Properties
What is it?
Composition Rectal suppositories contain active substance: Tenoxicam 20 mg. Excipient: Witepsol H 15. Description: Elongated suppositories, uniform, yellow in color, with a faint odor. See blog: Artroxan – Non-Steroidal Anti-Inflammatory Drug Pharmacological Properties Artroxan – an effective non-steroidal anti-inflammatory drug (NSAID) with potent anti-inflammatory, analgesic, and less pronounced antipyretic effects. The drug's properties are due to the inhibition of both isoforms of the enzyme cyclooxygenase, which leads to a disruption of arachidonic acid metabolism and blockade of prostaglandin synthesis. Artroxan's anti-inflammatory effect is due to reduced capillary permeability (limiting exudation), stabilization of lysosomal membranes (preventing the release of tissue-damaging lysosomal enzymes), and suppression or inactivation of the synthesis of inflammatory mediators (prostaglandins, histamine, bradykinin, lymphokines, complement factors). The drug reduces the amount of free radicals at the site of inflammation, reduces chemotaxis and phagocytosis; inhibits the development of the proliferative phase of inflammation; reduces post-inflammatory tissue sclerosis; possesses chondroprotective action. The drug reduces pain sensation at the site of inflammation and acts on thalamic pain centers, has a desensitizing effect (with prolonged use). In rheumatic diseases, it reduces joint pain, both at rest and during movement, reduces morning stiffness and joint swelling, improves their function, and increases the range of motion. Pharmacokinetics With rectal administration, bioavailability is 80%. Cmax is reached in 2 hours. It is 99% bound to plasma proteins. After a single oral dose of 20-40 mg, maximum plasma concentration of 2-4 mg/L is achieved in plasma. With daily intake of 20 mg of tenoxicam (once a day), an approximately equal steady-state plasma concentration of 11 mg/L is reached in 10-12 days. The volume of distribution is 0.15 L/kg, and the half-life is 60-75 hours. 2/3 of the absorbed dose is excreted in urine, 1/3 – in feces. Tenoxicam easily penetrates the synovial fluid of patients with osteoarthritis and rheumatoid arthritis. Transformation in the liver into inactive metabolites is confirmed. One of them (5-hydroxypyridyl) is excreted in urine, the rest are excreted with bile in the form of glucuronide conjugates. Indications Inflammatory-degenerative diseases of the musculoskeletal system with concomitant pain syndrome: - Joint syndrome in gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, osteochondrosis, articular form of rheumatism (periarthritis, tendinitis, bursitis, myositis); - Back pain, neuralgia, myalgia, sciatica, lumbago; - Algomenorrhea; - Pain during trauma, burns. Dosage and Administration For rectal use. Usually prescribed at a dose of 20 mg once a day at the same time. In acute gouty arthritis, it is prescribed at 40 mg once a day for 2 days, then 20 mg once a day for 5 days. Pediatric Use: Safety of use in children has not been established. Side Effects Gastrointestinal: dyspepsia, nausea, vomiting, heartburn, diarrhea, flatulence, abdominal pain and discomfort, stomatitis, anorexia; with prolonged use at high doses, erosive-ulcerative gastrointestinal complications. Nervous system and sensory organs: headache, dizziness, depression, increased excitability. Allergic reactions: urticaria, itching, erythema, Stevens-Johnson and Lyell's syndromes. Other: impaired kidney function, increased plasma concentrations of creatinine, nitrogen, urea, bilirubin, increased activity of liver transaminases, prolonged bleeding time. Local irritation, painful defecation may occur with the use of suppositories. Contraindications - Hypersensitivity to tenoxicam or other NSAIDs; - Erosive-ulcerative lesions of the digestive system; - Gastrointestinal bleeding; - Aspirin triad (accompanied by bronchial asthma); - Severe liver and kidney impairment; - Diabetes mellitus; - Arterial hypertension, heart failure, edema; - Pregnancy, lactation period; - Blood diseases. Pregnancy and Lactation The drug is contraindicated during pregnancy. If necessary, the decision to prescribe during lactation should be made regarding the discontinuation of breastfeeding. Special Instructions Use with caution in elderly patients, when taking diuretics, nephrotoxic drugs, immediately after surgical intervention. Artroxan should be discontinued a few days before surgery. During long-term treatment, it is necessary to monitor liver and kidney function, prothrombin index in blood, blood glucose levels. In case of erosive-ulcerative lesions of the gastrointestinal tract or bleeding during treatment, it is necessary to discontinue the drug and initiate appropriate treatment. Effect on ability to drive and operate machinery: During treatment, caution must be exercised when driving a car and performing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Overdose Cases of overdose have not been reported. Drug Interactions Artroxan enhances the effect of lithium preparations (including toxicity), indirect anticoagulants, oral hypoglycemic agents (sulfonylurea derivatives). Other NSAIDs increase the risk of side effects, especially gastrointestinal. Myelotoxic drugs enhance hematotoxicity. Storage Conditions and Shelf Life Store protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Pharmacy Dispensing Category Pharmaceutical product group II (Dispensing regime: by prescription)
