Instruction for use: Texared

Active substance Tenoxicam

ÀÒÕ M01AC02Tenoxicam

Pharmacological group

Non-steroidal anti-inflammatory drug [NSAIDs - Oxicams]

Nosological classification (ICD-10)

G43 Migraine

The pain of migraine, Migraine, hemiplegic migraine, Migraine headache, A migraine attack, Continuous headache, hemicranias

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M10.9 Gout, unspecified

Arthritis Gouty, Acute gouty arthritis, Acute attack of gout, Gouty Arthritis, Articular syndrome with exacerbation of gout, Articular syndrome with gout, Urarturia, Chronic arthritic arthritis, Acute gout, Salt diathesis

M13.9 Arthritis, unspecified

Arthritis,Purulent arthritis (non-infectious), acute Arthritis,Pain in acute inflammatory diseases of the musculoskeletal system,Pain in chronic inflammatory diseases of the musculoskeletal system,The pain in osteoarthritis, Inflammation in osteoarthritis, Inflammatory arthropathy, Inflammatory and degenerative joint diseases, Inflammatory disease of the musculoskeletal system, Inflammatory joint disease, Inflammatory diseases of the musculoskeletal system, destructive arthritis, The disease of the musculoskeletal system, Diseases of the musculoskeletal system, Diseases of the musculoskeletal system and connective tissue, Infections musculoskeletal system, monoartrit, Non-infectious arthritis, rheumatic arthritis, Osteoarthritis, Acute inflammation of the musculoskeletal tissue, Acute inflammatory diseases of the musculoskeletal system, Acute inflammatory condition of the musculoskeletal system, Acute arthritis, Acute osteoarthritis, Post-traumatic osteoarthritis, Reactive arthritis, Chronic inflammatory diseases of the joints, Chronic arthritis, Chronic inflammatory arthritis, Chronic inflammation of the inner layer of the joint capsule, Chronic inflammation of the joint capsule,Chronic inflammatory disease of the joints, Exudative arthritis

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M65 Synovitis and tendosynovitis

Acute tenosynovitis, Tendovaginitis (tenovaginitis), Tendosinovit (tenosynovitis), Tendovaginitis, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Nonspecific tenosynovitis, Tendosinovit

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R51 Headache

Pain in the head, Cephalgia, Pain with sinusitis, Pain in the back of the head, Painful headache, Headache of vasomotor genesis, Headache of vasomotor origin, Headache with vasomotor disorders, Headache, Neurological headache, Serial headache

R52.2 Other constant pain

Pain syndrome, rheumatic origin, Pain at vertebral lesions, Pain in the chamber, Pain for burns, Pain syndrome weak or moderate, Perioperative pain,Moderate to severe pain, Moderately or weakly expressed pain syndrome, Moderate to severe pain, Ear pain of otitis, Neuropathic pain, neuropathic pain

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

T30 Thermal and chemical burns, unspecified

Pain syndrome with burns, Pain in burns, Pain with burns, Sluggishly healing post-burn wounds, Deep burns with a wet scab, Deep burns with abundant compartments, Deep burn, Laser burn, Burn, Burning of the rectum and perineum, Burn with mild exudation, Burn disease, Burn injury, Superficial burn, Superficial burn of I and II degree, Superficial skin burns, After-burn trophic ulcer and wound, Post-burn complication, Loss of fluid during burns, Sepsis burn, Thermal burns, Thermal skin lesions, Thermal burn, Trophic after-burn ulcers, Chemical burn, Surgical burn

Composition

Lyophilizate for solution for injection 1 fl.

active substance:

tenoxicam 20 mg

auxiliary substances: mannitol - 57.33 mg; sodium hydroxide - 3.28 mg; trometamol - 3 mg; sodium metabisulphite - 2 mg; dnutriya edetat - 0.2 mg

Description of dosage form

Lyophilized yellow powder with a greenish shade of color.

pharmachologic effect

Pharmacological action - anti-inflammatory, analgesic, inhibiting COX (cyclooxygenase).

Pharmacodynamics

Tenoxicam, which is a thienothiazine oxycam derivative, is an NSAID. In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also interferes with the aggregation of platelets. Tenoxicam exerts its anti-inflammatory effect by suppressing the activity of COX isoenzymes involved in the metabolism of arachidonic acid, and thus suppresses the synthesis of PG. Tenoxicam does not affect the activity of lipoxygenases. In addition, tenoxicam suppresses certain functions of leukocytes, including phagocytosis, the release of histamine and reduces the content of active radicals in the inflammatory focus.

Pharmacokinetics

The drug is rapidly absorbed from the digestive tract in unchanged form. Cmax is achieved 2 hours after taking the drug. When taking the drug after a meal or together with antacids, the speed decreases, but not the degree of its absorption. The average T1 / 2 is 70 h. Tenoxicam is absorbed completely, 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 prolonged T1 / 2, which allows one to take Tenoxicum once a day.

2/3 of the accepted dose of the drug is excreted in the urine, 1/3 - with feces. With prolonged use cumulation of tenoxicam is not observed; the serum content of the preparation is 10-15 μg / ml.

Indications

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

pain syndrome (weak and moderate intensity): arthralgia, myalgia, neuralgia, migraine, dental and headache, algodismenorea;

pain with injuries, burns;

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

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

Contraindications

hypersensitivity;

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

gastrointestinal bleeding (including in the anamnesis);

severe gastritis;

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

hemophilia;

hypocoagulation;

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

inflammatory diseases of the digestive tract;

progressive kidney disease;

active liver disease;

condition after aorto-coronary bypass surgery;

confirmed hyperkalemia;

hearing loss;

pathology of the vestibular apparatus;

deficiency of glucose-6-phosphate dehydrogenase;

blood diseases;

pregnancy;

lactation period.

With caution: chronic heart failure; edema; arterial hypertension; diabetes; cardiac ischemia; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diseases of peripheral arteries; smoking; chronic renal failure (Cl creatinine 30-60 ml / min); presence of H. pylori infection; long-term use of NSAIDs; alcoholism; severe physical illness; simultaneous administration of oral GCS (including prednisone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline ); elderly age.

pregnancy and lactation

Tenoxicam is contraindicated in pregnancy and lactation.

Side effects

To undesirable phenomena that can be observed against the background of the use of the drug Texamed in the form of lyophilizate for the preparation of solution for injection, are downstream.

On the part of 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 dysfunction. With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of intestinal walls.

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

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

From the skin and subcutaneous tissue (2.5% of cases): rash, itching, erythema and urticaria, photodermatitis. Very rarely - Stevens-Johnson syndrome, Lyell's syndrome

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

On the part of the organs of hematopoiesis (1-2% of cases): agranulocytosis, leukopenia, anemia, thrombocytopenia.

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

Laboratory indices: hypercreatininaemia, hyperbilirubinemia, increased urea nitrogen concentration and hepatic transaminase activity, lengthening bleeding time.

The undesirable phenomena observed by the hematopoiesis system include a decrease in Hb and granulocytopenia. These undesirable phenomena were extremely rare.

On the background of treatment, there may be mental disorders (1.7%) and metabolic disorders (1%).

Interaction

Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiaggregants, fibrinolytic drugs, side effects of the hormone of the adrenal cortex and SCS and estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of sulfonylurea derivatives.

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

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 are a risk of side effects, especially from the digestive tract.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Dosing and Administration

Intramuscularly (intramuscularly), intravenously (intravenously). Injections of the drug Texared are prescribed for short-term treatment - 20 mg per day; with prolonged use - 10 mg per day.

With gouty arthritis 1-2 days 40 mg per day are prescribed, in the next 3-5 days - 20 mg per day. The prescribed dose should be applied in a single dose.

Overdose

Treatment: symptomatic.

special instructions

During the 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 test.

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 administered with diuretics to patients with arterial hypertension and CHF.

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

Impact on the ability to drive vehicles and manage 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. During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form of issue

Lyophilizate for solution for injection. A lyophilized powder containing 20 mg of active ingredient is placed in a colorless glass of type 3, sealed with a bromobutyl rubber stopper, crimped with an aluminum ring or an aluminum cap "flip off" with a plastic disc or plastic lid, over an aluminum one.

Solvent (water for injection): 2 ml each in an ampoule of colorless glass.

On 1 fl. with the drug and 1 amp. with a solvent is placed in a cassette made of PVC; 1 cassette in a cardboard box.

On 1 fl. with the drug and 1 amp. with solvent in a cardboard bundle.

On 50 fl. with the drug in a cardboard box (for hospitals); 50 amp. with the solvent is placed in a separate cardboard box (for hospitals).

Conditions of leave from pharmacies

On prescription.

storage Conditions

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.