Properties
What is it?
Composition Film-coated tablets Active substance: Tenoxicam 20 mg. Excipients: Lactose monohydrate, magnesium stearate, pregelatinized corn starch, talc. Coating composition: Opadry II 85F220095 (polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron yellow oxide, yellow sunset FCF aluminum lake, tartrazine aluminum lake). ATC code of the preparation: M01AC02 Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Oxicams. Pharmacological properties Pharmacodynamics Texamen is an effective non-steroidal anti-inflammatory drug (NSAID) with potent anti-inflammatory, analgesic, and moderate antipyretic effects. The properties of the preparation 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. The anti-inflammatory effect of Texamen is due to a decrease in capillary permeability (limits exudation), stabilization of lysosomal membranes (prevents the release of tissue-damaging lysosomal enzymes), and suppression or inactivation of the synthesis of inflammatory mediators (prostaglandins, histamine, bradykinin, lymphokines, complement factors). The preparation 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; has a chondroprotective effect. The preparation relieves or reduces pain syndrome of any etiology, reduces morning stiffness, and increases the range of motion of affected joints. It has a desensitizing effect with prolonged use. Pharmacokinetics Tenoxicam is rapidly and completely absorbed from the gastrointestinal tract; food and antacids slow down the absorption process without affecting the degree of absorption. Cmax is reached in 2 hours. Bioavailability is 100%. The preparation is 99% bound to plasma proteins. A distinguishing feature of tenoxicam is its long duration of action and a long half-life of 72 hours. Tenoxicam penetrates well into synovial fluid. It easily crosses the blood-brain barrier. It is metabolized in the liver to form inactive metabolites. The average half-life is 60-75 hours. Excretion occurs mainly through urine and partly through bile. Indications for use Inflammatory-degenerative diseases of the musculoskeletal system with accompanying pain syndrome: - Joint syndrome in gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, osteochondrosis, articular form of rheumatism (tendinitis, bursitis, myositis); - Back pain, neuralgia, myalgia, sciatica; - Algomenorrhea; Method of administration and dosage Texamen is taken orally. The preparation is prescribed at a dose of 20 mg once a day at the same time. In acute gouty arthritis, 40 mg is prescribed once a day for 2 days, then 20 mg once a day for 5 days. Contraindications - Hypersensitivity to the components of the preparation, acetylsalicylic acid or other NSAIDs; - Erosive-ulcerative lesions of the gastrointestinal tract; - Gastrointestinal bleeding; - Severe gastritis; - Severe liver and kidney disorders; - Arterial hypertension, heart failure, edema; - Pregnancy, lactation. Side effects Gastrointestinal tract: dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), abdominal pain and discomfort, stomatitis, anorexia; with prolonged use at high doses, gastrointestinal erosive-ulcerative complications. Nervous system: 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. Special instructions Texamen should be prescribed with caution in patients over 65 years of age, as well as in patients with mild to moderate liver and kidney impairment. Texamen should not be prescribed to patients who have planned surgery (in case of unplanned surgery, the doctor should be informed about taking Texamen). Texamen should be prescribed with caution in patients with gastrointestinal diseases (patient condition should be monitored, and Texamen intake should be discontinued if ulcerogenic action develops). It should be taken into account that in patients with arterial hypertension and heart failure, concomitant administration with diuretics may lead to sodium and water retention in the body. Effect on ability to drive vehicles and operate machinery During treatment with the preparation, caution should be exercised when driving vehicles and performing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Use during pregnancy and lactation The preparation is contraindicated during pregnancy. Tenoxicam and its metabolites pass into breast milk, so the use of the preparation during breastfeeding is not recommended. Use in pediatrics Safety in children has not been established. Interaction with other medicinal products Texamen should not be taken concurrently with salicylates, as well as non-steroidal anti-inflammatory drugs and corticosteroids. Concomitant use of Texamen enhances the effect of indirect anticoagulants and sulfonylurea derivatives. Probenecid may enhance the excretion of tenoxicam. Tenoxicam slightly reduces plasma levels of cardiac glycosides when used concurrently. Texamen should not be used concurrently with diuretics, as well as potentially nephrotoxic drugs. Texamen is not prescribed to patients taking antagonists of serotonin receptors and antiplatelet agents. Tenoxicam increases plasma concentrations of methotrexate and lithium. Antacid preparations reduce the absorption of tenoxicam. The risk of seizures is observed with concomitant use of tenoxicam with quinolone antibiotics. Overdose Symptoms: Intensification of side effects is observed. Treatment: There is no specific antidote; in case of suspected tenoxicam overdose, symptomatic therapy is recommended. Dosage form Film-coated tablets. 10 tablets in a blister. 1 blister in a cardboard box with instructions for use. Storage conditions Store in a dry place at a temperature not exceeding 25°C. Keep out of reach of children! Shelf life 3 years from the date of manufacture. The preparation must not be used after the expiry date. Conditions of dispensing Pharmaceutical product group III, available without a prescription
