Meloxicam (Amelotex) 7,5 mg rectal – [6 suppositories]

Description

Amelotex Pharmacodynamics
AMELOTEX® is a non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and antipyretic effects. Its anti-inflammatory effect is due to inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in the biosynthesis of prostaglandins in the area of inflammation. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), involved in the synthesis of prostaglandin, which protects the mucosa of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.
It suppresses prostaglandin synthesis in the area of inflammation to a greater extent than in the gastrointestinal mucosa or kidneys, which is due to the relatively selective inhibition of COX-2.

Indications
– Osteoarthritis;
– rheumatoid arthritis;
– Ankylosing spondylitis (Bechterew’s disease).
Designed for symptomatic therapy, to reduce pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications
– Hypersensitivity to the active substance or any auxiliary component of the drug;
– Contraindicated during 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 (including history);
– erosive-ulcerative changes of the mucous membrane of the stomach or duodenum, acute hemorrhagic gastritis, active gastrointestinal bleeding;
– inflammatory bowel disease in the acute phase (ulcerative colitis, Crohn’s disease);
– cerebrovascular bleeding or other bleeding;
– Severe hepatic insufficiency or active liver disease;
– severe renal failure in patients not undergoing dialysis (creatinine clearance (CK) less than 30 ml/min), advanced renal disease, including confirmed hyperkalemia;
– Pregnancy, breast-feeding;
– Children under 15 years of age.
The suppositories should not be used in patients with any inflammatory disease of the rectum or anus, or in patients with a recent history of bleeding from the rectum or anus.

Dosage and administration

• Rectally, loosening the suppository from the wrapping, injected deep into the anus. It is recommended to empty the bowels before using the suppository. 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. If necessary, the dose may be increased to 15 mg per day.
• Ankylosing spondylitis: 15 mg daily. Depending on the therapeutic effect, the dose may be reduced to 7.5 mg per day.
• Rectal suppositories are recommended at a dose of 7.5 mg once daily. In more severe cases, it is possible to use suppositories in a dose of 15 mg. The maximum daily dose should not exceed 15 mg.
• The drug should be used rectally for as short a time as possible, taking into account the summation of the risk of local toxicity and the risk associated with the systemic action of the drug.
• In patients at increased risk of side effects and in patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg per day.
• Combined use
  The total daily dose of meloxicam used as tablets, suppositories, injections and other dosage forms should not exceed 15 mg.