Meloxicam in the treatment of chronic diseases of the musculoskeletal system

Contraindications for use

The use of the drug is contraindicated in the following cases:

• third trimester of pregnancy and lactation (see section 4.6)
• children and adolescents under 18 years of age
• hypersensitivity to meloxicam or to any of the excipients listed in section 6.1, or to a substance with a similar effect, for example, to drugs from the NSAID group (non-steroidal anti-inflammatory drugs), acetylsalicylic acid. Meloxicam should not be used in patients with asthma symptoms, nasal polyps, angioedema and urticaria associated with the administration of acetylsalicylic acid or other NSAIDs.
• history of gastrointestinal bleeding or gastrointestinal perforation that has been associated with NSAID use
• active gastric and/or duodenal ulcer or history of recurrent ulcers and bleeding (two or more cases of confirmed ulceration or bleeding)
• severe liver dysfunction
• severe renal impairment in patients not on hemodialysis
• history of gastrointestinal bleeding and cerebral hemorrhage or other bleeding conditions
• hemostasis disorders or simultaneous use of anticoagulants (contraindications related to the method of drug administration)
• severe heart failure
• perioperative treatment of pain during vascular bypass surgery (by-pass surgery).

Instructions for use MELOXIPOL

Before starting to use Meloxipol, you must make sure that the patient does not currently have an exacerbation of esophagitis, gastritis or gastric ulcer.

The drug is prescribed with caution to patients with a history of gastrointestinal diseases, as this may worsen the condition. Medical supervision should be established to check for the appearance of symptoms of relapse of gastrointestinal diseases in such patients, especially signs of bleeding from the gastrointestinal tract.

If peptic ulcers or gastrointestinal bleeding occur, Meloxipol should be discontinued.

The risk of gastrointestinal bleeding, ulceration and perforation increases with increasing dose of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, as well as in elderly patients. In these patients, therapy should be started with the lowest possible doses. In this group of patients and in patients who require concomitant therapy with low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal bleeding, combination therapy with drugs that have a protective effect on the gastric mucosa (such as misoprostol) should also be considered. or proton pump inhibitors).

Caution should be exercised in patients receiving concomitant therapy with drugs that can increase the risk of ulceration or bleeding (corticosteroids, anticoagulants, selective serotonin reuptake inhibitors and antiplatelet agents).

There are extremely rare reports of serious skin reactions associated with NSAID therapy, some of which have been fatal. The maximum risk of developing these reactions in patients is observed at the initial stage of treatment; in most cases, these reactions developed in the first month of therapy. When the first signs of skin rash, damage to the mucous membranes or any other signs of hypersensitivity appear, treatment with Meloxipol must be interrupted.

In rare cases, NSAIDs may cause interstitial nephritis, glomerulonephritis, renal medulla necrosis, or nephrotic syndrome.

In rare cases, increased levels of serum transaminases or changes in other indicators of liver function have been reported. In most cases, deviations from the norm were minor and transient. If the disturbances in liver function indicators are more pronounced or permanent, you should stop taking Meloxipol and carry out control laboratory tests.

NSAIDs may promote sodium, potassium and water retention and reduce the natriuretic effect of diuretics. As a result, in the presence of predisposing factors, the administration of NSAIDs can lead to the progression of heart failure and hypertension.

NSAIDs inhibit the synthesis of renal prostaglandins, which are involved in maintaining sufficient levels of renal blood flow. Therefore, there is a risk of developing renal decompensation when prescribing NSAIDs to patients with reduced renal blood flow or volume (as a rule, renal function is restored after discontinuation of therapy). However, this fact should be taken into account when prescribing Meloxipol to patients with dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome, severe kidney disease, as well as patients taking diuretics who have undergone surgery leading to hypovolemia. In such patients, diuresis and renal function should be monitored from the very beginning of treatment.

Weakened and debilitated patients, as well as elderly patients, may tolerate side effects worse; such patients require careful monitoring. Meloxipol should be used with caution in elderly patients, who are more likely to have impaired renal, hepatic or cardiac function.

In case of insufficient therapeutic effect, the recommended maximum daily dose should not be exceeded, nor should another NSAID, including selective COX-2 inhibitors, be added to treatment. Adverse events can be minimized by using the minimum effective dose for the minimum period necessary to control the corresponding symptoms.

Use in pediatrics

Safety and effectiveness of Meloxipol in children under 15 years of age

have not been determined.

Impact on the ability to drive vehicles and operate machinery

No special studies have been conducted. However, in the event of impaired visual acuity, drowsiness, dizziness or other disorders of the central nervous system, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Side effects

Meloxicam

Other prostaglandin synthesis inhibitors, including glucocorticoids and salicylates, when taken concomitantly with meloxicam, increase the risk of gastrointestinal ulceration and gastrointestinal bleeding (due to synergistic action) and are therefore not recommended.

Concomitant use with other NSAIDs is not recommended.

Anticoagulants for oral administration, heparin for systemic use, thrombolytic agents. Concomitant use with meloxicam increases the risk of bleeding. In case of simultaneous use, careful monitoring of the blood coagulation system is necessary.

Lithium preparations. NSAIDs increase the concentration of lithium in the blood plasma by reducing its excretion by the kidneys. It is recommended to monitor lithium concentrations during the period of meloxicam administration when changing the dose of lithium preparations and their discontinuation.

Methotrexate. NSAIDs reduce the secretion of methotrexate by the kidneys, thereby increasing its concentration in the blood plasma. The simultaneous use of meloxicam and methotrexate (at a dose of more than 15 mg per week) is not recommended. In case of simultaneous use, careful monitoring of renal function and blood count is necessary. Meloxicam may increase the hematological toxicity of methotrexate, especially in patients with impaired renal function.

Contraception. There is evidence that NSAIDs may reduce the effectiveness of intrauterine contraceptive devices, but this has not been proven.

Diuretics. The use of NSAIDs in case of dehydration of patients is accompanied by the risk of developing acute renal failure.

Antihypertensive drugs (beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, vasodilators, diuretics). NSAIDs reduce the effect of antihypertensive drugs due to inhibition of prostaglandins, which have vasodilating properties.

Angiotensin-II receptor antagonists, as well as angiotensin-converting enzyme inhibitors, when used together with NSAIDs, increase the decrease in glomerular filtration, which can thereby lead to the development of acute renal failure, especially in patients with impaired renal function.

Cholestyramine, by binding meloxicam in the gastrointestinal tract, leads to its faster elimination.

Pemetrexed. When meloxicam and pemetrexed are used concomitantly in patients with a clearance of 45 to 79 mL/min, meloxicam should be discontinued five days before starting pemetrexed and possibly resumed 2 days after the end of treatment. If concomitant use of meloxicam and pemetrexed is necessary, patients should be closely monitored, particularly for myelosuppression and gastrointestinal side effects. In patients with creatinine clearance less than 45 ml/min, taking meloxicam with pemetrexed is not recommended. NSAIDs, by acting on renal prostaglandins, may enhance the nephrotoxicity of cyclosporine.

When medicinal products known to inhibit CYP2C9 and/or CYP3A4 (or are metabolized by these enzymes), such as sulfonylureas or probenecid, are used concomitantly with meloxicam, the possibility of pharmacokinetic interaction should be taken into account. When used together with oral antidiabetic agents (eg, sulfonylureas, nateglinide), interactions mediated by CYP2C9 are possible, which may lead to increased concentrations of both these drugs and meloxicam in the blood. Patients taking meloxicam concomitantly with a sulfonylurea or nateglinide should monitor their blood sugar carefully due to the potential for hypoglycemia.

With the simultaneous use of antacids, cimetidine, digoxin and furosemide, no significant pharmacokinetic interactions were identified.

Mode of application

Doses

Single administration of 15 mg per day.

MAXIMUM RECOMMENDED DAILY DOSE – 15 mg.

Treatment should be limited to a single dose of the drug; in exceptional cases, the course of treatment can be extended to 2-3 days (for example, when the drug cannot be administered orally or rectally). Adverse reactions can be minimized by using the lowest effective dose for the shortest period necessary to relieve symptoms (see section 4.4).

It is necessary to periodically monitor the patient's response to treatment and determine the degree of demand for symptomatic therapy.

Elderly patients and patients at increased risk of adverse reactions

The recommended daily dose for elderly patients is 7.5 mg. In patients at increased risk of adverse reactions, treatment should be started with a dose of 7.5 mg per day (½ 1.5 ml ampoule) (see section 4.4).

Patients with impaired renal function

In patients with severe renal impairment undergoing hemodialysis, the daily dose of the drug should not exceed 7.5 mg (½ 1.5 ml ampoule).

In patients with mild or moderate renal impairment and creatinine clearance above 25 ml/min, no dose adjustment is required.

Use in patients with severe renal impairment not on hemodialysis is contraindicated (see section 4.3).

Patients with liver dysfunction

In patients with mild or moderate liver dysfunction, no dose adjustment is required.

Use in patients with severe hepatic impairment is contraindicated (see section 4.3).

Children and teenagers:

Meloxipol 15 mg/1.5 ml injection solution is contraindicated for use in children and adolescents under 18 years of age (see section 4.3).

Intramuscularly.

The drug is administered slowly through a deep intramuscular injection into the upper outer quadrant of the buttock under strict aseptic conditions. If it is necessary to re-administer the drug, it is recommended to perform an injection into the second buttock. Before administering the drug, you need to make sure that the needle does not enter a blood vessel.

If severe pain occurs during injection, administration of the drug should be stopped immediately.

In patients with a hip joint endoprosthesis, the drug must be administered in the opposite direction.

To continue treatment, you should use the oral route (tablets).

Meloxicam-LF tablets 7.5 mg No. 10x2

Name

Meloxicam-lf

Description

Tablets are light yellow or yellow in color, flat-cylindrical in shape, with a chamfer and a score. Marbling on the surface of the tablets is allowed.

Main active ingredient

Meloxicam

Release form

tablets 10 tablets each in a blister pack made of polyvinyl chloride film and aluminum foil. One or two blister packs along with instructions for medical use in a cardboard pack.

Dosage

7.5 mg

Pharmacodynamics

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, which has anti-inflammatory, analgesic and antipyretic properties. The anti-inflammatory activity of meloxicam has been demonstrated in classical models of inflammation. As with other NSAIDs, the exact mechanism of action remains unknown. However, there is at least one common mechanism of action that is common to all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, known as mediators of inflammation.

Pharmacokinetics

Absorption Meloxicam is well absorbed from the gastrointestinal tract, which is reflected in its high absolute bioavailability (about 90% after oral administration). After a single dose of meloxicam, average maximum plasma concentrations are reached within 5-6 hours after taking solid oral dosage forms (tablets, capsules). With repeated use, equilibrium pharmacokinetics were achieved within 3-5 days. Administration of a single daily dose provides plasma concentrations of meloxicam with a relatively small peak fluctuation in the range of 0.4-1.0 mcg/ml for a dosage of 7.5 mg and 0.8-2.0 mcg/ml for a dosage of 15 mg (respectively Cmin and Cmax in equilibrium). The average maximum concentrations of meloxicam in blood plasma at steady state were achieved within 5-6 hours. The extent of oral absorption of meloxicam was not affected by food intake or the use of inorganic antacids. Distribution Meloxicam binds well to plasma proteins, mainly albumin (99%). Meloxicam penetrates into the synovial fluid, reaching concentrations corresponding to approximately 50% of the concentration in the blood plasma. The volume of distribution after multiple oral doses of meloxicam (7.5 mg to 15 mg) is approximately 16 L, with an interindividual coefficient of variation ranging from 11 to 32%. Metabolism Meloxicam is extensively metabolized in the liver. Four different pharmacodynamically inactive metabolites of meloxicam were detected in urine. The main metabolite 5′-carboxymeloxicam (60% of the administered dose) is formed by oxidation of the intermediate metabolite 5′-hydroxymethylmeloxicam, which is also excreted, but to a lesser extent (9% of the administered dose). In vitro studies have shown that CYP 2C9 plays an important role in this metabolic transformation, and the CYP 3A4 isoenzyme is of additional importance. The activity of peroxidase in the patient's body is likely responsible for the appearance of two other metabolites, which account for 16% and 4% of the administered dose, respectively. Excretion Meloxicam is excreted primarily in the form of metabolites, equally in feces and urine. Less than 5% of the daily dose is excreted unchanged in feces; unchanged meloxicam is found in urine only in trace amounts. The average half-life of meloxicam varies from 13 to 25 hours after oral, intramuscular and intravenous administration. The total plasma clearance is about 7-12 ml/min after a single oral dose. Linearity/non-linearity Linearity of meloxicam pharmacokinetics has been demonstrated at therapeutic doses administered orally or intramuscularly ranging from 7.5 mg to 15 mg. Special groups of patients Patients with hepatic/renal insufficiency Hepatic insufficiency and moderate renal insufficiency do not have a significant effect on the pharmacokinetics of meloxicam. A higher overall clearance of meloxicam was observed in patients with moderate renal impairment. In patients with end-stage renal failure, a decrease in binding to plasma proteins was observed. In end-stage renal failure, an increase in volume of distribution may result in higher concentrations of free meloxicam, so in these patients the daily dose should not exceed 7.5 mg. Elderly Patients Pharmacokinetic parameters for elderly male patients were similar to those for younger male patients. Elderly female patients had a higher AUC and longer half-life compared to younger patients of both sexes. In elderly patients, the average plasma clearance during steady-state pharmacokinetics is slightly lower than in younger patients.

Indications for use

Short-term symptomatic therapy for exacerbation of osteoarthritis; Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

Directions for use and doses

For oral administration. The score on the tablets is intended solely to make one tablet easier to take (by breaking the tablet into two halves) and not to divide the tablet into two doses. The daily dose of meloxicam is taken once during meals with water or other liquid. The likelihood of unwanted effects can be minimized by using the lowest effective dose of the drug for the shortest period of time necessary to control symptoms. The need for therapy and the patient's response to therapy should be periodically assessed, especially in patients with osteoarthritis. Exacerbation of osteoarthritis: 7.5 mg/day (one tablet 7.5 mg). If necessary, in the absence of improvement, the dose can be increased to 15 mg/day (two 7.5 mg tablets or one 15 mg tablet). Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg tablets or one 15 mg tablet). Depending on the severity of the response to therapy, the dosage may be reduced to 7.5 mg/day (one 7.5 mg tablet). Do not exceed the dose of 15 mg/day! Special Populations Elderly Patients and Patients at Increased Risk of Adverse Reactions The recommended dose for long-term treatment of elderly patients with rheumatoid arthritis or ankylosing spondylitis is 7.5 mg per day. Patients with an increased risk of adverse reactions should begin treatment with a dosage of 7.5 mg per day. Patients with impaired renal function In patients with severe renal impairment on dialysis, the dose should not exceed 7.5 mg per day. No dose reduction is required in patients with mild to moderate renal impairment (i.e., patients with creatinine clearance more than 25 ml/min). Patients with hepatic impairment In patients with mild to moderate hepatic impairment, no dose reduction is required. Children and adolescents The drug Meloxicam-LF is contraindicated in children and adolescents under 16 years of age

Use during pregnancy and lactation

Pregnancy Suppression of prostaglandin synthesis may have undesirable effects on pregnancy and fetal development. Data from epidemiological studies indicate an increased risk of spontaneous abortion, heart defects and gastroschisis in the fetus after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of developing cardiovascular defects increased from less than 1% to 1.5%. This risk increases with increasing dose and duration of therapy. In an animal study, it was shown that administration of a prostaglandin synthesis inhibitor leads to an increase in pre- and post-implantation losses and feto-embryonic lethality. In addition, in animals receiving a prostaglandin synthesis inhibitor during the period of organogenesis, an increase in the incidence of various malformations, including those of the cardiovascular system, was recorded. The use of meloxicam during the first and second trimester of pregnancy is not recommended unless absolutely necessary. When using meloxicam by a woman planning a pregnancy, or during the first and second trimester of pregnancy, the dose of the drug should be the smallest and the duration of treatment as short as possible. In the third trimester of pregnancy, the use of any inhibitors of prostaglandin synthesis can lead to the following disorders: In the fetus: due to toxic effects on the cardiopulmonary system - premature closure of the ductus arteriosus and the development of pulmonary hypertension; renal dysfunction with further development of renal failure with oligohydroamniosis. In the mother and newborn, when used at the end of pregnancy: the duration of bleeding may increase, and the antiaggregation effect can develop even at a low dosage; decreased contractility of the uterus, and, as a result, increased duration of labor. Therefore, meloxicam is contraindicated in the third trimester of pregnancy. Breastfeeding Period Despite the lack of data on experience with the use of meloxicam, it is known that NSAIDs pass into breast milk. Therefore, these medications are not recommended during breastfeeding. Fertility Meloxicam, like other drugs that block cyclooxygenase/prostaglandin synthesis, may affect fertility and is therefore not recommended for women planning pregnancy. If the ability to conceive in women is impaired or an examination for infertility is carried out, it is necessary to consider discontinuing meloxicam.

Precautionary measures

Effect on the ability to drive vehicles or potentially dangerous mechanisms. No special studies have been conducted on the effect of the drug on the ability to drive a car or other mechanisms. However, based on the pharmacodynamic profile and observed adverse reactions, meloxicam has no or negligible effect on these activities. However, patients who have experienced visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other central nervous system disturbances, are advised not to drive or operate machinery. Adverse effects can be minimized by administering the lowest effective dose needed to control symptoms for the shortest period of time. In case of insufficient therapeutic effect, you should not exceed the recommended maximum daily dose and/or prescribe additional NSAIDs, because this may lead to increased toxicity in the absence of therapeutic benefit. Concomitant use of meloxicam with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Meloxicam is not suitable for the relief of acute pain. If there is no clinical improvement after several days of taking the drug, it is recommended to re-evaluate the prescribed treatment. It is necessary to ensure that patients with a history of esophagitis, gastritis, and/or peptic ulcers are cured before prescribing meloxicam. Careful monitoring of these patients receiving meloxicam is necessary in order to timely detect relapse of the disease. Effects on the Gastrointestinal Tract As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration or perforation may occur at any time during treatment with or without prior symptoms or a history of serious gastrointestinal disease. The risk of gastrointestinal bleeding, ulceration, and perforation is higher with increasing doses of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should begin with the lowest effective dose. For such patients, combination therapy with protective drugs (such as misoprostol or proton pump inhibitors) should be considered, as well as for patients who require concomitant use of low dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal damage. In patients with a history of gastrointestinal toxicity, especially elderly patients, any unusual abdominal symptoms (especially gastrointestinal bleeding) should be reported, especially during the initial stages of treatment. Caution should be used in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as heparin prescribed for both definitive treatment and geriatric use, anticoagulants such as warfarin, or other nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid in anti-inflammatory doses (≥ 500 mg single dose or ≥ 3 g total daily dose). If gastrointestinal bleeding or ulceration develops in patients using meloxicam, treatment should be discontinued. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated. Effect on the cardiovascular system In patients with arterial hypertension and/or a history of mild to moderate congestive heart failure, careful monitoring is recommended as fluid retention and edema have been observed with NSAID therapy. In patients with risk factors, clinical monitoring of blood pressure is recommended at the beginning of therapy, especially at the beginning of treatment with meloxicam. Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and during long-term treatment) may be associated with a small increased risk of vascular thrombotic events (eg, myocardial infarction or stroke). There are insufficient data to exclude such a risk for meloxicam. Patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should be treated with meloxicam only after careful evaluation of their condition. Such an assessment is necessary before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smokers). Skin reactions Life-threatening severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of meloxicam. Patients should be aware of symptoms and signs and closely monitored for skin reactions. The highest risk of developing Stevens-Johnson syndrome and toxic epidermal necrolysis was observed during the first weeks of treatment. Meloxicam should be discontinued at the first symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (eg, progressive skin rash, often with blisters, or mucosal lesions). The best treatment outcome for Stevens-Johnson syndrome and toxic epidermal necrolysis was observed with early diagnosis and immediate discontinuation of the suspected drug. Early drug discontinuation was associated with a more favorable prognosis. If Stevens-Johnson syndrome or toxic epidermal necrolysis develops while taking it, then meloxicam should not be re-administered to this patient in the future. Liver and kidney function tests As with most NSAIDs, increases in serum transaminases, serum bilirubin or other liver function tests, as well as increases in creatinine, blood urea and other laboratory abnormalities have been reported rarely. In most cases, the violations were temporary and unexpressed. The development of a pronounced deviation of indicators from the norm or their persistence requires stopping the administration of meloxicam and conducting an appropriate examination. Functional renal failure NSAIDs, by inhibiting the vasodilatory effect of renal prostaglandins, can cause the appearance of functional renal failure as a result of a decrease in glomerular filtration. This reaction is dose-dependent. It is recommended to carefully monitor diuresis and renal function at the beginning of treatment or after increasing the dose in patients with the following risk factors: Elderly age; Concomitant therapy with ACE inhibitors, angiotensin II antagonists, sartans, diuretics; Hypovolemia (regardless of the cause); Heart failure; Kidney failure; Nephrotic syndrome; Lupus nephropathy; Severe liver dysfunction (serum albumin

Interaction with other drugs

Drug interaction studies have been conducted in adults only. Risk of hyperkalemia Certain drugs or therapeutic groups may contribute to the development of hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim. The development of hyperkalemia may depend on the presence of risk factors. The risk of developing hyperkalemia increases with simultaneous use of the above drugs and meloxicam. Pharmacodynamic interactions Other NSAIDs and acetylsalicylic acid Concomitant use with other NSAIDs, including acetylsalicylic acid in anti-inflammatory doses (≥ 500 mg once or ≥ 3 g per day) is not recommended. Corticosteroids (eg, glucocorticoids) Caution is advised when used concomitantly with corticoids due to an increased risk of GI bleeding or perforation. Anticoagulants or heparin Significantly increases the risk of bleeding by inhibiting platelet function and damaging the gastric and duodenal mucosa. NSAIDs may enhance the effects of anticoagulants such as warfarin. The simultaneous use of NSAIDs and anticoagulants or heparin in therapeutic doses or in geriatrics is not recommended. In other cases, heparin is prescribed with caution due to the increased risk of bleeding. If it is necessary to prescribe this combination, careful monitoring of the INR is recommended. Thrombolytics and antiplatelet drugs Increase the risk of bleeding by inhibiting platelet function and damaging the gastric and duodenal mucosa. Selective serotonin reuptake inhibitors (SSRIs) Increased risk of gastrointestinal bleeding. Diuretics, ACE inhibitors and angiotensin receptor antagonists NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, those who are dehydrated or elderly patients with impaired renal function), concomitant use of an ACE inhibitor or angiotensin II receptor antagonist and drugs that block cyclooxygenase may lead to a further deterioration of renal function, including the development of acute renal disease. failure, which is usually reversible. Therefore, this combination should be used with caution, especially in old age. In patients, it is necessary to exclude possible dehydration (including latent), and monitor renal function after initiation and periodically during combination therapy. Other antihypertensive drugs (eg, beta-blockers) The antihypertensive effect of beta-blockers may be reduced by inhibiting the synthesis of prostaglandins with a vasodilatory effect. Calcineurin inhibitors (for example, cyclosporine, tacrolimus) Due to the effect of NSAIDs on the synthesis of renal prostaglandins, the nephrotoxicity of calcineurin inhibitors may increase. When carrying out this combination therapy, it is necessary to monitor renal function, especially in elderly patients. Deferasirox Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal side effects. In this regard, these drugs should be taken simultaneously with caution. Pharmacokinetic interactions: effects of meloxicam on the pharmacokinetics of other medicinal products Lithium It has been reported that NSAIDs may increase plasma lithium concentrations (by reducing the renal excretion of lithium), which may reach toxic levels. The simultaneous use of lithium and NSAIDs is not recommended. If combination therapy is necessary, plasma lithium levels should be carefully monitored during treatment initiation, dose adjustment, and discontinuation of meloxicam treatment. Methotrexate NSAIDs can reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration. For this reason, concomitant use of NSAIDs is not recommended in patients taking high doses of methotrexate (more than 15 mg/week). The risk of interaction between NSAIDs and methotrexate should also be considered in patients taking low doses of methotrexate, especially in patients with impaired renal function. If combined treatment is required, it is necessary to monitor blood counts and kidney function. Caution should be exercised if the use of NSAIDs and methotrexate lasts for 3 days, since plasma levels of methotrexate and, accordingly, its toxicity may increase. Although the pharmacokinetics of methotrexate (15 mg/week) was not altered by concomitant treatment with meloxicam, it should be considered that the hematological toxicity of methotrexate may be increased during treatment with NSAIDs. Pemetrexed If meloxicam and pemetrexed are to be used concomitantly in patients with mild to moderate renal impairment (creatinine clearance 45-79 mL/min), meloxicam should not be administered for at least 5 days before pemetrexed administration, on the day of administration, and for 2 days after administration of pemetrexed. If the combination of meloxicam and pemetrexed is necessary, close monitoring of the patient is recommended, especially due to myelosuppression and gastrointestinal side effects. In patients with severe renal impairment (creatinine clearance

Contraindications

Third trimester of pregnancy. Children and adolescents under 16 years of age. Hypersensitivity reactions to meloxicam or any auxiliary component, or hypersensitivity to substances with a similar effect, for example, NSAIDs, acetylsalicylic acid. Meloxicam should not be prescribed to patients who have experienced symptoms of bronchial asthma, nasal mucosal polyps, angioedema or urticaria after administration of acetylsalicylic acid or other NSAIDs. History of gastrointestinal bleeding or gastrointestinal perforation associated with previous NSAID therapy. Active phase or recurrent course of gastrointestinal ulcers/bleeding (two or more separate episodes in which the presence of an ulcer or bleeding is confirmed). Severe liver dysfunction. Severe renal failure without dialysis. History of gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders. Severe heart failure.

Compound

Each tablet contains: active substance: meloxicam – 7.5 mg or 15 mg; excipients: magnesium stearate, sodium citrate, povidone, crospovidone, colloidal anhydrous silicon dioxide, microcrystalline cellulose, lactose monohydrate.

Overdose

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with maintenance therapy. Gastrointestinal bleeding may occur. Severe poisoning may be accompanied by hypertension, acute renal failure, liver dysfunction, respiratory depression, coma, seizures, cardiovascular failure and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic use of NSAIDs and may also occur in overdose. In case of overdose of NSAIDs, patients are recommended symptomatic and supportive therapy. Studies have shown accelerated elimination of meloxicam with oral administration of 4 g of cholestyramine 3 times a day.

Side effect

Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a small increased risk of vascular thrombotic events (such as myocardial infarction or stroke). Edema, hypertension and heart failure have been observed with the use of NSAIDs. Most side effects were observed in the gastrointestinal tract. The development of ulcers, perforation or gastrointestinal bleeding, including death, may occur, especially in elderly patients. Cases of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following use. Gastritis was observed with less frequency. Severe skin adverse reactions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis. The incidence of the following adverse reactions is based on relevant adverse event reports from 27 clinical studies with a treatment duration of at least 14 days. The information is based on clinical studies involving 15,197 patients taking meloxicam at a daily dose of 7.5 mg or 15 mg in tablet and capsule form for a period of up to one year. Post-marketing adverse reactions are also included. Criteria for assessing the incidence of adverse drug reactions: very often (≥1/10); often (≥1/100,

Storage conditions

In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life: 2 years. Do not use after the expiration date stated on the package.

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