentrations by decreasing renal excretion. Plasma lithium concentrations can reach toxic levels. The simultaneous use of meloxicam with lithium preparations is not recommended. If simultaneous use is necessary, careful monitoring of plasma lithium concentrations is recommended throughout the course of lithium use. NSAIDs may decrease tubular secretion of methotrexate and thereby increase plasma concentrations of methotrexate. The simultaneous use of meloxicam and methotrexate (at a dose of more than 15 mg per week) is not recommended. The risk of interaction with concomitant use of methotrexate and meloxicam is also possible in patients receiving low doses of methotrexate, especially in patients with impaired renal function. Meloxicam may increase the hematological toxicity of methotrexate, especially in patients with impaired renal function. In case of simultaneous use, careful monitoring of renal function and blood count is necessary. Caution must be exercised if meloxicam and methotrexate are used together for 3 days, because The plasma concentration of methotrexate may increase and, as a result, the risk of toxic effects increases. Concomitant use of meloxicam did not affect the pharmacokinetics of methotrexate at a dose of 15 mg per week, however, it should be taken into account that the hematological toxicity of methotrexate is enhanced by concomitant use of NSAIDs. When co-administering medicinal products with meloxicam that are known to inhibit CYP2C9 and/or CYP3A4 (or are metabolized by these enzymes), such as sulfonylureas or probenecid, the possibility of pharmacokinetic interaction should be taken into account. When used concomitantly with oral hypoglycemic agents (eg, sulfonylureas, nateglinide), a CYP2C9-mediated interaction is possible, which may lead to increased blood concentrations of both the hypoglycemic agents and meloxicam. Patients taking meloxicam concomitantly with a sulfonylurea or nateglinide should carefully monitor blood glucose concentrations due to the potential for hypoglycemia. Cholestyramine, by binding meloxicam in the gastrointestinal tract, leads to its faster elimination. With simultaneous use of meloxicam with antacids, cimetidine, digoxin and furosemide, no significant pharmacokinetic interaction was detected. Previously, it was reported that the effectiveness of intrauterine contraceptives was reduced when using NSAIDs. This observation requires further confirmation.

Instructions for use MELOXICAM-MAXPHARMA

Gastrointestinal tract

Use of NSAIDs may cause serious gastrointestinal toxic reactions such as inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine at any time, with or without warning symptoms. Minor upper GI problems such as dyspepsia are common and may also occur at any time during NSAID therapy. Therefore, doctors and patients should be prepared for the appearance of ulcers and bleeding, even in the absence of past gastrointestinal symptoms.

As with other NSAIDs, meloxicam should be prescribed with extreme caution to patients with a history of peptic ulcers and gastrointestinal bleeding. Caution should be exercised when treating elderly and debilitated patients. It is recommended to start therapy with the lowest effective dose and carry out treatment as soon as possible. Alternative therapy without the use of NSAIDs should be explored in patients at increased risk.

Anaphylactic reactions

There are known cases of anaphylactic reactions in patients who have not taken meloxicam in the past. Therefore, meloxicam should not be used in patients taking aspirin triad drugs. Emergency medical care should be provided if an anaphylactic reaction occurs.

Kidney disease

The use of meloxicam is not recommended for advanced kidney disease. If therapy is necessary, close monitoring of renal function should be performed.

Children

The effectiveness and safety of meloxicam have not been established in patients under 18 years of age.

Aged people

Caution should be exercised when treating elderly people (65 years and older) with meloxicam.

Meloxicam is not a substitute for corticosteroids and is not intended for the treatment of corticosteroid deficiency. Therefore, corticosteroid therapy should be tapered slowly if the decision is made to discontinue corticosteroids.

As with other NSAIDs, increases in one or more liver tests may occur after taking meloxicam. These laboratory abnormalities may progress, may remain unchanged, or may be reversible with continued therapy. Patients exhibiting signs and/or symptoms suggestive of liver dysfunction should be evaluated to rule out the development of more serious liver dysfunction while taking meloxicam. If clinical signs and symptoms indicate progression of liver disease or if systemic manifestations (eg, eosinophilia or rash) are observed, meloxicam should be discontinued.

Caution should be exercised when initiating treatment with meloxicam in patients with significant dehydration. It is recommended to first rehydrate the patient and then begin treatment with meloxicam. Caution should be exercised when taking meloxicam in patients with a history of kidney disease, impaired renal function, heart failure, liver dysfunction, taking diuretics and ACE inhibitors, as well as in elderly patients. There are known cases of anemia when taking meloxicam for a long time. Therefore, it is recommended to check hemoglobin or hematocrit in patients taking meloxicam for a long time and who exhibit any signs or symptoms of anemia. Meloxicam does not generally affect platelet count, prothrombin time, or partial thromboplastin time. When taking meloxicam, patients who show signs of changes in platelet status, such as bleeding disorders, or patients taking anticoagulants should be closely monitored.

As with other NSAIDs, caution should be exercised when taking meloxicam in patients with fluid retention, hypertension, or heart failure.

Some patients may develop aspirin-induced asthma. Use of aspirin by patients with aspirin-induced asthma is associated with severe bronchospasm, which can be fatal. Since there are known cases of cross-reactivity, including bronchospasm, between aspirin and other NSAIDs, such aspirin-sensitive patients should not take meloxicam. Meloxicam should be used with caution in patients with a history of asthma.

For patients taking NSAIDs for a long time, a complete blood count and chemical profile should be performed periodically.

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