ARTEFIT [Tenoxicam] 20 mg Tablets
instructions for the medical use of a medicinal product
ARTEFIT
Tradename
Artefit, Артефит
International
non-proprietary name or generic name
Tenoxicam, Теноксикам
Dosage form
Tablets.
Composition
Each tablet contains:
active substance: tenoxicam BP 20 mg;
excipients: lactose monohydrate, starch, talc, magnesium stearate, sodium starch
glycolate, pregelatinized starch.
Nonsteroidal anti-inflammatory drug
(NSAID).
Code АТХ: M01AC02
Pharmacodynamics
Non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. It has
a powerful analgesic and anti-inflammatory effect, the antipyretic effect is
less pronounced. The mechanism of action is based on the inhibition of the
activity of COX-1 and COX-2 isoenzymes, as a result of which the synthesis of
prostaglandins in the inflammation focus, as well as in other tissues of the
body, decreases. In addition, tenoxicam reduces the accumulation of leukocytes
in the inflammation focus. A distinctive feature of tenoxicam is its long
duration of action.
Pharmacokinetics
Tenoxicam is rapidly absorbed from the gastrointestinal tract unchanged,
bioavailability is 100%. Cmax is achieved 2 hours after oral administration.
Plasma protein binding is 99%. Tenoxicam penetrates well into the synovial
fluid. No accumulation is observed with prolonged use. Tenoxicam is almost
completely metabolized in the liver by hydroxylation. It is characterized by
low systemic clearance and prolonged T1 / 2. The average T1 / 2 is approximately
72 hours. 2/3 of the administered tenoxicam is excreted by the kidneys as an
inactive 5-hydroxypyridyl metabolite, the remainder is excreted in the bile as
conjugated hydroxymetabolites. Less than 1% of the administered dose is
excreted by the kidneys unchanged.
Indications for use
Symptomatic treatment as an anti-inflammatory and analgesic agent:
rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular
syndrome during exacerbation of gout, bursitis, tendovaginitis; pain syndrome
of weak and moderate intensity (arthralgia, myalgia, neuralgia, migraine,
toothache and headache, algomenorrhea); pain in injuries, burns. Inflammatory
and degenerative diseases of the musculoskeletal system, accompanied by pain
syndrome, such as sciatica, lumbago, epicondylitis.
Contraindications
Hypersensitivity to tenoxicam and other NSAIDs; erosive and ulcerative
gastrointestinal tract lesions (including history), gastrointestinal bleeding
(including history), inflammatory gastrointestinal diseases (Crohn's disease or
ulcerative colitis in the acute phase); severe renal failure (CC less than 30
ml / min), progressive kidney disease; severe liver failure; complete or
incomplete combination of bronchial asthma, recurrent nasal polyposis and
paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs
(including history); established diagnosis of diseases of the blood coagulation
system; decompensated heart failure; therapy of perioperative pain during
coronary artery bypass grafting; pregnancy, lactation (breastfeeding); children
and adolescents up to 18 years of age.
Method of administration
and dosage
Orally, without chewing, with a small amount of liquid. The recommended
dose is 20 mg once a day. The duration of the course of treatment is 7-14 days.
The duration of use depends on the indications and effectiveness of the
treatment.
Special instructions and precautions
Before using the drug, consult a doctor. When using Artefit, carefully
monitor the gastrointestinal tract. If the first signs of ulcerogenesis or
gastrointestinal bleeding are detected, the drug should be discontinued
immediately. It should be used with caution in patients with impaired renal
function (including those caused by diabetes mellitus). Prostaglandins
synthesized in the kidneys regulate the volumetric blood flow in the renal
parenchyma. If prostaglandin synthesis is impaired under the influence of
tenoxicam, it is possible to develop a decrease in renal blood flow, leading to
renal failure, as well as interstitial nephritis, glomerulonephritis, papillary
necrosis and nephrotic syndrome. Tenoxicam should be used with particular
caution during treatment with diuretics or potentially nephrotoxic drugs. In
case of renal failure, patients with CC more than 25 ml / min require careful
monitoring by a doctor without adjusting the dosage regimen. Clinical data on
the use of tenoxicam in patients with CC less than 25 ml/min are limited.
During the period of drug administration, it is necessary to monitor the
prothrombin index (while taking indirect anticoagulants), blood glucose
concentration (while taking hypoglycemic agents), peripheral blood picture and
functional state of the liver and kidneys.
Should be used with caution in patients with impaired liver function. If
excessive increase in transaminase levels is observed during the use of
Artefit, which persists during therapy, the drug should be discontinued.
Tenoxicam is capable of retaining potassium, sodium and water ions. In
this regard, tenoxicam may worsen the course of arterial hypertension or heart
failure.
Tenoxicam reduces platelet aggregation and increases bleeding time,
which should be kept in mind for upcoming surgical interventions. It is not
recommended to use tenoxicam in combination with salicylates. If it is
necessary to determine 17-ketosteroids, tenoxicam should be discontinued 48
hours before the study. Due to the negative effect on fertility, the drug is
not recommended for use in women who want to become pregnant. In patients with
systemic lupus erythematosus and mixed connective tissue disease, the risk of
aseptic meningitis increases.
It should be used with caution in patients over 65 years of age
(especially in patients receiving diuretics, weakened patients and patients
with low body weight).
Influence on the ability to drive vehicles and
machinery
During the period of drug use, patients should exercise caution when
driving vehicles and operating machinery, as well as when engaging in other
potentially dangerous activities that require increased concentration and speed
of psychomotor reactions.
Side effect
From the digestive system: dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAID
gastropathy, abdominal pain, stomatitis, anorexia, liver dysfunction,
ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal,
hemorrhoidal).
From the nervous system: dizziness, headache, drowsiness, depression, agitation, hearing loss,
tinnitus, irritation and swelling of the eyelids, visual impairment.
From the cardiovascular system: tachycardia, increased blood pressure.
From the urinary system: increased levels of urea nitrogen and creatinine in the blood plasma.
From the skin and subcutaneous tissues: skin itching, rash, urticaria, erythema, photodermatitis,
Stevens-Johnson syndrome, Lyell's syndrome.
From the hematopoietic system: agranulocytosis, leukopenia, anemia, thrombocytopenia, pancytopenia.
If any of the side effects listed in the instructions
worsen, or you notice any other side effects not listed in the instructions,
tell your doctor.
Interaction with other medicinal products
Since tenoxicam can cause a decrease in lithium excretion, intoxication
may occur in patients receiving lithium preparations.
Tenoxicam has a high degree of albumin binding and can, like other NSAIDs,
enhance the anticoagulant effect of warfarin and other anticoagulants.
As with other NSAIDs, the risk of nephrotoxicity increases with the
simultaneous use of tenoxicam and cyclosporine.
The risk of seizures increases with the simultaneous use of tenoxicam
and quinolones.
The risk of gastrointestinal complications increases with the
simultaneous use of tenoxicam and other NSAIDs. The simultaneous use of NSAIDs
and methotrexate reduces the excretion of the latter, and its toxicity may
increase.
NSAIDs should not be used within 8-12 hours after the use of
mifepristone, since the effect of the latter may decrease. It is necessary to
take into account the increased risk of gastrointestinal bleeding with the
combined use of tenoxicam and corticosteroids.
When used simultaneously, tenoxicam reduces the effectiveness of
uricosuric drugs, enhances the effect of anticoagulants, fibrinolytics, side
effects of mineralocorticoids and glucocorticoids, estrogens; reduces the
effectiveness of antihypertensive drugs and diuretics.
Inducers of microsomal oxidation in the liver (phenytoin, ethanol,
barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase
the production of hydroxylated active metabolites. With the simultaneous use of
tenoxicam with antiplatelet agents and selective serotonin reuptake inhibitors,
the risk of gastrointestinal bleeding increases.
The simultaneous use of cardiac glycosides and NSAIDs can increase heart
failure, reduce the glomerular filtration rate and increase the concentration
of cardiac glycosides in the plasma. The risk of nephrotoxicity increases with
the concomitant use of NSAIDs and tacrolimus.
The risk of hematological toxicity increases with the concomitant use of
NSAIDs and zidovudine.
Overdose
There is no clinical experience with drug overdose. If necessary, the
drug should be discontinued, supportive and symptomatic therapy should be
administered.
Storage conditions
Store in a dry, dark place at a temperature below 25°C.
Keep out of reach of children!
Shelf life
3 years. Do not use after the expiration date stated on the package.
Vacation
conditions
By prescription.
Release form
10 tablets in an aluminum foil blister. 1 blister together with instructions for use in a cardboard box.