Amelotex, pills 15mg, 10pcs

Composition

1 tablet contains:

Active ingredient:

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,

colloidal silicon dioxide 1.44 mg,

magnesium stearate 2.34 mg

Composition

.

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.

Use during pregnancy and lactation

Amelotex is contraindicated in children under 15 years of age, during pregnancy and lactation.

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.

C astronotus reduce the risk of adverse events should use the minimum effective dose of the minimum possible short 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 ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection in the elderly, long-term use of nonsteroidal anti-inflammatory drugs, frequent alcohol use, 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.

How to take, course of use and dosage

The drug Amelotex is taken orally with a meal once a day.

Recommended dosage regimen:

Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day. Osteoarthritis: 7.5 mg per day. If ineffective, 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 insufficiency who are on hemodialysis, the dose should not exceed 7.5 mg per day.

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

Tablets

Storage conditions

In a dark place at a temperature of 8 to 25 °C. Do not store in the refrigerator.

Active ingredient

Meloxicam

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 15 years of age

Indications

Arthritis, Osteoarthritis, Sciatica, Osteochondrosis, Sciatica, Osteoarthritis, Lumbago, Periarthritis, Rheumatoid Arthritis