Artoxan - instructions for use, dose, side effects, contraindications

Active substanceTenoxicamTenoxicam

Similar drugsTo uncover

Artoxane

lyophilizate w / m in / in

Rotafarm Limited United Kingdom

The Texman

lyophilizate w / m in / in

Mustafa Nevzat Ilach Sanai A.Sh. Turkey

The Texman

pills inwards

Mustafa Nevzat Ilach Sanai A.Sh. Turkey

Dosage form: & nbsplyophilizate for the preparation of solution for intravenous and intramuscular administration

Composition:

Each vial of the preparation contains:

Active substance: tenoxicam - 20 mg.

Excipients: 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 ampoule of the solvent contains: water for injection - 2 ml.

Description:The lyophilized powder or the condensed mass in the form of a tablet of green-yellow color, solvent: colorless transparent liquid without a smell.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug

ATX: & nbsp

M.01.A.C.02 Tenoxicam

Pharmacodynamics:

Tenoxicam, which is a thienothiazine oxycam derivative, is a non-steroidal anti-inflammatory drug (NSAID). In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also interferes with the aggregation of platelets. The mechanism of action is based on inhibition of the activity of cyclooxygenase-1 and cyclooxygenase-2 isoenzymes,as a result of which the synthesis of prostaglandins in the inflammatory focus is reduced, as well as in other tissues of the body. In addition, tenoxicam reduces the accumulation of leukocytes in the inflammatory focus, reduces the activity of proteoglycanase and collagenase in human cartilage.

Anti-inflammatory effect develops by the end of the first week of therapy.

Pharmacokinetics:

Suction.

Absorption is fast and complete. Bioavailability of 100%.

Distribution.

The maximum concentration in the blood plasma is observed after 2 hours. The distinctive ability of tenoxicam is a long duration of action and a long half-life of 72 hours. The drug is 99% bound to blood plasma proteins. Tenoxicam well penetrates into the synovial fluid. Easily penetrates through the histohematological barriers.

Metabolism.

Metabolised in the liver by hydroxylation to form 5-hydroxypyridyl.

Excretion.

1/3 is secreted through the intestine with bile, 2/3 is excreted by the kidneys in the form of inactive metabolites.

Indications:

- Rheumatoid arthritis;

- osteoarthritis;

- ankylosing spondylitis;

- articular syndrome with exacerbation of gout;

- bursitis;

- tenosynovitis;

- pain syndrome (mild and moderate intensity): arthralgia, myalgia, neuralgia, migraine, dental and headache, algodismenorea;

- pain with injuries, burns;

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

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 stage of exacerbation;

- gastrointestinal bleeding (including in the anamnesis);

- inflammatory bowel disease: Crohn's disease or ulcerative colitis in the acute stage;

- severe renal failure (creatinine clearance (CK) less than 30 ml / min.);

- progressive kidney disease;

- severe hepatic impairment;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid (ASA) or other NSAIDs (including in the anamnesis);

- established diagnosis of blood coagulation system diseases;

- Decompensated heart failure;

- perioperative pain therapy during coronary artery bypass surgery;

- pregnancy, the period of breastfeeding;

- age to 18 years.

Carefully:

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 / hyperlipidemia, diabetes mellitus, 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 serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Pregnancy and lactation:

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

For intramuscular or intravenous administration.

Intramuscular or intravenous administration is used for short-term (1-2 days) treatment at a dose of 20 mg once a day. If necessary, further therapy is transferred to oral dosage forms of tenoxicam.

The injection solution is prepared immediately before use by dissolving the contents of the vial with the supplied solvent. After preparation, the needle is replaced. Intramuscular injections are done deeply. Duration of intravenous administration should not be less than 15 seconds.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), not established.

From the digestive system: very often - dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAID-gastropathy, abdominal pain, stomatitis, anorexia, impaired liver function; rarely - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, uterine, hemorrhoidal), perforation of intestinal walls.

From the cardiovascular system: rarely - heart failure, tachycardia, increased blood pressure.

From the central nervous system: often - gdizziness, headache, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, visual impairment.

Disturbances from the skin and subcutaneous tissue: often - itching, rash, hives and erythema; very rarely - photodermatitis, Stevens-Johnson syndrome, Lyell's syndrome.

Disorders from the urinary system: often - an increase in the content of urea nitrogen and creatinine in the blood.

From the hematopoiesis: often - agranulocytosis, leukopenia, rarely - anemia, thrombocytopenia, leukopenia, pancytopenia.

Disorders from the hepatobiliary system: often - increased ALT activity, ACT, gamma-HT and serum bilirubin levels.

Laboratory indicators: hyperkreatinemia, hyperbilirubinemia, increased urea nitrogen concentration and activity of "hepatic" transaminases, prolongation of bleeding time.

On the background of treatment, there may be mental disorders and metabolic disorders.

Overdose:

Symptoms (with 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 vital body functions). Hemodialysis is ineffective.

Interaction:

Tenoxicam has a high degree of binding to albumin and can, like all NSAIDs, enhance the anticoagulant effect of warfarin and other anticoagulants. It is recommended to monitor indicators at ωin the local application with anticoagulants and hypoglycemic drugs for oral administration, especially in the initial stages of administration of Arthoksan.

There was no possible interaction with digoxin.

As with other NSAIDs, it is recommended that the drug be used with caution when cyclosporine is used because of the increased risk of developing nephrotoxicity.

Joint use with quinolones may increase the risk of seizures.

Salicylates can displace tenoxicam from the bond with albumin and, accordingly, to 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 connection with these patients receiving lithium therapy, should more often monitor the concentration of lithium in the blood.

NSAIDs can cause sodium, potassium and fluid retention in the body, disrupting the action of natriuretic diuretics. This should be remembered when combined with such diuretics in patients with CHF and 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 administration of mifepristone, tk. can reduce its effect.

It is necessary to take into account the increased risk of developing gastrointestinal bleeding when combined with corticosteroids.

Reduces the effectiveness of uricosuric medicines, strengthens the effect of anticoagulants, fibrinolytics, side effects of mineralocorticosteroids and glucocorticosteroids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.

Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Co-administration with antiplatelet agents and selective serotonin reuptake inhibitors increases the risk of developing gastrointestinal bleeding.

Cardiac glycosides when taken together with NSAIDs can increase heart failure, reduce the rate of glomerular filtration and increase the plasma level of cardiac glycosides.

There was no interaction with the use of tenoxicam with cimetidine. There was no clinically significant interaction in the treatment with tenoxicam and penicillamine or parenteral gold.

Increased risk of nephrotoxicity in the combined use of NSAIDs with tacrolimus.

Increased risk of hematological toxicity when using NSAIDs with zidovudine.

Special instructions:

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys, the prothrombin index (against the background of indirect anticoagulants), the concentration of glucose in the blood (against hypoglycemic agents).

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

There may be an increase in bleeding time, which should be taken into account in surgical interventions.

It is necessary to consider 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 by IHD and / or cerebrovascular disease should take the drug under medical supervision.

The presence of a history of kidney disease can lead to the development of interstitial nephritis, papillary necrosis and nephrotic syndrome.Unwanted effects can be minimized by applying the minimum effective dose of the drug as short a course as possible.

In connection with the negative effect on fertility, women who want to become pregnant, the drug is not recommended. In patients with infertility (including undergoing examination) it is recommended to cancel the drug. In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease, the risk of developing aseptic meningitis increases.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from driving transport and occupations with other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Lyophilizate for the preparation of a solution for intravenous and intramuscular administration of 20 mg.

Packaging:

Primary packaging. The lyophilized powder containing 20 mg of the active ingredient is placed in a vial of clear glass sealed with a bromobutyl rubber stopper, crimped with a combined aluminum cap of the type "flip off" with a plastic lid of red color. Solvent (water for injection): 2 ml per ampoule of colorless glass.

Secondary packaging. 3 bottles with lyophilized powder and 3 ampoules with a capacity of 2 ml with a solvent in the outline cell packaging. 1 contour mesh package in a cardboard bundle together with instructions for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Do not freeze!

Shelf life:

Lyophilizate - 3 years.

Solvent - 4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004089

Date of registration:23.01.2017

Expiration Date:23.01.2022

The owner of the registration certificate:Rotafarm LimitedRotafarm Limited United Kingdom

Manufacturer: & nbsp

Representation: & nbspTROKAS PHARMA LLCTROKAS PHARMA LLCRussia

Information update date: & nbsp25.09.2017

Illustrated instructions

Instructions

Artoxane (Artoxan)