Amelotex, 10 mg/ml 1.5 ml 10 pcs
€22.35 €18.63
Pharmacotherapeutic group: nonsteroidal anti-inflammatory drugs.
ATX code: M01AC06
Pharmacological properties
Pharmacodynamics
Nonsteroidal 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 gastric mucosa
or kidneys. Less often causes erosive and ulcerative lesions of the gastrointestinal tract.
It belongs to the class of oxycams; a derivative of enolic acid.
Pharmacokinetics
The binding to plasma proteins is 99%. Passes through the histohematic barriers, penetrates into
synovial fluid. Concentration in synovial fluid reaches 50% of the maximum concentration in plasma. Less than 5% of the daily dose is excreted unchanged through the intestines, only trace amounts of the drug are found unchanged in
the urine. The half-life (T
1/2) of meloxicam is 15-20 hours. Plasma clearance averages 8 ml/min. The drug clearance is decreased in elderly patients. Distribution volume is low and averages 11 l.
Hepatic or renal insufficiency of moderate severity has no significant effect on the pharmacokinetics of meloxicam.
Indications
- rheumatoid arthritis
- osteoarthritis
- ankylosing spondylitis (Behterev’s disease);
- inflammatory and degenerative diseases of the joints, accompanied by pain
syndrome.
.
Active ingredient
Meloxicam
Composition
1 ampoule (1.5 ml) contains as active ingredient meloxicam – 15 mg excipients: meglumine, glycafurfurole, poloxamer 188, sodium chloride, glycerol, sodium hydroxide solution 1 M, water for injection.
How to take, the dosage
Intramuscularly, deeply – 7.5-15 mg once daily. No dose adjustment is required in mild to moderate renal function impairment (creatinine clearance greater than 25 ml/min) and in liver cirrhosis in stable clinical condition. The initial dose in patients with increased risk of side effects is 7.5 mg/day. The maximum daily dose is 15 mg, in patients with severe renal insufficiency on hemodialysis – 7.5 mg.
Interaction
Concomitant use with other nonsteroidal anti-inflammatory drugs increases the risk of gastrointestinal ulcers and gastrointestinal bleeding. Increases plasma concentration of lithium; decreases the effectiveness of intrauterine contraceptives, hypotensive drugs. Indirect anticoagulants, ticlopidine, heparin, thrombolytics increase the risk of bleeding; methotrexate increases myelodepressive effects; diuretics increase the risk of renal dysfunction; cyclosporine increases nephrotoxic effects; cholestyra-min accelerates excretion. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Special Instructions
In case of peptic ulcers or gastrointestinal bleeding, development of skin and mucous membrane side effects, the drug should be discontinued. Patients with decreased circulating blood volume and decreased glomerular filtration (dehydration, chronic heart failure, surgical operations) may have clinically pronounced chronic renal failure, which is completely reversible after drug withdrawal (daily urine output and renal function should be monitored in such patients at the beginning of treatment). In case of persistent and significant increase in transaminases and changes in other liver function parameters, the drug should be discontinued and control tests should be performed. In patients with an increased risk of side effects, treatment should be started with a dose of 7.5 mg. In end-stage chronic renal failure patients on dialysis, the dose should not exceed 7.5 mg/day. During treatment, caution should be exercised when driving motor transport and engaging in other potentially hazardous activities that require increased concentration and rapid psychomotor reactions (if dizziness and somnolence occur).
Synopsis
Transparent or slightly opalescent liquid of yellow with a greenish hue.
Contraindications
- hypersensitivity to the active substance or excipients;
- contraindicated in the period after coronary artery bypass grafting;
- uncompensated heart failure;
- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and
paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (incl.ч. history)
Errotic ulcerative changes of the mucosa of the stomach or duodenum, active gastro-
gastrointestinal bleeding;
- inflammatory bowel disease (non-specific ulcerative colitis, Crohn’s disease);
- cerebrovascular bleeding or other bleeding;
- severe hepatic insufficiency or active liver disease;
- severe renal insufficiency in patients not undergoing dialysis (creatinine clearance
less than 30 ml/min), advanced renal disease including - pregnancy, breastfeeding
- children under 15 years of age.
Cautious
To reduce the risk of adverse events, use the lowest
effective dose of the shortest possible course at:
Ischemic heart disease, cerebrovascular disease, congestive heart
failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peri-
feric artery disease, smoking, creatinine clearance less than 60 ml/min, anamnestic
Data on the development of gastrointestinal ulcer disease, the presence of Helicobacter pylori infection, the elderly, prolonged use of non-steroidal
anti-inflammatory drugs, frequent alcohol consumption, severe somatic
diseases, concomitant therapy with the following drugs: anticoagulants (e.
warfarin), antiaggregants (e.
acetylsalicylic acid, clopidogrel), oral
glucocorticosteroids (e.
prednisolone), selective serotonin reuptake inhibitors (e.
citalopram, fluoxetine, paroxetine, sertraline).
Side effects
Digestive system disorders: nausea, vomiting, belching, abdominal pain, constipation or
diarrhea, flatulence, increased activity of “hepatic” transaminases, hyperbilirubinemia,
Stomatitis, erosive-ulcerative lesions of the gastrointestinal tract, esophagitis, gastritis,
colitis, gastrointestinal perforation, gastrointestinal bleeding
(latent or overt), hepatitis.
Nervous system disorders:dizziness, vertigo, headache, tinnitus, confusion, drowsiness, disorientation, emotional lability.
In the respiratory system: bronchospasm.
Hematopoietic organs:anemia, leukopenia, thrombocytopenia.
Cardiovascular system disorders:peripheral edema, increased arterial
pressure, “rushes” of blood to the face and upper chest, palpitations.
Urinary system disorders:edema, hypercreatininemia, increased serum urea
concentration. In rare cases – acute renal failure, interstitial nephritis, albuminuria, hematuria.
Sensory organs:conjunctivitis, visual impairment including blurred vision.
Skin disorders:Itching, skin rash, urticaria, photosensitization, bullous
rashes, erythema multiforme, toxic epidermal necrolysis.
Allergic reactions:angioneurotic edema, anaphylactoid, anaphylactic re-
reactions.
Local reactions:possible burning and pain at the injection site.
Overdose
Symptoms: intensification of side effects. Treatment: symptomatic. No specific antidotes or antagonists.
Similarities
Movalis, Meloxicam, Amelotex, Movasin, Arthrosan, Meloxicam-Teva, Meloxicam DS, Meloxicam Stada, Petcam Tabs, Meloxidil, Elox-SOLofar
Weight | 0.135 kg |
---|---|
Shelf life | 4 years. Do not use after the expiration date. |
Conditions of storage | List B. In a light-protected place at 8 to 25 °C. Do not store in the refrigerator. Keep out of the reach of children. |
Manufacturer | PharmFirm Sotex, Russia |
Medication form | solution |
Brand | PharmFirm Sotex |
Other forms…
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