Meloxicam pills 7.5 mg 20 pcs
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Active ingredients
Meloxicam
Release form
Pills
Composition
Meloxicam 7.5 mg; Excipients: lactose (milk sugar), microcrystalline cellulose, sodium citrate dihydrate, povidone (polyvinylpyrrolidone), sodium carboxymethyl starch (primogel), colloidal silicon dioxide (aerosil), calcium stearate.
Pharmacological effect
Meloxicam is a non-steroidal anti-inflammatory drug that has analgesic, anti-inflammatory and antipyretic effects. The anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in the biosynthesis of prostaglandins in the area of inflammation. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), which is involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.
Pharmacokinetics
Well absorbed from the gastrointestinal tract, the absolute bioavailability of meloxicam - 89%. Simultaneous ingestion of food does not change the absorption. When using the drug orally in doses of 7.5 and 15 mg, its concentration is proportional to the dose.; Equilibrium concentration is reached within 3-5 days. With prolonged use of the drug (more than 1 year), the concentrations are similar to those observed after the first achievement of the equilibrium state. Plasma protein binding is 99%. The range of differences between the maximum and basal concentrations of the drug after it is taken once a day is relatively small and amounts to 0.4-1 μg / ml when using a dose of 7.5 mg, and when using a dose of 15 mg, it is 08-2 μg / ml. Meloxicam penetrates histohematogenous barriers, the concentration in synovial fluid reaches 50% Cmax of the drug in plasma. Almost completely metabolized in the liver to form four pharmacologically inactive derivatives. The main metabolite, 5'-carboxy-meloxicam (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 CYP 2C9 plays an important role in this metabolic transformation, CYP 3A4 isoenzyme is of additional importance.Peroxidase is involved in the formation of two other metabolites (constituting 16% and 4% of the dose of the drug, respectively), the activity of which is likely to vary individually.; Equalized with feces and urine, mainly in the form of metabolites. With feces in unchanged form, less than 5% of the daily dose is excreted, in the urine, the drug is found in unchanged form only in trace amounts. T1 / 2 meloxicam is 15-20 hours. Plasma clearance averages 8 ml / min. In the elderly, the clearance of the drug is reduced. Vd is low and averages 11 l.; Hepatic or renal failure of moderate severity does not significantly affect the pharmacokinetics of meloxicam.
Indications
- symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (ankylosing spondylitis) and other inflammatory and degenerative diseases accompanied by pain syndrome.
Contraindications
- Anamnestic data on the attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance of acetylsalicylic acid - rhinosinusitis, urticaria, polyps of the nasal mucosa, asthma (bronchial)); - 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; - in the period after coronary artery bypass surgery; - decompensated heart failure; - severe liver failure or active liver disease; - severe renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml / min), progressive kidney disease, including confirmed hyperkalemia; - pregnancy; - breastfeeding period; - children's age up to 15 years; - hypersensitivity to any component of the drug. With caution: coronary artery disease, cerebrovascular diseases, chronic heart failure, dyslipidemia / hyperlipidemia, diabetes, peripheral artery disease, smoking,creatinine clearance less than 60 ml / min; anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infections, old age, prolonged use of NSAIDs, frequent use of alcohol, severe somatic diseases, concomitant therapy with the following drugs: - anticoagulants (eg, warfarin); - antiplatelet agents (for example, acetylsalicylic acid, clopidogrel); - oral glucocorticosteroids (for example, 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 not recommended for use during pregnancy and lactation.
Dosage and administration
The drug is taken orally during meals 1 time / day; Recommended dosing regimen: Rheumatoid arthritis: 15 mg / day. After achieving a therapeutic effect, the dose can be reduced to 7.5 mg / day; Osteoarthrosis: 7.5 mg / day. If necessary, the dose can be increased to 15 mg / day; Ankylosing spondylitis: 15 mg / day. The maximum daily dose should not exceed 15 mg. In patients with an increased risk of side effects, as well as in patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg / day.
Side effects
On the part of the digestive system: more than 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: more than 1% - anemia; 0.1-1% - change in blood formula, incl. leukopenia, thrombocytopenia; On the part of the skin: more than 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: more than 1% - dizziness, headache; 0.1-1% - vertigo, tinnitus,drowsiness; less than 0.1% - confusion, disorientation, emotional lability. On the part of the cardiovascular system: more than 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.
Overdose
Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal tract bleeding, acute renal failure, liver failure, respiratory arrest, asystole.; Treatment: no specific antidote; With an overdose of the drug should be a gastric lavage, taking activated charcoal (within the next hour), symptomatic therapy. Kolestiramin accelerates the excretion of the drug from the body. Forced diuresis, alkalization of urine, hemodialysis are ineffective due to the high association of the drug with blood proteins.
Interaction with other drugs
With simultaneous use with other NSAIDs (as well as with acetylsalicylic acid), the risk of erosive and ulcerative lesions and bleeding in the gastrointestinal tract increases. its toxic effect (it is recommended to control the concentration of lithium in the blood). When used simultaneously with methotrexate, the side effect of the last on the hematopoietic system (the risk of anemia and leukopenia, periodic monitoring of the complete blood count is indicated) .; If used simultaneously with diuretics and cyclosporine, the risk of developing renal failure increases. use with anticoagulants (heparin, ticlopidine, warfarin),as well as with thrombolytic drugs (streptokinase, fibrinolysin) the risk of bleeding increases (periodic monitoring of blood clotting parameters is necessary)
special instructions
Caution should be exercised when using the drug in patients with a history of peptic ulcer or duodenal ulcer, as well as in patients undergoing anticoagulant therapy. Such patients have an increased risk of erosive and ulcerative diseases 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 insufficient blood circulation, patients with cirrhosis of the liver, as well as hypovolemia as a result of surgical interventions. In patients with renal insufficiency, if the creatinine clearance is more than 25 ml / min, no correction of the dosage regimen is required. In patients on dialysis, the dosage of the drug should not exceed 7.5 mg / day.; Patients taking both diuretics and meloxicam should take a sufficient amount of liquid.; If during the treatment allergic reactions (itching, skin rash, urticaria, photosensitization ) it is necessary to stop taking the drug and consult a doctor .; Impact on the ability to drive vehicles and control mechanisms; The use of the drug can cause the occurrence of undesirable effects in the form of headache and dizziness, drowsiness. You should abandon driving and maintenance of machines and mechanisms that require concentration.