Texared lyophilisate for preparation of injection solution 20mg, No. 1

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

• pain syndrome (weak and medium intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea; pain with injuries, burns.

For inflammatory and degenerative diseases of the musculoskeletal system, accompanied by pain, such as sciatica, lumbago, epicondylitis. Designed for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Intramuscularly, intravenously. Texared injections are prescribed for short-term treatment - 20 mg per day, with long-term treatment - 20 mg per day, with 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 administered in one dose.

1 bottle contains:

Active substance:

Tenoxicam - 20.00 mg

Auxiliary components:

Mannitol - 57.33 mg

Sodium hydroxide - 3.28 mg

Trometamol - 3.00 mg

Sodium metabisulfite - 2.00 mg

Disodium edetate - 0.20 mg

• Hypersensitivity

• erosive and ulcerative lesions of the gastrointestinal tract (including history),

• gastrointestinal bleeding (including history),

• severe gastritis;

• complete or incomplete combination of bronchial asthma,

• recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including a history);

• hemophilia,

• hypocoagulation,

• hepatic and / or renal failure (CC less than 30 ml / min),

• inflammatory diseases of the gastrointestinal tract,

• progressive kidney disease

• active liver disease

• condition after CABG;

• confirmed hyperkalemia,

• hearing loss

• pathology of the vestibular apparatus,

• deficiency of glucose-6-phosphate dehydrogenase;

• blood diseases,

• pregnancy, lactation.

Carefully:

CHF, edema, arterial hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), the presence of H. pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, concomitant use of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram , fluoxetine, paroxetine, sertraline), old age.

Trade name of the drug:

Texared

International Non-Proprietary Name (INN):

Tenoxicam

Dosage form:

lyophilisate for preparation of solution for injection 20 mg.

Chemical name:

4-hydroxy-2-methyl-1,1-dioxo-N- (2-pyridyl) -1,2-dihydro-1? 6-thieno [2,3-e] [1,2] -thiazine-3- carboxamide

Composition:

1 bottle contains:

Active substance:

Tenoxicam - 20.00 mg

Auxiliary components:

Mannitol - 57.33 mg

Sodium hydroxide - 3.28 mg

Trometamol - 3.00 mg

Sodium metabisulfite - 2.00 mg

Disodium edetate - 0.20 mg

Description:

Lyophilized powder, yellow with a greenish tinge.

Pharmacotherapeutic group:

Non-steroidal anti-inflammatory drug (NSAID)

ATX code:

[M01AC02]

Pharmacodynamics
Tenoxicam, which is a thienothiazine derivative of oxicam, is a non-steroidal anti-inflammatory drug. 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 cyclooxygenase isoenzymes involved in the metabolism of arachidonic acid, and thus inhibits the synthesis of prostaglandins. Tenoxicam has no effect on lipoxygenase activity. In addition, tenoxicam inhibits several leukocyte functions, including phagocytosis, histamine release, and reduces the content of active radicals at the site of inflammation.

Pharmacokinetics
The drug is rapidly absorbed from the gastrointestinal tract unchanged. Cmax is reached 2 hours after taking the drug. When the drug is taken after a meal or together with antacids, the rate, but not the degree of its absorption, decreases. The average elimination half-life is 70 hours. Tenoxicam is completely absorbed, its bioavailability? one hundred%. In the blood, the drug binds to proteins by 99%. The drug penetrates well into the synovial fluid, is characterized by low systemic clearance and a long half-life, which allows tenoxicam to be taken once a day. Two thirds 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 ?g / ml.

Indications for use:

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, bursitis, tendovaginitis; pain syndrome (weak and medium intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea; pain with injuries, burns.

For inflammatory and degenerative diseases of the musculoskeletal system, accompanied by pain, such as sciatica, lumbago, epicondylitis. Designed for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Method of administration and dosage:

Intramuscularly, intravenously. Texared injections are prescribed for short-term treatment - 20 mg per day, with long-term treatment - 20 mg per day, with 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 administered in one dose.

Contraindications:

Hypersensitivity, erosive and ulcerative lesions of the gastrointestinal tract (including history), gastrointestinal bleeding (including history), severe gastritis; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including a history); hemophilia, hypocoagulation, hepatic and / or renal failure (CC less than 30 ml / min), inflammatory diseases of the gastrointestinal tract, progressive kidney disease, active liver disease, condition after CABG; confirmed hyperkalemia, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; blood diseases, pregnancy, lactation.

Carefully:

CHF, edema, arterial hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), the presence of H. pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, concomitant use of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram , fluoxetine, paroxetine, sertraline), old age.

Overdose:

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

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 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 discontinued. It is necessary to take into account the possibility of Na + and water retention in the body when administered with diuretics to patients with arterial hypertension and CHF.

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used in the smallest possible short course.

Side effects:

The undesirable phenomena that can be observed against the background of the use of Texared in coated tablets include the following:

Digestive system disorders (11.4% of cases):
Burning sensation in the stomach, stomach pain, vomiting, nausea, diarrhea, constipation, flatulence, etc. NSAID gastropathy, abdominal pain, stomatitis, anorexia, liver dysfunction. With prolonged use in high doses - ulceration of the mucous membrane of the gastrointestinal tract of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of the intestinal walls.

From the side of the cardiovascular system:
heart failure, tachycardia, increased blood pressure.

Central nervous system 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, Stevens-Johnson syndrome, Leil's syndrome were extremely rare.

From the urinary system (1-2%):
Increase in the content of urea nitrogen and creatinine in the blood.

Hematopoietic disorders (1-2%):
Agranulocytosis, leukopenia, rarely anemia, thrombocytopenia.

Disturbances from the hepatobiliary system (1-2%):
Increased ALT, AST, gamma-HT and serum bilirubin levels.

Laboratory indicators:
Hypercreatininemia, hyperbilirubinemia, increased concentration of urea nitrogen and the activity of 'hepatic' transaminases, prolonged bleeding time.

Undesirable phenomena observed on the part of hematopoiesis include a decrease in hemoglobin levels and granulocytopenia. These adverse events were extremely rare.

During treatment, mental disorders (1.7%) and metabolic disorders (1%) can be observed.

Drug interactions:

Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of MCS and GCS, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of sulfonylurea derivatives.

Increases the concentration in the blood of drugs Li +, methotrexate. Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Antacids and cholestyramine reduce absorption.

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

Myelotoxic drugs increase the manifestations of the drug's hematotoxicity.

Application during pregnancy and lactation:

Tenoxicam is contraindicated in pregnancy and lactation.

Influence on the ability to drive vehicles and use mechanisms

One of the undesirable effects of the drug is dizziness, this should be taken into account in situations requiring the patient's close attention, for example, when driving a motor vehicle or complex technical devices.

Packaging

Primary packaging.
The lyophilized powder containing 20 mg of the active ingredient is placed in a type 3 colorless glass vial, sealed with a bromobutyl rubber stopper, crimped with an aluminum ring or an aluminum flip off cap with a plastic disc or plastic cap, on top of an aluminum one.

Solvent (water for injection): 2 ml in a colorless glass ampoule.

Secondary packaging:
1 bottle with the drug and 1 ampoule with a solvent are placed in a polyvinyl chloride cassette; 1 cassette together with instructions for use is placed in a cardboard box.
1 bottle with the drug and 1 ampoule with a solvent, together with instructions for use, are placed in a cardboard box.
50 vials with the drug are placed in a cardboard box (for hospitals) with instructions for use; 50 ampoules with solvent are placed in a separate cardboard box (for hospitals).

Storage conditions:

In a dry, dark place at a temperature not exceeding 25 ? C.
Keep out of reach of children.

Shelf life:

3 years.
Do not use the drug with an expired expiry date indicated on the package.

Terms of dispensing from pharmacies:

On prescription.