Amelotex, 10 mg/ml 1.5 ml 3 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

Amelotex is a non-steroidal anti-inflammatory drug with 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 mucosa of the stomach or kidneys. Less often causes erosive-ulcerative lesions of the gastrointestinal tract.

Related to the class of oxycams; a derivative of enolic acid.

Pharmacokinetics:

The binding to plasma proteins is 99%. Passes through the histohematic barriers, penetrates the synovial fluid. Concentration in synovial fluid reaches 50% of the maximum concentration in plasma.

Extracted equally through the intestines and kidneys, mainly as metabolites. Less than 5% of daily dose is excreted unchanged in intestine; in urine the drug is excreted unchanged only in trace amounts.

Half-life period (T1/2) of meloxicam is 15-20 hours. Plasma clearance averages 8 ml/min. The drug clearance is decreased in elderly patients. The volume of distribution is low and averages 11 liters.
Hepatic or renal failure of moderate severity has no significant effect on the pharmacokinetics of meloxicam.

Indications

Active ingredient

Composition

1 ampoule (1.5 ml) contains as active ingredient meloxicam – 15 mg;

supplements:

Meglumine,

glycafurfural,

poloxamer 188,

sodium chloride,

glycerol,

sodium hydroxide solution 1 M,

water for injection.

How to take, the dosage

Amelotex is administered intramuscularly, deeply – 7.5 – 15 mg once a day.

In mild to moderate impairment of renal function (creatinine clearance greater than 25 ml/min), as well as in liver cirrhosis in stable clinical condition, no dose adjustment is required. 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 failure who are on hemodialysis, 7.5 mg.

Special Instructions

In case of peptic ulcers or gastrointestinal bleeding, development of side effects on the skin and mucous membranes the drug should be discontinued.

In patients with decreased volume of circulating blood and decreased glomerular filtration (dehydration, chronic heart failure, surgical operations) there may be clinically expressed chronic renal failure which is completely reversible after discontinuation of the drug (daily urine output and renal function should be monitored in such patients at the beginning of treatment).

In case of persistent and significant elevation of transaminases and changes in other liver function parameters the drug should be discontinued and control tests should be performed. In patients with increased risk of side effects, treatment should be started with 7.5 mg dose.

In end-stage chronic renal failure patients on dialysis, the dose should not exceed 7.5 mg/day.

At the time of treatment, caution should be exercised when driving motor vehicles and engaging in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (if dizziness and somnolence occur).

Contraindications

Hypersensitivity to the active substance or excipients;
Contraindicated in the period after aortocoronary bypass surgery;
uncompensated heart failure;
Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (incl.ч. In anamnesis);
Erosive-ulcerative changes of the mucosa of the stomach or duodenum, active gastrointestinal bleeding;
Inflammatory bowel diseases (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), progressive renal disease including.including confirmed hyperkalemia;
Pregnancy, breastfeeding;
Childhood age less than 15 years old.

Cautions

. To reduce the risk of adverse events, use the lowest effective dose for the shortest possible course in ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes, peripheral artery disease, smoking, creatinine clearance less than 60 ml/min, anamnestic data on the development of gastrointestinal ulcers, the presence of Helicobacter pylori infection, the elderly, long-term use of nonsteroidal anti-inflammatory drugs, frequent use of alcohol, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e.g., warfarin), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Digestive system disorders: nausea, vomiting, belching, abdominal pain, constipation or diarrhea, flatulence, increased activity of “liver” transaminases, hyperbilirubinemia, stomatitis, erosive and ulcerative lesions of the gastrointestinal tract, esophagitis, gastritis, colitis, gastrointestinal organ perforation, gastrointestinal bleeding (latent or overt), hepatitis.

Nervous system disorders: dizziness, vertigo, headache, tinnitus, confusion, drowsiness, disorientation, emotional lability.

Respiratory system: bronchospasm.

Hematopoietic disorders: anemia, leukopenia, thrombocytopenia.

Cardiovascular system: peripheral edema, increased blood pressure, “rushes” of blood to the face and upper chest, palpitations.

Urinary system disorders: edema, hypercreatininemia, increased concentration of urea in blood serum. In rare cases – acute renal failure, interstitial nephritis, albuminuria, hematuria.

Senses: conjunctivitis, visual impairment including blurred vision.

Skin disorders: itching, skin rash, urticaria, photosensitization, bullous rash, erythema multiforme, toxic epidermal necrolysis.

Allergic reactions: angioedema, anaphylactoid, anaphylactic reactions.

Local reactions: burning and pain in the injection site are possible.

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