Amelotex solution 10mg/ml 1.5ml ampoules, 3pcs

Composition

1 ampoule (1.5 ml) contains as an Active ingredient meloxicam-15 mg;

excipients:

meglumin,

glycofurfural,

poloxamer 188,

sodium chloride,

glycerol,

sodium hydroxide solution of 1 M,

water for injection.

Pharmacological action

Pharmaceutical Group:

NSAIDs.

Pharmaceutical action:

 Amelotex is a nonsteroidal anti-inflammatory drug that has anti-inflammatory, antipyretic, and analgesic effects.

Selectively inhibits the enzymatic activity of cyclooxygenase-2. Inhibits 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.

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

Pharmacokinetics:

Binding to plasma proteins is 99%. Passes through histohematic barriers, penetrates synovial fluid. The synovial fluid concentration 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 unchanged through the intestines, and only trace amounts of the drug are detected unchanged in the urine.

The half-life (T 1/2) of meloxicam is 15-20 hours. The average plasma clearance is 8 ml/min. In the elderly, the clearance of the drug decreases. The volume of distribution is low and averages 11 liters. Moderate hepatic or renal insufficiency does not significantly affect the pharmacokinetics of meloxicam.

Indications

• osteoarthritis;
• rheumatoid arthritis;
• ankylosing spondylitis (Ankylosing spondylitis);
• inflammatory and degenerative joint diseases accompanied by pain syndrome.

Contraindications

Hypersensitivity to the Active ingredient or excipients; It is contraindicated in the period after coronary artery bypass grafting; uncompensated heart failure; Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (including in the anamnesis); Erosive and ulcerative changes in the gastric or duodenal mucosa, active gastrointestinal bleeding;Inflammatory bowel diseases (ulcerative colitis, Crohn’s disease); Cerebrovascular or other bleeding; Severe liver failure or active liver disease; Severe renal insufficiency in patients not undergoing dialysis (creatinine clearance less than 30 ml / min), progressive renal diseases, including confirmed hyperkalemia; Pregnancy, breast-feeding period; Children under 15 years of age.

With caution

To reduce the risk of adverse events, the minimum effective dose should be used in the shortest possible course in ischemic heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial diseases, smoking, creatinine clearance less than 60 ml/min, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, in the presence of Helicobacter pylori infection, in the elderly, with prolonged use of nonsteroidal anti-inflammatory drugs. 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. citalopram, fluoxetine, paroxetine, sertraline).

Side effects

From 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, esophagitis, gastritis, colitis, perforation of the gastrointestinal tract, gastrointestinal bleeding (latent or obvious), hepatitis.

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

Respiratory system disorders:  bronchospasm.

From the side of hematopoietic organs:  anemia, leukopenia, and 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.

From the side of the senses:  conjunctivitis, visual impairment, including blurred vision.

From the side of the skin:  pruritus, skin rash, urticaria, photosensitivity, bullous rash, erythema multiforme, toxic epidermal necrolysis.

Allergic reactions:  angioedema, anaphylactoid, anaphylactic reactions.

Local reactions:  possible burning and pain at the injection site.

How to take, course of use and dosage

Amelotex is administered intramuscularly, deep-7.5-15 mg 1 time a day.

If there is a slight or moderate decrease in renal function (creatinine clearance more than 25 ml/min), as well as cirrhosis of the liver in a stable clinical condition, no dose adjustment is required. The initial dose in patients with an increased risk of side effects is 7.5 mg / day.

The maximum daily dose is 15 mg, in patients with severe renal insufficiency who are on hemodialysis – 7.5 mg.

Special instructions

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

In patients with reduced circulating blood volume and reduced glomerular filtration (dehydration, chronic heart failure, surgery), clinically pronounced chronic renal failure may occur, which is completely reversible after discontinuation of the drug (in such patients, daily diuresis and renal function should be monitored at the beginning of treatment).

If there is a persistent and significant increase in transaminases and changes in other indicators of liver function, the drug should be discontinued and control tests should be performed. In patients with an increased risk of side effects, treatment begins with a dose of 7.5 mg.

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

During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (with dizziness and drowsiness).

Form of production

Solution for intramuscular use.

Storage conditions

In a dark place, at a temperature of 8-25 °C

Shelf life

2 years

Active ingredient

Meloxicam

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection