Artoxan for injections 20mg #3

Artoxan user manual

You can buy Artoxan here

Release form, composition and packaging

Lyophilisate for preparation of solution for in / in and in / m of introduction - the lyophilized powder or the condensed weight in the form of a tablet of green-yellow color; the solvent is a colorless, transparent, odorless liquid.
1 fl.
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 - q.s.
Solvent: water d / and - 2 ml.
Vials of colorless glass (3) complete with a solvent (amp. 2 ml 3 pcs.) - blister packs (1) - packs cardboard.

pharmachologic effect

Tenoksikam is a thienothiazine derivative of oxycam, is an NSAID. In addition to anti-inflammatory, analgesic and antipyretic effects, Artoxan also prevents platelet aggregation. The basis of the mechanism of action is the inhibition of the activity of isoenzymes COX-1 and COX-2, resulting in reduced 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.
Anti-inflammatory effect develops by the end of the first week of therapy.

Pharmacokinetics

Suction

Absorption is fast and complete. Bioavailability is 100%. Cmax in the blood plasma is noted after 2 h. The distinctive ability of tenoxicam is a long duration of action and a long T1 / 2 - 72 h.

Distribution

Artoxan is 99% bound to plasma proteins. Tenoxam well penetrates the synovial fluid. Easily penetrates histohematogenous barriers.

Metabolism

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

Removal

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

Indications for Artoxan

- rheumatoid arthritis;
- osteoarthritis;
- ankylosing spondylitis;
- articular syndrome in acute exacerbation of gout;
- bursitis;
- tendovaginitis;
- pain syndrome (low and medium intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea;
- pain with injuries, burns.
Artoxan is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications for Artoxan

- hypersensitivity to the active substance or auxiliary components of Artoxan; 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 and in the anamnesis);
- 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 nasal polyposis and paranasal sinuses and intolerance to ASA or other NSAIDs (including in the anamnesis);
- The established diagnosis of diseases of the blood coagulation system;
- decompensated heart failure;
- therapy of perioperative pain during coronary artery bypass surgery;
- pregnancy;
- breastfeeding period;
- age up to 18 years.
With caution: gastric ulcer and duodenal ulcer, 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 reduction in BCC ( including after surgical intervention), elderly patients (over 65 years old) (including receiving diuretics, weakened patients and with low body mass), asthma, coronary heart disease, cerebrovascular diseases, dyslipidemia I / hyperlipedimia, diabetes mellitus, peripheral arterial disease, smoking, Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease), simultaneous administration of GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Dosage of Artoxan

For the / m or / in the introduction.
V / m or in / 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 transferred to the oral dosage forms of tenoxicam.
The solution for injection is prepared immediately before use by dissolving the contents of the vial with the attached solvent. After preparation, the needle is replaced.
V / m injections do deep.
Duration on / in the introduction should not be less than 15 seconds.

Side effects

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 rarely (<1/10 000), not established.
On the part of the digestive system: very often - dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAID-gastropathy, abdominal pain, stomatitis, anorexia, abnormal liver function; rarely - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, uterine, hemorrhoidal), perforation of the intestinal walls.
Since 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, blurred vision.
On the part of the skin and subcutaneous tissue: often - pruritus, rash, urticaria, and erythema; very rarely - photodermatitis, Stevens-Johnson syndrome, Lyell's syndrome.
On the part of the urinary system: often - an increase in the content of urea nitrogen and creatinine in the blood.
From the side of blood-forming organs: often - agranulocytosis, leukopenia; rarely - anemia, thrombocytopenia, leukopenia, pancytopenia.
From the hepatobiliary system: often - increased activity of ALT, AST, GGT and serum bilirubin level.
From the laboratory parameters: hypercreatininemia, hyperbilirubinemia, increased concentration of urea nitrogen and activity of hepatic transaminases, prolonged bleeding time.
Other: on the background of treatment, mental disorders and metabolic disorders can be observed.

Overdose

Symptoms (with a single injection): abdominal pain, nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, impaired renal function and liver, metabolic acidosis.
Treatment: conducting symptomatic therapy (maintaining the vital functions of the body). Hemodialysis is ineffective.

Drug interaction

Tenoxics are characterized by 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 blood parameters when used together with anticoagulants and hypoglycemic drugs for oral administration, especially in the initial stages of Artoksan.
No possible interaction with digoxin was noted.
As with the use of other NSAIDs, it is recommended to use Artoxan along with cyclosporine with caution due to the increased risk of nephrotoxicity.
Combined use with quinolones may increase the risk of seizures.
Salicylates can displace tenoxicam from association with albumin and, accordingly, increase clearance and distribution of Artoxan. 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 should be more likely to control the concentration of lithium in the blood.
NSAIDs can cause sodium, potassium and fluid retention in the body, disrupting the effects of natriuretic diuretics. This should be remembered when used together with such diuretics in patients with CHF and arterial hypertension.
With caution is recommended to use NSAIDs with methotrexate, NSAIDs reduce the excretion of methotrexate and may increase its toxicity.
NSAIDs should not be used within 8-12 hours after applying mifepristone, as 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.
Inductors 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.
When taken together with NSAIDs, cardiac glycosides can increase heart failure, decrease glomerular filtration rate, and increase plasma concentrations of cardiac glycosides.
No interaction was found with the use of tenoxicam with cimetidine.
There were no clinically significant interactions in the treatment with tenoxicam and penicillamine or parenteral gold preparations.
The risk of nephrotoxicity increases with the combined use of NSAIDs with tacrolimus.
The risk of hematologic toxicity increases with the use of NSAIDs with zidovudine.

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 hypoglycemic agents).
If it is necessary to determine 17-ketosteroids, Artoxan should be discontinued 48 hours before the study.
There may be an increase in bleeding time, which should be considered during surgical interventions.
It is necessary to consider the possibility of sodium and water retention in the body when prescribing with diuretics in patients with arterial hypertension and heart failure.
Patients with uncontrolled arterial hypertension, chronic heart failure, peripheral arterial disease, confirmed IHD and / or cerebrovascular diseases should take Artoxan under medical supervision.
A history of kidney disease can lead to the development of interstitial nephritis, papillary necrosis and nephrotic syndrome.
Unwanted effects can be minimized by using the minimum effective dose of Artoxan as soon as possible.
Due to the negative effect on fertility, women who want to become pregnant are not recommended to take Artoxan. In patients with infertility (including those undergoing examination), it is recommended to cancel Artoxan.
In patients with systemic lupus erythematosus and mixed connective tissue disease, the risk of aseptic meningitis is increased.

Influence on ability to drive vehicles and mechanisms

During the period of treatment, the rate of mental and motor reactions may decrease, therefore it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions.

Pregnancy and lactation

The use of Artoxan during pregnancy and during breastfeeding is contraindicated.

In case of impaired renal function

With care: chronic renal failure (CC 30-60 ml / min).

With abnormal liver function

With caution: a history of liver disease, hepatic porphyria.

Pharmacy sales terms

You can buy Artoxan without a prescription.

Terms and conditions of storage

Artoxan should be kept out of the reach of children, at a temperature not higher than 25 ° C. Do not freeze. The shelf life of the lyophilisate is 3 years, the solvent is 4 years.