Name:
Artoksan lyof.d / solution for IV and IM introduction. 20mg No. 3 + R-l No. 3 Storage conditions The drug should be stored out of the reach of children, at a temperature not exceeding 25 ° C Shelf life from the date of manufacture Shelf life of the lyophilizate is 3 years, the solvent is 4 years
Description:
of goods Lyophilisate for the preparation of a solution for intravenous and intramuscular injection – lyophilized powder or compacted mass in the form of a green-yellow tablet; solvent – colorless transparent liquid without a smell. Pharmacological action Tenoxicam is a thienothiazine derivative of oxicam, is an NSAID. In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also prevents platelet aggregation. The mechanism of action is based on the inhibition of the activity of COX-1 and COX-2 isoenzymes, resulting in a decrease in the synthesis of prostaglandins in the focus of inflammation, as well as in other tissues of the body. In addition, tenoxicam reduces the accumulation of leukocytes in the focus of inflammation, reduces the activity of proteoglycanase and collagenase in human cartilage. The anti-inflammatory effect develops by the end of the first week of therapy. Pharmacokinetics Absorption Absorption is rapid and complete. Bioavailability 100%. Cmax in blood plasma is noted after 2 hours. The distinctive ability of tenoxicam is a long duration of action and a long T1 / 2 – 72 hours. Distribution The drug is 99% bound to plasma proteins. Tenoxicam penetrates well into the synovial fluid. Easily penetrates through histohematic barriers. Metabolism Metabolized in the liver by hydroxylation to form 5-hydroxypyridyl. Excretion 1/3 is excreted through the intestines with bile, 2/3 is excreted by the kidneys in the form of inactive metabolites. Indications for use rheumatoid arthritis; – osteoarthritis; – ankylosing spondylitis; – articular syndrome during exacerbation of the course of gout; – bursitis; – tendovaginitis; – pain syndrome (low and moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea; – pain from injuries, burns. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease. Use during pregnancy and lactation The use of the drug during pregnancy and during breastfeeding is contraindicated. Special instructions During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys, the prothrombin index (against the background of taking indirect anticoagulants), the concentration of glucose in the blood (against the background of the use of hypoglycemic agents). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. An increase in bleeding time is possible, which should be taken into account during surgical interventions. It is necessary to take into account the possibility of sodium and water retention in the body when administered with diuretics in patients with arterial hypertension and heart failure. Patients with uncontrolled arterial hypertension, chronic heart failure, peripheral arterial disease, confirmed coronary artery disease and / or cerebrovascular disease should take the drug under medical supervision. A history of kidney disease can lead to the development of interstitial nephritis, papillary necrosis, and nephrotic syndrome. Undesirable effects can be minimized by using the minimum effective dose of the drug for as short a course as possible. Due to the negative effect on fertility, women who wish to become pregnant are not recommended to take the drug. In patients with infertility (including those undergoing examination), it is recommended to discontinue the drug. Patients with systemic lupus erythematosus and mixed connective tissue disease have an increased risk of developing aseptic meningitis. Influence on the ability to drive vehicles and mechanisms During the period of treatment, a decrease in the speed of mental and motor reactions is possible, therefore, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. With caution (Precautions) With caution: peptic ulcer of the stomach and duodenum, ulcerative colitis and Crohn’s disease without exacerbation, history of liver disease, hepatic porphyria, chronic renal failure (CC 30-60 ml / min), chronic heart failure, arterial hypertension, a significant decrease in BCC (including after surgery), elderly patients (over 65 years old) (including those receiving diuretics, debilitated patients and those with low body weight), bronchial asthma, coronary artery disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, the presence of Helicobacter pylori infection, long-term use of NSAIDs, alcoholism, severe somatic diseases, autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease), simultaneous use of GCS (incl. prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicy lic acid, clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline). Contraindications Hypersensitivity to the active substance or auxiliary components of the drug; there is a possibility of cross-sensitivity to acetylsalicylic acid, ibuprofen and other NSAIDs; – erosive and ulcerative lesions of the stomach and duodenum in the acute phase; – gastrointestinal bleeding (including history); – inflammatory bowel disease: Crohn’s disease or ulcerative colitis in the acute phase; – severe renal failure (CC less than 30 ml / min); – progressive kidney disease; – severe liver failure; – complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including history); – an established diagnosis of diseases of the blood coagulation system; – decompensated heart failure; – therapy of perioperative pain during coronary artery bypass surgery; – pregnancy; – the period of breastfeeding; – age up to 18 years. Dosage and administration For intramuscular or intravenous administration. In / m or / in the introduction is used for short-term (1-2 days) treatment at a dose of 20 mg 1 time / day. If necessary, further therapy is switched to oral dosage forms of tenoxicam. The solution for injection is prepared immediately before use by dissolving the contents of the vial with the supplied solvent. After preparation, the needle is replaced. In / m injections are done deeply. The duration of the / in the introduction should not be less than 15 seconds. Overdose Symptoms (with a single injection): abdominal pain, nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, impaired renal and hepatic function, metabolic acidosis. Treatment: symptomatic therapy (maintenance of vital body functions). Hemodialysis is ineffective. Side effect Definition of categories of frequency of side effects (in accordance with WHO recommendations): very often (> 1/10); often (from > 1/100, < 1/10); infrequently (> 1/1000, < 1/100); rarely (> 1/10,000, <1/1000); very rare (<1/10,000), not established. From the digestive system: very often - dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAID gastropathy, abdominal pain, stomatitis, anorexia, abnormal liver function; rarely - ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, uterine, hemorrhoidal), perforation of the intestinal wall. From the side of the cardiovascular system: rarely - heart failure, tachycardia, increased blood pressure. From the side of the central nervous system: often - dizziness, headache, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, visual impairment. On the part of the skin and subcutaneous tissue: often - pruritus, rash, urticaria and erythema; very rarely - photodermatitis, Stevens-Johnson syndrome, Lyell's syndrome. From the urinary system: often - an increase in the content of urea nitrogen and creatinine in the blood. On the part of the hematopoietic organs: often - agranulocytosis, leukopenia; rarely - anemia, thrombocytopenia, leukopenia, pancytopenia. From the hepatobiliary system: often - increased activity of ALT, AST, GGT and serum bilirubin levels. On the part of laboratory parameters: hypercreatininemia, hyperbilirubinemia, increased urea nitrogen concentration and liver transaminase activity, prolongation of bleeding time. Others: against the background of treatment, mental disorders and metabolic disorders may occur. Composition Active substance: tenoxicam 20 mg Excipients: mannitol - 80 mg, ascorbic acid - 0.4 mg, disodium edetate - 0.2 mg, trometamol - 3.3 mg, sodium hydroxide and hydrochloric acid - qs Solvent: water for injection - 2 ml. Interactions with other drugs Tenoxicam is characterized by a high degree of binding to albumin and, like all NSAIDs, may enhance the anticoagulant effect of warfarin and other anticoagulants. It is recommended to monitor blood counts when combined with anticoagulants and hypoglycemic drugs for oral administration, especially in the initial stages of Artoxan's use. No possible interaction with digoxin has been noted. As with the use of other NSAIDs, it is recommended to use the drug with caution simultaneously with cyclosporine due to an increased risk of nephrotoxicity. Co-administration with quinolones may increase the risk of seizures. Salicylates can displace tenoxicam from its association with albumin and, accordingly, increase the clearance and volume of distribution of the drug. It is necessary to avoid the simultaneous use of salicylates or two or more NSAIDs (increased risk of complications from the gastrointestinal tract). There is evidence that NSAIDs reduce the excretion of lithium. In this regard, in patients receiving lithium therapy, the concentration of lithium in the blood should be monitored more often. NSAIDs can cause sodium, potassium, and fluid retention in the body by interfering with the action of natriuretic diuretics. This must be remembered when combined with such diuretics in patients with CHF and arterial hypertension. With caution, it is recommended to use NSAIDs in conjunction with methotrexate, NSAIDs reduce the excretion of methotrexate and may increase its toxicity. NSAIDs should not be used within 8-12 hours after the use of mifepristone, because. may reduce its effect. It is necessary to take into account the increased risk of gastrointestinal bleeding when used together with corticosteroids. Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, fibrinolytics, side effects of mineralocorticoids and glucocorticoids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics. Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Combined use with antiplatelet agents and selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding. Cardiac glycosides, when taken together with NSAIDs, can exacerbate heart failure, reduce glomerular filtration rate and increase plasma concentrations of cardiac glycosides. There was no interaction when using tenoxicam with cimetidine. There was no clinically significant interaction in the treatment of tenoxicam and penicillamine or parenteral gold preparations. The risk of nephrotoxicity is increased when NSAIDs are co-administered with tacrolimus. There is an increased risk of hematological toxicity when using NSAIDs with zidovudine. Release form Lyophilizate for the preparation of a solution for intravenous and intramuscular injection - lyophilized powder or compacted mass in the form of a green-yellow tablet; solvent - colorless transparent liquid without a smell. 1 vial Active substance: tenoxicam 20 mg Excipients: mannitol - 80 mg, ascorbic acid - 0.4 mg, disodium edetate - 0.2 mg, trometamol - 3.3 mg, sodium hydroxide and hydrochloric acid - qs Solvent: water for injection - 2 ml. Colorless glass vials (3) complete with solvent (amp. 2 ml 3 pcs.) - blister packs (1) - cardboard packs. Buy Artoxan lyophilized powder for solution for injection in 20 mg vials complete with solvent No. Artoxan lyophilized powder for solution for injection in 20 mg vials complete with solvent No. 3x1 Instructions for use for Artoxan lyophilized powder for solution for injection in 20 mg vials complete with solvent No. 3x1
Artoxan lyophilized powder for solution for injection in vials 20mg complete with solvent No. 3×1
$30.00
INN | TENOXICAM |
---|---|
The code | 37 624 |
Barcode | 6 221 032 311 115 |
Dosage | 20mg |
Active substance | Tenoxicam |
Manufacturer | Rotafarm Limited, UK, E.I.P.I. Co., Egypt |
Importer | PTCHUP "Novamedica" Minsk, 223017 Minsk district, Gatovo village, Metallurgical street, 16a-3; Limited Liability Company "Vitvar", 210023, Vitebsk, Frunze Ave., 26, building 3; Closed joint-stock company "Unipharm", 223060, Minsk region, Novodvorsky s / council, 40-1, room. 36, area of the village of Bolshoye Stiklevo; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, office 1; [x] PTCUP "Novamedica" Minsk, 223017 Minsk district, Gatovo village, Metallurgical street, 16a-3; Limited Liability Company "Vitvar", 210023, Vitebsk, Frunze Ave., 26, building 3; Closed joint-stock company "Unipharm", 223060, Minsk region, Novodvorsky s / council, 40-1, room. 36, area of the village of Bolshoye Stiklevo; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, room 1 |
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