Movalis active ingredient. Composition, forms of release, packaging. Indications for use

Thanks

Description

Medicine Movalis considered one of the most effective non-steroidal anti-inflammatory drugs. Movalis is actively used in the treatment of various disorders of the musculoskeletal system. The drug is available in several dosage forms:
  • tablets;
  • rectal suppositories;
  • solution for intramuscular injection.

pharmachologic effect

The main active ingredient of the drug is meloxicam. This substance has an analgesic effect on the body, and also prevents the development of inflammatory processes due to the inhibition of specific enzymes.

Most of the active substance that enters the body binds to albumin. Meloxicam enters the inflamed organs through the so-called histohematic barriers. Meloxicam is metabolized in the liver.

Indications for use

1. Osteoarthritis.
2. Rheumatoid arthritis .
3. Ankylosing spondylitis.
4. Pain syndromes:
  • with arthrosis;
  • with osteoarthritis;
  • with osteochondrosis;
  • with degenerative changes in the joints.

Instructions for use of tablets, suppositories and injection solution
(shots)

Intramuscular use of the drug is recommended only during the first few days of therapy. Further treatment is continued using the tablet form of the drug.

1. The standard dose is usually 7.5 mg once a day. In each individual case, the dosage is calculated depending on how intensely the pain is expressed and how severe the inflammatory processes are.
2. The maximum allowable daily dose is 15 mg. High dosage can lead to the development of undesirable effects, so it is recommended to choose the lowest effective dose.
3. The total daily dose of Movalis, used in the form of several dosage forms (suppositories, injections, tablets), should not exceed 15 mg.

In persons with renal insufficiency, who undergo hemodialysis, the dosage of Movalis should not exceed the standard (7.5 mg).

Movalis for osteochondrosis

Osteochondrosis is the most common indication for the use of Movalis. Pain, degenerative changes in the joints - the drug copes well with all this due to its analgesic effect and suppression of inflammatory mediators. Of considerable importance is the fact that the drug is well tolerated by patients - therefore, it can be prescribed to almost everyone (except those who have obvious contraindications).


Side effects

Exposure to the drug can cause adverse reactions in most organs and tissues.

1. Digestive system: flatulence, epigastric pain, nausea, belching, colitis, ulcerative formations in the gastrointestinal tract.
2. Hematopoietic system: leukopenia, thrombocytopenia.
3. Skin reactions: itching, urticaria, photosensitivity, stomatitis.
4. Respiratory system: acute attack of bronchial asthma.
5. Nervous system: drowsiness, tinnitus, dizziness, irritability.
6. The cardiovascular system: swelling, pressure changes, hot flashes.
7. Vision: conjunctivitis.

Contraindications

  • peptic ulcer;
  • taking anticoagulants;
  • severe liver or kidney failure;
  • "aspirin triad" (this term refers to the combination of polypous rhinosinusitis with bronchial asthma and aspirin intolerance);
  • inflammatory diseases of the rectum (this contraindication applies to the use of rectal suppositories);
  • old age and childhood.

Movalis during pregnancy

Movalis is prohibited for use during pregnancy and lactation. The drug is also contraindicated for women who want to become pregnant - Movalis affects fertility.

Mydocalm, Milgamma

Movalis, Mydocalm, Milgamma - these drugs are well combined in the complex therapy of diseases of the musculoskeletal system. Patients with these problems tend to have severe joint pain. Movalis and Mydocalm have an analgesic and relaxing effect. In addition, Movalis is neutral with respect to cartilage tissue, that is, it does not have a negative effect on it. Milgamma is used as a general tonic.

Diclofenac, or what can replace Movalis?

Diclofenac, like Movalis, has anti-inflammatory and analgesic effects.

Thanks to Diclofenac, in patients:
1. Reduces pain in rheumatic diseases.
2. Increased range of motion.
3. Eliminates swelling and morning stiffness of the joints.

This drug, like Movalis, belongs to the group of non-steroidal anti-inflammatory drugs, although it has a different active ingredient. Both drugs are available in the same dosage forms.

These drugs can replace each other in the treatment of disorders of the musculoskeletal system. However, the prescription of the drug should only come from a doctor. Self-assignment is not allowed.

Several years ago, a six-month comparative study of Movalis and Diclofenac was conducted. 335 patients were examined, who complained of pain in the hip joints, swelling of the knee joints. In terms of effectiveness, both drugs have proven to be the same. But the side effects that were observed in both experimental groups had a different frequency of occurrence. If Movalis influenced the development of side effects in 11% of patients, then Diclofenac - in 14%.

Movalis and alcohol

It is categorically impossible to combine taking the drug, or its analogues, with alcohol. This can provoke the development or exacerbation of hepatitis, peptic ulcer. Sometimes, in case of violation of this recommendation, the patient may experience severe pain in the epigastric region.

Interaction

  • The drug may reduce the effectiveness of the intrauterine device.
  • The drug in combination with diuretics: patients should drink plenty of fluids and regularly check kidney function.
  • The drug reduces the effectiveness of drugs that normalize blood pressure.

Overdose

Since Movalis tends to accumulate in the tissues of the body, an overdose when using it may well happen, especially if the patient took a dose above the average. Symptomatically, this condition is manifested by increased side effects. Treatment - cleaning the stomach with lavage.

Release form - tablets, ampoules, suppositories (suppositories)

The drug is available in the form of tablets, injection, rectal suppositories. The active ingredient in all forms of the drug is the same, but the additional components differ.

1. Injection:

  • N-methyl-D-glucamine;
  • glycofurol;
  • sodium hydroxide;
  • sodium chloride;
  • Pluronic F68.
2. Tablets:
  • sodium citrate;
  • povidone;
  • anhydride colloidal silicon dioxide;
  • lactose;
  • magnesium stearate;
3. Candles:
  • macrogol glyceryl hydroxystearate;
  • suppository mass.

Features of the use of various dosage forms of Movalis

Injections (shots)

Given the potential incompatibility, it is undesirable to mix the solution for intramuscular injection with other solutions in the same syringe. The use of the drug in the form of a solution for injection is exclusively intramuscular. Injections show greater effectiveness than tablets or suppositories.

Tablets

Tablets, as one of the dosage forms of the drug, have their advantages and disadvantages. These disadvantages, first of all, can be attributed to the negative impact on the gastrointestinal tract. This is due to the fact that the drug inhibits the synthesis of prostaglandins, which are involved in the formation of the inflammatory process, but it has almost no effect on the synthesis of similar prostaglandins, which protect the gastric mucosa. This is the difference between the drug and other non-steroidal anti-inflammatory drugs, which inhibit the synthesis of absolutely all prostaglandins.

Tablets differ from the solution for parenteral administration in that they act on the body more gently and slowly. Therefore, with severe pain, they are prescribed in combination with injections. In the event that pain and inflammation are moderately expressed, only tablets can be used.

Candles (rectal suppositories)

As for suppositories, they are a very convenient form of the drug: they are absorbed faster and, accordingly, act faster. Candles, unlike other dosage forms of the drug, are actively used in gynecology (to relieve pain during menstruation) and urology (to relieve inflammation of the prostate gland).

Additional instructions

The drug affects renal function, therefore, patients whose age is approaching the elderly should take the drug only after an appropriate diagnostic examination.

The drug can affect the reaction rate and alertness. When using it, it is undesirable to drive a car or engage in work that requires high accuracy of actions.

Analogues

  • Meloxicam;
  • Amelotex;
  • Movasin;
  • Movix;
  • Artrozan;
  • Bi-xicam;
  • Matarin;
  • M-Kam;
  • Melbek forte;
  • Melbeck;
  • Meloflam;
  • Melox;
  • Mesipol.

Movalis is a drug that is available in the form of ampoules with a solution for injection, suppositories for rectal use and tablets. Indications for the use of the drug Movalis are inflammatory processes in the bones and muscles of the human body. Movalis tablets have a round shape and a slightly rough surface. The color of the tablets may vary from pale yellow to yellow. One of the sides of the tablets is convex, the manufacturer's logo is placed on it. Movalis rectal suppositories have a smooth surface, their base is slightly deepened. The solution for injection is produced in ampoules of 15 milligrams each and has a yellowish-green color. The medicine Movalis is an effective remedy for high temperature, acute pain syndromes and inflammatory processes, and its indications for use are quite diverse. The drug is recommended for arthritis, osteoarthritis, spondylitis and other diseases of the musculoskeletal system, accompanied by acute pain. The medicine also has contraindications, which differ for each type of drug.

The medicine Movalis in the form of tablets has the following indications for use:

  • inflammation of the joints, autoimmune diseases of connective tissues;
  • degenerative-dystrophic diseases of the musculoskeletal system.

The main constituent of the tablets is meloxicam, which, when administered internally, is absorbed in the body, concentrating in the synovial fluid. The advantage of this form of the drug is that the tablets act mainly on cyclooxygenase-2, which helps to avoid negative effects on the gastrointestinal tract. It is recommended to take the tablets once a day, preferably with meals. It is strictly forbidden to drink the medicine with any liquid other than water. Indications for the use of the drug Movalis are diverse in various diseases: in osteoarthritis, the daily dose is 7.5 mg, and in other inflammatory diseases with pain syndrome - 15 mg.

  • renal and liver failure;
  • acute inflammation of the stomach;
  • stomach and duodenal ulcer;
  • pronounced diseases of the cardiovascular system.

In any situation, the decision to prescribe the drug should be made by the attending physician. The information provided is for informational purposes only.

What does Movalis look like?

Candles Movalis

Indications for the use of the drug Movalis in the form of rectal suppositories include not only arthritis, endometritis, arthrosis and osteochondrosis, but also hemorrhoids, various inflammatory processes of the genital organs, as well as pain syndromes in gynecological diseases in women. With rectal use of the drug, its main component, meloxicam, is absorbed into the bloodstream, bypassing the gastrointestinal tract, which allows the drug to act on the focus of inflammation much faster than when using tablets.

The medicine Movalis in the form of suppositories has the following indications for use: 7.5 mg no more than once a day. However, in the acute stages of inflammatory processes, as well as with severe pain, the daily dose of the drug can be increased to 15 mg.

It is forbidden to use rectal suppositories in the following cases:

  • damage or cracks in the anus;
  • the last trimester of pregnancy and the period of breastfeeding;
  • pathological processes in the kidneys and liver;
  • inflammatory processes of the gastrointestinal tract;
  • bleeding from the rectum.

Movalis in the form of injections

Indications for the use of Movalis in the form of injections include short-term treatment of acute attacks of arthritis and spondylitis, in cases where the use of tablets or suppositories is impossible due to any circumstances. With the introduction of the Movalis solution into the patient's muscle, the latter feels pain relief after thirty to forty minutes, since in this case meloxicam is quickly absorbed and concentrated in the plasma. However, this type of treatment can be used only during the first few days of therapy, and then it should be replaced with tablets or rectal suppositories.

The medicine Movalis in the form of injections has the following indications for use: the drug should be administered once a day intramuscularly, dosing the drug from 7.5 to 15 mg, depending on the intensity of the patient's pain. The drug is prohibited for use in the following diseases:

  • gastrointestinal bleeding;
  • severe hepatic and renal failure;
  • diseases of the cardiovascular system;
  • postoperative pain during coronary bypass surgery;
  • cerebrovascular bleeding.

Analogues of the drug Movalis

Indications for the use of the drug Movalis are quite extensive, however, due to its significant cost, this drug is not available to every consumer. That is why, after consulting a doctor, you can purchase analogues of this medicine (that is, drugs that have the same international non-proprietary name). Indications for the use of Movalis analogues include symptomatic treatment of arthritis, arthrosis, spondylitis, Bechterew's disease, gout and neuralgia. All analogues of Movalis have anti-inflammatory, analgesic and anti-inflammatory effects. Analogues are produced as well as Movalis himself, in the form of tablets, injections and rectal suppositories.

Movalis analogues include the following drugs:

  • Meloxicam, Meloxicam-Prana, Meloxicam Sandoz and Meloxicam-Teva;
  • Artrozan;
  • Amelotex;
  • Movasin;
  • Movix;
  • Bi-xicam;
  • Aspicam;
  • Brexin;
  • Zeloxim;
  • Movalgin;
  • Texamen;
  • Fedin;
  • Matarin;
  • Melbek and Melbek forte.

The price range is large. The cost is determined by the country where the drug is produced (imported ones are more expensive, of course), the high cost of raw materials, and the authority of the brand.

The composition of the medicinal product Movalis

Solution for intramuscular injection 1 amp.
active substance:
meloxicam 15 mg
excipients: meglumine; glycofurol; poloxamer 188 (Pluronic F68); sodium chloride; glycine; sodium hydroxide; water for injections

in colorless glass ampoules type I, 1.5 ml each, in a blister pack of 3 or 5 ampoules; in a pack of cardboard 1 pack.
Tablets 1 tab.
active substance:
meloxicam 7.5 mg
15 mg
excipients: sodium citrate; lactose; MCC; povidone (collidone 25), colloidal silicon dioxide; crospovidone; magnesium stearate

in a blister 10 pcs.; in a pack of cardboard 1 or 2 blisters.
Suppositories for rectal use 1 supp.
active substance:
meloxicam 7.5 mg
15 mg
excipients: suppository mass (suppocir BP), macrogol glyceryl hydroxystearate (polyethylene glycol glyceryl hydroxystearate - cremophor RH40)

in blister packs of 6 pcs.; in a box 1 or 2 packs.

Dosage form

Tablets, capsules, oral suspensions, injections and rectal suppositories.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs

Pharmacological properties

The main active ingredient of the drug is meloxicam. It is a non-steroidal anti-inflammatory drug that is a selective inhibitor of cyclooxygenase-2. It is a derivative of enolic acid. The active substance has an analgesic, anti-inflammatory and antipyretic effect on the body, and also blocks the work of a specific enzyme that is directly involved in the development of inflammatory processes.

Pharmakinetics:
Distribution
The active substance of the drug binds to plasma proteins by 99 percent. Penetration into inflamed organs occurs through histohematic barriers.

Metabolism
Metabolization occurs in the liver.

breeding
Occurs within 20 hours of ingestion. About 5 percent of the daily dose of the drug passes unchanged through the intestines

Indications for use Movalis

- symptoms of rheumatoid arthritis;
- symptoms of osteoarthritis;
- symptoms of ankylosing spondylitis (Bekhterev's disease):
- pain syndromes in osteoarthritis, arthrosis, degenerative diseases of the joints.

Contraindications

This drug has a lot of them. When prescribing it, do not forget to notify the doctor if you have the following diseases and disorders in the functioning of the organs:
- active phase of peptic ulcer;
- severe forms of liver and kidney failure;
- hypersensitivity to any drugs and allergic reactions;
- a pronounced "aspirin" triad (in essence, this is a combination of recurrent polyposis of the nose and paranasal sinuses, bronchial asthma and intolerance to pyrazolone drugs).

A contraindication for injectable movalis is the patient taking anticoagulants, as this can provoke the development of intramuscular hematomas.
Rectal administration of the drug is highly undesirable in inflammatory diseases of the rectum and anal region.
Contraindications for taking the drug are also old age, pregnancy and lactation.

Usage Precautions

The drug is contraindicated in pregnancy. Particular care must be taken when prescribing the drug to the elderly.

Interaction with drugs

If drugs from the NSAID group are prescribed for the treatment of any diseases, then there is a risk of diseases of the gastrointestinal tract, bleeding and the development of peptic ulcers. In some cases, the drug may reduce the effectiveness of intrauterine devices. Patients who use movalis with diuretics should first examine their kidneys and constantly drink fluids in sufficient quantities.
In addition, the drug significantly reduces the effect of antihypertensive drugs.
It can provoke a delay of sodium, potassium, weakens the effect of saluretics, progression of heart failure, arterial hypertension is possible.

The drug for injection should not be mixed in one syringe with others.
With the simultaneous administration of anatacids, cimetidan, digoxin, furosemide with meloxicam, no pharmacokinetic drug interactions were identified.

Method of application and dosage Movalis

V/m.

In / m administration of the drug is indicated only during the first 2-3 days of therapy. In the future, 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 drug is administered by deep intramuscular injection.

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

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

The drug should not be administered intravenously.

Inside, during meals, drinking 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 insufficiency 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.

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

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

Side effects

In fact, the drug can affect almost all organs and systems of the body.

Digestive system:
Nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation can be experienced by up to 5 percent of those taking the drug. Other symptoms (such as belching, esophagitis, gastrointestinal ulcers, occult or macroscopic gastrointestinal hemorrhages, colitis and gastritis) are experienced by less than 0.1 percent.

Hematopoietic system:
Occasionally, the use of the drug can provoke anemia, even less often - leukopenia, thrombocytopenia, contributes to a change in the number of individual types of leukocytes per unit of measurement.

Skin reactions:
Itching, rash, stomatitis, urticaria, photosensitivity.
In some cases, an allergic reaction may occur.

Respiratory system:
Extremely rarely there can be acute attacks of bronchial asthma.

Nervous system:
Headaches, dizziness, tinnitus, drowsiness, mood swings, nervousness.
The cardiovascular system:
Edema, changes in blood pressure, hot flashes and palpitations.

Vision:
Visual impairment and conjunctivitis.

Overdose

In case of an overdose, the above side effects of the drug may increase. To avoid this, gastric lavage is recommended.

Storage conditions

Store in a cool, dark place. The maximum temperature at which the drug can be stored should not exceed 30 degrees. Shelf life 5 years. Germany Greece Spain Italy UNITED STATES

Product group

Anti-inflammatory drugs (NSAIDs)

Non-steroidal anti-inflammatory drug - NSAID

Release form

  • 1.5 ml - colorless glass ampoules (3) - contour plastic pallets (1) - cardboard boxes. 1.5 ml - colorless glass ampoules (5) - contour plastic trays (1) - cardboard boxes. 1.5 ml - colorless glass ampoules (3) - contour plastic trays (1) - cardboard boxes. 1.5 ml - colorless glass ampoules (5) - contour plastic trays (1) - cardboard boxes. 1.5 ml - colorless glass ampoules (5) - contour plastic pallets (1) - cardboard boxes 10 - blisters (1) - cardboard packs. 10 - blisters (2) - packs of cardboard. 10 - blisters (1) - packs of cardboard. 10 - blisters (2) - packs of cardboard. 10 - blisters (1) - packs of cardboard. 10 - blisters (2) - packs of cardboard. 100 ml - dark glass bottles (1) complete with dosing spoon - packs of cardboard. 5 packs of 10 ampoules 6 - contour packs (1) - packs of cardboard. 6 - contour packages (2) - packs of cardboard.

Description of the dosage form

  • Solution for i / m administration is transparent, yellow with a green tint. Solution for i / m is transparent, yellow with a green tint. The solution for i / m administration is transparent, yellow with a green tint. Rectal suppositories are smooth, yellowish-green in color, with a depression at the base. Suspension for oral administration Pale yellow to yellow tablets, round, one side is convex with a bevelled edge, on the convex side - the company's logo, on the other side - a concave line, on both sides of which "77C" is engraved. Tablets from pale yellow to yellow, round, one side is convex with a bevelled edge, on the convex side there is a company logo, on the other side there is a code and a concave risk mark; roughness of tablets is allowed.

pharmachologic effect

Movalis is a non-steroidal anti-inflammatory drug, 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 prostaglandins, known inflammatory mediators. In vivo, meloxicam inhibits the synthesis of prostaglandins 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 cyclooxygenase-2 (COX-2) compared to cyclooxygenase-1 (COX-1). It is believed that inhibition of COX-2 provides the therapeutic effect of NSAIDs, while inhibition of the constantly present COX-1 isoenzyme can cause side effects from the stomach and kidneys. The selectivity of meloxicam for COX-2 has been confirmed in various test systems, both in vitro and ex vivo. The selective ability of meloxicam to inhibit COX-2 has been shown when used as a test system in human whole blood in vitro. It was found ex vivo that meloxicam (at doses of 7.5 and 15 mg) inhibited COX-2 more actively, exerting a greater inhibitory effect on the production of prostaglandin E2 stimulated by lipopolysaccharide (COX-2-controlled response) than on the production of thromboxane involved in the process. blood clotting (a reaction controlled by COX-1). These effects were dose dependent. Ex vivo showed that meloxicam at recommended doses did not affect platelet aggregation and bleeding time, in contrast to indomethacin, diclofenac, ibuprofen and naproxen, which significantly inhibited platelet aggregation and increased bleeding time. In clinical studies, gastrointestinal (GI) side effects were generally less common with meloxicam 7.5 and 15 mg than with the other NSAIDs compared. This difference in the frequency of side effects from the gastrointestinal tract is mainly due to the fact that when taking meloxicam, such phenomena as dyspepsia, vomiting, nausea, and abdominal pain were less common. The frequency of perforations in the upper gastrointestinal tract, ulcers and bleeding, which were associated with the use of meloxicam, was low and depended on the dose of the drug.

Pharmacokinetics

Absorption Meloxicam is well absorbed from the gastrointestinal tract, as evidenced by the high absolute bioavailability (90%) after oral administration. After a single application of meloxicam, Cmax in plasma is reached within 2 hours. Simultaneous ingestion of food and inorganic antacids does not change absorption. When using the drug inside (in doses of 7.5 and 15 mg), its concentrations are proportional to doses. Steady state pharmacokinetics is achieved within 3-5 days. The range of differences between Cmax and Cmin of the drug after taking it 1 time / day is relatively small and amounts to 0.4-1.0 μg / ml when using a dose of 7.5 mg, and 0.8-2.0 μg / ml when using a dose of 15 mg (the values ​​of Cmin and Cmin during the steady state of pharmacokinetics), although values ​​outside the specified range were also noted. Cmax in plasma during the steady state of pharmacokinetics is achieved within 5-6 hours after ingestion. Distribution Meloxicam binds very well to plasma proteins, especially albumin (99%). Penetrates into the synovial fluid, the concentration in the synovial fluid is approximately 50% of the plasma concentration. Vd after repeated oral administration of meloxicam (in doses from 7.5 mg to 15 mg) is about 16 liters, with a coefficient of variation from 11 to 32%. 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 the CYP2C9 isoenzyme plays an important role in this metabolic transformation, and the CYP3A4 isoenzyme plays an additional role. In the formation of two other metabolites (constituting 16% and 4% of the dose of the drug, respectively), peroxidase takes part, the activity of which, probably, varies individually. Withdrawal Excreted equally through the intestines and kidneys, mainly in the form of metabolites. Less than 5% of the daily dose is excreted unchanged in the feces; in the urine, unchanged, the drug is found only in trace amounts. The average T1 / 2 of meloxicam varies from 13 to 25 hours. Plasma clearance averages 7-12 ml / min after a single dose of meloxicam. Pharmacokinetics in special clinical situations Lack of liver function, as well as mild renal failure, does not significantly affect the pharmacokinetics of meloxicam. The rate of elimination of meloxicam from the body is significantly higher in patients with moderately severe renal insufficiency. Meloxicam binds worse to plasma proteins in patients with end-stage renal disease. In end-stage renal disease, an increase in Vd may lead to higher concentrations of free meloxicam, so in these patients the daily dose should not exceed 7.5

Special conditions

Patients with gastrointestinal diseases should be monitored regularly. If an ulcerative lesion of the gastrointestinal tract or gastrointestinal bleeding occurs, Movalis® must be discontinued. Gastrointestinal ulcers, perforation, or bleeding may occur at any time during treatment, whether or not there are warning signs or a history of serious gastrointestinal complications. The consequences of these complications are generally more serious for the elderly. When using NSAIDs, serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis can develop. Therefore, special 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 the event of the first signs of a skin rash, changes in the mucous membranes or other signs of hypersensitivity, the question of discontinuing the use of Movalis® should be considered. Cases are described when taking NSAIDs increase the risk of developing serious cardiovascular thrombosis, myocardial infarction, angina attack, possibly fatal. This risk increases with prolonged use of the drug, as well as in patients with a history of the above diseases and predisposed to such diseases. NSAIDs inhibit the synthesis of prostaglandins in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or a reduced volume of circulating blood can lead to decompensation of latent renal failure. After discontinuation of NSAIDs, kidney function usually returns to baseline. Elderly patients, patients with dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome or acute renal dysfunction, patients concomitantly taking diuretics, ACE inhibitors, angiotensin II receptor antagonists, as well as patients who have undergone major surgical interventions that lead to hypovolemia. In such patients, diuresis and renal function should be carefully monitored at the beginning of therapy. The use of NSAIDs in conjunction with diuretics can lead to sodium, potassium and water retention, as well as to a decrease in the natriuretic effect of diuretics. As a result, in predisposed patients, signs of heart failure or hypertension may be exacerbated. Therefore, careful monitoring of the condition of such patients is necessary, and they must be maintained adequate hydration. Before starting treatment, a study of kidney function is necessary. In the case of combination therapy, renal function should also be monitored. When using the drug Movalis® (as well as most other NSAIDs), an episodic increase in the activity of transaminases in the blood serum or other indicators of liver function is possible. In most cases, this increase was small and transient. If the identified changes are significant or do not decrease over time, Movalis® should be discontinued, and monitoring of the identified laboratory changes should be carried out. Debilitated or debilitated patients may be less able to tolerate adverse events, and therefore, such patients should be carefully monitored. Like other NSAIDs, Movalis may mask the symptoms of an underlying infectious disease. As a drug that inhibits the synthesis of cyclooxygenase / prostaglandin, Movalis® can 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 stop taking Movalis®. In patients with mild or moderate renal insufficiency (CC more than 25 ml / min), dose adjustment is not required. In patients with cirrhosis of the liver (compensated), dose adjustment is not required. Influence on the ability to drive vehicles and control mechanisms Special clinical studies of the effect of the drug on the ability to drive a car and mechanisms have not been conducted. However, when driving and working with mechanisms, the possibility of dizziness, drowsiness, visual impairment or other disorders of the central nervous system should be taken into account. During the period of treatment, patients must be careful when driving and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Overdose Data on cases associated with overdose of the drug has not been accumulated enough. It is likely that there will be symptoms characteristic of an overdose of NSAIDs in severe cases: drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole. Treatment: no known antidote. In case of an overdose of the drug, symptomatic therapy should be used. Cholestyramine is known to accelerate the elimination of meloxicam.

Compound

  • 1 amp. meloxicam 15 mg Excipients: meglumine - 9.375 mg, glycofurfural - 150 mg, poloxamer 188 - 75 mg, sodium chloride - 4.5 mg, glycine - 7.5 mg, sodium hydroxide - 228 mcg, water for injection - 1279.482 mg. 1 tab. meloxicam 7.5 mg Excipients: sodium citrate dihydrate - 15 mg, lactose monohydrate - 23.5 mg, microcrystalline cellulose - 102 mg, povidone K25 - 10.5 mg, colloidal silicon dioxide - 3.5 mg, crospovidone - 16.3 mg, magnesium stearate - 1.7 mg. 1 supp. meloxicam 7.5 mg Excipients: suppository mass (suppository BP), macrogol glyceryl hydroxystearate (polyethylene glycol glyceryl hydroxystearate). meloxicam 15 mg Excipients: sodium citrate, lactose, microcrystalline cellulose, povidone (collidon 25), colloidal silicon dioxide, crospovidone, magnesium stearate. Meloxicam 7.5 mg; Auxiliary substances: colloidal silicon dioxide, hyetylose, sorbitol 70%, glycerol 85%, xylitol, sodium saccharinate, sodium benzoate, citric acid monohydrate, flavor Movalis raspberry solution for intramuscular injection 1 ml: meloxicam 10 mg Excipients: meglumine - 9.375 mg, glycofurfurol - 150 mg, poloxamer 188 - 75 mg, sodium chloride - 4.5 mg, glycine - 7.5 mg, sodium hydroxide - 228 mcg, water for injection - 1279.482 mg.

Movalis indications for use

  • Initial therapy and short-term symptomatic treatment for: osteoarthritis (arthrosis, degenerative joint diseases); rheumatoid arthritis; ankylosing spondylitis; other inflammatory and degenerative diseases of the musculoskeletal system such as arthropathy. dorsopathy (for example, sciatica, lower back pain, shoulder periarthritis and others), accompanied by pain.

Movalis contraindications

  • - a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and pyrazolone drugs; - peptic ulcer / perforation of the stomach and duodenum in the acute stage or recently transferred; - inflammatory bowel disease - Crohn's disease or ulcerative colitis in the acute stage; - severe liver failure; - severe renal failure, chronic renal failure in patients not undergoing hemodialysis with KK

Movalis dosage

  • 15 mg 15 mg/1.5 ml 7.5 mg 7.5 mg, 15 mg

Movalis side effects

  • The following describes the side effects, the relationship of which with the use of the drug Movalis® was regarded as possible. Side effects registered during post-marketing use, the relationship of which with the use of the drug was regarded as possible, are marked with *. Within the systemic organ classes, the following categories are used in terms of the incidence of side effects: very often (?1/10); often (?1/100,

drug interaction

With the simultaneous use of other prostaglandin synthesis inhibitors with meloxicam, incl. GCS and salicylates, increases the risk of gastrointestinal ulcers and gastrointestinal bleeding (due to synergism of action). The simultaneous use of meloxicam and other NSAIDs is not recommended. Anticoagulants for oral administration, heparin for systemic use, thrombolytic agents, while used with meloxicam, increase the risk of bleeding. In the case of simultaneous use, careful monitoring of the blood coagulation system is necessary. Antiplatelet drugs, serotonin reuptake inhibitors, when used simultaneously with meloxicam, increase the risk of bleeding due to inhibition of platelet function. In the case of simultaneous use, careful monitoring of the blood coagulation system is necessary. NSAIDs increase plasma lithium concentration by decreasing its excretion by the kidneys. The simultaneous use of meloxicam with lithium preparations is not recommended. In case of need for simultaneous use, careful monitoring of the concentration of lithium in plasma is recommended during the entire course of the use of lithium preparations. NSAIDs reduce the tubular secretion of methotrexate by the kidneys, thereby increasing its plasma concentration. The simultaneous use of meloxicam and methotrexate (at a dose of more than 15 mg per week) is not recommended. In the case of simultaneous use, careful monitoring of kidney function and blood counts is necessary. Meloxicam may increase the haematological toxicity of methotrexate, especially in patients with impaired renal function. There is evidence that NSAIDs can reduce the effectiveness of intrauterine contraceptive devices, but this has not been proven. The use of NSAIDs while taking diuretics in case of dehydration of patients is accompanied by a risk of developing acute renal failure. NSAIDs reduce the effect of antihypertensive drugs (beta-blockers, ACE inhibitors, vasodilators, diuretics) due to inhibition of prostaglandins that have vasodilatory properties. The combined use of NSAIDs and angiotensin II receptor antagonists, as well as ACE inhibitors, enhances the effect of reducing glomerular filtration, thereby may lead to the development of acute renal failure, especially in patients with impaired renal function. Colestyramine, binding meloxicam in the gastrointestinal tract, leads to its faster elimination. In patients with CC from 45 to 79 ml / min, the use of meloxicam should be stopped 5 days before the start of pemetrexed and may be resumed 2 days after the end of pemetrexed. If there is a need for the combined use of meloxicam and pemetrexed, then patients should be carefully monitored, especially in relation to myelosuppression and the occurrence of side effects from the gastrointestinal tract. In patients with CC

Overdose

Data on cases associated with an overdose of the drug has not been accumulated enough. It is likely that there will be symptoms characteristic of an overdose of NSAIDs in severe cases: drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole. Treatment: no known antidote. In case of an overdose of the drug, symptomatic therapy should be used. Cholestyramine is known to accelerate the elimination of meloxicam.

Storage conditions

  • store at room temperature 15-25 degrees
  • keep away from children
  • store in a place protected from light
Information provided by the State Register of Medicines.

Synonyms

  • Lem, Melbek, Melbek forte, Melox, Meloxicam, Movasin, Artrozan

Movalis tablets is an anti-inflammatory non-steroidal drug, which is a derivative of enolic acid. The drug has analgesic, anti-inflammatory, antipyretic effect. The strong antiphlogistic effect of meloxicam has been established in every standard model of inflammation.

The principle of action of the drug, the active substance of which is meloxicam, is to suppress the synthesis of prostaglandins - inflammatory mediators. In vivo, meloxicam slows down the synthesis of prostaglandins in the area of ​​inflammation much more than in the kidneys or gastric mucosa.

These differences are associated with a strong selective inhibition of COX-2 in comparison with COX-1. Presumably, inhibition of COX-2 has a therapeutic effect of NSAIDs, while inhibition of the COX-1 isoenzyme can provoke side effects that extend to the functioning of the kidneys and stomach.

Indications Ex vivo found that the active substance of the drug, subject to the recommended dosage, did not affect the bleeding period and platelet aggregation in comparison with:

  • naproxen;
  • indomethacin;
  • ibuprofen;
  • diclofencom.

These drugs significantly inhibit platelet aggregation and increase bleeding time.

After conducting clinical studies, it turned out that the side effects associated with the work of the gastrointestinal tract in the case of taking 7.5 mg and 15 mg of meloxicam were less common in comparison with taking NSAIDs.

The difference in the intensity of side effects in the gastrointestinal tract, as a rule, is based on the fact that if you take meloxicam 15 mg, complications manifested by abdominal pain, dyspepsia, nausea and vomiting are not so common.

The instruction for the use of the drug states that the intensity of perforations in the gastrointestinal tract, bleeding and ulcers associated with taking meloxicam was not high and was based on the dosage of the drug.

Pharmacokinetics and indications for use

Movalis tablets are well absorbed from the gastrointestinal tract. This is proven by the high and absolute bioavailability (89%) when taken orally. Eating food combined with taking tablets does not affect the absorption of the drug.

Meloxicam is almost completely metabolized in the liver. In this case, 4 pharmacologically passive derivatives are formed. It is excreted evenly with urine and feces, usually in the form of metabolites.

Part (5%) of the daily dose of the drug is excreted with the feces, and in the urine the unchanged part of the drug can be detected only in a trace volume.

Symptomatic therapy:

  • rheumatoid arthritis;
  • osteoarthritis.

That is, indications for the use of Movalis are degenerative joint diseases and arthrosis.

Release form:

  1. rectal suppositories - 7.5/15 mg;
  2. tablets - 7.5 / 15 mg;
  3. suspension for internal use;
  4. solution in ampoules intended for intramuscular injection (for injections) 1.5 ml.

Dosage and instructions for use

With arthrosis (osteoarthritis), the daily dosage should be no more than 7.5 mg. If necessary, the doctor can increase the daily dose to 15 mg.

With ankylosing spondylitis and rheumatoid arthritis, the drug is prescribed at 15 mg per day, and when a positive effect is achieved, the dosage can be reduced to 7.5 mg.

Important! For people who are likely to develop side effects, it is better to start taking the drug with a dosage of 7.5 mg.

For patients with renal insufficiency who are on hemodialysis, the daily dosage of Movalis should not be more than 7.5 mg.

And how many mg of Movalis should be taken in adolescence? Adolescents should take the drug at a rate of 0.25 mg per 1 kg of body weight. The maximum dosage of the drug for 1 day is 15 mg.

The medicine is taken during a meal while it should be washed down with water.

Due to the fact that the appearance of side effects is associated with the volume of the dose and the duration of the application, the drug should be used for a short time and most likely at a low effective dosage.

The daily amount of taking tablets, solution and suspensions of Movalis should be no more than 15 mg.

Side effects

An increased dose, incorrect intake and individual intolerance can cause side effects, as a result of which there will be:

  • visual impairment;
  • changes in the leukocyte formula;
  • conjunctivitis (shown in the photo);
  • anemia;
  • glomerulonephritis;
  • thrombocytopenia;
  • acute renal failure;
  • leukopenia;
  • frequent heartbeat;
  • migraine;
  • high blood pressure;
  • dizziness;
  • bronchial asthma;
  • noise in ears;
  • photosensitivity;
  • drowsiness;
  • mood swings;
  • perforation of the gastrointestinal tract;
  • hives;
  • bleeding that occurs in the intestines and stomach, which can be fatal;
  • skin rashes;
  • gastroduodenal ulcers;
  • angioedema;
  • colitis;
  • flatulence;
  • gastritis;
  • constipation;
  • esophagitis;
  • vomiting, nausea;
  • stomatitis;
  • diarrhea;
  • stomach ache.

Contraindications for use

Despite the indications (arthritis, arthrosis) for use, the instructions for the drug states that it should not be taken in the presence of peptic ulcer, duodenal perforation and gastric ulcer, which are at an acute stage. Also, you can not take Movalis in the presence of Crohn's disease or ulcerative colitis, which is in the acute stage.

Moreover, the medicine should not be taken with bronchial asthma, urticaria (as in the photo), nasal polyposis, angioedema, and after taking aspirin or other NSAIDs in history. Uncontrolled severe cardiac, severe renal (hemodialysis) and liver failure, pregnancy, lactation can also become an obstacle to taking Movalis.

Also, the instructions for use states that the medicine should not be taken after suffering cerebrovascular bleeding or diagnosing a disease of the blood coagulation system and with acute bleeding occurring in the stomach and intestines.

High sensitivity to the active substance of Movalis or its other components (there is a risk of cross-sensitivity to ACC and other NSAIDs), treatment of perioperative pain or coronary artery bypass surgery and age up to 12 years (with the exception of rheumatoid arthritis) are significant reasons due to which you should stop taking the drug.

With extreme caution, it is necessary to take Movalis in the presence of gastrointestinal disease (in history), renal and heart failure, prolonged use of NSAIDs and frequent drinking.

In addition, Movalis is undesirable in diabetes mellitus, coronary artery disease, cerebrovascular diseases, and hyperlipidemia.

In addition, smokers and the elderly and those who have peripheral arterial disease and dyslipidemia should be careful with the use of the drug.

Use in lactation and pregnancy

The use of Movalis during breastfeeding and pregnancy should be treated with extreme caution.

Also, the drug inhibits cyclooxygenesis and the synthesis of prostaglandins, so it can affect fertility. Therefore, it should not be taken by women who are planning a pregnancy.

special instructions

Patients with gastrointestinal diseases should be systematically observed by a doctor. In the event of an ulcer or bleeding of the gastrointestinal tract, Movalis should be discontinued.

Peptic ulcer disease, bleeding, and perforation may occur at any time during treatment, as well as with suspicious symptoms or a history of complications and in the absence of any symptoms. As a rule, serious consequences occur in people who are in old age.

With special care, it is necessary to treat Movalis to people who develop adverse events associated with the mucous membrane, skin and have high sensitivity reactions to the agent. In particular, if reactions of this kind were manifested during past courses of therapy.

The occurrence of such reactions can be observed in the first 30 days of treatment. In this case, the doctor may prohibit the patient from taking Movalis.

Also, like other NSAIDs, tablets, solution and injections of meloxicam increase the likelihood of developing cardiovascular thrombosis, myocardial infarction and an angina attack, which can even lead to death.

Also, the likelihood of complications increases with prolonged use of the drug and in people with a history of the above diseases and in those who have a predisposition to these diseases.

NSAIDs slow down the process of synthesizing prostaglandins in the kidneys, which are actively involved in supporting renal perfusion. The use of NSAIDs in people with minimal renal blood flow or reduced BCC leads to decompensated renal failure, which occurs in a latent form.

Cancellation of NSAIDs will help restore kidney function. Often, the likelihood of developing such a reaction is typical for older people and for those who have been noted:

  • dehydration;
  • cirrhosis of the liver;
  • congestive heart failure;
  • failure of the kidneys;
  • nephrotic syndrome.

Also, the phenomenon can develop in people who have undergone surgery, leading to hypovolemia and in those who have taken diuretic drugs. Such people at the initial stage of treatment need to monitor the work of the kidneys and control diuresis.

Taking NSAIDs in combination with diuretics often leads to water retention of potassium and sodium in the body and to a decrease in the natriuretic effect of diuretics. As a result, in patients with a predisposition, symptoms of hypertension and heart failure may increase.

Consequently, the health status of such patients must be constantly monitored, and it is also important that such a person maintains adequate hydration. In this case, before starting therapy, it is necessary to conduct a study of kidney function. Conducting combined therapy, it is also necessary to monitor the work of the kidneys.

In the case of using Movalis, an episodic indicator of transaminase or other indicators of liver function in the blood serum was noticed. But in general, the rise in the level was insignificant and transient. In the event that the changes turn out to be more significant or do not go away in the future, then Movalis should be canceled and a study should be carried out for the established laboratory changes.

People who are emaciated or in a weakened state tolerate complications much worse; for these reasons, such patients need to be constantly monitored.

Note! Meloxicam may mask symptoms infectious disease.

People with hereditary glucose intolerance, lapp lactase deficiency or galactose/glucose malabsorption should not take this medicine.

With simultaneous internal administration of anticoagulants, heparin, ticlopidine, thrombolytic drugs, the effect of anticoagulants should be carefully monitored.

Special studies that determine the degree of influence of the drug on the ability to control transport and other mechanisms have not been conducted. However, it is better to refuse driving for people who are in a sleepy state and for those who have visual and nervous system impairments.

Interaction with other drugs

When combined with meloxicam, other inhibitors of prostaglandin synthesis, namely salicylates and glucocorticosteroids, which increase the likelihood of peptic ulcer and gastrointestinal bleeding, complications may occur due to synergism of action. Simultaneous administration of the drug with other NSAIDs also leads to adverse effects.

In the case of a one-time use of selective serotonin reuptake inhibitors with meloxicam, the occurrence of bleeding in the intestines and stomach increases.

Due to the fact that Movalis contains sorbitol, its simultaneous use with sodium polystyrene sulfonate increases the likelihood of colon necrosis, which can result in death.

When Movalis is combined with serotonin reuptake inhibitors, anticoagulants for internal use, thrombolytic drugs, heparin (systemic use), antiplatelet agents, the likelihood of bleeding due to suppression of platelet function increases.

NSAIDs increase the content of lithium in the blood by reducing the renal excretion of lithium. Therefore, it is necessary to control the concentration of lithium within a few days after the appointment of Movalis and in the event of a change in the dosage of drugs with lithium and their cancellation.

NSAIDs in some cases reduce the tubular secretion of methotrexate, increasing its hematological toxicity. At the same time, the pharmacokinetics of methotrexate remains unchanged. Therefore, the combined use of methotrexate and Movalis at a dosage of more than 15 mg for 7 days is not desirable.

The possibility of an interaction between methotrexate and NSAIDs may occur in people taking methotrexate in low doses, in particular, complications may develop in people with kidney problems. In this regard, it is necessary to constantly monitor the number of cells in the blood and the functioning of the kidneys. In the case of simultaneous use of methotrexate and meloxicam for 3 days, the likelihood of an increase in the toxicity of methotrexate increases.

Taking NSAIDs along with diuretics in the event of dehydration can lead to acute renal failure.

NSAIDs reduce the effect of intrauterine contraceptives.

Antihypertensive drugs (diuretics, beta-blockers, vasodilators, ACE inhibitors, inhibitors), NSAIDs reduce the effect of antihypertensive drugs, due to a slowdown in the effectiveness of prostaglandins that have a vasodilatory effect.

Similar posts