Movalis, tablets 15 mg 20 pcs

Movalis is a non-steroidal anti-inflammatory drug, refers 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 mediators of inflammation.

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 due to more selective inhibition of cyclooxygenase-2 (COX-2) compared to cyclooxygenase-1 (COX-1). Inhibition of COX-2 is thought to provide the therapeutic effect of NSAIDs, whereas inhibition of the ever-present COX-1 isoenzyme may cause gastric and renal side effects.

The selectivity of meloxicam against COX-2 has been confirmed in various test systems, both in vitro and ex vivo. The selective ability of meloxicam to inhibit COX-2 was shown when human whole blood was used as a test system in vitro.

Ex vivo, meloxicam (at doses of 7.5 and 15 mg) was found to be more active in inhibiting COX-2, having a greater inhibitory effect on lipopolysaccharide-stimulated prostaglandin E2 production (COX-2-controlled response) than on thromboxane production involved in blood clotting (COX-1-controlled response). These effects were dose-dependent.

Ex vivo it was shown that meloxicam at the recommended doses had no effect on platelet aggregation and bleeding time, unlike indomethacin. diclofenac. ibuprofen and naproxen. which significantly inhibited platelet aggregation and increased bleeding time.

In clinical trials, gastrointestinal (GI) side effects were generally less frequent with meloxicam 7.5 and 15 mg than with the other NSAIDs compared. This difference in the frequency of gastrointestinal side effects was mainly due to the fact that dyspepsia, vomiting, nausea, and abdominal pain were less frequently observed while taking meloxicam.

The incidence of upper gastrointestinal perforations, ulcers and bleeding associated with the use of meloxicam was low and depended on the size of the drug dose.

Indications

Back pain, Joint pain (arthralgia), Osteoarthritis, Rheumatoid arthritis, Neck pain, Arthrosis and arthritis, Pain

• .Osteoarthritis (arthrosis, degenerative joint disease);
• rheumatoid arthritis;
• ankylosing spondylitis.

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Active ingredient

Meloxicam

Composition

Active ingredient:

meloxicam 15 mg;

Associates:

sodium citrate;

lactose;

MCC;

povidone (collidone 25), <

colloidal silicon dioxide;

crospovidone;

magnesium stearate.

How to take, the dosage

Overly, with meals, with water or other liquids; 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 may 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 significant renal impairment who are on hemodialysis, the dose should not exceed 7.5 mg/day.

Adolescents

The maximum dose for adolescents is 0.25 mg/kg.

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

Rectal suppositories are recommended at a dose of 7.5 mg once daily. In more severe cases, a 15-mg dose of suppositories may be used.

Because the risk of adverse reactions depends on the size of the dose and the 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 as tablets, suppositories, injections should not exceed 15 mg.

Interaction

Other GH synthesis inhibitors, including GK and salicylates, when taken concomitantly with meloxicam increase the risk of gastrointestinal ulcers and bleeding (due to synergistic action) and therefore their combination is not recommended. Simultaneous use with other NSAIDs is not recommended.

SIOZS – increased risk of gastrointestinal bleeding.

Lithium drugs – NSAIDs increase plasma lithium concentrations by reducing renal excretion. It is recommended that lithium concentrations be monitored during the administration of Movalis®, when the dose of lithium drugs is changed and when they are withdrawn.

Methotrexate – NSAIDs decrease tubular secretion of methotrexate, thereby increasing its plasma concentrations and hematological toxicity, the pharmacokinetics of methotrexate is not altered. In this regard, concomitant administration of Movalis® and methotrexate in dose more than 15 mg/day is recommended. The risk of interaction between NSAIDs and methotrexate may also occur in patients using methotrexate in low doses, especially in patients with impaired renal function. Therefore, continuous monitoring of blood cell count and renal function is necessary.

The concomitant use of meloxicam had no effect on the pharmacokinetics of methotrexate at a dose of 15 mg per week, but it should be taken into account that hematological toxicity of methotrexate is increased by concomitant use of NSAIDs.

The co-administration of meloxicam and methotrexate for 3 days increases the risk of increased toxicity of the latter.

Contraception – NSAIDs reduce the effectiveness of intrauterine contraceptive devices.

Diuretics – the use of NSAIDs in patients who are dehydrated is accompanied by a risk of acute renal failure.

In patients receiving Movalis® and diuretics, adequate hydration must be maintained. Renal function should be investigated prior to initiation of treatment.

Antihypertensive agents (beta-adrenoblockers, ACE inhibitors, vasodilators, diuretics) – NSAIDs decrease the effect of antihypertensive agents, due to inhibition of PGs, which have vasodilatory properties.

Angiotensin II receptor antagonists when combined with NSAIDs increase decrease of glomerular filtration, which may lead to acute renal failure, especially in patients with impaired renal function. In case of combined therapy, renal function should be monitored.

The NSAIDs may increase the nephrotoxicity of cyclosporine by acting on renal GHGs.

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

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

When concomitant use of antacids, cimetidine, digoxin and furosemide, no significant pharmacokinetic interactions have been found.

Special Instructions

Movalis should be used with caution in concomitant diseases of the upper gastrointestinal tract, as well as in patients receiving anticoagulant therapy. In case of peptic ulcer or gastrointestinal bleeding, the drug should be discontinued.
When prescribing Movalis, gastrointestinal bleeding, ulceration or perforation is possible, both with and without indications in patients’ anamnesis of previous symptoms and episodes of such GI complications. The course of these complications is more severe in the elderly.

Particular attention must be paid to patients who have had adverse effects on the skin and mucous membranes, in these cases discontinuation of Movalis should be considered.

The NSAIDs inhibit the synthesis of renal prostaglandins, which are involved in maintaining adequate renal blood flow. Administration of NSAIDs to patients with decreased renal blood flow and CBC may precipitate renal decompensation, but renal function generally returns to previous levels after NSAID therapy is discontinued.

The risk of adverse reactions is particularly high in patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome, and severe renal disease, in patients treated with diuretics, and in patients who have undergone significant surgery resulting in hypovolemia. Such patients require careful monitoring of diuresis and renal function from the beginning of treatment.

In rare cases, elevated serum transaminases or changes in other parameters characterizing liver function have been reported. In most cases, deviations from the norm were minor and transient. If liver function abnormalities are more pronounced or persistent, the use of Movalis should be discontinued and control laboratory tests should be performed.
In patients with clinically nonadvanced cirrhosis there is no need to reduce the dose of the drug.

Weakened and debilitated patients may have more severe side effects and these patients should be closely monitored.
Movalis should be used with caution in elderly patients who are more likely to have impaired renal, hepatic or cardiac function. NSAIDs may contribute to sodium, potassium and water retention and weaken the natriuretic effect of diuretics. As a result, in the presence of predisposing factors, prescribing NSAIDs may lead to progression of heart failure and hypertension.

Impact on driving and operating machinery

During treatment, if visual acuity, dizziness or somnolence are observed, one should refrain from driving and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

• high sensitivity to the active ingredient or excipients of the drug. There is a possibility of cross-sensitivity to acetylsalicylic acid and other NSAIDs;
• symptoms of bronchial asthma, nasal polyps, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs in the history;
• gastric and duodenal ulcer/perforation, acute or recent;
• Cron’s disease or acute ulcerative colitis;
• severe liver failure;
• acute gastrointestinal bleeding, recent cerebrovascular bleeding, or established diagnosis of coagulation disorders;
• severe uncontrolled heart failure;
• pregnancy;
• breastfeeding;
• therapy of perioperative pain during coronary artery bypass grafting.
• children under 12 years of age, except for use in juvenile rheumatoid arthritis (if this indication is registered).
  

Side effects

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

Immune system disorders: anaphylactic shock, anaphylactoid/anaphylactic reactions, other immediate-type hypersensitivity reactions.

CNS disorders: headache, dizziness, tinnitus, drowsiness, confusion, disorientation, mood changes.

Gastrointestinal disorders: Gastrointestinal perforation, hidden or overt gastrointestinal bleeding, possibly fatal, gastroduodenal ulcers, colitis, gastritis, esophagitis, stomatitis, abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, bloating, belching, transient changes in liver function parameters (such as increased transaminase or bilirubin activity), hepatitis.

Skin and skin appendages: toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, bullous dermatitis, erythema multiforme, pruritus, skin rash, urticaria, photosensitization.

Respiratory system disorders: bronchial asthma in patients with allergy to acetylsalicylic acid or other NSAIDs.

Systemic diseases: increase in blood pressure, palpitations, blood rush to the face, edema.

Urogenital system disorders: acute renal failure, changes in renal function (increased serum creatinine and/or serum urea levels), urinary disorders, including acute urinary retention.

Visual organs: conjunctivitis, visual disturbances, including blurred vision.

Overdose

Treatment: gastric lavage and standard supportive measures. A specific antidote is not known. During clinical trials it was shown that colestyramine accelerates excretion of meloxicam.

Similarities

Movalis, Meloxicam, Amelotex, Movasin, Arthrosan, Meloxicam-Teva, Meloxicam DS, Meloxicam Stada, Petcam Tabs, Meloxidil, Elox-SOLofar