Amelotex, tablets 15 mg 10 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

Amelotex is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic, analgesic action.

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 l.

Hepatic or renal insufficiency of moderate severity has no significant effect on the pharmacokinetics of meloxicam.

Indications

Active ingredient

Composition

1 tablet contains:

the 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.

Magnesium stearate 2.34 mg.

How to take, the dosage

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

The recommended dosing 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. In case of ineffectiveness the dose can be increased to 15 mg per day.

Ankylosing spondylitis: 15 mg daily.

The maximum daily dose of Amelotex should not exceed 15 mg.

In patients at increased risk of side effects, and in patients with significant renal impairment who are on hemodialysis, the dose should not exceed 7.5 mg daily.

Special Instructions

In case of peptic ulcers or gastrointestinal bleeding, development of skin and mucous membrane side effects, the drug should be discontinued. In patients with decreased circulating blood volume and 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 a dose of 7.5 mg. In terminally ill chronic renal failure patients on dialysis, the dose should not exceed 7.5 mg/day.

When using during the treatment it is necessary to be careful when driving motor transport and carrying out other potentially dangerous activities requiring high concentration and quick 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.

With caution
. To reduce the risk of adverse events, the lowest effective dose should be used for the shortest possible course in ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes, peripheral arterial 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 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.

Pregnancy use

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

Similarities