Description
Release form
Tablets.
Packaging
In a package of 20pcs. tab.
Pharmacological action
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory and antipyretic effects. Belongs to the class of oxycams is a derivative of enolic acid. The pronounced anti-inflammatory effect of meloxicam is established on all standard models of inflammation. The mechanism of action of meloxicam is to inhibit the synthesis of prostaglandins – inflammatory mediators.
Meloxicam in vivo inhibits the synthesis of prostaglandins in the area of inflammation to a greater extent than in the mucous membrane of the stomach or kidneys, which is associated with a relatively selective inhibition of the enzyme cyclooxygenase-2 (COX-2) compared with cyclooxygenase-1 (COX-1). It is believed that inhibition of COX-2 provides a therapeutic effect of NSAIDs, while inhibition of the constantly present COX-1 isoenzyme can cause side effects from the stomach and kidneys.
Meloxicam selectivity 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 is shown when using in vitro human whole blood as a test system. In vivo, it was found that meloxicam (at doses of 7.5 mg and 15 mg) more actively inhibited COX-2, exerting a greater inhibitory effect on the production of prostaglandin E2 stimulated by lipopolysaccharide (a reaction controlled by COX-2) than on the production of thromboxane, which is involved in blood coagulation (reaction controlled by COX-1). These effects were dose dependent. In vivo studies have shown that meloxicam (at doses of 7.5 mg and 15 mg) had no effect on platelet aggregation and bleeding time.
Indications
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis (ankylosing spondylitis) and other inflammatory and degenerative joint diseases accompanied by pain.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
Contraindications
hypersensitivity to the active substance or auxiliary components of the drug (including other NSAIDs)
lactase deficiency, lactose intolerance, glucose galactose malabsorption
complete or incomplete combination of bronchial asthma paralysis and nasal reacidase other NSAIDs (including a history of)
exacerbation of gastric ulcer and duodenal ulcer
gastrointestinal bleeding, recent hemorrhagic stroke or confirmed diagnosis of blood coagulation system diseases
inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
severe liver failure or liver disease in the active phase
severe renal failure in patients not undergoing hemodialysis (creatine clearance ) less than 30 ml / min), progressive kidney disease, including confirmed hyperkalemia
heart failure in the deco stage pensation
period after coronary artery bypass grafting
children’s age (12 years)
pregnancy during breastfeeding.
Precautions: Coronary heart disease, cerebrovascular disease, chronic heart failure (CHF), dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min. Anamnestic data on the development of gastrointestinal ulcer, the presence of Helicobacter pylori infections, old age, prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e.g. warfarin)
antiplatelet agents (e.g. acetylsalicylic acid, k oral glucocorticosteroids (e.g. prednisone)
selective serotonin reuptake inhibitors (e.g. citalopram, fluoxetine, paroxetine, sertraline).
To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used with the lowest possible short course.
Recommended Use Inside, while eating, without chewing, washing down with water or other liquid.
Multiplicity of admission – once a day.
Rheumatoid arthritis
15 mg per day. After achieving a therapeutic effect, the dose can be reduced to 7.5 mg per day.
Osteoarthrosis
7.5 mg per day. If necessary, the dose can be increased to 15 mg per day.
Ankylosing spondylitis
15 mg per day. After achieving a therapeutic effect, the dose can be reduced to 7.5 mg per day.
The maximum daily dose should not exceed 15 mg.
The initial dose in patients with an increased risk of side effects is 7.5 mg per day.
In patients with severe renal failure undergoing hemodialysis, the dose should not exceed 7.5 mg per day.
Adolescents over 12 years of age
The maximum dose in adolescents is 0, 25 mg / kg body weight. The maximum recommended daily dose is 15 mg.
Use during pregnancy and lactation
Contraindicated.
Composition of
Active ingredient:
meloxicam – 7.5 mg
excipients:
lactose monohydrate – 88.0 mg
microcrystalline cellulose – 62.4 mg
sodium citrate dihydrate – 7.5 mg sodium carbide 7pm mg
povidone K-30 – 3.6 mg
silicon dioxide colloidal – 2, 0 mg
calcium stearate – 1.8 mg.
Side effects of the
Digestive system: nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, erosive and ulcerative lesions of the gastrointestinal tract, perforation of the stomach or intestines, bleeding from the gastrointestinal tract (hidden or obvious), increased activity of liver enzymes, hepatitis , colitis, stomatitis, dry mouth, esophagitis.
From the cardiovascular system: tachycardia, increased blood pressure, sensation of hot flashes.
From the respiratory system: exacerbation of the course of bronchial asthma.
From the side of the central nervous system: headache, dizziness, tinnitus, disorientation, confusion of thoughts, sleep disturbance.
From the urinary system: edema, interstitial nephritis, renal medullary necrosis, urinary tract infection, proteinuria, hematuria, renal failure.
Dermatological reactions: itching, skin rash, urticaria, increased photosensitivity.
From the hemopoietic system: anemia, leukopenia, thrombocytopenia.
Allergic reactions: anaphylactoid reactions (including anaphylactic shock), swelling of the lips and tongue, allergic vasculitis, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).
Other: fever.
Drug Interactions
Other prostaglandin synthesis inhibitors, including glucocorticoids and
salicylates. Concomitant use of prostaglandin synthesis inhibitors with meloxicam increases the risk of gastrointestinal ulcers and gastrointestinal bleeding (due to synergistic action). Concomitant use of meloxicam with other NSAIDs is not recommended (see section “With caution”).
Anticoagulants for oral administration, heparin for systemic use, thrombolytic agents
Concomitant use with meloxicam increases the risk of bleeding. In case of simultaneous use, careful monitoring of the blood coagulation system is necessary.
antiplatelet drugs, serotonin reuptake inhibitors
Concomitant use with meloxicam increases the risk of bleeding due to inhibition of platelet function. In case of simultaneous use, careful monitoring of the blood coagulation system is necessary.
Lithium preparations
With the simultaneous use of meloxicam with lithium preparations, lithium accumulation is possible due to a decrease in renal excretion and an increase in its toxic effect (it is recommended to control the concentration of lithium in blood plasma if such combination therapy is necessary).
Methotrexate
NSAIDs reduce the secretion of methotrexate by the kidneys, thereby increasing its concentration in blood plasma. The simultaneous use of meloxicam and methotrexate (at a dose of more than 15 mg per week) is not recommended. In case of simultaneous use, careful monitoring of renal function and blood count is necessary. Meloxicam may enhance hematologic toxicity of methotrexate, especially in patients with impaired renal function.
With the combined use of meloxicam and methotrexate for three days, the risk of increasing the toxicity of the latter increases.
Contraception
With simultaneous use with intrauterine contraceptives, the effectiveness of the latter may be reduced.
Diuretics
The simultaneous use of NSAIDs and diuretics in case of dehydration of patients is associated with a risk of acute renal failure. Patients taking Meloxicam and diuretics should maintain an adequate level of hydration.
Antihypertensive drugs (beta-blockers, vasodilators, angiotensin-converting enzyme inhibitors, diuretics)
NSAIDs reduce the effect of antihypertensive drugs due to inhibition of prostaglandins with vasodilating properties.
Angiotensin-II receptor antagonists
With the combined use of NSAIDs and angiotensin II receptor antagonists, the effect of reducing glomerular filtration is enhanced, which can lead to the development of acute renal failure, especially in patients with impaired renal function.
Cholestyramine
Cholestyramine binds to meloxicam in the gastrointestinal tract, which leads to its faster elimination (see section “Overdose”).
Cyclosporine
NSAIDs, acting on renal prostaglandins, may enhance cyclosporin nephrotoxicity.
Other possible interactions
When used in conjunction with meloxicam drugs, which 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 ruled out.
With the simultaneous use of antacids, cimetidine, digoxin and furosemide, no significant pharmacokinetic interactions were detected.
Overdose
Symptoms
Disturbance of consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, hepatic failure, respiratory arrest, asystole.
Treatment
Symptomatic therapy, gastric lavage, absorbent (activated carbon) intake. Cholestyramine accelerates the elimination of the drug from the body. There is no specific antidote. Forced diuresis, alkalinization of urine, hemodialysis – are ineffective due to the high association of the drug with blood proteins.
Storage conditions
Store in a dark place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
3 years.
Do not use after expiration date.
Deystvuyushtee substance
Meloxicam
Terms and conditions
prescription
Dosage form
tablets
Possible product names
Meloxicam tab 7, 5 mg N20 *
Meloxicam tablets 7.5 mg 20 pcs.
Vertex, Russia
