Amcinafal

Inflammatory and degenerative diseases of the musculoskeletal system, accompanied by pain: joint syndrome with gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, osteochondrosis, joint rheumatism (tendinitis, bursitis, myositis), spinal pain, neuralgia, myalgia, trauma.

rheumatoid arthritis,

osteoarthritis,

ankylosing spondylitis,

articular syndrome with exacerbation of the course of gout,

bursitis,

tendovaginitis,

pain syndrome (mild to moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algodismenorrhea,

pain from injuries, burns.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, fibrositis, tendinitis, tendovaginitis, bursitis, lumbalgia, lumboishialgia, epicondylitis, injuries and inflammation of the soft tissues and musculoskeletal system.

Inside, rectally. According to 1 table. or 1 sup. 1 time a day (preferably at the same time).

In acute attacks of gout according to 2 tables. or 2 suppers. 1 time a day for the first two days, then 1 table. or 1 sup. 1 time a day for 5 days.

V / m, v / V.

In / m injections are made deep.

The duration of the intravenous injection should not be less than 15 seconds.

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

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

Inside, 20 mg (1 capsule) 1 time per day (preferably at the same time). In acute attacks of gout — 40 mg once a day for the first days, then-20 mg once a day for another 5 days.

Hypersensitivity, active peptic ulcer, severe liver function disorders in the active stage, renal failure, diabetes mellitus, arterial hypertension, heart failure, childhood.

hypersensitivity to the active substance or auxiliary components of the drug (there is a possibility of cross-sensitivity to acetylsalicylic acid( ASA), ibuprofen and other NSAIDs),

erosive and ulcerative lesions of the stomach and duodenum in the acute stage,

gastrointestinal bleeding (including in the anamnesis),

inflammatory bowel diseases: Crohn's disease or ulcerative colitis in the acute stage,

severe renal insufficiency (Creatinine Cl less than 30 ml / min),

progressive kidney disease,

severe liver failure,

complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to ASA or other NSAIDs (including in the anamnesis),

established diagnosis of diseases of the blood coagulation system,

decompensated heart failure,

treatment of perioperative pain during coronary artery bypass grafting,

pregnancy,

breastfeeding period,

age up to 18 years.

With caution: gastric and duodenal ulcer, ulcerative colitis and Crohn's disease without exacerbation, a history of liver disease, hepatic porphyria, chronic renal failure (creatinine Cl 30-60 ml / min), chronic heart failure, arterial hypertension, a significant decrease in BCC (in t.tsch. after surgery), elderly patients (over 65 years of age) (in t.tsch. patients receiving diuretics, debilitated patients and those with low body weight), bronchial asthma, coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipedemia, diabetes mellitus, peripheral artery diseases, smoking, infection Helicobacter pylori long-term use of NSAIDs, alcoholism, severe somatic diseases, autoimmune diseases (systemic lupus erythematosus (SLE) and mixed connective tissue disease), simultaneous administration of corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including ASA, clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline).

Hypersensitivity, erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), "aspirin" asthma, severe renal dysfunction.

Nausea, heartburn, abdominal pain, diarrhea, flatulence, stomatitis, anorexia, erosive and ulcerative lesions, bleeding, headache, dizziness, insomnia, depression, increased excitability, edema in the eye area, eye irritation, visual impairment, peripheral edema, increased plasma concentrations of creatinine, nitrogen urea, bilirubin and liver transaminase activity, allergic reactions (urticaria, itching), when using suppositories, local irritation, painful defecation is possible.

The frequency of side effects is classified according to WHO recommendations: very common (>1/10), common (from >1/100, <1/10), infrequent (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), not established.

From the digestive system: very often — dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), NSAIDs-gastropathy, abdominal pain, stomatitis, anorexia, impaired liver function, rarely — ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, uterine, hemorrhoid), perforation of the intestinal walls.

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

From the central nervous system: often — dizziness, headache, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, visual impairment.

From the skin and subcutaneous tissue: often-skin itching, rash, urticaria and erythema, very rarely-photodermatitis, Stevens-Johnson syndrome, Lyell syndrome.

From the urinary system: often-an increase in the content of urea nitrogen and creatinine in the blood.

From the side of the hematopoietic organs: often-agranulocytosis, leukopenia, rarely-anemia, thrombocytopenia, leukopenia, pancytopenia.

From the side of the hepatobiliary system: often-an increase in the activity of ALT, AST, GGT and the level of bilirubin in the serum.

Laboratory parameters: hypercreatininemia, hyperbilirubinemia, increased urea nitrogen concentration and hepatic transaminase activity, prolonged bleeding time.

Against the background of treatment, mental disorders and metabolic disorders may occur.

Headache, dizziness, nausea, heartburn, abdominal pain and discomfort, diarrhea, skin rash, itching, urticaria, erythema.

It has a powerful and long-lasting analgesic (occurs after 30 minutes) and anti-inflammatory effect with less pronounced antipyretic. In rheumatic diseases, it relieves joint pain at rest and when moving, reduces morning stiffness and swelling, improves function and increases the volume of joint movements.

Tenoxicam, which is a thienothiazine derivative of oxycam, 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 COX-1 and COX-2 isoenzymes, which reduces the synthesis of PG in the focus of inflammation, as well as in other tissues of the body. In addition, tenoxicam reduces the accumulation of white blood cells in the focus 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.

It is quickly and completely absorbed into the gastrointestinal tract. The bioavailability of 100%. C_max it is reached after 2 hours. It binds to plasma proteins by 99%. The volume of distribution is about 0.15 l/kg. T_1/2 — 60-75 hours. It is hydroxylated in the liver. Easily passes the blood-tissue barriers. The main part is excreted in the form of inactive metabolites in the urine, the rest - with bile.

Suction. Absorption is fast and complete. Bioavailability is 100%.

Distribution. C_max in the blood plasma, it is noted after 2 hours. The distinctive ability of tenoxicam is a long duration of action and a long T_1/2 - 72 hours — The drug is 99% bound to plasma proteins. Tenoxicam penetrates well into the synovial fluid. Easily penetrates through the blood-tissue barriers.

Metabolism. It is metabolized in the liver by hydroxylation to form 5-hydroxypyridyl.

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

Bioavailability of 70-80%. After taking 1-2 capsules (20 or 40 mg) C_max in plasma, it is reached after 0.5-2 hours. It is excreted through the kidneys (2/3) and the gastrointestinal tract (1/3).

Increases the effect of lithium preparations (including toxicity), indirect anticoagulants, oral hypoglycemic agents (sulfonylurea derivatives). Antacids reduce the rate of absorption. Simultaneous use of others. NSAIDs increase the risk of side effects (especially from the gastrointestinal tract).

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 parameters when combined with anticoagulants and hypoglycemic drugs for oral administration, especially in the initial stages of Amcinafal use.

No possible interaction with digoxin was observed.

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

Concomitant use with quinolones may increase the risk of seizures.

Salicylates can displace tenoxicam from the albumin bond and, accordingly, increase the clearance and V_d the drug. It is necessary to avoid the simultaneous use of salicylates or two or more NSAIDs (increased risk of gastrointestinal complications).

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

NSAIDs can cause sodium, potassium, and fluid retention in the body, disrupting the effects of natriuretic diuretics. This should be kept in mind when used together with such diuretics in patients with CHF and arterial hypertension.

With caution, it is recommended to use NSAIDs together with methotrexate, NSAIDs reduce the excretion of methotrexate and may increase its toxicity.

NSAIDs should not be used for 8-12 hours after the use of mifepristone, because they can reduce its effect.

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

Reduces the effectiveness of uricosuric drugs, increases 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 can increase heart failure, reduce GFR, and increase the plasma level of cardiac glycosides.

No interaction was found when using tenoxicam with cimetidine.

There was no clinically significant interaction between tenoxicam and penicillamine or parenteral gold.

The risk of nephrotoxicity increases when NSAIDs are co-administered with tacrolimus.

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

Reduces the diuretic effect of diuretics. Antacids slow down the absorption and reduce the maximum plasma concentrations.