Revmalgyn (meloxicam) rectal suppositories 15 mg. №10

Description

Revmalgyn (meloxicam) rectal suppositories 15 mg. №10

Composition 

active ingredient: meloxicam;

1 suppository contains meloxicam in terms of 100% dry matter 15 mg;

excipients: hard fat, polyethoxylated hydrogenated castor oil.

Dosage form

Suppositories are rectal.

Basic physical and chemical properties: smooth yellowish-green suppositories. There are no inclusions on the longitudinal section, the presence of a funnel-shaped recess and an air rod is allowed.

Pharmacological group

Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A C06.

Pharmacological properties 

Meloxicam is a non-steroidal anti-inflammatory drug of the enolic acid class, which has anti-inflammatory, analgesic and antipyretic effects. Meloxicam has high anti-inflammatory activity in all standard models of inflammation. The general mechanism of these effects may be the ability of meloxicam to inhibit the biosynthesis of prostaglandins – inflammatory mediators.

The safer mechanism of action of meloxicam is associated with the selective inhibition of cyclooxygenase-2 (COX-2) compared to cyclooxygenase-1 (COX-1). The therapeutic effect of NSAIDs is associated with inhibition of COX-2 synthesis, while inhibition of COX-1 leads to side effects from the stomach and kidneys.

The selectivity of COX-2 inhibition by meloxicam has been confirmed by many researchers both in vitro and ex vivo. Meloxicam (15 mg) preferentially inhibits COX-2 ex vivo, as evidenced by the greater inhibition of PGE2 production in response to lipopolysaccharide stimulation, compared to thromboxane production in coagulated blood (COX-1). These effects are dose-dependent. Meloxicam does not affect platelet aggregation or bleeding time when used in recommended doses ex vivo, whereas indomethacin, diclofenac, ibuprofen and naproxen significantly inhibit platelet aggregation and prolong bleeding.

Clinical trials have shown a low incidence of gastrointestinal side effects (perforation, ulceration and bleeding) with the recommended doses of meloxicam compared to standard doses of other NSAIDs.

Indications 

Revmalgyn rectal suppositories are used for the symptomatic treatment of pain syndrome with:

• pain syndrome in osteoarthritis (arthrosis, degenerative joint diseases);
• rheumatoid arthritis;
• ankylosing spondylitis.

Contraindications:

• Hypersensitivity to meloxicam or to other components of the drug or to active substances with a similar effect, such as NSAIDs, aspirin;
• meloxicam should not be administered to patients who have experienced symptoms of asthma, nasal polyps, angioedema or urticaria after using aspirin or other NSAIDs;
• pregnancy and lactation;
• children under the age of 18;
• gastrointestinal bleeding or perforation associated with previous NSAID therapy in history;
• a history of active or recurrent peptic ulcer / bleeding (two or more separate confirmed cases of ulcer or bleeding);
• active inflammatory bowel disease (Crohn’s disease or ulcerative colitis);
• severe liver failure;
• severe renal failure without dialysis;
• gastrointestinal bleeding, history of cerebrovascular bleeding, or other bleeding disorders;
• severe heart failure;
• treatment of perioperative pain in coronary artery bypass grafting (CABG).

Method of administration and dosage

• Osteoarthritis: 15 mg / day (1 suppository).
• Rheumatoid arthritis: 15 mg / day (1 suppository).
• Ankylosing spondylitis: 15 mg / day (1 suppository).

The maximum recommended daily dose of meloxicam is 15 mg.
Since with an increase in the dose and duration of treatment, the risk of adverse reactions increases, it is necessary to use the lowest effective daily dose for the shortest period of treatment.
With the combined use of various forms of the drug (capsules, tablets, suppositories, suspension or injection solution), the total daily dose of meloxicam should not exceed 15 mg.

Children

The drug should not be used to treat children under 18 years of age.

Overdose

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with maintenance therapy. Gastrointestinal bleeding may occur. Severe poisoning can lead to hypertension, acute renal failure, liver dysfunction, respiratory depression, coma, seizures, cardiovascular failure, and cardiac arrest. Anaphylactoid reactions have been reported with the therapeutic use of NSAIDs, which can also occur with overdose.
In case of an overdose of NSAIDs, patients are recommended symptomatic and supportive measures. Studies have shown an acceleration of the elimination of meloxicam by taking 4 oral doses of cholestyramine 3 times a day.

Side effects:

• Changes in laboratory parameters: anemia, change in the number of leukocytes, thrombocytopenia, agranulocytosis, increased levels of transaminases, bilirubin, increased levels of creatinine / urea.
• Immune disorders: allergies (including anaphylactic shock).
• Mental disorders: mood changes, confusion, nightmares, disorientation, insomnia.
• Neurological disorders: dizziness, drowsiness, headache.
• Ophthalmic disorders: conjunctivitis, blurred vision.
• Otolaryngological disorders: ringing in the ears.
• Cardiac disorders: palpitations, heart failure.
• Vascular disorders: arterial hypertension, hot flashes.
• Respiratory disorders: asthma attacks, coughs, respiratory tract infections.
• Digestive disorders: abdominal pain, diarrhea, nausea, vomiting, latent or overt gastrointestinal bleeding, esophagitis, gastroduodenal ulcer, stomatitis, belching, constipation, flatulence, perforation, colitis, gastritis, peptic ulcer.
• Hepatobiliary disorders: hepatitis, liver failure, jaundice.
• Skin changes: itching, angioedema, rash, Stevens-Johnson syndrome, urticaria, epidermal necrolysis, bullous dermatitis, photosensitivity, erythema multiforme, exfoliative dermatitis.
• Urinary disorders: hyperkalemia, sodium and water retention, acute renal failure, urinary tract infections, acute urinary retention.
• Musculoskeletal disorders: back pain, arthralgia.
• General disorders: edema, flu-like symptoms.