Artoksan lyophilisates for solution for injection 20mg fl + 3 pieces sol-l amp №3


Artoksan lyophilisates for solution for injection 20mg fl + 3 pieces sol-l amp №3



Active substance:
Tenoxicam – 20 mg.
Mannitol – 80.00 mg Ascorbic Acid – 0.400 mg Disodium edetate – 0.20 mg, trometamol – 3.30 mg, sodium hydroxide and hydrochloric acid – q.s.
Each solvent ampoule contains: water for injections – 2 ml.
The lyophilized powder or the compacted mass in the form of tab-taphole green-yellow color, solvent: colorless clear odorless liquid.
Product form:
Lyophilizate for preparation of solution for intravenous and intramuscular administration of 20 mg.
Primary packaging. The lyophilized powder containing 20 mg of active substance, placed in a vial of colorless glass, rubber stoppers of bromobutyl rubber, combined crimped aluminum cap type «flip off» with a plastic lid red color. The solvent (water for injection) in 2 ml ampoule colorless glass.
Secondary packaging. 3 vials of lyophilized powder and 3 ampoules of 2 ml capacity with a solvent in blisters. 1 blisters in a cardboard package, along with instructions for use.
– hypersensitivity to the active substance or auxiliary ingredients. There is a possibility of cross-sensitivity to aspirin, ibuprofen and other NSAIDs; – erosive and ulcerative lesions of the stomach and duodenal in the acute stage; – gastrointestinal bleeding (including in history); – inflammatory bowel disease: Crohn’s disease or ulcerative colitis in the acute stage; – severe renal failure (creatinine clearance (CC) of less than 30 ml / min.); – progressive kidney disease; – severe hepatic impairment; – full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and the intolerance of acetylsalicylic acid (ASA) and other NSAIDs (including history); – establishing the diagnosis of diseases of the blood coagulation system; – decompensated heart failure; – treatment of perioperative pain during coronary artery bypass surgery; – pregnancy, breast-feeding; – up to age 18 years.
Peptic ulcer and duodenal ulcer, ulcerative colitis and Crohn’s disease is worsening, history of liver disease, hepatic porphyria, chronic renal failure (creatinine clearance of 30-60 ml / min), chronic heart failure, arterial hypertension, a significant reduction in circulating blood volume ( including after surgery), older patients (over 65 years) (including receiving diuretics, debilitated patients with low body weight), asthma, coronary heart disease, n rebrovaskulyarnye diseases, dyslipidemia / giperlipedimiya, diabetes, peripheral arterial disease, smoking, presence of infection Helicobacter pylori, long-term use of NSAIDs, alcoholism, severe somatic diseases, autoimmune diseases (systemic lupus erythematosus (SLE) and mixed connective tissue disease), concomitant use of corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel) selective inhibitors reuptake serotinina (including citalopram, fluoxetine, paroxetine, sertraline).
20 mg
– rheumatoid arthritis; – osteoarthritis; – ankylosing spondylitis; – articular syndrome in exacerbation of gout; – bursitis; – tenosynovitis; – pain (mild to moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache, and headaches, tuberculosis; – pain in trauma, burns;
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
Tenoxicam has a high degree of binding to albumin and can, as with all NSAIDs, enhance the anticoagulant effect of warfarin and other anticoagulant. It is recommended to monitor blood counts or combined with anticoagulants and hypoglycemic prep-ter for oral administration, particularly in the initial stages of application Artlet-san.
There was no possible interactions with digoxin.
As with other NSAIDs, it is recommended to use the drug with caution in conjunction with cyclosporine due to increased risk of nephrotoxicity.
The combined use of 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, patients receiving lithium therapy must frequently monitor blood lithium concentration.
NSAIDs can cause sodium retention, potassium and fluids in the body, on-rushaya action natriuretic diuretics. This should be remembered when combined with such diuretics in patients with chronic heart failure and hypertension.
The caution is recommended to use in conjunction with methotrexate NSAIDs, NSAIDs reduce the excretion of methotrexate and may increase its toxicity.
NSAIDs should not be used within 8-12 hours after administration of mifepristone, as may reduce its effect.
It is necessary to take into account the increased risk of gastrointestinal bleeding when combined with a corticosteroid.
It reduces the efficiency of uricosuric medicament enhances the effect of anticoagulants, fibrinolytics, mineralokortikosteroidov and side effects of glucocorticoids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.
Inductors microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of active hydroxylated metabolites.
Joint application with antiplatelet agents and selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.
Cardiac glycosides when taking in conjunction with NSAIDs could enhance cardiac failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides.
There were no interaction between the application tenoxicam with cimetidine.
No clinically significant interaction with treatment tenoxicam penicillamine and gold or parenterally.
Increased risk of nephrotoxicity of NSAIDs when used together with tacrolimus.
Increased risk of haematological toxicity when NSAIDs with zidovudine.
Symptoms (a single administration): abdominal pain, nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, impaired renal and hepatic function, metabolic acidosis.
Treatment: symptomatic (maintenance of the vital functions of the body). Hemodialysis – is ineffective.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug.
Tenoxicam representing tienotiazinovoe oxicam derivative, is a nonsteroidal anti-inflammatory drug (NSAID). In addition to antiinflammatory, analgesic and antipyretic actions, the drug also inhibits platelet aggregation. The basis of the mechanism of action is inhibition of cyclooxygenase isoenzymes-1 and COX-2, thereby reducing the synthesis of prostaglandins in inflammation, as well as in other body tissues. Furthermore, tenoxicam reduces leukocyte accumulation in the inflammation, reduces the activity proteoglikanazy and collagenase in human cartilage.
Develops anti-inflammatory effect by the end of the first week of therapy.
Absorption is fast and complete. Bioavailability is 100%.
The maximum plasma concentration observed after 2 hours. The distinctive ability of tenoxicam is a long duration of action and a long half-life – 72 hours. The drug is 99% bound to plasma proteins. Tenoxicam penetrates well into the synovial fluid. Easily penetrates the blood-tissue barriers.
It is metabolized in the liver by hydroxylation to form a 5-hydroxypyridyl.
Withdrawal. 1/3 excreted through intestine with bile, 2/3 kidneys displayed as inactive metabolites.
Pregnancy and breast-feeding
Use of the drug during pregnancy and lactation is contraindicated.
Conditions of supply of pharmacies
side effects
The frequency of side effects is classified according to the recommendations of the World Health Organization: very common (> 1/10); often (by> 1/100, 1/1000, 1/10000,
From the digestive system: very often – dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAID-gastropathy, abdominal pain, stomatitis, anorexia, abnormal liver function; rarely – mucosal ulceration gastrointestinal bleeding (gastrointestinal, uterine, hemorrhoids), perforation of the intestinal wall.
Cardio-vascular system: seldom – heart failure, tachycardia, increased blood pressure.
Central nervous system: often – dizziness, headache, somnolence, depression, agitation, hearing loss, tinnitus, eye irritation, blurred vision.
Violations of the skin and subcutaneous tissue: often – itching, rash, urticaria and erythema; very rarely – fotodermatit, Steven-sa-Johnson syndrome, Lyell’s syndrome.
The urinary system: often – increase of urea nitrogen and creatinine in the blood.
From the side of hematopoiesis: often – agranulocytosis, leucopenia, rarely – anemia, thrombocytopenia, leukopenia, pancytopenia.
Violations by the hepatobiliary system: often – increased ALT, AST, gamma-GT and bilirubin levels in the serum.
Laboratory parameters: hypercreatininemia, hyperbilirubinemia, increased concentrations of urea nitrogen and “liver” Trans-minaz, elongation of bleeding time.
The treatment can be observed mental disorders and metabolic disorders.
special instructions
During treatment requires monitoring picture peripheral blood and functional state of the liver and kidneys, prothrombin index (while taking anticoagulants), blood glucose (against application hypoglycemic agents).
If necessary, the definition of 17-ketosteroids drug should be discontinued 48 hours prior to the study.
May increase bleeding time, which should be considered for surgical interventions.
It is necessary to consider the possibility of delay sodium and water in the body by administration with diuretics in patients with hypertension and heart failure.
Patients with uncontrolled hypertension, congestive heart failure, peripheral artery disease confirmed by coronary artery disease and / or cerebrovascular disease should take the drug under medical supervision.
A history of kidney disease can lead to interstitial nephritis, papillary necrosis and nephrotic syndrome.
Undesirable effects may be minimized by using the minimum effective dose short course possible.
Due to the adverse effect on fertility, women wishing to become pregnant, the drug is not recommended. In patients with infertility (including the passing of examinations) it is recommended to cancel the drug. In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease increases the risk of aseptic meningitis.
The effect on the ability to operate vehicles, machinery
The treatment period may reduce the rate of mental and motor reactions, so you must refrain from driving vehicles and other classes of potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Do not freeze !.
Dosing and Administration
For intramuscular or intravenous administration.
Intramuscular or intravenous administration is used for short-term (1-2 days) of treatment in a dose of 20 mg 1 time per day. If necessary, further treatment by oral dosage forms tenoxicam.
injectable solution is prepared immediately before use by dissolving the supplied solvent vial contents. After cooking, the needle is replaced. Intramuscular injections were deep. The duration of intravenous administration must not be less than 15 seconds.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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