Artoxan (Tenoxicam) 20 mg x 5 rectal suppositories
The instruction for medical use of APTOKCAH medicine the Trade name Artoksan Mezhdunarodnoye the unlicensed name Tenoksikam Lekarstvennaya a form Suppositories rectal Structure 1 suppository contains active agent – to tenoksika of 20 mg, excipient – vitepsol S55. The description Uniform torpedo-shaped suppositories of yellow color with a slight smell. Pharmacotherapeutic group Anti-inflammatory and antirheumatic drugs. Non-steroidal anti-inflammatory drugs. Oksikama. Tenoksikam the ATX M01AC02 Code the Pharmacological Pharmacokinetics Bioavailability properties at rectal administration makes 80%. The maximum concentration in blood plasma is reached in 2 hours. Therapeutic concentration in blood plasma, equal 2 mg/l and 4 mg/l, are reached after single dose of a dose of 20 mg and 40 mg of a tenoksikam respectively. Steady concentration in blood plasma – about 11 mg/l – is reached in 10-12 days after daily reception of a tenoksikam in a dose of 20 mg. The volume of distribution is 0.15 l/kg, elimination half-life – 60-75 hours. Tenoksikam easily gets into synovial fluid. Is exposed to transformation in a liver with formation of inactive metabolites. One of them (5-hydroksipiridit) is brought with urine, the others in the form of glucuronic conjugates – with bile. Artoksan’s pharmacodynamics – effective non-steroidal anti-inflammatory drug (NPVP) with powerful anti-inflammatory, analgeziruyushchy and moderate febrifugal action. Properties of drug are caused by inhibition of both isoforms of enzyme of cyclooxygenase that leads to disturbance of metabolism of arachidonic acid and blockade of synthesis of prostaglandins. The anti-inflammatory effect is caused by reduction of permeability of capillaries (limits exudation), stabilization of lizosomalny membranes (interferes with an exit of enzymes of the lysosomes causing damage of fabrics), oppression of synthesis or an inactivation of mediators of inflammation (prostaglandins, a histamine, bradykinin, lymphokines, complement factors). Reduces the number of free radicals in the inflammation center, the chemotaxis and phagocytosis oppresses. Brakes a proliferative phase of inflammation, reduces a post-inflammatory sklerozirovaniye of fabrics. Has hondroprotektorny effect. Drug reduces painful sensitivity in the inflammation center, possesses the desensibilizing action (at prolonged use). In rheumatic diseases weakens a joint pain at rest and at the movement, reduces morning constraint and a swelling of joints, improves functions and increases the volume of movements of joints. Indications Inflammatory and degenerative diseases of the musculoskeletal system which are followed by a pain syndrome: – a joint syndrome in gout, a pseudorheumatism, the osteoarthrosis ankylosing a spondylitis, osteochondrosis, joint rheumatism (tendinites, a bursitis, miozita) – backbone pain, neuralgia, myalgia, an ischialgia – algodismenoreya. The route of administration and Artoksan’s doses accept rektalno. Drug appoint in a dose 20 mg of 1 times a day at the same time. In acute gouty arthritis appoint 40 mg of 1 times a day within 2 days, then – on 20 mg of 1 times a day within 5 days. Side effects – dyspepsia (nausea, vomiting, heartburn, diarrhea, a meteorism), pain and unpleasant feelings in a stomach, stomatitis, anorexia, at prolonged use in high doses – GIT erosive cankers – a headache, dizziness, a depression, hyperexcitability – a small tortoiseshell, naggers, an erythema, syndromes Stephens-Johnson and Layell – a renal failure, increase in concentration in plasma of creatinine, urea nitrogen, bilirubin and activity of hepatic transaminases, lengthening of a bleeding time, perhaps local irritation. Contraindications – hypersensitivity to drug components, acetylsalicylic acid or other NPVP – erosive cankers of the digestive tract (DT), – gastrointestinal bleeding – gastritis of a heavy course – the profound abnormal liver functions and kidneys – arterial hypertension, heart failure, hypostases – pregnancy, the lactation period – to children and teenagers up to 18 years. Medicinal interactions Artoksan are not appointed along with drugs of group of salicylates and also non-steroidal anti-inflammatory drugs and corticosteroids. Artoksan at the combined use exponentiates effect of indirect anticoagulants and derivatives of sulphonylurea. Probenetsid can exponentiate removal of a tenoksikam. Tenoksikam at simultaneous use reduces the level of cardiac glycosides in blood plasma a little. Artoksan it is not necessary to apply along with diuretic means and also potentially nephrotoxic drugs. It is not necessary to appoint Artoksan to the patients receiving antagonists of serotoninovy receptors and antiagregantny means. Tenoksikam increases plasma concentration of a methotrexate and lithium. Increase in risk of developing spasms at the combined use of a tenoksikam with hinolonovy antibiotics is noted. Artoksan with care appoint special instructions to patients 65 years and also to patients with disturbances of functions of kidneys and a liver easy and moderate severity are more senior. It is not necessary to appoint Artoksan to patients to whom planned surgeries are coming (when performing unplanned surgeries it is necessary to report to the doctor about administration of drug Artoksan). It is necessary to appoint with care the drug Artoksan to patients with digestive tract diseases (it is necessary to control a condition of the patient and at development of ulcerogenic action to cancel the drug Artoksan). It is necessary to consider a possibility of a delay of sodium and water in an organism when assigning with diuretics to patients with arterial hypertension and heart failure. Use in pediatrics Safety of use of drug for children is not established. Pregnancy and a lactation Drug is contraindicated to use during pregnancy. Tenoksikam and his metabolites get into breast milk therefore drug should not be used during breastfeeding. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms during treatment needs to abstain from occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: strengthening of side effects is noted. Treatment: specific antidote does not exist. At suspicion on overdose of a tenoksikam the symptomatic therapy is recommended. A form of release and packing On 5 suppositories in blister strip packaging. On 1 or 2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh. Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami to the Dzhad Yole. No. 50 K. 1B Zemin 4-5-6, Istanbul, Turkey. The owner of the registration certificate of ROTAFARM ILACHLARY LIMITED of SHIRKETI, TURKEY the Address of the organization accepting in the territory of the Republic of Kazakhstan a claim (offer) from consumers on quality of RK medicine, Almaty, Turksibsky district, Suyunbaya Ave., 222b Ph. / fax: 2529090 Address of the organization responsible for post-registration observation of safety of medicine: TROKA-S PHARMA LLP, RK, Almaty, Suyunbaya Ave., 222 B Cellular ph. +7 701 786 33 98, (24-hour access).
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