Amelotex tablets 15 mg, 20 pcs. (meloxicam)

Release form

Tablets.

Packaging

20 pcs.

Pharmacological action

Amelotex - non-steroidal 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 mucous membrane of the stomach or kidneys. Less commonly, it causes erosive and ulcerative lesions of the gastrointestinal tract.

The enolic acid derivative belongs to the class of oxycams.

Indications

Rheumatoid arthritis osteoarthritis osteoarthritis ankylosing spondylitis (ankylosing spondylitis) is an inflammatory and degenerative joint disease accompanied by pain.

Contraindications

Hypersensitivity to the active substance or auxiliary components

Contraindicated in the period after coronary artery bypass grafting

uncompensated heart failure

Complete or incomplete combination of bronchial asthma, non-relapsing syndrome and non-relapsing syndrome h in history)

Erosive-ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding

Inflammatory bowel disease (ulcerative colitis, Crohn's disease)

Cerebrovascular bleeding or other bleeding

Severe liver failure or active liver disease

Severe renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml / min), progressive kidney disease, including confirmed hyperkalemia

Pregnancy, breastfeeding

Children under 15 years of age.

Caution

To reduce the risk of adverse events, the minimum effective dose should be used with the smallest possible short course for coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, creatinine clearance less than 60 ml / min anamnestic data on the development of gastric ulcer, in the presence of Helicobacter pylori infection, in old age, with prolonged use of non-steroidal 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. Imer citalopram, fluoxetine, paroxetine, sertraline).

Use during pregnancy and lactation

Contraindicated in pregnancy, during breastfeeding.

Composition

1 tablet contains meloxicam 15 mg.

Dosage and administration

The drug is taken orally with meals once a day.

Recommended dosage: - Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day.

- Osteoarthrosis: 7.5 mg per day. With inefficiency, the dose can be increased to 15 mg per day.

- Ankylosing spondylitis: 15 mg per day. The maximum daily dose should not exceed 15 mg.

In patients with an increased risk of side effects, as well as in patients with severe renal failure undergoing hemodialysis, the dose should not exceed 7.5 mg per day.

Side effects of the

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, colitis, perforation of the gastrointestinal tract, gastrointestinal bleeding (hidden or obvious), hepatitis.

From the nervous system: dizziness, vertigo, headache, tinnitus, confusion, drowsiness, disorientation, emotional lability.

From the respiratory system: bronchospasm.

From the hemopoietic organs: anemia, leukopenia, thrombocytopenia.

From the side of 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.

On the part of the sensory organs: conjunctivitis, visual impairment incl. blurred vision.

From the skin: itching, skin rash, urticaria, photosensitization, bullous eruptions, erythema multiforme, toxic epidermal necrolysis.

Allergic reactions: angioedema, anaphylactoid, anaphylactic reactions.

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При одноврРмРнном примРнРнии с другими нРстРроидн ми противовоспалитРльн ми прРпаратами (а такжРс ацРтилсалициловой кислотой) увРличиваРтся риск возникновРния эрозивно-язвРнн х поражРний и кровотРчРний из жРлудочно-кишРчного тракта. При одноврРмРнном примРнРнии с гипотРнзивн ми прРпаратами, возможно снижРниРэффРктивности дРйствия послРдних.

При одноврРмРнном примРнРнии с прРпаратами лития возможно развитиРкумуляции лития и увРличРния Рго токсичРского дРйствия (рРкомРндуРтся контроль концРнтрации лития в крови).

При одноврРмРнном примРнРнии с мРтотрРксатом усиливаРтся побочноРдРйствиРпослРднРго на кровРтворную систРму (опасность возникновРния анРмии и лРйкопРнии, показан пРриодичРский контроль общРго анализа крови).

При одноврРмРнном примРнРнии с диурРтиками и с циклоспорином возрастаРт риск развития почРчной нРдостаточности.

При одноврРмРнном примРнРнии с внутриматочн ми контрацРптивн ми срРдствами возможно снижРниРэффРктивности дРйствия послРдних.

При одноврРмРнном примРнРнии с антикоагулянтами (гРпарин, тиклопидин, варфарин), а такжРс тромболитичРскими прРпаратами (стрРптокиназа. фибринолизин) увРличиваРтся риск развития кровотРчРний (нРобходим пРриодичРский контроль показатРлРй свРрт ваРмости крови).

При одноврРмРнном примРнРнии с колРстирамином, в рРзультатРсвяз вания мРлоксикама усиливаРтся Рго в вРдРниРчРрРз жРлудочно-кишРчн й тракт.

При одноврРмРнном примРнРнии с сРлРктивн ми ингибиторами обратного захвата сРротонина возрастаРт риск развития жРлудочно-кишРчн х кровотРчРний.

Overdose

Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, hepatic failure, respiratory arrest, asystole.

Treatment: there is no specific antidote for overdose of the drug should be gastric lavage, activated charcoal (within the next hour), symptomatic therapy. Cholestyramine accelerates the elimination of the drug from the body. Forced diuresis, hemodialysis are ineffective due to the high association of the drug with blood proteins.

Storage conditions

In a dark place at a temperature of 8 to 25 ° C

Expiration

2 years.

Active ingredient

Meloxicam

Pharmacy terms

Prescription

dosage form

dosage form

tablets



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