Expiration date: 10/2025

The owner of the registration certificate:

Dr. REDDY'S LABORATORIES, LTD. (India)

Generated:

MUSTAFA NEVZAT ILAC SANAYII (Turkey)

Code ATX: M01AC02 (Tenoxicam)

Active substance: tenoxicam (tenoxicam)

Dosage form

The drug is released according to the recipe Texared

Lyophilizate for preparation of solution for injection

reg. ? : LS-000295 from 04.03.10-Indefinitely

Date of re-registration: 23.06.17

Tablets, film-coated

reg. ? : LS-000294 from 10.10.12-Indefinitely

Date of re-registration: 23.06.17

Form of production, packaging and composition Texared

Tablets covered with a film shell of yellow with a brown tint of color, oval, biconvex, with a risk on one side; on the cross section-the core of bright yellow.

1 tablet contains: tenoxicam 20 mg

Excipients: lactose monohydrate-90 mg, corn starch-70 mg, starch pre-gelatinized-16 mg, talc-3 mg, magnesium stearate-1 mg, opadray OY-S22989 yellow-5.6 mg, hypromellose-2.9 mg, titanium dioxide-1.8 mg, macrogol 400 (polyethylene glycol 400) - 0.3 mg, iron oxide yellow-0.6 mg.

10 PCs. - blisters (1) - cardboard packs.

Lyophilizate for the preparation of solution for injection of yellow with a greenish tint of color.

1 flask contains: tenoxicam 20 mg

Auxiliary substances: mannitol - 57.33 mg, sodium hydroxide - 3.28 mg, trometamol 3 mg, sodium metabisulfite 2 mg, disodium edetate is 0.2 mg.

Solvent: water d / I - 2 ml.

1 PCs - colorless glass vials (1) together with the solvent (ILA. 2 ml 1 PC.) - cardboard packs.

1 PCs - colorless glass vials (1) together with the solvent (ILA. 2 ml 1 PC.) - cassettes of polyvinyl chloride (1) - cardboard packs.

Clinical and pharmacological group: NSAIDs

Pharmaco-therapeutic group: NSAIDs

Pharmacological action

Tenoxicam - tantisiriwat derived oxicam, NSAIDs. In addition to anti-inflammatory, analgesic and antipyretic action, the drug also prevents platelet aggregation. Tenoxicam has an anti-inflammatory effect by suppressing the activity of COX isoenzymes involved in the metabolism of arachidonic acid, and thus inhibits the synthesis of prostaglandins. Tenoxicam has no effect on the activity of lipoxygenases. In addition, tenoxicam suppresses some functions of leukocytes, including phagocytosis, histamine release and reduces the content of active radicals in the focus of inflammation.

Pharmacokinetics

Suction and distribution

The drug is rapidly absorbed from the gastrointestinal tract unchanged. Cmax is achieved after 2 hours after taking the drug. Tenoxicam is absorbed completely, bioavailability-100%. When taking the drug after a meal or in conjunction with antacids decreases the speed, but not the degree of absorption.

In the blood, the drug binds to proteins by 99%. The drug penetrates well into the synovial fluid. With prolonged use, tenoxicam accumulation is not observed; serum content of the drug is 10-15 µg / ml.

Breeding

The drug is characterized by low systemic clearance and a long half-life, which allows to take tenoxicam 1 time/day. The average T1/2 of 70 part 2/3 of the dose of the drug is excreted in the urine and 1/3 in feces.

The testimony of the drug Texared

rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint syndrome in acute gout, bursitis, tendovaginitis;

pain syndrome of weak and medium intensity (arthralgia, myalgia, neuralgia, migraine, tooth and headache, algodismenorrhea);

pain with injuries, burns;

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

Designed for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

ICD-10 codes

Dosage regimen

Tablets

The drug is taken orally after eating (preferably at the same time).

Assign 20 mg (1 tab.) 1 time / day, with long-term use ? 10 mg/day.

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

Elderly patients drug administered at a dose of 20 mg / day.

Solution for injection

Apply/m,/in.

Injections Texared prescribed for short-term treatment of 20 mg/day, long-term use - 10 mg/day.

With gout arthritis 1-2 days appoint a dose of 40 mg/day, in the next 3-5 days - 20 mg / day.

The prescribed dose should be used in one dose.

Side effect

The following adverse events were observed during treatment with the drug Texared with the following frequency: very often (?1/10); often (?1/100-<1/10); infrequently (?1/1000-<1/100); rarely (?1/10 000-<1/1000); very rarely (<1/10 000), the frequency is unknown (the frequency cannot be determined on the basis of available data).

To undesirable phenomena that can occur on the background of the drug Texared the coated tablets include the following:

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

Hepatobiliary system (1-2%): increased ALT, AST, GGT activity and serum bilirubin level.

From the cardiovascular system: heart failure, tachycardia, increased blood PRESSURE.

From the nervous system (2.6% of cases): headache, dizziness, drowsiness, depression, excitement, hearing loss, tinnitus, eye irritation, visual impairment.

Allergic reactions (2.5% of cases): rash, itching, erythema and urticaria. Photodermatitis, Stevens-Johnson syndrome, Layla syndrome were extremely rare.

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

From the hematopoietic system (1-2%): agranulocytosis, leukopenia, rarely anemia, thrombocytopenia.

Laboratory parameters: hypercreatinemia, hyperbilirubinemia, increased concentration of urea nitrogen and liver transaminases activity, lengthening of bleeding time.

To undesirable phenomena on the part of hematopoiesis include the reduction of hemoglobin and granulocytopenia. These adverse events were extremely rare.

Mental disorders (1.7%) and metabolic disorders (1%) can be observed during treatment.

Contraindications to use

• erosivno-azwenne shock syndrome (W. in history);
  
• gastrointestinal bleeding (including history);
  
• severe gastritis;
  
• inflammatory diseases of the gastrointestinal tract;
  
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history);
  
• hemophilia;
  
• hypocoagulation;
  
• hepatic and / or renal insufficiency (CC less than 30 ml / min);
  
• progressive kidney disease;
  
• active liver disease;
  
• status after CABG;
  
• confirmed hyperkalemia;
  
• depression of hearing;
  
• pathology of the vestibular apparatus;
  
• deficiency of glucose-6-phosphate dehydrogenase;
  
• blood disease;
  
• pregnancy;
  
• lactation;
  
• hypersensitivity.
  

Caution: congestive heart failure, swelling, arterial hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, peripheral artery disease, Smoking, chronic renal insufficiency (QC 30-60 ml/min), infection with Helicobacter pylori, prolonged use of NSAIDs, alcoholism, severe somatic diseases, simultaneous administration of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), elderly.

Use during pregnancy and breast-feeding

Tenoxicam is contraindicated in pregnancy and breastfeeding.

Use in violation of liver function

Contraindicated use of the drug in liver failure, active liver disease.

Use in renal impairment

Contraindicated use of the drug in renal failure (CC less than 30 ml/min), progressive kidney disease.

With caution in chronic renal insufficiency (QC 30-60 ml/min).

Use in elderly patients

With caution, the drug should be used in the elderly.

Special instruction

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, cancel the drug.

It is necessary to take into account the possibility of sodium and water retention in the body while prescribing diuretics to patients with hypertension and chronic heart failure.

To reduce the risk of adverse events from the gastrointestinal tract should use the minimum effective dose of the minimum possible short course.

Impact on the ability to drive and operate machinery

During the period of treatment must be careful when driving and occupation of other potentially hazardous activities, require high concentration and psychomotor speed reactions.

Overdose

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

Drug interaction

Reduces the effectiveness of uricosuric drugs, enhances the action of anticoagulants, antiplatelets, fibrinolytics, side effects of mineralocorticoids and glucocorticoids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of sulfonylurea derivatives.

Increases blood concentrations of lithium, 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 the absorption.

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

Mielotoksicnae drugs increase the manifestation gematotoksichnosti drug.

Storage conditions Texared

The drug should be stored out of reach of children, dry, protected from light at a temperature not exceeding 25°C.

Shelf life Texared

Shelf life-3 years. Do not use the drug with expired shelf life.