$46.80
Manufacturer: Turkey
Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID). It has analgesic, anti-inflammatory, antipyretic effect.
- Relief of pain and inflammation in osteoarthritis and rheumatoid arthritis.
- Short-term treatment of acute diseases of the musculoskeletal system, including sprains, dislocations and other soft tissue injuries.
With these indications, the drug is used if it is impossible to use tenoxicam in the form of tablets.
Description
Artoxan lyophilizate for solution for injections, 20 mg in vials, 3 pcs. + solvent 2 ml in ampoules, 3 pcs. – Instructions for use
Ingredients
active ingredient: tenoxicam;
1 bottle of lyophilizate for solution for injection contains tenoxicam 20 mg;
excipients : mannitol (E 421) trilon B; ascorbic acid; trometamol; sodium hydroxide sodium hydroxide or dilute hydrochloric acid.
1 ampoule of the solvent contains 2 ml of water for injection.
Dosage form
Lyophilisate for solution for injection.
Basic physical and chemical properties : yellow lyophilized powder.
Solvent (water for injection): clear, colorless solution.
The reconstituted solution is a clear yellow-green solution.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Oxycams. ATX code M01A C02.
Pharmacodynamics
Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID). It has analgesic, anti-inflammatory, antipyretic effect.
The mechanism of action is based on non-selective blocking of the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) isoenzymes, which leads to disruption of the synthesis of prostaglandins and thromboxane. Inhibits platelet aggregation.
In vitro studies also indicate that tenoxicam can act as an active oxygen scavenger at the site of inflammation and has the ability to suppress metalloproteinases (stromelysin and collagenases) that cause cartilage destruction.
Pharmacokinetics
The bioavailability of tenoxicam with in and oral administration is similar. When administered intravenously at a dose of 20 mg, its plasma level decreases rapidly within 2 hours, which is associated with the distribution process. After this short period, there is no difference in plasma concentrations of tenoxicam between intravenous and oral administration. Tenoxicam is highly (99%) bound to plasma proteins and penetrates well into the synovial fluid.
The average value of the distribution in the equilibrium phase is 10-12 liters. With the recommended regimen of 20 mg per day, the equilibrium concentration in blood plasma is reached within 10-15 days. Cumulation is not observed.
Tenoxicam is completely metabolized in the body. Approximately 2/3 of the dose is mainly excreted in the urine as a pharmacologically inactive metabolite of 5-hydroxypyridyl, the rest in the bile, mainly in the form of hydroxymetabolites conjugated with glucuronic acid. The half-life is 72 hours. The total clearance of blood plasma – 2 ml / min.
The pharmacokinetics of tenoxicam is linear in the studied dose range from 10 to 100 mg.
Changes in the pharmacokinetics of tenoxicam depending on the age of the patient were not found, although individual differences are usually greater in elderly patients.
Indications
- Relief of pain and inflammation in osteoarthritis and rheumatoid arthritis.
- Short-term treatment of acute diseases of the musculoskeletal system, including sprains, dislocations and other soft tissue injuries.
With these indications, the drug is used if it is impossible to use tenoxicam in the form of tablets.
Contraindications
- Hypersensitivity to the active substance or other components of the drug.
- A history of hypersensitivity symptoms (including asthma symptoms, rhinitis, angioedema, urticaria) to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs);
- Recurrent peptic ulcer / active bleeding or history of relapses (2 or more pronounced episodes of peptic ulcer or bleeding), ulcerative colitis, Crohn’s disease, severe gastritis;
- A history of gastrointestinal bleeding (ground, hematomesis) and perforations associated with previous NSAID therapy;
- history of cerebrovascular bleeding or other bleeding disorders;
- Severe heart, liver, kidney failure;
- III trimester of pregnancy;
- The period of breastfeeding;
- Age up to (18 years).
Dosage and administration
The drug is intended for intravenous and intramuscular use.
Before use, the contents of the vial must be dissolved in 2 ml of water for injection, which is included in the preparation kit. After complete dissolution of the lyophilisate, the solution should be used immediately.
adults
The recommended dose is 20 mg per day during the first 1-2 days of treatment, then you should switch to taking tablets, which should be taken every day at the same time.
The recommended doses of the drug should not be exceeded, since when using high doses, a more pronounced therapeutic effect is not always achieved, and the risk of adverse reactions increases.
The duration of treatment with tenoxicam for acute disorders of the musculoskeletal system usually does not exceed 7 days. In exceptional cases, the duration of therapy can be extended up to 14 days.
Elderly patients
The drug, like other NSAIDs, should be used with caution in elderly patients. They have an increased risk of developing adverse reactions and are more likely to receive concomitant medications or with impaired renal, hepatic, or cardiovascular function. If necessary, the drug should be used in elderly patients at the most effective dose of 20 mg for a short period of time necessary to control the symptoms of the disease. These patients should be carefully monitored for gastrointestinal bleeding within 4 weeks of initiation of therapy.
Patients with impaired renal and / or liver function
Patients with a creatinine clearance of 25 ml / min do not need to adjust the dosing regimen. These patients should be carefully monitored.
There are insufficient data to recommend dosing of tenoxicam in patients with creatinine clearance less than 25 ml/min.
There are insufficient data to recommend dosing of tenoxicam in patients with hepatic impairment.
The drug should be used with caution at low albumin concentrations (for example, with nephrotic syndrome) or at high plasma bilirubin concentrations, since tenoxicam binds to a large extent with plasma proteins.
Package
20 mg lyophilizate for solution for injection in a vial;
2 ml of solvent (water for injection) in ampoules;
3 bottles with lyophilizate for solution for injection complete with 3 ampoules of the solvent in a blister pack; 1 blister in a cardboard box.
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