Description
Release form
Tablets
Packing
10 pcs.
Pharmacological action
Pharmaceutical group: NSAIDs.
Pharmaceutical action: Amelotex is a non-steroidal anti-inflammatory drug, has anti-inflammatory, antipyretic, analgesic effects.
Selectively inhibits the enzymatic activity of cyclooxygenase-2. Suppresses the synthesis of prostaglandins in the area of inflammation to a greater extent than in the mucous membrane of the stomach or kidneys. Less commonly, it causes erosive and ulcerative lesions of the gastrointestinal tract.
The enolic acid derivative belongs to the class of oxycams.
Pharmacokinetics: Communication with plasma proteins – 99%. It passes through the histohematological barriers, penetrates into the synovial fluid. The concentration in the synovial fluid reaches 50% of the maximum plasma concentration.
It is excreted equally through the intestines and kidneys, mainly in the form of metabolites. Less than 5% of the daily dose is excreted through the intestine in an unchanged form, in the urine in an unchanged form, the drug is found only in trace amounts. The half-life (T1 / 2) of meloxicam is 15-20 hours. Plasma clearance is an average of 8 ml / min. In the elderly, the clearance of the drug is reduced. The volume of distribution is low and averages 11 liters.
Hepatic or renal failure of moderate severity does not significantly affect the pharmacokinetics of meloxicam.
Indications
osteoarthritis
rheumatoid arthritis
ankylosing spondylitis (ankylosing spondylitis)
inflammatory and degenerative joint diseases accompanied by pain.
Contraindications
Hypersensitivity to the active substance or auxiliary components
Contraindicated in the period after coronary artery bypass grafting
uncompensated heart failure
Complete or incomplete combination of bronchial asthma, recurrent nasosuosylozoic acid and polypeptic anti-peptic acidosis h in history)
Erosive-ulcerative changes in the gastric mucosa or duodenum, active eludochno-intestinal bleeding
Inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
Cerebrovascular bleeding or other bleeding
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
Children under 15 years of age.
Caution
To reduce the risk of developing adverse events, the minimum effective dose should be used with the smallest possible short course for coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, creatinine clearance less than 60 ml / min anamnestic data on the development of gastric ulcer, in the presence of Helicobacter pylori infection, in old age, with prolonged use of non-steroidal anti-inflammatory drugs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e.g. warfarin), antiplatelet agents ( e.g. acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g. prednisone), selective serotonin reuptake inhibitors (e.g. Imer citalopram, fluoxetine, paroxetine, sertraline).
Use during pregnancy and lactation
Amelotex is contraindicated in children under the age of 15 years, during pregnancy and lactation.
Special instructions
If peptic ulcers or gastrointestinal bleeding occur, side effects of the skin and mucous membranes develop, the drug should be discontinued. In patients with a decrease in circulating blood volume and reduced glomerular filtration (dehydration, chronic heart failure, surgery), the appearance of clinically pronounced chronic renal failure, which is completely reversible after drug withdrawal (in such patients, diuresis and renal function should be monitored at the beginning of treatment) . With persistent and significant increase in transaminases and changes in other indicators of liver function, the drug should be discontinued and control tests performed. In patients with an increased risk of side effects, treatment begins with a dose of 7.5 mg. In the terminal stage of chronic renal failure in patients on dialysis, the dose should not exceed 7.5 mg / day. During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (with the appearance of dizziness and drowsiness).
Composition
1 tablet contains: active substance: meloxicam 15 mg
excipients: lactose monohydrate 71.22 mg, microcrystalline cellulose 55.8 mg, sodium citrate 18 mg, povidone 5.4 mg, crospovidone 10.8 mg, silicon dioxide colloidal 1.44 mg 2., mg
Dosing and Administration
Amelotex is taken orally with food once a day.
Recommended dosage: Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day.
Osteoarthrosis: 7.5 mg per day. With inefficiency, the dose can be increased to 15 mg per day.
Ankylosing spondylitis: 15 mg per day.
The maximum daily dose of Amelotex should not exceed 15 mg.
In patients with an increased risk of side effects, as well as in patients with severe renal failure undergoing hemodialysis, the dose should not exceed 7.5 mg per day.
Side effects of the digestive system: nausea, vomiting, belching, abdominal pain, constipation or diarrhea, flatulence, increased activity of hepatic transaminases, hyperbilirubinemia, stomatitis, erosive and ulcerative lesions of the gastrointestinal tract, colitis, perforation of the gastrointestinal tract, gastrointestinal bleeding (hidden or obvious), hepatitis.
From the nervous system: dizziness, vertigo, headache, tinnitus, confusion, drowsiness, disorientation, emotional lability.
From the respiratory system: bronchospasm.
From the hemopoietic organs: anemia, leukopenia, thrombocytopenia.
From the cardiovascular system: peripheral edema, increased blood pressure, Flushes of blood to the skin of the face and upper chest, palpitations.
From the urinary system: edema, hypercreatininemia, increased serum urea concentration. In rare cases, acute renal failure, interstitial nephritis, albuminuria, hematuria.
On the part of the sensory organs: conjunctivitis, visual impairment incl. blurred vision.
From the skin: itching, skin rash, urticaria, photosensitivity, bullous eruptions, erythema multiforme, toxic epidermal necrolysis.
Allergic reactions: angioedema, anaphylactoid, anaphylactic reactions.
Storage conditions
In a dark place at a temperature of 8 to 25 ° C. Do not store in the refrigerator.
Deystvuyuschee substances
meloxicam
Conditions of release from drugstores
Prescription
dosage form
tablets
Appointment
For adults by doctor’s appointment, Children older than 15 years, Children by doctor’s appointment
