Artoxan, 20 mg, lyophilisate for preparing a solution for intravenous and intramuscular administration, complete with solvent, 3 pcs.

Composition and dosage form

The drug is produced in the form of a lyophilized concentrate - a dense mass of greenish-yellow color. In some cases - in the form of large tablets sold together with a solvent. The drug is intended for parenteral administration: making intramuscular and intravenous injections. The cardboard packaging of Artoxan contains 3 sealed glass bottles of lyophilisate and ampoules with water.

The active substance is tenoxicam, which has a complex antipyretic, analgesic and antiplatelet effect. A dose of Artoxan contains 20 mg. tenoxicam, auxiliary and stabilizing components.

Pharmacokinetics

Suction.

Absorption is fast and complete. Bioavailability - 100%.

Distribution.

Cmax in blood plasma is observed after 2 hours. The distinctive ability of tenoxicam is its long duration of action and long T1/2 - 72 hours. The drug is 99% bound to blood plasma proteins. Tenoxicam penetrates well into synovial fluid. Easily penetrates histohematic barriers.

Metabolism.

Metabolized in the liver by hydroxylation to form 5-hydroxypyridyl.

Excretion.

1/3 is excreted through the intestines with bile, 2/3 is excreted by the kidneys in the form of inactive metabolites.

Mechanism of action

Artoxan inhibits the production of prostaglandins and the accumulation of enzymes in lesions, including in the cartilaginous elements of the skeleton. The drug has a cumulative effect. A pronounced anti-inflammatory and analgesic effect develops 5–7 days after the first injection. Therefore, the drug is used for joint pathologies.

In addition to eliminating the symptoms of inflammation and pain, the drug reduces platelet aggregation, preventing the formation of blood clots and thrombi. When the active substance enters the blood, it quickly penetrates into all tissues and fluids and interacts with albumin almost 100%. Metabolism occurs in liver cells. Excretion of the drug is regulated by the intestines and kidneys.

Pharmacodynamics

Tenoxicam, a thienothiazine derivative of oxicam, is an NSAID. In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also prevents platelet aggregation.

The mechanism of action is based on the inhibition of the activity of the COX-1 and COX-2 isoenzymes, as a result of which the synthesis of PG in the area of ​​inflammation, as well as in other tissues of the body, is reduced. In addition, tenoxicam reduces the accumulation of leukocytes at the site of inflammation, reduces the activity of proteoglycanase and collagenase in human cartilage.

The anti-inflammatory effect develops by the end of the first week of therapy.

When is Artoxan needed?

The scope of application of non-steroidal anti-inflammatory drug injections is pathology of the musculoskeletal system: the pain syndrome they cause. Injections are prescribed:

• for osteoarthritis;
• degenerative processes in the area of ​​hard tissues of the spine and joints;
• exacerbations of osteochondrosis;
• for rheumatoid arthritis;
• for gout;
• tendovaginitis, bursitis, consequences of mechanical injuries to joints and ligaments.

Artoxan is also used to relieve pain of various origins: headaches, dental pain, neuralgic attacks, migraines, pathologically painful periods. And also for burns and soft tissue injuries.

special instructions

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys, the prothrombin index (while taking indirect anticoagulants), and the concentration of glucose in the blood (while using hypoglycemic agents).

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Bleeding time may increase, which should be taken into account during surgical interventions.

It is necessary to consider the possibility of sodium and water retention in the body when prescribed with diuretics in patients with arterial hypertension and heart failure.

Patients with uncontrolled arterial hypertension, CHF, peripheral arterial disease, confirmed coronary artery disease and/or cerebrovascular diseases should take the drug under medical supervision.

A history of kidney disease can lead to the development of interstitial nephritis, papillary necrosis and nephrotic syndrome.

Undesirable effects can be minimized by using the minimum effective dose of the drug in the shortest possible course.

Due to the negative effect on fertility, the drug is not recommended for women wishing to become pregnant. In patients with infertility (including those undergoing examination), it is recommended to discontinue the drug. Patients with SLE and mixed connective tissue disease are at increased risk of developing aseptic meningitis.

Influence on the ability to drive vehicles and machinery.

During the treatment period, the speed of mental and motor reactions may decrease, so it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

How to use Artoxan: instructions

The drug does not affect the progress of the general disease; it is used only to reduce symptoms. The solution is prepared a few minutes before administration; the diluted medication cannot be stored.

• The contents of the bottle are combined with the liquid and thoroughly shaken several times until the mass is completely dissolved, becomes homogeneous, and yellowish in color.
• The needle in the syringe is replaced after mixing the drug.
• With an intramuscular injection, the drug is injected deep into the gluteal or other large muscle.
• For intravenous injection, the drug is injected as slowly as possible.

The frequency of Artoxan injections is 1 time per day, one dose of the drug. The duration of pain relief is no more than two days in a row. In the future, you need to use oral medications containing tenoxicam to avoid intoxication of the body.

Directions for use and doses

IM, IV.

IM injections are made deeply.

The duration of IV administration should not be less than 15 seconds.

IM or IV administration is used for short-term (1-2 days) treatment at a dose of 20 mg/day. If further therapy is necessary, switch to oral dosage forms of tenoxicam.

The injection solution is prepared immediately before use by dissolving the contents of the bottle with the supplied solvent. After preparation, the needle is replaced.

Side effects

When using Artoxan, reactions from internal organs and systems are possible:

• from the digestive tract: heaviness in the abdomen, gastritis, nausea, abdominal cramps, heartburn, diarrhea;
• from the central nervous system: dizziness, asthenia, increased drowsiness, weakness, decreased mood, apathy, tinnitus, blurred vision;
• from the heart: tachycardia, arrhythmic manifestations;
• changes in blood count, high levels of liver tests, leukocytosis.

Skin symptoms are also likely: itching, erythema, rashes.

The drug is prescribed with caution to patients with low body weight, inflammatory diseases of the heart, kidneys, autoimmune pathologies, diabetes mellitus, and other chronic somatic disorders.

Interaction

Tenoxicam has a high degree of binding to albumin and can, like all NSAIDs, enhance the anticoagulant effect of warfarin and other anticoagulants. It is recommended to monitor blood counts when used together with anticoagulants and hypoglycemic drugs for oral administration, especially in the initial stages of using the drug Artoxan.

No possible interaction with digoxin was noted.

As with other NSAIDs, it is recommended to use the drug with caution concomitantly with cyclosporine due to an increased risk of nephrotoxicity.

Concomitant use with quinolones may increase the risk of seizures.

Salicylates can displace tenoxicam from its binding to albumin and, accordingly, increase the clearance and Vd of the drug. The simultaneous use of salicylates or two or more NSAIDs should be avoided (increased risk of gastrointestinal complications).

There is evidence that NSAIDs reduce lithium excretion. In this regard, patients receiving lithium therapy should monitor the concentration of lithium in the blood more often.

NSAIDs may cause sodium, potassium, and fluid retention in the body, interfering with the action of natriuretic diuretics. This must be remembered when used together with such diuretics in patients with CHF and arterial hypertension.

It is recommended to use NSAIDs with caution in combination with methotrexate; NSAIDs reduce the elimination of methotrexate and may increase its toxicity.

NSAIDs should not be used within 8–12 hours after taking mifepristone, because may reduce its effect.

It is necessary to take into account the increased risk of gastrointestinal bleeding when used together with corticosteroids.

Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, fibrinolytics, side effects of mineralocorticosteroids and corticosteroids, 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.

Combined use with antiplatelet agents and SSRIs increases the risk of gastrointestinal bleeding.

Cardiac glycosides, when taken together with NSAIDs, may worsen heart failure, reduce GFR and increase plasma levels of cardiac glycosides.

No interaction has been identified when using tenoxicam with cimetidine.

No clinically significant interaction has been identified during treatment with tenoxicam and penicillamine or parenteral gold.

The risk of nephrotoxicity increases when NSAIDs are used concomitantly with tacrolimus.

The risk of hematological toxicity increases when using NSAIDs with zidovudine.

Contraindications

It is necessary to stop using Artoxan:

• with high sensitivity of the body to ibuprofen, acetylsalicylic acid and other NSAIDs;
• allergic reactions to the components of the drug: skin itching, severe rashes;
• gastric ulcer, erosive lesions of the intestinal mucosa;
• for bronchial asthma in combination with other pathologies of the respiratory tract;
• in preparation for heart bypass surgery and during the recovery period after surgery;
• severe form of renal or liver failure;
• with heart failure (uncompensated);
• for pathologies of the hematopoietic system, low coagulability.

Artoxan is also contraindicated during pregnancy and for mothers who are breastfeeding, since its active substance penetrates the placenta and into milk.

The drug should not be used by patients under 18 years of age.

Artoxan-Reb tablets p/o 20 mg No. 10x1

Name

Artoxan-reb tablets.

Release forms

Pills.

INN

Tenoxicam.

Description

Film-coated tablets are yellow, round with a biconvex surface.

Compound

1 film-coated tablet contains: active substance: tenoxicam – 20.0 mg; excipients: lactose monohydrate, corn starch 1500, partially pregelatinized, talc, magnesium stearate. Shell composition: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol/polyethylene glycol, talc, iron oxide yellow (E172), tartrazine (E102), orange-yellow S / “Sunset” FCF (E110).

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Oxycams. ATX code: M01AC02

Pharmacological properties

Pharmacodynamics Artoxan-Reb is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, antipyretic effects, and also inhibits platelet aggregation. Tenoxicam reduces prostaglandin biosynthesis by inhibiting cyclooxygenase 1 (COX 1) and cyclooxygenase 2 (COX 2), which has been demonstrated both in vitro (sheep testicular gland) and in vivo (protection of mice against arachidonic acid-induced toxicity). In in vitro studies of cyclooxygenase isoenzymes obtained from human COS7 cells, it was shown that tenoxicam inhibits cyclooxygenase 1 (COX 1) and cyclooxygenase 2 (COX 2) to approximately equal extent, i.e. the COX 1/COX 2 ratio is 1 ,34. In vitro studies of leukocyte peroxidase suggest that tenoxicam may act as an active oxygen scavenger at the site of inflammation. Artoxan-Reb is a potent inhibitor of human metalloproteases in vitro (stromelysin and collagenase), which cause cartilage destruction. Another possible mechanism of action is a decrease in nitrite levels, indicating changes in nitric oxide (NO) metabolic pathways. These pharmacological effects explain, at least in part, the therapeutic effect of Artoxan-Reb in the treatment of painful inflammatory and degenerative diseases of the musculoskeletal system. Pharmacokinetics Tenoxicam has a long-term effect, a single daily dose is effective. Absorption Tenoxicam is rapidly and completely absorbed in unchanged form after oral administration. Taking with food reduces the rate, but does not affect the amount of absorption of tenoxicam. When administered at the recommended dose of 20 mg once daily, steady-state plasma concentrations are achieved within 10–15 days, with no unexpected accumulation observed. The average steady-state concentration is 11 mg/L when tenoxicam is administered at a dose of 20 mg orally once daily, and the concentration does not change even with treatment for up to 4 years. As would be expected, plasma concentrations at steady state were 6 times higher than after a single dose. The pharmacokinetics of tenoxicam is linear in the studied dose range from 10 to 100 mg. Distribution Tenoxicam penetrates well into the synovial fluid, achieving concentrations approximately half those in plasma. In the blood, more than 99% of tenoxicam is bound to albumin. Metabolism and excretion Tenoxicam is eliminated primarily through the metabolic route. About 2/3 of the administered dose is excreted in the urine (mostly in the form of the inactive 5-hydroxypyridyl metabolite), and the rest in the bile (most in the form of the glucuronic conjugate hydroxymetabolite). Less than 1% of the administered dose is excreted in the urine as unchanged tenoxicam. The average half-life of tenoxicam is approximately 72 hours (range, 59 to 74 hours). The total plasma clearance is 2 ml/min. Pharmacokinetics in different patient groups No age-related changes in the pharmacokinetics of tenoxicam were detected, although inter-individual variability tends to be greater in the elderly. No differences in the pharmacokinetics of tenoxicam have been established, despite individual variations in trends toward increased similar characteristics in older patients. Studies in the elderly and patients with renal failure or cirrhosis confirm that no dose adjustment is necessary to achieve similar plasma concentrations observed in healthy patients. Elderly patients with rheumatic diseases show a similar kinetic profile to healthy volunteers. Due to the high degree of binding of tenoxicam to plasma proteins, caution should be exercised if there is a marked decrease in plasma albumin levels (see section "Precautions").

Indications for use

Artoxan-Reb is indicated for the relief of pain and inflammation in osteoarthritis and rheumatoid arthritis. Artoxan-Reb is also used for short-term treatment of acute diseases of the musculoskeletal system, including sprains, dislocations and other soft tissue injuries.

Directions for use and dosage

Adult patients. The recommended dose is 20 mg per day. It is advisable to take it at the same time every day, during or after meals, with a sufficient amount of liquid. Higher doses should not be used, as this does not always achieve a significantly more pronounced therapeutic effect, and the risk of adverse events increases. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration. Duration of therapy. Treatment of acute musculoskeletal disorders usually does not exceed 7 days. In exceptional cases, the duration of therapy can be extended to 14 days. At sufficiently low concentrations of albumin in the blood plasma (for example, nephrotic syndrome) or at high concentrations of bilirubin, use with caution due to the high affinity of tenoxicam for plasma proteins. Elderly patients. Prescribe with caution, because against the background of concomitant treatment or impaired renal, hepatic or cardiovascular function, the likelihood of side effects increases compared to younger patients. During treatment with NSAIDs, patients should be regularly monitored for gastrointestinal bleeding. Children. There is not enough information on the use of tenoxicam in children. Patients with impaired renal and liver function. Tenoxicam can be used with caution in patients with mild to moderate renal and hepatic impairment (see section "Precautions"). Due to the high level of plasma protein binding of tenoxicam, caution should be used when plasma albumin concentrations are significantly reduced (eg, in nephrotic syndrome) or when bilirubin levels are high. Available information is insufficient to provide dosage recommendations for tenoxicam in patients with pre-existing hepatic impairment. Tenoxicam is contraindicated in severe renal impairment (creatinine clearance

Side effect

Artoxan-Reb is usually well tolerated, most side effects are short-term and go away without stopping treatment. Adverse reactions are classified by frequency of occurrence: very often (≥ 1/10), often (≥ 1/100,

Contraindications

hypersensitivity to the active substance or any of the auxiliary components; a history of gastrointestinal bleeding or perforation associated with previous cases of treatment with NSAIDs, as well as cases of symptoms of asthma, rhinitis or urticaria when taking aspirin or other non-steroidal anti-inflammatory drugs (there is a possibility of cross-sensitivity with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs); active peptic ulcer/bleeding or history of recurrent ulcer/bleeding (two or more separate episodes of proven ulceration or bleeding); severe gastritis, inflammatory bowel diseases such as Crohn's disease, ulcerative colitis; severe heart failure (NYHA stage III–IV), condition after coronary artery bypass surgery; severe renal or liver failure; blood diseases; pregnancy and lactation (see subsections “Pregnancy”, “Lactation”); childhood.

Precautionary measures

Artoxan-Reb should not be used with other NSAIDs, including selective oxygenase-2 cycle inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time. The drug contains lactose, so it should not be used in patients with rare hereditary diseases such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Due to the presence of azo dyes, Artoxan-Reb may cause allergic reactions. Cardiovascular and cerebrovascular effects Appropriate monitoring and counseling of patients with hypertension and/or mild to moderate congestive heart failure is recommended as fluid retention and edema have been reported with the use of NSAIDs. Clinical trial and epidemiological data indicate that the use of some NSAIDs (particularly at high doses and long-term treatment) may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke). Available data are insufficient to exclude a similar risk with tenoxicam. Therefore, long-term treatment with tenoxicam in patients with risk factors for cardiovascular disease, as well as patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, is possible only after careful consideration of the case. Similar recommendations should be taken into account before initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, smoking). Renal and liver failure The use of NSAIDs can cause a dose-dependent decrease in prostaglandin formation and the occurrence of induced renal failure. Patients taking diuretics and the elderly are at greater risk of this reaction. Such patients undergo monitoring of renal function. Isolated cases of increased levels of serum transaminases or other indicators of liver function have been reported. In most cases, data above the normal range of values ​​were weak and transient. If there is a significant or persistent deviation, you should stop using the drug Artoxan-Reb and repeat the tests. Particular care must be taken when treating patients with existing liver disease. In rare cases, NSAIDs can cause interstitial nephritis, glomerulonephritis, papillary necrosis and nephrotic syndrome. Such substances inhibit renal prostaglandin synthesis, which plays an auxiliary role in maintaining renal perfusion in patients with reduced blood flow and blood volume. The use of NSAIDs in these patients may cause clinical renal decompensation with a return to the pre-therapy state after cessation of treatment. Patients at greatest risk for this reaction are those with existing kidney disease (including patients with diabetes and renal impairment), nephrotic syndrome, increased interstitial fluid volume, liver disease, heart failure, and patients receiving concurrent treatment with diuretics or potentially nephrotoxic agents. In such patients, careful monitoring of renal, liver and cardiac function should be established. The dosage used should be minimal. Dermatological effects Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rarely reported with the use of NSAIDs. The risk of developing such reactions is highest at the beginning of treatment: the first manifestation was noted during the first month of therapy. At the first signs of skin rash, lesions of the mucous membranes or other signs of hypersensitivity, you should stop using the drug. Elderly patients Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation. Particular care should be taken and regular monitoring of elderly patients should be carried out to detect possible interactions with concomitant drugs and monitoring of renal, hepatic and cardiovascular functions that may be affected by NSAIDs. Impaired fertility in women The use of the drug may impair the fertility of women, therefore its use is not recommended for women planning pregnancy. Gastrointestinal bleeding, ulceration and perforation Caution should be exercised when using NSAIDs in patients with a history of gastrointestinal disease. With all NSAIDs, gastrointestinal bleeding, ulceration and perforation have been reported at any time during treatment, with or without warning symptoms or previous serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, and in elderly patients. Treatment of such patients should begin with the lowest possible dose. For such patients, treatment in combination with protective agents (eg, misoprostol or proton pump inhibitors) should be considered, as well as for patients taking concomitant low-dose aspirin or other drugs that may increase the risk of gastrointestinal damage. Patients with a history of GI toxicity, especially older patients, should report unusual abdominal symptoms (especially GI bleeding), especially during the initial stages of treatment. Caution should be exercised when treating patients concomitantly taking medications that may increase the risk of ulceration or bleeding, such as corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as aspirin). Patients taking tenoxicam who have gastrointestinal symptoms should be closely monitored. If a peptic ulcer or gastrointestinal bleeding occurs, you must immediately stop using the drug. The use of NSAIDs in patients with gastrointestinal diseases (ulcerative colitis, Crohn's disease) can cause exacerbation of the disease (see section "Contraindications"). Hematological effect Tenoxicam reduces platelet aggregation and may increase bleeding time. This should be taken into account when treating patients undergoing major surgery (eg, joint replacement) and when determining bleeding time. Ophthalmic Effects: Adverse eye effects have been reported with the use of NSAIDs. For this reason, patients who experience visual disturbances during treatment with tenoxicam should undergo an ophthalmological examination. Respiratory disorders Caution should be exercised when treating patients with bronchial asthma or a history of this disease, as NSAIDs have been reported to cause bronchospasm in such patients. Antipyretic effect Just like other anti-inflammatory drugs, Artoxan-Reb can mask the usual signs of infection. Laboratory tests NSAIDs inhibit renal prostaglandin synthesis and may therefore have undesirable effects on renal hemodynamics and fluid balance. When prescribing tenoxicam, it is necessary to properly monitor the condition, especially the functions of the kidneys and heart (blood urea nitrogen, creatinine, development of edema, weight gain, etc.), in patients with risk factors for the development of renal failure, such as pre-existing kidney disease, impaired renal function in patients with diabetes mellitus, liver cirrhosis, chronic heart failure, dehydration or concomitant treatment with potentially nephrotoxic drugs, diuretics and corticosteroids. These groups of patients are at particular risk during the peri- and postoperative periods of major surgery due to the potential for severe blood loss. Therefore, they require careful monitoring in the postoperative and recovery periods. Due to the high degree of binding of tenoxicam to plasma proteins, caution should be exercised when there is a significant decrease in plasma albumin concentrations. Systemic lupus erythematosus and mixed connective tissue disease Patients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of developing aseptic meningitis.

Impact on the ability to drive vehicles and operate machinery

Patients experiencing adverse reactions such as vertigo, dizziness, drowsiness, fatigue or visual disturbances should avoid driving or operating machinery.

Pregnancy

The safety of using the drug Artoxan-Reb during pregnancy and lactation has not been established; for this reason, the use of the drug during pregnancy and lactation is not recommended. Congenital anomalies caused by NSAID use in humans have been reported, but the incidence is low and no consistent pattern has been found. Due to the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of the ductus arteriosus), the use of NSAIDs in the third trimester of pregnancy is contraindicated. The onset of labor may be delayed, and its duration may increase; There is also a tendency for increased bleeding in mother and child. The use of NSAIDs in the first two trimesters of pregnancy and during childbirth is possible only in cases where the potential benefit to the patient outweighs the potential risk to the fetus.

Lactation

Studies, the number of which has been small to date, have shown that NSAIDs pass into breast milk in very low concentrations. If possible, the use of NSAIDs should be avoided during breastfeeding. Although there is no evidence of adverse reactions, if tenoxicam is strictly necessary for a nursing woman, breastfeeding should be discontinued.

Overdose

Symptoms Symptoms of NSAID overdose usually include nausea, vomiting, epigastric pain, rarely diarrhea, gastrointestinal bleeding, tinnitus, headache, blurred vision and dizziness. There have been isolated cases of more serious toxicity following oral administration of the drug at higher doses; these include convulsions, irritation, drowsiness due to hypotension, dyspnea, coma due to electrolyte imbalance and renal failure. A possible effect is exacerbation of asthma. Treatment Treatment is symptomatic. In case of overdose, you should stop taking the drug; the following may be prescribed: gastric lavage, ingestion of activated charcoal, antacids, proton pump inhibitors. The use of activated charcoal should only be considered within one hour of taking an excess dose of the drug. There are no specific antidotes. The effectiveness of gastric lavage is not clear. Dialysis does not completely remove NSAIDs from the bloodstream. Good diuresis must be ensured to maintain adequate hydration levels. Liver and kidney function should be carefully monitored. It is necessary to monitor patients for at least four hours after ingesting the drug at an increased dose. Frequent and prolonged convulsions should be treated with intravenous diazepam. Other measures may be taken depending on the clinical condition of the patients.

Interaction with other drugs

Other analgesics, including selective cyclooxygenase-2 inhibitors The simultaneous use of two or more NSAIDs (including aspirin) should be avoided as this may increase the risk of unwanted side effects. Acetylsalicylic acid and salicylates Salicylates can replace protein-bound tenoxicam, thereby increasing the clearance and volume of distribution of tenoxicam. The simultaneous use of salicylates with the drug Artoxan-Reb should be avoided, as this may increase the risk of unwanted side effects (mainly gastrointestinal). Antacids and H2-receptor antagonists Antacids may reduce the rate, but not the amount, of absorption of tenoxicam. These differences are not clinically significant. No interactions were observed with concomitant use of cimetidine. Anticoagulants Tenoxicam is highly bound to serum albumin and, like all NSAIDs, can enhance the anticoagulant effect of warfarin and other anticoagulants. It is recommended to carefully monitor the effects of anticoagulants and oral glycemic agents, especially during the initial stages of treatment with Artoxan-Reb. No interaction with digoxin was observed. In healthy subjects, no clinically significant interaction was observed between tenoxicam and low molecular weight heparin. Oral antidiabetic agents Tenoxicam does not significantly affect the clinical effect of the oral antidiabetic agents glibornuride, glibenclamide, and tolbutamide. However, as with other NSAIDs, close monitoring of patients is recommended when taking oral antidiabetic agents concomitantly. Cholestyramine Cholestyramine may increase the clearance and decrease the half-life of tenoxicam. Dextromethorphan Concomitant use of tenoxicam and dextromethorphan may increase the analgesic effect compared to monotherapy. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) When used simultaneously with NSAIDs, the risk of gastrointestinal bleeding increases. Antihypertensives Tenoxicam and other NSAIDs may reduce the effect of antihypertensives. Cardiac glycosides NSAIDs can exacerbate heart failure, reduce the glomerular filtration rate and increase the level of cardiac glycosides in the blood plasma when used in parallel. Cyclosporine As with other NSAIDs, caution should be exercised when taking cyclosporine concomitantly as the risk of nephrotoxicity increases. Corticosteroids As with other NSAIDs, caution should be exercised when taking corticosteroids concomitantly as there is an increased risk of ulcers or gastrointestinal bleeding. Diuretics The effect of diuretics is reduced. NSAIDs may cause sodium, potassium, and fluid retention and may interfere with the natriuretic effects of diuretics, which may increase the risk of NSAID nephrotoxicity. These features should be taken into account when treating patients with cardiac dysfunction or hypertension, since these effects may cause a deterioration in the patient's condition. Lithium NSAIDs have been reported to reduce lithium excretion. When prescribing tenoxicam to a patient taking lithium, lithium levels should be monitored frequently and the patient should be warned about adequate fluid intake and symptoms of lithium toxicity. Methotrexate Concomitant administration of methotrexate requires caution, as NSAIDs reduce the elimination of methotrexate, thereby increasing the risk of toxicity. Mifepristone NSAIDs should not be used for 8–12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of the latter. Penicillamine and parenteral gold In a small number of patients receiving penicillamine or parenteral gold, no clinically significant interaction was observed. Quinolones Data from animal studies suggest that NSAIDs may increase the risk of seizures caused by quinolone antibiotics. Patients receiving NSAIDs and quinolones may be at increased risk of seizures. Tacrolimus When NSAIDs are used concomitantly with tacrolimus, there may be an increased risk of nephrotoxicity. Zidovudine When NSAIDs are used concomitantly with zidovudine, the risk of hematological toxicity increases. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia taking both zidovudine and ibuprofen. Others: Coadministration of probenecid and tenoxicam may increase plasma concentrations of tenoxicam. The clinical significance of this observation has not been established.

Storage conditions and shelf life

Store in a place protected from moisture 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 stated on the package.

Vacation conditions

By doctor's prescription.

Package

10 tablets each in a blister pack made of PVC/PVDC film and flexible packaging based on aluminum foil. 1 blister pack together with an insert in a cardboard box.

Buy Artoxan-Reb tb.p.o., 20 mg in container packaging. No. 10x1 in the pharmacy

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Instructions for use for Artoxan-Reb tb.p/o, 20 mg in a container pack. №10x1

Note!

Description of the drug Artoxan table. p/o 20 mg No. 10 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Manufacturer

Egyptian International Pharmaceutical Manufacturing Company (E.I.P.I.Co), Egypt, Tens ov Ramadan City, First Industrial Zone B1, PO Box 149 Tens.

Owner of the trademark and registration certificate: ROTAPHARM LIMITED, Great Britain. 23 The Kilns, Thaxted Road, Saffron Walden, ESSEX CB10 2UQ.

Tel.: 44 (0) 845 0667700; fax: 44 (0) 845 06677.

Claims regarding the quality of the drug should be sent to the following address: TROCAS PHARMA LLC. 141400, Russian Federation, Moscow region, Khimki, st. Spartakovskaya, 5, bldg. 7, off. 8.

Tel/fax: 8-800-700-45-68.