Movasin pills 7.5 mg 20 pcs
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Active ingredients
Meloxicam
Release form
Pills
Composition
Meloxicam 7.5 mg; Excipients: povidone 12600 - 6 mg, lactose monohydrate - 52.5 mg, crospovidone (collidon CL-M) - 4.5 mg, potato starch - 1.25 mg, talc - 4.5 mg, magnesium stearate - 1.5 mg, microcrystalline cellulose - up to 150 mg.
Pharmacological effect
NSAIDs. It has an analgesic, anti-inflammatory and antipyretic effect. The mechanism of action is associated with inhibition of the synthesis of prostaglandins as a result of the selective suppression of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in the biosynthesis of prostaglandins in the area of inflammation. When administered in high doses, long-term use and individual characteristics of the body, selectivity for COX-2 decreases. Inhibits prostaglandin synthesis in the area of inflammation to a greater extent than in the gastric mucosa or kidneys, which is associated with relatively selective inhibition of COX-2. Rarely causes erosive and ulcerative diseases of the gastrointestinal tract. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), which is involved in the synthesis of prostaglandins that protect the gastrointestinal mucosa and are involved in the regulation of blood flow in the kidneys.
Pharmacokinetics
Absorption; After taking the drug inside meloxicam is well absorbed from the gastrointestinal tract, the absolute bioavailability is 89%. Simultaneous intake with food does not change the absorption. The concentration of meloxicam when taking the drug orally in doses of 7.5 and 15 mg is proportional to the dose.; After i / m administration, the relative bioavailability is almost 100%. After i / m administration of the drug in a dose of 5 mg Cmax is 1.62 mcg / ml and is reached within about 60 minutes; Meloxicam demonstrates linear pharmacokinetics in doses of 7.5-15 mg when i / m administration; Distribution; Css are achieved within 3- 5 days of regular admission. With prolonged use of the drug (more than 1 year), concentrations are similar to those observed after the first achievement of a steady state pharmacokinetics. Plasma protein binding (especially albumin) is more than 99%. The range of differences between the maximum and basal concentrations of the drug after taking it 1 time / day is relatively small and, when using a dose of 7.5 mg, 0.4-1 μg / ml,and when using a dose of 15 mg, 0.8–2 mcg / ml (respectively, the values of Cmin and Cmax are given); Meloxicam penetrates histohematogenous barriers, the concentration in synovial fluid reaches 50% of the maximum concentration of the drug in plasma; l Interindividual differences are 30-40%; Metabolism; Meloxicam is almost completely metabolized in the liver with the formation of four pharmacologically inactive metabolites. The main metabolite to 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, CYP3A4 isoenzyme plays an additional role. Peroxidase is involved in the formation of two other metabolites (constituting 16% and 4%, respectively, of the dose), the activity of which is likely to vary individually.; Excretion; is eliminated equally through the intestines and kidneys, mostly as metabolites. Less than 5% of the daily dose is excreted unchanged through the intestine; in the urine, the drug is found in unchanged form only in trace amounts. T1 / 2 meloxicam after oral administration is 15-20 hours, with i / m administration - 20 hours. Plasma clearance averages 8 ml / min; Pharmacokinetics in special clinical situations; In elderly people, the clearance of the drug is reduced.; Hepatic or moderate renal failure does not significantly affect the pharmacokinetics of meloxicam.
Indications
Symptomatic therapy: - osteoarthritis; - rheumatoid arthritis; - ankylosing spondylitis (ankylosing spondylitis).
Contraindications
- condition after coronary artery bypass surgery; - decompensated heart failure; - complete or incomplete combination of asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in history); - erosive and ulcerative changes of the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; - inflammatory bowel disease (ulcerative colitis,Crohn's disease); - cerebrovascular bleeding or other bleeding; - severe liver failure or active liver disease; - chronic renal failure in patients not undergoing dialysis (CC less than 30 ml / min), progressive kidney disease (including confirmed hyperkalemia); - children's age up to 12 years (for pills); - children's age up to 18 years (for solution for intramuscular administration); - pregnancy; - lactation (breastfeeding); - hypersensitivity to meloxicam and other components of the drug.; The drug in the form of pills includes lactose, so patients with rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption, should not take the drug. With caution; - CHD; - cerebrovascular diseases; - compensated heart failure; - dyslipidemia / hyperlipidemia; - diabetes; - diseases of peripheral arteries; - smoking; - KK 30-60 ml / min; - anamnestic data on the development of ulcerative lesions of the gastrointestinal tract; - the presence of infection with Helicobacter pylori; - elderly age; - long-term use of NSAIDs; - frequent use of alcohol; - severe somatic diseases; - concomitant therapy with the following drugs: anticoagulants (for example, warfarin); antiplatelet agents (eg, acetylsalicylic acid, clopidogrel); oral corticosteroids (eg, prednisone); selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline); To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose for the shortest possible course.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding) .; the use of Movasin, like other drugs that block the synthesis of prostaglandins, can affect fertility, so it is not recommended to appoint women who want to become pregnant.
Dosage and administration
Tablets; The drug is taken orally, during a meal, at a daily dose of 7.5-15 mg, 1 time / day. For rheumatoid arthritis, the recommended dose is 15 mg / day; depending on the therapeutic effect, the dose can be reduced to 7.5 mg / day; With osteoarthritis, the drug is prescribed at a dose of 7.5 mg / day,in the absence of effect, the dose can be increased up to 15 mg / day. In ankylosing spondylitis, the daily dose is 15 mg.; The maximum daily dose of Movasin should not exceed 15 mg. In patients with an increased risk of side effects and in patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg / day; Solution for i / m administration; V / m drug administration is shown only during the first 2-3 days. Further treatment is continued with the use of oral forms (pills); the recommended dose is 7.5 mg or 15 mg 1 time / day, depending on the intensity of pain and the severity of the inflammatory process.; The drug is administered deeply in / m. In / in the introduction of the drug is prohibited!; In patients with an increased risk of adverse reactions, the daily dose should not exceed 7.5 mg; When i / m administration in patients with end-stage renal failure on hemodialysis, and in patients with minor or moderate dysfunction kidney (QC more than 30 ml / min), the dose of the drug should not exceed 7.5 mg. The dosage regimen for intramuscular injections in children and adolescents is not defined, this dosage form can be used only in adult patients. The maximum recommended daily dose is 15 mg. With the combined use of various dosage forms of the drug, its maximum daily dose in pills, suppositories and as a solution for injection is 15 mg.
Side effects
On the part of the digestive system:> 1% - dyspepsia, incl. nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% - transient increase in liver transaminase activity, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, gastrointestinal bleeding (including latent), stomatitis; less than 0.1% - gastrointestinal perforation, colitis, hepatitis, gastritis. From the blood-forming organs:> 1% - anemia; 0.1-1% - change in blood formula, incl. leukopenia, thrombocytopenia; On the part of the skin:> 1% - itching, skin rash; 0.1-1% - urticaria; less than 0.1% - photosensitization, bullous eruptions, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis.; On the part of the respiratory system: less than 0.1% - bronchospasm.; On the part of the nervous system:> 1% - dizziness, headache; 0.1-1% - vertigo, tinnitus,drowsiness; less than 0.1% - confusion, disorientation, emotional lability. From the side of the cardiovascular system:> 1% - peripheral edema; 0.1-1% - increase in blood pressure, palpitations, flushing to the skin of the face. From the urinary system: 0.1-1% - hypercreatininemia and / or increase in serum urea; less than 0.1% - acute renal failure; connection with the reception of meloxicam has not been established - interstitial nephritis, albuminuria, hematuria.; From the sense organs: less than 0.1% - conjunctivitis, visual impairment, incl. blurred vision.; Allergic reactions: less than 0.1% - angioedema, anaphylactoid / anaphylactic reactions.; Local reactions:> 1% - swelling at the injection site; less than 0.1% - pain at the injection site
Overdose
Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, bleeding from the gastrointestinal tract, acute renal failure, liver failure, respiratory arrest, asystole; Treatment: while taking the drug inside - gastric lavage, taking activated carbon (within the next hour); if necessary, conduct symptomatic therapy. Forced diuresis, alkalization of urine, hemodialysis are ineffective due to the high degree of binding of meloxicam with blood proteins. There is no specific antidote.
Interaction with other drugs
With simultaneous use with other NSAIDs (including acetylsalicylic acid), the risk of erosive and ulcerative lesions and bleeding of the gastrointestinal tract increases. With simultaneous use with antihypertensive drugs, a decrease in the effectiveness of the latter is possible. lithium and increase its toxic action (it is recommended to control the concentration of lithium in the blood) .; If used simultaneously with methotrexate, the likelihood of developing toxins increases effects on hematopoiesis and the occurrence of anemia and leukopenia (periodic blood count is shown) .; If used concurrently with diuretics and cyclosporine, the risk of developing renal failure increases. If used simultaneously with intrauterine contraceptives, the effectiveness of the latter can be reduced. use with anticoagulants (including with heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (includingwith streptokinase, fibrinolysin) increases the risk of bleeding (requires periodic monitoring of blood clotting); With simultaneous use with Kolestiramin, meloxicam excretion through the gastrointestinal tract increases (due to binding); Gastrointestinal tract.
special instructions
Care should be taken when using the drug in patients with a history of gastric ulcer and duodenal ulcer, and in patients receiving anticoagulant therapy, because in this category of patients an increased risk of erosive and ulcerative lesions of the gastrointestinal tract.; Care should be taken to monitor renal function when using the drug in elderly patients, patients with chronic heart failure with symptoms of circulatory failure, in patients with liver cirrhosis with hypovolemia as a result of surgical interventions.; Patients with a slight or moderate decrease in renal function (QA more than 30 ml / min) do not require correction dosage regimen ; patients taking diuretics and meloxicam should take enough liquid.; If allergic reactions (itching, skin rash, urticaria, photosensitivity) occur, stop taking the drug.; Meloxicam, like other NSAIDs, can mask the symptoms infectious diseases.; Impact on the ability to drive vehicles and control mechanisms; The use of the drug may cause undesirable effects in the form of headache and dizziness, drowsiness, this during the period of taking the drug should be abandoned driving and maintenance of machines and mechanisms that require concentration.