Teraflex Advance capsules, No. 120

The drug is taken orally after meals. The capsules should be taken with a little water.

Adults are prescribed 2 capsules 3 times / day.

The duration of admission without consulting a doctor should not exceed 3 weeks. Further use of the drug should be discussed with your doctor.

Opaque hard gelatin capsules, No. 0, consisting of two parts: a blue cap and a white body, with a blue inscription 'THERAFLEX ADVANCE'; the contents of the capsules are a white or almost white powder with a faint odor.

1 caps.

glucosamine sulfate (in the form of D-glucosamine sulfate potassium chloride) 250 mg

chondroitin sodium sulfate 200 mg

ibuprofen 100 mg

Excipients: microcrystalline cellulose - 17.4 mg, corn starch (pregelatinized starch) - 4.1 mg, stearic acid - 10.2 mg, sodium carboxymethyl starch sodium - 10 mg, crospovidone - 10 mg, magnesium stearate - 3 mg, silicon dioxide - 2 mg, povidone - 0.3 mg.

• Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute phase, Crohn's disease, ulcerative colitis);

• complete and incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses;

• confirmed hyperkalemia;

• hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

• gastrointestinal bleeding and intracranial hemorrhage;

• severe renal failure (CC <30 ml / min);

• progressive kidney disease;

• severe liver failure;

• active liver disease;

• severe heart failure;

• period after coronary artery bypass grafting;

• pregnancy;

• lactation period (breastfeeding);

• children under 18 years of age;

• history of hypersensitivity to acetylsalicylic acid or other NSAIDs;

• hypersensitivity to any of the components that make up the drug.

The drug should be prescribed with caution in case of heart failure, arterial hypertension, cirrhosis of the liver with portal hypertension, hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia, gastric ulcer and duodenal ulcer (in history), gastritis, enteritis, colitis, blood diseases not clear etiology (leukopenia and anemia), bronchial asthma, diabetes mellitus, peripheral arterial disease, moderate renal failure (CC 30-60 ml / min), dyslipidemia / hyperlipidemia, ischemic heart disease, cerebrovascular diseases, Helicobacter pylori infection, long-term use of NSAIDs, tuberculosis , severe somatic diseases, concomitant therapy with anticoagulants, antiplatelet agents, GCS, selective serotonin reuptake inhibitors, smoking, alcoholism,as well as elderly patients. With intolerance to seafood (shrimp, shellfish), the likelihood of developing allergic reactions to the drug increases.

pharmachologic effect

TeraflexЃ Advance is a combined preparation containing chondroitin sulfate, glucosamine sulfate and ibuprofen as active components.

Chondroitin sulfate is involved in the construction and restoration of cartilage tissue, protects it from destruction and improves joint mobility.

Glucosamine sulfate activates the synthesis of proteoglycans, hyaluronic, chondroitinsulfuric acids and other substances that make up the articular membranes, intra-articular fluid and cartilage tissue.

Ibuprofen is a propionic acid derivative and has analgesic, antipyretic and anti-inflammatory effects through the indiscriminate blockade of COX-1 and COX-2.

Glucosamine sulfate and chondroitin sulfate contained in the preparation potentiate the analgesic effect of ibuprofen.

Pharmacokinetics

Glucosamine sulfate

Suction

The oral bioavailability of glucosamine is 25% (due to the 'first pass' effect through the liver), the highest concentrations are found in the liver, kidneys and articular cartilage. About 30% of the dose taken persists for a long time in bone and muscle tissue.

Withdrawal

It is excreted mainly in the urine unchanged, partly in the feces. T1 / 2 - 68 h.

Chondroitin sulfate

Suction

More than 70% of chondroitin sulfate is absorbed in the digestive tract. Bioavailability is about 13%. With a single oral administration of an average therapeutic dose, Cmax in plasma is achieved after 3-4 hours, in synovial fluid - after 4-5 hours.

Distribution and excretion

The drug absorbed in the gastrointestinal tract accumulates in the synovial fluid. It is excreted by the kidneys.

Ibuprofen

Absorption and distribution

Ibuprofen is well absorbed from the stomach. Tmax - about 1 hour. Ibuprofen is approximately 99% bound to plasma proteins. Slowly distributed in synovial fluid and excreted from it more slowly than from plasma.

Metabolism

Ibuprofen is metabolized in the liver, mainly by hydroxylation and carboxylation of the isobutyl group. The isoenzyme CYP2C9 is involved in the metabolism of the drug. After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly transformed into the active S-form.

Withdrawal

Ibuprofen has a biphasic elimination kinetics. T1 / 2 from plasma is 2-3 hours. Up to 90% of the dose can be detected in urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and, to a lesser extent, in the bile. Ibuprofen is completely eliminated within 24 hours.

Side effect

When using TeraflexЃ Advance, nausea, abdominal pain, flatulence, diarrhea, constipation, and allergic reactions are possible. These reactions disappear after discontinuation of the drug.

The possibility of the development of adverse reactions associated with the ibuprofen included in the drug should be taken into account.

From the digestive system: NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, exacerbation of colitis and Crohn's disease.

From the hepatobiliary system: hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations; rarely - aseptic meningitis (more often in patients with autoimmune diseases).

From the senses: hearing impairment (hearing loss, ringing or tinnitus), visual impairment (toxic damage to the optic nerve, blurred vision or double vision, scotoma, dry and irritated eyes, conjunctival edema and eyelids of allergic genesis).

From the side of the cardiovascular system: development or worsening of heart failure, tachycardia, increased blood pressure, increased risk of arterial thrombosis.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

From the hematopoietic system: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Allergic reactions: skin rash (usually erythematous), urticaria, pruritus, Quincke's edema, anaphylactoid reactions, anaphylactic shock, dyspnea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome) , eosinophilia, allergic rhinitis.

Laboratory indicators: an increase in bleeding time, a decrease in serum glucose concentration, a decrease in CC, a decrease in hematocrit or hemoglobin, an increase in serum creatinine concentration, an increase in the activity of hepatic transaminases, the concentration of urea in the blood may increase, the concentration of bilirubin in the blood may increase.

Others: increased sweating.

Application during pregnancy and lactation

Not recommended for use during pregnancy and during breastfeeding.

Application for violations of liver function

The use of the drug is contraindicated in severe hepatic insufficiency, active liver disease.

The drug should be prescribed with caution in liver failure.

Application for impaired renal function

The use of the drug is contraindicated in severe renal failure (CC <30 ml / min), progressive kidney disease.

The drug should be prescribed with caution in case of renal failure.

Application in children

The use of the drug is contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

The drug should be prescribed with caution to elderly patients.

special instructions

During long-term treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys.

When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, fecal occult blood test.

If necessary, the simultaneous use of additional NSAIDs and analgesic drugs, the doctor should take into account the presence of ibuprofen in the drug. If you need long-term use of additional NSAIDs, you should use TeraflexЃ, which does not contain ibuprofen.

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

With intolerance to seafood (shrimp, shellfish), the likelihood of developing allergic reactions to the drug increases.

During the treatment period, alcohol intake is not recommended.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, patients should refrain from driving vehicles and other activities that require concentration of attention or speed of psychomotor reactions.

Overdose

Symptoms (associated with ibuprofen overdose): abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, hypokalemia, hyperkalemia, bradycardia, tachycardia, atrial fibrillation , respiratory arrest.

Treatment: gastric lavage (effective only within 1 hour after ingestion), the use of activated carbon, alkaline drink; carrying out forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure).

Drug interactions

Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of ibuprofen, increasing the risk of severe hepatotoxic reactions.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic effects.

The drug reduces the hypotensive effect of vasodilators (including slow calcium channel blockers and ACE inhibitors).

The drug reduces the natriuretic and diuretic activity of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

Enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of hemorrhagic complications).

Strengthens the ulcerogenic effect (with the development of bleeding) GCS, NSAIDs, colchicine, estrogens, ethanol.

Enhances the effect of oral hypoglycemic drugs and insulin.

Antacids and cholestyramine reduce the absorption of ibuprofen.

The drug increases the concentration in the blood of digoxin, lithium preparations and methotrexate.

Caffeine enhances the analgesic effect.

With the simultaneous appointment of ibuprofen, it reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving acetylsalicylic acid as an antiplatelet agent in small doses after starting ibuprofen).

The simultaneous use of drugs containing glucosamine and coumarin anticoagulants (for example, warfarin) can lead to an increase in INR and the risk of bleeding; it is necessary to monitor blood clotting indicators.

With simultaneous use with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases.

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the incidence of hypoprothrombinemia.

Myelotoxic drugs increase the manifestations of hematotoxicity.

Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase the plasma concentration of ibuprofen.

Due to the content of glucosamine in the preparation, it is possible to reduce the effectiveness of hypoglycemic drugs, doxorubicin, teniposide, etoposide.

Glucosamine increases the absorption of antibiotics of the tetracycline group, reduces the effect of semi-synthetic penicillins, chloramphenicol.

Co-administration with potassium-sparing diuretics increases the risk of hyperkalemia.

NSAIDs can reduce the effects of mifepristone.

Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Concomitant use with zidovudine increases the risk of hematological toxicity of NSAIDs.

With the simultaneous use of quinolones and NSAIDs, the risk of seizures increases.