Cheaper analogues of Movalis: review and comparison of more affordable drugs

Movalis is the best and most effective of the meloxicam drugs. This means that all other drugs containing meloxicam as a chemical compound came later, and Movalis was the leader, or the first original drug from Boehringer Ingelheim. Movalis is highly effective for spinal hernias; it reduces pain and allows the patient to regain freedom of movement.

How does Movalis work? Does it cure a hernia or not? How should it be used, what side effects might it have, and how much does this medicine cost? These and other questions will be answered in this material. This article is written in simple language and is intended for people without medical education.

Does Movalis cure a hernia or not?

Any injections or tablets work only after the drug has entered the bloodstream. The original meloxicam, or Movalis, is no exception. It acts on tissue, creating a therapeutic concentration in the blood. On the other hand, all cartilages, including intervertebral discs, do not come into contact with blood. The type of nutrition, or trophism, they have is completely different, just like the optically transparent media of the eye. The vessels will only make it impossible for the cartilage, lens and vitreous body in the eyeball to work.

If the cartilage were intertwined with vessels, then any movement in the joints would be impossible. Vessels and capillaries would rupture, permanent hematomas would form, and as a result of their organization, any movement in the joints would be stopped - ankylosis would occur. Nature has found another mechanism for feeding intervertebral discs and cartilage tissue - this is a diffuse method of assimilation of nutrients from the surrounding synovial fluid by the “whole body” of the cartilage.

Movalis, which gets into the blood, cannot directly affect the hernia, and in general, the cartilage. Let's say more. No drug, including potent corticosteroid hormones, can eliminate protrusion or herniated discs. This can only be done through surgery.

It can be said that any physiotherapeutic procedures, massage, manual therapy, as well as newfangled methods of treatment, such as administering the patient’s own platelet-rich plasma, or PRP therapy, electrical stimulation, and carboxytherapy, also have no effect on the protrusion or hernia.

What then is the effect of Movalis? Why does it help with protrusions and hernias? The fact is that protrusion and hernia have nothing to do with it. This medicine simply relieves acute back pain that originates from the musculoskeletal system, regardless of the exact cause. The thing is that the body’s universal reaction to pain, to compression of soft tissues is inflammation. An elementary callus on the heel, which has formed as a result of prolonged rubbing with a new shoe, is a simple model of protrusion or hernia.

Hernia on MRI.

When moving, the resulting defect in the intervertebral disc gradually irritates, rubs, and compresses the surrounding ligaments, muscle structures and nerve roots. The result is the classic symptoms of inflammation: swelling, increased local temperature, and pain with impaired function. Movalis, as a drug belonging to the class of non-steroidal anti-inflammatory drugs, fully lives up to its name. It removes this inflammatory reaction, reduces swelling and pain. And the hernia, as it was, remains in its place. The body simply stops perceiving this cartilage defect as an extremely strong irritant. How does Movalis achieve its anti-inflammatory effect?

Mechanism of action of meloxicam

Any inflammation cannot develop on its own. We need special mediators, or carriers. They are called prostaglandins and are produced by the metabolism of arachidonic acid. It is prostaglandins that trigger the release of biologically active substances from mast cells, which initiate inflammation, pain and dysfunction. These substances include, for example, histamine. For this cascade of reactions to work, the work of cyclooxygenase, COX, is needed, a special enzyme that plays a critical role in the development of inflammation. It is with COX that non-steroidal anti-inflammatory compounds work, including Movalis.

It is very important to understand that this enzyme has two varieties, which are abbreviated as cyclooxygenase type 1 and 2, COX-1 and COX-2. It is COX-2 that causes specific inflammation in any tissue, and type 1 enzyme (COX-1) is necessary to maintain the normal mucous membrane of the stomach and duodenum. And if you block COX-1 and COX-2 at once, then as a side effect you will develop stomach ulcers, erosive gastritis and other diseases that are well known as complications from taking NSAIDs. More precisely, not all NSAIDs, but only first-generation drugs. This is the well-known Diclofenac, ibuprofen and other drugs.

They really help, they are highly active, relieve pain well, but at the same time they block both types of cyclooxygenase, and the most common side effect is heartburn, and with long-term use - exacerbation of stomach ulcers, even bleeding. Since these first-generation drugs did not make any difference between the two types of COX enzymes and blocked both types, these drugs were called non-selective COX inhibitors. Movalis is a selective COX-2 inhibitor that leaves type 1 enzyme alone, does not damage the stomach, and at the same time works only with type 2 cyclooxygenase.

Of course, meloxicam and Movalis still have a slight effect on type 1 cyclooxygenase, but tens and hundreds of times weaker than older, non-selective drugs. This means that Meloxicam (Movalis) is much safer than the same Diclofenac. Therefore, side effects such as heartburn and exacerbation of peptic ulcers occur much less frequently when using Movalis.

Indications

If you carefully study the official instructions for Movalis, it will not be written anywhere about protrusions and hernias. But it is enough for us that the indications include a disease of the musculoskeletal system and acute back pain. Protrusions and hernias in the form of exacerbation fit well into this definition. What other indications exist for the use of Meloxicam? We can briefly list them:

• all inflammatory rheumatic diseases of connective tissue, such as spondyloarthritis, rheumatoid and psoriatic arthritis;
• osteoarthritis with an inflammatory component;
• glenohumeral periarthritis;
• compression of the nerve roots is what causes protrusions and hernias. Compression radiculopathy is manifested by acute, piercing pain in the back and leg (sciatica, lumbago, radiculitis);
• various plexites.

Movalis is also used for acute periods of sports injury, for sprained ligaments.

Short description

Movalis is a non-steroidal anti-inflammatory drug produced by the German pharmaceutical company Boehringer Ingelheim. The main active ingredient of the drug is meloxicam, which has the following properties:

• antipyretic;
• painkillers;
• anti-inflammatory.

Indications for the use of Movalis are pathologies of the musculoskeletal system, accompanied by inflammatory processes and severe pain.

Contraindications:

• hypersensitivity to the active component;
• acute gastrointestinal ulcer/perforation;
• nonspecific intestinal inflammation in the acute stage;
• severe forms of renal/liver failure;
• gastrointestinal bleeding;
• uncontrolled heart failure;
• pregnancy, lactation;
• age up to 12 years (tablets) and up to 18 years (solution for intramuscular administration).

Has 4 release forms:

• tablets for oral administration;
• solution for intramuscular administration;
• suspension;
• rectal suppositories.

The cost of Movalis is approximately 600-700 rubles, depending on the form of release. For some people, this is a high price, and therefore, when a doctor prescribes a medicine, they have questions about what to replace the drug with and whether it is possible to find analogues cheaper? Let's look at a few of them.

Release form and dosage regimen

Since Movalis is the very first, most researched and safest of all meloxicams, the rest of the meloxicam medications, the so-called generics, or commercial copies, are equal to the flagship of the line - Movalis, and are produced in the same dosage and concentration.

Meloxicam is available as:

• solution for intramuscular use - injection solution 15 mg/1.5 ml, three ampoules or five ampoules in a package;
• tablets, tablets in the following dosages: 15 mg No. 10 or 20, 7 mg tablets package No. 10 and 20;
• suspension for oral administration - a 100 ml bottle, with 5 ml of suspension corresponding to one 7 mg tablet. The suspension is prescribed infrequently and is rarely available in pharmacies.

The presence of such dosage forms makes it possible to cover almost all routes of administration, and mainly ampoules and tablets are in demand in pharmacies. But how to start treatment for acute back pain?

As already noted, in the article on drug treatment of hernias, first, on the first or second day, it is necessary to eliminate swelling, inflammation and relieve pain as quickly as possible. Therefore, it is necessary to administer Movalis intramuscularly, and then switch to tablets. There is a special package that contains three ampoules, especially for such a short, three-day course of treatment.

Subsequent intake of tablets is possible according to the following scheme: three days - 15 mg tablets, and another 3 days - 7 mg tablets. If the patient has a history of ulcers or exacerbation of gastritis, then just in case, it is advisable to prescribe proton pump inhibitors for prophylactic purposes while taking the drug. The standard is Omeprazole, one capsule 20 mg 2 times a day. This scheme will allow you to avoid exacerbation of gastric ulcers or exacerbation of erosive gastritis.

Of course, the use of Movalis requires complex therapy, together with the prescription of centrally acting muscle relaxants, vitamins, as well as the use of local remedies. But this will be discussed in other articles.

Analogs in ampoules

Movalis injection solution is administered intramuscularly. A single dosage is 7.5 mg or 15 mg. Injections are given once a day. For patients with an increased risk of adverse reactions and renal failure, the drug is administered in a minimum dosage of 7.5 mg.

Treatment is usually limited to one injection, but in severe cases therapy can last up to 3 days. Since there is a high risk of adverse reactions, the lowest effective daily dosage is used for long-term use.

Analogues of Movalis in injections are both Russian-made and foreign. Among them the most popular are:

• Amelotex;
• Bi-xicam;
• Mesipol;
• Melbek;
• Artoxan.

One of the analogues
The cost of Movalis in ampoules (3 pieces per package) is 642 rubles. Similar drugs mentioned above are much cheaper.

Amelotex

Russian analogue of Movalis in ampoules. Its production is carried out by pharmaceutical companies. These drugs not only have a similar mechanism of action, but also an identical composition. Even their contraindications and side effects are the same. The daily dosage of Amelotex is 15 mg. It is divided into 2-3 injections.

The only difference between these medications is the expiration date. Movalis is stored for 3 years, Amelotex - 5. And their prices are different. The cost of the analog for 10 ampoules is 465 rubles.

Bi-xicam

Another substitute for injections, produced in Russia. . Meloxicam also acts as an active ingredient. Indications for use of the medicine are:

Analogue of the drug Artra

• joint pathologies accompanied by degenerative-dystrophic processes;
• systemic diseases affecting connective tissues;
• Bekhterev's disease;
• shoulder periarthritis;
• neuritis of the sciatic nerve, etc.

Bi-xim is used exclusively for the relief of acute inflammatory processes and pain. Both the analogue and Movalis have the same contraindications and provoke the appearance of similar adverse reactions. However, the domestic drug costs almost 3 times less - the cost of 3 ampoules is 140 rubles.

Artoxan

You can also replace Movalis with the drug Artoxan. But this remedy is similar only in its mechanism of action. Its composition is different. The active substance is tenoxicam. The medicine can be administered not only intramuscularly, but also intravenously.

The product itself is a lyophysilate for preparing a solution. It is prepared immediately before injection into the gluteal muscle or into a vein. The drug contains both powder and solvent. Replacing Movalis with this medicine is advisable only if pharmacies do not have the German medicine, since the cost of Artoxan is 600-620 rubles.

Mesipol

This is not a Russian, but a Polish drug, but compared to Movalis it is also inexpensive. Like previous products, this medicine is also made on the basis of meloxicam. But it has a shorter shelf life - only 2 years. Mesipol is used in injections only for persons over 18 years of age.

It is administered intramuscularly for no more than 2-3 days. After this, be sure to switch to tablets. Injections are given 1-2 times a day depending on the severity of the pain syndrome. The daily dosage is also 15 mg. The cost of Mesipol for 3 ampoules is 350 rubles.

Melbek

Speaking about what cheap analogues of Movalis there are, one cannot fail to mention the Turkish medicine Melbek in ampoules. Its active component is also meloxicam. Contraindications, adverse reactions, indications are similar. Both remedies are used to relieve pain in joints and muscles.

Melbek is also recommended to be administered intramuscularly 1-2 times a day, but not more than 3 days. The cost of the medicine is 260 rubles. The package contains 3 ampoules.

Contraindications and side effects

Meloxicam, and therefore Movalis, has standard contraindications for NSAIDs. These include: individual intolerance, the manifestation of allergic reactions, the presence of an allergy to acetylsalicylic acid, and especially the occurrence of aspirin bronchial asthma. If a person has nasal polyposis in combination with aspirin-induced asthma, then NSAIDs in any form are strictly contraindicated for him.

Peptic ulcers of the stomach and duodenum, as well as erosive ulcerative gastritis, have already been discussed above. There are other contraindications, for example, pregnancy and breastfeeding, children under 12 years of age, decompensated heart and kidney failure, as well as ulcerative colitis, which is sometimes called Crohn's disease.

The shorter the course of use of Movalis, the lower the risk of various side effects. Leukopenia, drug-induced hepatitis, and various severe skin lesions, such as Lyell's syndrome, almost never develop. Various allergic reactions and headaches occur much more often, but in any case - no more often than in 10% of all cases.

Gastrointestinal bleeding can be a complication, but it can be easily avoided if the patient's history is collected before prescribing the drug, and if necessary, “covered up” with omeprazole.

It must be remembered that when prescribing Movalis, a second drug from the NSAID group is not prescribed; for example, it makes no sense to use Movalis and ketoprofen (Ketonal) together, and it would be a completely gross and dangerous mistake to prescribe Movalis together with diclofenac. It is also not compatible with drugs from the SSRI antidepressant group, and with some diuretics. A complete and detailed description of compatibility, side effects and contraindications can be read in the official instructions for the drug.

Instructions:

in ampoules made of colorless glass type I, 1.5 ml each, in blister packs 3 or 5 ampoules; in a cardboard pack 1 package.

10 pcs in blister; in a cardboard pack 1 or 2 blisters.

in contour cell packs of 6 pcs.; 1 or 2 packages in a box.

Description of the dosage form

Solution for intramuscular administration: transparent, yellow with a green tint.

Tablets: round, pale yellow to yellow. One side is convex with a beveled edge. On the convex side is the company logo; on the other side there is a concave line, on both sides of which “59D” is engraved for 7.5 mg tablets or “77C” for 15 mg tablets. The surface of the tablets may be rough.

Suppositories: smooth, yellowish-green in color, with a depression at the base.

pharmachologic effect

Pharmacological action - anti-inflammatory, analgesic, antipyretic.

Pharmacokinetics

Solution

Meloxicam is completely absorbed after intramuscular administration. Relative bioavailability compared to oral bioavailability is almost 100%. Therefore, when switching from injection to oral forms, dose selection is not required. After administration of 15 mg of the drug IM, a peak plasma concentration of about 1.62 μg/ml is achieved within approximately 60 minutes. Meloxicam binds very well to plasma proteins, mainly albumin (99%). Penetrates into synovial fluid, the concentration in synovial fluid is approximately 50% of the concentration in plasma. Vd is low, on average 11 l. Interindividual differences are 30–40%.

Pills

Meloxicam is well absorbed from the gastrointestinal tract, as evidenced by its high absolute oral bioavailability of 89%. With a single dose of the drug in tablet form, the average Cmax in plasma is achieved within 5–6 hours. With repeated use, a steady state of pharmacokinetics is achieved within 3 to 5 days. The range of differences between the maximum (Cmax) and basal concentrations (Cmin) of the drug during the period of steady state pharmacokinetics after taking it once a day is relatively small and amounts to 0.4–1 mcg/ml for a dose of 7.5 mg, and 0.8 –2 µg/ml – for a dose of 15 mg. Cmax in plasma during steady state pharmacokinetics is achieved within 5–6 hours when taking tablets.

Concentrations of the drug after continuous use for more than 6 months are similar to the concentrations observed after 2 weeks of oral administration of 15 mg per day. Concomitant food intake does not affect the absorption of the drug.

Suppositories

Suppositories have been shown to be bioequivalent to tablets. Cmax of the drug in plasma during the period of steady state pharmacokinetics is achieved approximately 5 hours after administration of the drug.

The ranges of differences between maximum (Cmax) and basal concentrations (Cmin) are similar for tablets and suppositories.

Distribution

Meloxicam binds well to plasma proteins (albumin - 99%).

Meloxicam penetrates into the synovial fluid; local concentrations are approximately 50% of plasma concentrations.

Vd is low, averaging 11 liters. Individual fluctuations are 30–40%.

Metabolism

Meloxicam is almost completely metabolized in the liver to form 4 pharmacologically inactive derivatives. The main metabolite, 5-carboxymeloxicam (60% of the dose), is formed by oxidation of the intermediate metabolite, 5-hydroxymethylmeloxicam, which is also excreted, but to a lesser extent (9% of the dose). In vitro studies have shown that CYP2C9 plays an important role in this metabolic transformation, and the CYP3A4 isoenzyme is of additional importance. Peroxidase, the activity of which probably varies individually, takes part in the formation of the other two metabolites (constituting 16 and 4% of the drug dose, respectively).

Removal

It is excreted equally in feces and urine, mainly in the form of metabolites. In unchanged form, less than 5% of the daily dose is excreted in feces; in urine, unchanged, the drug is found only in trace amounts. The average T1/2 of meloxicam is 20 hours. Plasma clearance averages 8 ml/min.

Meloxicam exhibits linear pharmacokinetics in doses of 7.5–15 mg when administered orally or intramuscularly.

Insufficiency of liver and/or kidney function

Failure of liver function, as well as mild or moderate renal failure, do not have a significant effect on the pharmacokinetics of meloxicam. In end-stage renal failure, an increase in Vd may lead to higher concentrations of free meloxicam, so in these patients the daily dose should not exceed 7.5 mg.

Elderly patients

In elderly patients, the average plasma clearance during steady-state pharmacokinetics is slightly lower than in younger patients.

Children

During a study of meloxicam in children, the pharmacokinetics of the drug was studied at doses used at a rate of 0.25 mg/kg. When comparing indicators in children of different ages (2–6 years old, n = 7 and 7–14 years old, n = 11), a trend towards lower Cmax (−34%) and AUC0-∞ (−28%) was established in younger children , and drug clearance (adjusted for body weight) in this group of children was higher. Plasma concentrations of meloxicam are similar in older children and adults. In children of both age groups, T1/2 of meloxicam from plasma were similar (13 hours) and slightly shorter than in adults (15–20 hours).

Pharmacodynamics

Movalis® is an NSAID, belongs to enolic acid derivatives and has anti-inflammatory, analgesic and antipyretic effects. The pronounced anti-inflammatory effect of meloxicam has been established in all standard models of inflammation. The mechanism of action of meloxicam is its ability to inhibit the synthesis of PGs, known mediators of inflammation.

Meloxicam in vivo inhibits PG synthesis at the site of inflammation to a greater extent than in the gastric mucosa or kidneys.

These differences are associated with more selective inhibition of COX-2 compared to COX-1. Inhibition of COX-2 is thought to mediate the therapeutic effects of NSAIDs, whereas inhibition of the constitutively present isoenzyme COX-1 may be responsible for gastric and renal side effects. The selectivity of meloxicam for COX-2 has been confirmed in various test systems, both in vitro and in vivo. The selective ability of meloxicam to inhibit COX-2 was demonstrated when using human whole blood as a test system in vitro. It was found that meloxicam (in doses of 7.5 and 15 mg) more actively inhibited COX-2, having a greater inhibitory effect on the production of PGE2 stimulated by lipopolysaccharide (reaction controlled by COX-2) than on the production of thromboxane, which is involved in the blood coagulation process ( reaction controlled by COX-1). These effects were dose dependent.

Ex vivo it was shown that meloxicam at recommended doses did not affect platelet aggregation and bleeding time, in contrast to indomethacin, diclofenac, ibuprofen and naproxen, which significantly suppressed platelet aggregation and increased bleeding time. In clinical studies, gastrointestinal side effects generally occurred less frequently with meloxicam 7.5 and 15 mg than with other NSAIDs compared. This difference in the incidence of side effects from the gastrointestinal tract is mainly due to the fact that when taking meloxicam, phenomena such as dyspepsia, vomiting, nausea, and abdominal pain were less frequently observed. The incidence of upper gastrointestinal perforations, ulcers and bleeding associated with meloxicam use was low and dose dependent.

Indications for Movalis®

Solution for intramuscular administration

The initial period of treatment of pain syndrome and short-term symptomatic therapy of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

Tablets and suppositories

Symptomatic treatment:

osteoarthritis (arthrosis, degenerative joint diseases);

rheumatoid arthritis;

ankylosing spondylitis.

Contraindications

Common to all dosage forms

hypersensitivity to the active ingredient or auxiliary components of the drug. There is a possibility of cross-hypersensitivity to acetylsalicylic acid and other NSAIDs;

a history of symptoms of bronchial asthma, nasal polyps, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs;

peptic ulcer/perforation of the stomach and duodenum in the acute stage or recently suffered;

Crohn's disease or ulcerative colitis in the acute stage;

severe liver failure;

severe renal failure (if hemodialysis is not performed, creatinine Cl less than 30 ml/min, as well as with confirmed hyperkalemia), progressive kidney disease;

acute gastrointestinal bleeding, recent cerebrovascular bleeding or an established diagnosis of diseases of the blood coagulation system;

severe uncontrolled heart failure;

pregnancy;

breast-feeding;

therapy of perioperative pain during coronary artery bypass surgery.

For solution for intramuscular administration additionally:

children under 18 years of age.

For tablets and suppositories additionally:

children under 12 years of age, with the exception of use for juvenile rheumatoid arthritis (if this indication is registered).

Carefully

Solution - history of gastrointestinal diseases (presence of H. pylori infection); congestive heart failure; renal failure (creatinine Cl 30–60 ml/min); IHD; cerebrovascular diseases; dyslipidemia/hyperlipidemia; diabetes; concomitant therapy with the following drugs: anticoagulants, oral corticosteroids, antiplatelet agents, SSRIs; peripheral arterial disease; elderly age; long-term use of NSAIDs; smoking; frequent drinking of alcohol.

Tablets and suppositories - NSAIDs inhibit the synthesis of PGs in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced 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 have dehydration, congestive heart failure, liver cirrhosis, nephritic syndrome or overt kidney disease; patients receiving diuretics, ACE inhibitors, AT-II receptor antagonists, as well as patients who have undergone major surgery leading to hypovolemia. In such patients, diuresis and renal function should be carefully monitored when initiating therapy.

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

In patients with end-stage renal failure on hemodialysis, the dose of Movalis should not exceed 7.5 mg. In patients with mild or moderate renal impairment, i.e., if creatinine Cl is more than 25 ml/min, no dose reduction is required.

Use during pregnancy and breastfeeding

Movalis® is contraindicated during pregnancy. Suppression of PG 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 PG synthesis inhibitors during pregnancy.

The absolute risk of developing heart defects increased from less than 1 to 1.5%. This risk increases with increasing dose and duration of therapy.

In the third trimester of pregnancy, the use of PG synthesis inhibitors can lead to the following disorders in the fetus:

- premature closure of the ductus arteriosus and pulmonary hypertension due to toxic effects on the cardiopulmonary system;

- kidney dysfunction with further development of renal failure with a decrease in the amount of amniotic fluid.

During labor, the mother may experience an increase in bleeding time and a decrease in uterine contractility, and as a result, an increase in labor time. The antiplatelet effect can occur even when taking low doses.

It is known that NSAIDs pass into breast milk, so Movalis® is not recommended for use during breastfeeding.

Side effects of the drug Movalis®

Common to all dosage forms

Side effects, the connection of which with the use of the drug was regarded as possible, and which were registered with widespread use of the drug, are marked with *.

From the hematopoietic organs: changes in the number of blood cells, including changes in the leukocyte formula, leukopenia, thrombocytopenia, anemia. A predisposing factor for the occurrence of cytopenias appears to be the simultaneous use of potentially myelotoxic drugs, in particular methotrexate.

From the immune system: anaphylactic shock*, anaphylactoid/anaphylactic reactions*, other immediate hypersensitivity reactions*.

From the central nervous system: headache, dizziness, tinnitus, drowsiness, confusion*, disorientation*, mood changes*.

From the gastrointestinal tract: gastrointestinal perforation, hidden or obvious gastrointestinal bleeding, possibly fatal, gastroduodenal ulcers, colitis, gastritis*, esophagitis, stomatitis, abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, bloating, belching , transient changes in liver function indicators (for example, increased activity of transaminases or bilirubin), hepatitis*.

From the skin and skin appendages: toxic epidermal necrolysis*, Stevens-Johnson syndrome*, angioedema*, bullous dermatitis*, erythema multiforme*, itching, skin rash, urticaria, photosensitivity.

From the respiratory system: bronchial asthma in patients with allergies to acetylsalicylic acid or other NSAIDs.

From the cardiovascular system: increased blood pressure, palpitations, flushing of the face, swelling.

From the genitourinary system: acute renal failure*, changes in kidney function indicators (increased levels of creatinine and/or urea in the blood serum), urinary disorders, including acute urinary retention*.

On the part of the organ of vision: conjunctivitis*, visual disturbances, including blurred vision*.

For solution for intramuscular administration additionally

From the genitourinary system: as with other NSAIDs, the possibility of interstitial nephritis, glomerulonephritis, renal medullary necrosis, nephrotic syndrome cannot be excluded.

General phenomena: pain and swelling at the injection site.

Interaction

Common to all dosage forms

Other inhibitors of PG synthesis, including GCs and salicylates, when taken simultaneously with meloxicam, increase the risk of ulceration in the gastrointestinal tract and gastrointestinal bleeding (due to synergistic action) and therefore their combination is not recommended. Concomitant use with other NSAIDs is not recommended.

SSRIs increase the risk of gastrointestinal bleeding.

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

Methotrexate - NSAIDs reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration and hematological toxicity, but the pharmacokinetics of methotrexate does not change. In this regard, simultaneous use of Movalis® and methotrexate at a dose of more than 15 mg/week is not recommended. The risk of interaction between NSAIDs and methotrexate may also occur in patients using low doses of methotrexate, especially in patients with impaired renal function. Therefore, constant monitoring of the number of blood cells and kidney function is necessary.

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 meloxicam and methotrexate are used together for 3 days, the risk of increased toxicity of the latter increases.

Contraception - NSAIDs reduce the effectiveness of intrauterine contraceptive devices.

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

Adequate hydration should be maintained in patients receiving Movalis® and diuretics. Before starting treatment, a kidney function test is necessary.

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

Angiotensin II receptor antagonists, when co-administered with NSAIDs, increase the reduction in glomerular filtration, which can lead to the development of acute renal failure, especially in patients with impaired renal function. In case of combination therapy, renal function should be monitored.

NSAIDs, having an effect on renal PGs, can increase the nephrotoxicity of cyclosporine.

When using medicinal products with a known ability to inhibit CYP2C9 and/or CYP3A4 (or are metabolized by these enzymes) with meloxicam, the possibility of pharmacokinetic interaction should be taken into account.

The possibility of interaction with oral hypoglycemic drugs cannot be excluded.

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

For tablets and suppositories additionally

Co-administration of aspirin (1000 mg 3 times daily) and meloxicam in healthy volunteers resulted in an increase in the AUC (10%) and Cmax (24%) of meloxicam. The clinical significance of this interaction is not known.

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

Overdose

Symptoms: There is insufficient data on cases associated with drug overdose. There will likely be symptoms characteristic of an overdose of NSAID drugs, in severe cases - drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole. In case of an overdose of tablets or suppositories, side effects may increase.

Treatment: no known antidote. In case of drug overdose, symptomatic therapy should be used. In case of an overdose of tablets, gastric lavage.

Directions for use and doses

V/m.

IM administration of the drug is indicated only during the first 2–3 days of therapy. Subsequently, treatment is continued with the use of enteral forms. The recommended dose is 7.5 mg or 15 mg 1 time per day, depending on the intensity of pain and the severity of the inflammatory process.

The maximum recommended daily dose is 15 mg.

The drug is administered via deep intramuscular injection.

Given possible incompatibility, the contents of Movalis® ampoules should not be mixed in the same syringe with other drugs.

Renal dysfunction. In patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg/day.

The drug cannot be administered intravenously.

Inside, during meals, with water or other liquid; rectally.

Osteoarthritis, rheumatoid arthritis - 7.5 mg/day. If necessary, this dose can be increased to 15 mg/day. Depending on the therapeutic effect, this dose can be reduced to 7.5 mg/day.

Ankylosing spondylitis - 15 mg/day. Depending on the therapeutic effect, this dose can be reduced to 7.5 mg/day.

In patients with an increased risk of adverse reactions, it is recommended to start treatment with a dose of 7.5 mg/day. For patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg/day.

Teenagers

The maximum dose for adolescents is 0.25 mg/kg.

As a rule, the drug should only be used in adolescents and adults (see section "Contraindications"). The maximum recommended daily dose is 15 mg.

Rectal suppositories are recommended to be used at a dose of 7.5 mg once a day. In more severe cases, it is possible to use suppositories at a dose of 15 mg.

Due to the fact that the risk of adverse reactions depends on the dose size and duration of use, the drug should be used for the shortest possible time at the lowest possible effective dose.

Combined use. The total daily dose of Movalis®, used in the form of tablets, suppositories, injections, should not exceed 15 mg.

special instructions

Common to all dosage forms

Patients suffering from gastrointestinal diseases should be monitored regularly. If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, Movalis® should be discontinued. Gastrointestinal ulcers, perforation or bleeding may occur at any time during treatment, either in the presence of warning symptoms or a history of serious gastrointestinal complications, or in the absence of these signs. The consequences of these complications are generally more serious in older people.

When using Movalis® (as well as most other NSAIDs), episodic increases in serum transaminase activity or other indicators of liver function are possible. In most cases, this increase was small and transitory. If the identified changes are significant or do not decrease over time, Movalis® should be discontinued and the identified laboratory changes should be monitored.

Weakened or malnourished patients may be less able to tolerate adverse events and should therefore be monitored closely.

Like other NSAIDs, Movalis® can mask the symptoms of an underlying infectious disease.

Solution for intramuscular administration

Particular attention should be paid to patients reporting the development of adverse events from the skin and mucous membranes, as well as hypersensitivity reactions to the drug, especially if such reactions were observed during previous courses of treatment. The development of such reactions is observed, as a rule, during the first month of treatment. In such cases, discontinuation of Movalis® should be considered.

Like other NSAIDs, Movalis® may increase the risk of serious cardiovascular thrombosis, myocardial infarction, and angina, possibly fatal. This risk increases with long-term use of the drug, as well as in patients with a history of the above diseases and those predisposed to such diseases.

NSAIDs inhibit the synthesis of PGs in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced volume may lead to decompensation of latent renal failure. After discontinuation of NSAIDs, renal function usually returns to baseline levels. Those most at risk for developing this reaction are elderly patients, patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome or acute renal impairment who are concomitantly taking diuretics, and patients who have undergone major surgery that leads to hypovolemia. In such patients, diuresis and renal function should be carefully monitored when initiating therapy. The use of NSAIDs in combination with diuretics can lead to sodium, potassium and water retention, as well as a decrease in the natriuretic effect of diuretics. As a result, predisposed patients may experience increased signs of heart failure or hypertension. Therefore, such patients should be closely monitored and adequate hydration maintained. Before starting treatment, a kidney function test is necessary.

In case of combination therapy, renal function should also be monitored.

As a drug that inhibits COX and PG synthesis, Movalis® may affect fertility and is therefore not recommended for women who have difficulty conceiving. In this regard, in women undergoing examination for this reason, it is recommended to discontinue taking Movalis®.

Influence on the ability to drive vehicles and machinery. No special clinical studies have been conducted on the effect of the drug on the ability to drive a car or use machinery. However, when driving a car and working with machinery, the possibility of developing dizziness, drowsiness or other central nervous system disorders should be taken into account.

For tablets, suppositories additionally

Caution should be exercised (as with other NSAIDs) when treating patients with a history of gastrointestinal diseases and patients receiving anticoagulants. During the use of NSAIDs, the development of serious allergic reactions (some of which resulted in the death of patients), incl. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk for patients to develop these reactions appears to be early in the course of treatment, and these reactions in most cases began within the first month of treatment. If the first signs of skin rash, changes in mucous membranes or any other symptoms of hypersensitivity appear, meloxicam should be discontinued. NSAIDs may increase the risk of serious thrombotic cardiovascular disease, myocardial infarction, and stroke, which can be fatal. This risk may increase as the duration of NSAID use increases. The greatest risk may be observed in patients with cardiovascular diseases or in the presence of risk factors for the development of cardiovascular diseases, renal failure, and those on hemodialysis (the dose of Movalis® should not exceed 7.5 mg). In patients with mild or moderate renal impairment (i.e., if creatinine Cl >25 ml/min), no dose reduction is required. In patients with clinically stable liver cirrhosis, a dose reduction is not required.

Caution (as with other NSAIDs) 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. Clinical monitoring of patients at risk of developing these complications is recommended.

The drug is intended for symptomatic therapy, reducing pain and inflammation. As with other NSAIDs, combination treatment of the disease is necessary to influence disease progression.

Suppositories should not be used in patients with any inflammatory lesions of the rectum or anus, or in patients with recent bleeding from the rectum or anus.

Influence on the ability to drive vehicles and machinery. No special studies have been conducted regarding the effect of the drug on the ability to drive vehicles and operate machinery. Patients with visual impairments, patients experiencing drowsiness or other disorders of the central nervous system should refrain from this activity.

The 7.5 and 15 mg tablets contain 47 and 20 mg of lactose, respectively.

Patients with rare hereditary galactose intolerance, lapp-lactase deficiency or impaired glucose/galactose absorption should not take this drug.

Conditions for dispensing from pharmacies

On prescription.

Storage conditions for the drug Movalis®

List B.: In a place protected from light, at a temperature below 30 °C.