Texared tablets p / o 20mg, No. 10

• 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.

Inside. 20 mg (1 tablet) 1 time per day, after meals (preferably at the same time, with prolonged use - 10 mg per day.

In acute attacks of gout - 40 mg 1 time per day for the first 2 days, then switch to 20 mg 1 time per day for 5 days.

Elderly patients are prescribed at a dose of 20 mg / day.

one tablet contains:

Active substance:

Tenoxicam - 20 mg

Excipients:

Lactose monohydrate - 90.0 mg

Corn starch - 70.0 mg

Pregelatinized starch - 16.0 mg

Talc - 3.0 mg

Magnesium stearate - 1.0 mg

Opadry OY-S 22989 yellow - 5.6 mg

Hypromellose - 2.9 mg

Titanium dioxide - 1.8 mg

Macragol-400 (polyethylene glycol 400) - 0.3 mg

Iron oxide yellow - 0.6 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 aminosalicylic acid or other non-steroidal anti-inflammatory drugs (including history);

• hemophilia, hypocoagulation,

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

• inflammatory diseases of the gastrointestinal tract,

• progressive kidney disease

• active liver disease

• condition after coronary artery bypass grafting;

• confirmed hyperkalemia,

• hearing loss

• pathology of the vestibular apparatus,

• deficiency of glucose-6-phosphate dehydrogenase;

• blood diseases,

• pregnancy, lactation.

Carefully:

Chronic heart failure, edema, arterial hypertension, diabetes mellitus, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), H. pylori infection, long-term use non-steroidal anti-inflammatory drugs, alcoholism, severe somatic diseases, concomitant use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective reuptake inhibitors serotonin (including citalopram, fluoxetine, paroxetine, sertraline), advanced age.

Trade name of the drug:

Texared

International non-proprietary name:

Tenoxicam

Dosage form:

film-coated tablets 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:

one tablet contains:

Active substance:

Tenoxicam - 20 mg

Excipients:

Lactose monohydrate - 90.0 mg

Corn starch - 70.0 mg

Pregelatinized starch - 16.0 mg

Talc - 3.0 mg

Magnesium stearate - 1.0 mg

Opadry OY-S 22989 yellow - 5.6 mg

Hypromellose - 2.9 mg

Titanium dioxide - 1.8 mg

Macragol-400 (polyethylene glycol 400) - 0.3 mg

Iron oxide yellow - 0.6 mg

Description:

Yellow with a brown shade of color, oval, biconvular film-coated tablets with a scored on one side. In cross section, the core is bright yellow.

Pharmacotherapeutic group:

Non-steroidal anti-inflammatory drug (NSAID)

ATX code: [M01AC02].

Pharmacological properties

Pharmacodynamics

Tenoxicam, 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 suppresses some of the functions of leukocytes, including phagocytosis, the release of histamine and reduces the content of active radicals in the focus of inflammation.

Pharmacokinetics

The drug is rapidly absorbed from the gastrointestinal tract unchanged. Cmax is achieved 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 is 100%. 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.

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 aminosalicylic acid or other non-steroidal anti-inflammatory drugs (including history); hemophilia, hypocoagulation, hepatic and / or renal failure (correlation coefficient less than 30 ml / min), inflammatory diseases of the gastrointestinal tract, progressive kidney disease, active liver disease, condition after coronary artery bypass grafting; confirmed hyperkalemia, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; blood diseases, pregnancy, lactation.

Carefully:

Chronic heart failure, edema, arterial hypertension, diabetes mellitus, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), H. pylori infection, long-term use non-steroidal anti-inflammatory drugs, alcoholism, severe somatic diseases, concomitant use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective reuptake inhibitors serotonin (including citalopram, fluoxetine, paroxetine, sertraline), advanced age.

Application during pregnancy and lactation:

Tenoxicam is contraindicated in pregnancy and lactation.

Method of administration and dosage:

Inside. 20 mg (1 tablet) 1 time per day, after meals (preferably at the same time, with prolonged use - 10 mg per day.

In acute attacks of gout - 40 mg 1 time per day for the first 2 days, then switch to 20 mg 1 time per day for 5 days. Elderly patients are prescribed at a dose of 20 mg / day.

Side effect

The following adverse events were observed during treatment with texamen with the following frequency:

Very often (> 1/10); often (> 1/100 - <1/10); not often (> 1/1000 - <1/100); rarely (> 1/10000 - <1/1000); very rare (<1/10000), frequency unknown (frequency cannot be determined from available data).

Adverse events that can occur with the use of texamen in film-coated tablets include the following: Not often (> 1/1000 - <1/100)

From the digestive system:

A burning sensation in the stomach, stomach pain, vomiting, nausea, diarrhea, constipation, flatulence and gastropathy, abdominal pain, stomatitis, anorexia, liver dysfunction. With prolonged use in high doses - ulceration of the mucous membrane of the gastrointestinal tract), bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of the intestinal walls.

On the part of the cardiovascular system :

heart failure, tachycardia, increased blood pressure. Rarely - 1 / 10000- <1/1000) Allergic reactions:

Rash, pruritus, erythema, and urticaria. Photodermatitis.

From the nervous system:

Headache, dizziness, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, visual impairment.

From the genitourinary system:

Increase in the content of urea nitrogen and creatinine in the blood.

From the side of the hematopoietic organs:

Agranulocytosis, leukopenia, rarely anemia, thrombocytopenia.

From the hepatobiliary system:

Increased activity of alanine transaminase, aspartate aminotransferase and gamma-glutamyl transferase and serum bilirubin levels.

Laboratory indicators:

Hypercreatininemia, hyperbilirubinemia, increased concentration of urea nitrogen and hepatic transaminase activity, prolonged bleeding time.

Mental and metabolic disorders may occur during treatment. Very rare (<1/10000): Stevens-Johnson syndrome, Lyell's syndrome.

The undesirable phenomena observed on the part of the hematopoietic system include a decrease in hemoglobin levels and granulocytopenia.

Overdose:

In case of drug overdose, symptomatic treatment is necessary.

Interaction with other medicinal products

Reduces the efficiency of uricosuric drugs enhances the action antikoa-
gulyantov, antiplatelet agents, fibrinolytic agents, the side effects of the adrenal cortex and Harmon
glucocorticoids and estrogens; reduces the effectiveness of antihypertensive drugs
and diuretics; enhances the hypoglycemic effect of sulfonyl-urea 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.

Other non-steroidal anti-inflammatory drugs - the risk of side effects, especially from the gastrointestinal tract. Myelotoxic drugs increase the manifestations of the drug's hematotoxicity.

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 canceled 48 hours
before the study, a few days before the surgery, the drug should be canceled .
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 chronic heart failure.
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 shortest possible short course.

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 close attention of the patient, for example, when driving a motor vehicle or complex technical devices.

Release form:

10 tablets in a PVC / Al blister. 1 blister with instructions for use is placed in a cardboard box.

Storage conditions:

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

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of dispensing from pharmacies:

On prescription.