Texamen, vial, 20mg

Composition

1 bottle of lyophilizate for the preparation of a solution for intramuscular and intravenous use contains:  active ingredients:  tenoxicam 20 mg. excipients: mannitol, sodium hydroxide, trometamol, sodium metabisulfide, sodium edetate; 1 ampoule of solvent contains: 2 ml of water for injection.

Pharmacological action

Tenoxicam is a nonsteroidal anti-inflammatory drug, it has a powerful anti-inflammatory and analgesic effect, the antipyretic effect is less pronounced, and also prevents platelet aggregation. The mechanism of action is based on inhibition of the activity of cyclooxygenase-1 and cyclooxygenase-2 isoenzymes, which reduces 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 white blood cells in the focus of inflammation. The anti-inflammatory effect develops by the end of the first week of treatment.

Pharmacokinetics.

Absorption – fast and complete (food intake slows down). Bioavailability – 100%. The maximum concentration is noted after 2 hours. A distinctive feature of tenoxicam is the long duration of action and a long half-life of 72 hours. The drug is 99% bound to plasma proteins. Tenoxicam penetrates well into the synovial fluid. Easily penetrates through histohematic barriers. It is metabolized in the liver by hydroxylation to form 5-hydroxytenoxicam. 1/3 is excreted in the bile,2/3 in the urine as inactive metabolites.

Indications

• Rheumatoid arthritis,
• osteoarthritis,
• ankylosing spondylitis,
• joint syndrome with gout exacerbation,
• bursitis,
• tendovaginitis;

pain syndrome (mild to moderate intensity):

• arthralgia,
• myalgia,
• neuralgia,
• migraine,
• tooth and headache,
• algodismenorrhea;
• pain from injuries, burns.

Contraindications

• Hypersensitivity,
• erosive and ulcerative lesions of the gastrointestinal tract (incl. history),
• gastrointestinal bleeding (including in history),
• gastritis severe,
• “aspirin” triad,
• hemophilia,
• hypocoagulation,
• hepatic and/or renal failure,
• hearing loss,
• pathology of the vestibular apparatus,
• deficiency of glucose-6-phosphate dehydrogenase;
• blood diseases,
• pregnancy,
• lactation,
• age under 18 years.

With caution: heart failure, edema, hypertension, diabetes mellitus, the elderly.

Side effects

From the digestive system: dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAID-gastropathy, abdominal pain, stomatitis, anorexia, liver dysfunction. With prolonged use in large doses – ulceration of the mucous membrane of the gastrointestinal tract( GIT), bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of the intestinal walls. From the cardiovascular system: heart failure, tachycardia, increased blood pressure. Nervous system disorders:  headache, dizziness, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, visual impairment. Hematopoietic disorders: agranulocytosis, leukopenia, rarely-anemia, thrombocytopenia. Allergic reactions: skin rash, pruritus, urticaria, angioedema, Stevens-Johnson and Lyell syndromes. Laboratory parameters; hypercreatininemia, hyperbilirubinemia, increased concentration of urea nitrogen and activity of “hepatic” transaminases, prolongation of bleeding time. Other; bronchospasm, impaired renal function, increased sweating, edematous syndrome (including periorbital edema).

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of mineralocorticosteroids, glucocorticosteroids, estrogens; reduces the effectiveness of antihypertensive and diuretic drugs; increases the hypoglycemic effect of sulfonylurea derivatives. Antacids and colestyramine reduce absorption. Increases the concentration of lithium and methotrexate preparations in the blood. Other NSAIDs are at risk of developing side effects, especially from the gastrointestinal tract.

How to take, course of use and dosage

Intramuscularly and intravenously. Texamen injections are prescribed for short – term treatment-20 mg per day; for long-term use-10 mg per day. For gouty arthritis,40 mg per day is prescribed for 1-2 days, and 20 mg per day for the next 3-5 days. The prescribed dose should be applied in one step.

Overdose

In case of overdose of the drug, symptomatic treatment is necessary.

Special instructions

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys, prothrombin index (against the background of indirect anticoagulants), blood glucose (against the background of oral hypoglycemic drugs). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

A few days before surgery, the drug is canceled. During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions. It is necessary to take into account the possibility of sodium and water retention in the body when prescribing diuretics to patients with arterial hypertension and heart failure. The presence of a history of kidney diseases can lead to the development of interstitial nephritis, papillary necrosis and nephrotic syndrome, do not use nephrotoxic drugs immediately after surgery.

Storage conditions

Store at a temperature not exceeding 25°C in a dry, dark place.

Shelf

life is 2 years.

Active ingredient

Tenoxicam

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion