Texared lyophilizate for preparation of solution for injection 20mg vial with solvent, 1 pack

Composition

Lyophilizate for solution preparation for injectionactive substance: tenoxicam-20 mg, excipients: mannitol-57.33 mg; sodium hydroxide-3.28 mg; trometamol-3 mg; sodium metabisulfite-2 mg;sodium edetate-0.2 mg

Pharmacological action

Tenoxicam, which is a thienothiazine derivative of oxycam, is an NSAID. In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also prevents platelet aggregation. Tenoxicam exerts its anti-inflammatory effect by suppressing the activity of COX isoenzymes involved in arachidonic acid metabolism, and thus suppresses the synthesis of PG.

Tenoxicam does not affect the activity of lipoxygenases. In addition, tenoxicam suppresses certain functions of white blood cells, including phagocytosis, histamine release, and reduces the content of active radicals in the inflammatory focus.

Pharmacokinetics

The drug is rapidly absorbed from the gastrointestinal tract in unchanged form. _{Cmax is} reached 2 hours after taking the drug. When taking the drug after a meal or together with antacids, the rate decreases, but not the degree of its absorption. The average T_1/2 is 70 hours. Tenoxicam is completely absorbed, its bioavailability is 100%. In the blood, the drug binds to proteins by 99%.

The drug penetrates well into the synovial fluid, is characterized by a low systemic clearance and a long T_1/2, which allows you to take tenoxicam 1 time a day.

2/3 of the taken dose of the drug is excreted in the urine,1/3-in the feces. With prolonged use, accumulation of tenoxicam is not observed; the serum content of the drug is 10-15 mcg / ml.

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;

inflammatory and degenerative diseases of the musculoskeletal system, accompanied by pain syndrome, such as sciatica, lumbago, epicondylitis.

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

hypersensitivity;

erosive-ulcerative lesions of the gastrointestinal tract (including in the anamnesis);

gastrointestinal bleeding (including in the anamnesis);

gastritis severe course;

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

hemophilia;

hypocoagulation;

hepatic and/or renal insufficiency (Cl creatinine less than 30 ml/min);

inflammatory diseases of the gastrointestinal tract;

degenerative diseases of the kidneys;

active liver disease;

status after conducting coronary artery bypass grafting;

confirmed hyperkalemia;

hearing loss;

pathology of the vestibular apparatus;

deficiency of glucose-6-phosphate dehydrogenase;

blood diseases;

pregnancy;

lactation.

With caution:  chronic heart failure; edema; arterial hypertension; diabetes mellitus; ischemic heart disease; cerebrovascular diseases; dyslipidemia/hyperlipidemia; peripheral arterial diseases; smoking; chronic renal failure (creatinine clearance 30-60 ml / min) ; presence of infection H. pylori; long-term use of NSAIDs; alcoholism; severe somatic diseases; concomitant use of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline); elderly age.

Side effects

Undesirable phenomena that may occur against the background of the use of the drug Texared in the form of lyophilizate for the preparation of a solution for injection include the following.

From the digestive system (11.4% of cases):  burning sensation in the stomach, stomach pain, vomiting, nausea, diarrhea, constipation, flatulence and NSAIDs-gastropathy, abdominal pain, stomatitis, anorexia, liver function disorders. With prolonged use in large doses — ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of the intestinal walls.

From the CCC side:  heart failure, tachycardia, increased blood pressure.

CNS disorders (2.6% of cases):  headache, dizziness, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, visual impairment.

Skin and subcutaneous tissue disorders (2.5% of cases):  rash, pruritus, erythema and urticaria, photodermatitis. Extremely rare-Stevens-Johnson syndrome, Lyell’s syndrome

Urinary tract disorders (1-2% of cases):  increased urea nitrogen and creatinine levels in the blood.

Hematopoietic disorders (1-2% of cases):  agranulocytosis, leukopenia, anemia, thrombocytopenia.

From the side of the hepatobiliary system (1-2% of cases):  increased activity of ALT, AST and GGT and serum bilirubin levels.

Laboratory parameters:  hypercreatininemia, hyperbilirubinemia, increased urea nitrogen concentration and hepatic transaminase activity, prolonged bleeding time.

Adverse events observed on the part of the hematopoiesis system include a decrease in Hb levels and granulocytopenia. These adverse events were extremely rare.

During treatment, mental disorders (1.7%) and metabolic disorders (1%) may occur.

Interaction

Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of the adrenal cortex hormone and corticosteroids and estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; increases the hypoglycemic effect of sulfonylurea derivatives.

Increases the concentration of lithium and methotrexate preparations in the blood.

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Antacids and colestyramine reduce absorption.

Other NSAIDs — risk of side effects, especially from the gastrointestinal tract.

Myelotoxic Drugs increase the manifestations of hematotoxicity of the drug.

How to take, course of use and dosage

In / m, in/V. Texared 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 used in 1 dose.

Overdose

Treatment:  symptomatic.

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 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.

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 CHF.

To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

Influence on the ability to drive motor vehicles and manage mechanisms. One of the undesirable effects of the drug is dizziness, this should be taken into account in situations that require close attention of the patient, for example, when driving a vehicle or complex technical devices. During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Active ingredient

Tenoxicam

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

For adults as directed by your doctor

Indications

Osteoarthritis and Arthritis, Periarthritis, Rheumatoid Arthritis, Bursitis