Teraflex® Advance (Theraflex® Advance)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGlucosamine + Ibuprofen + Chondroitin sulfateGlucosamine + Ibuprofen + Chondroitin sulfate
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  • Teraflex® Advance
    capsules inwards 
    BAYER, AO     Russia
    • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains

    Active substances: glucosamine sulfate in the form of D-glucosamine potassium chloride sulfate 250 mg, chondroitin sodium sulfate1 200 mg, ibuprofen2 100 mg.

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

    Gelatine capsule: gelatin 97.07 mg, titanium dioxide 2.83 mg, a dye of a brilliant blue aluminum lacquer of 0.09 mg.

    1 chondroitin sodium sulfate is contained in the form of 90% of the substance, taking into account 10% loss in weight during drying and excess - 241 mg;

    2 ibuprofen is present in the form of direct compression granules 66% containing: ibuprofen 66%, pregelatinized starch 8%, croscarmellose sodium 2%, microcrystalline cellulose 14%, silicon colloidal dioxide 1%, stearic acid 1.5%, corn starch 6%, povidone 1.5% -152 mg.

    Composition of ink: Shellac NF, ethyl alcohol, dehydrated USP, isopropyl alcohol USP, butyl alcohol NF, propylene glycol USP, ammonia solution NF, indigo carmine aluminum varnish, titanium dioxide USP.

    Description:

    Opaque hard gelatin capsules with a size of 0, consisting of two parts: a blue cap and a white body, with a blue "THERAFLEX ADVANCE", filled with a white or almost white powder with a faint smell.

    Pharmacotherapeutic group:Reparation of tissue stimulant + non-steroidal anti-inflammatory drug
    ATX: & nbsp

    M.01.A.E.51   Ibuprofen in combination with other drugs

    Pharmacodynamics:

    Teraflex® Advance is a combination preparation containing as active ingredients chondroitin sulfate, glucosamine sulfate and ibuprofen. Chondroitin sulfate participates in the construction and restoration of cartilaginous tissue, protects it from destruction and improves the mobility of the joints.

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

    Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of cyclooxygenases 1 and 2.The glucosamine sulfate and chondroitin sulfate potentiate the analgesic effect of ibuprofen.

    Pharmacokinetics:Bioavailability of glucosamine in oral administration is 25% (the effect of "first passage" through the liver), the highest concentrations are found in the liver, kidneys and articular cartilage. About 30% of the dose is persistently persistent in bone and muscle tissue. Excreted mainly with urine in unchanged form, partly with feces. Half-life is 68 hours.

    More than 70% of chondroitin sulfate is absorbed in the digestive tract. Bioavailability is about 13%. With a single admission of the medial therapeutic dose, the maximum concentration in the plasma is noted after 3-4 hours, in the synovial fluid after 4-5 hours. Absorbed in the GIT, the drug accumulates in the synovial fluid. It is excreted by the kidneys.

    Ibuprofen is well absorbed from the stomach. Tmah - about 1 hour. Ibuprofen approximately 99% is associated with plasma proteins. It is slowly distributed in the synovial fluid and is withdrawn from it more slowly than from the plasma. Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. The isozyme 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 an active S-form. Ibuprofen has a two-phase kinetics of elimination. The half-life (T 1/2) of plasma is 2-3 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and, to a lesser extent, with bile. Ibuprofen fully output in 24 hours.

    Indications:Osteoarthritis of large joints, osteochondrosis of the spine, accompanied by a moderate pain syndrome.
    Contraindications:

    - Hypersensitivity to any of the ingredients that make up the drug.

    - Hypersensitivity to acetylsalicylic acid or other NSAIDs in history.

    - Erosive and ulcerative diseases of the gastrointestinal tract (including gastric ulcer and duodenal ulcer in the acute stage, Crohn's disease, ulcerative colitis).

    - Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses.

    - Confirmed hyperkalemia.

    - Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

    - Gastrointestinal bleeding and intracranial hemorrhage.

    - Severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease.

    - Severe liver failure or active liver disease.

    - Severe heart failure, a period after aortocoronary bypass surgery.

    - Pregnancy, lactation.

    - Children under 18 years.

    Carefully:Elderly age, heart failure, arterial hypertension, liver cirrhosis with portal hypertension, hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia, stomach and duodenal ulcer (in history), gastritis, enteritis, colitis, blood diseases of unclear etiology (leukopenia and anemia), bronchial asthma, diabetes mellitus, concomitant therapy with anticoagulants, antiplatelet agents, glucocorticosteroids, selective serotonin reuptake inhibitors, rheumatic arteries, moderate renal failure (CK 30-60 ml / min),smoking, alcoholism, dyslipidemia / hyperlipidemia, ischemic heart disease, cerebrovascular disease, the presence of Helicobacter pilori infection, prolonged use of NSAIDs, tuberculosis, severe physical illnesses. With intolerance to seafood (shrimp, shellfish), the likelihood of developing an allergic reaction to the drug increases.

    Pregnancy and lactation:Not recommended for use during pregnancy and during breastfeeding.
    Dosing and Administration:Inside. Adults take 2 capsules 3 times a day after meals. Capsules are taken orally, with a small amount of water. Duration of admission without consulting a doctor should not exceed 3 weeks. Further use of the drug should be agreed with the doctor.
    Side effects:

    With the use of the drug Teraflex® Advance are possible: nausea, abdominal pain, flatulence, diarrhea, constipation, allergic reactions; these reactions disappear after the drug is discontinued.

    Consider the possibility of developing side effects associated with the ibuprofen present in the preparation.

    Gastrointestinal tract (GIT): NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn,decreased 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.

    Hepatobiliary system: hepatitis.

    Respiratory system: shortness of breath, bronchospasm.

    Sense organs: Hearing impairment (hearing loss, ringing or tinnitus); visual impairment (toxic damage to the optic nerve, blurred vision or dying, scotoma, dry and irritated eyes, conjunctival edema and allergic age).

    Central and peripheral 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).

    The cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure, increased risk of arterial thrombosis.

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

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

    Hematopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia. Other: increased sweating.

    Laboratory indicators: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), activity of "hepatic" transaminases (may increase), concentration urea in the blood (may increase), the concentration of bilirubin in the blood (may increase).

    Overdose:

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

    Treatment: gastric lavage (effective only within 1 hour after administration), activated charcoal, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

    Interaction:

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

    Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action. Reduces the hypotensive activity of vasodilators (including blockers of slow calcium channels and ACE inhibitors), natriuretic and diuretic - furosemide and hydrochlorothiazide.

    Reduces the effectiveness of uricosuric medicines, increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents (increased risk of hemorrhagic complications), ulcerogenic effects with bleeding of glucocorticosteroids, NSAIDs, colchicine, estrogens, ethanol; enhances the effect of oral hypoglycemic drugs and insulin.

    Antacids and colestramine reduce the absorption of ibuprofen.

    Increases the concentration in the blood of digoxin, lithium and methotrexate.

    Caffeine increases the analgesic effect.

    With simultaneous appointment ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving as antiplatelet agents acetylsalicylic acid, low dose, after initiation of ibuprofen).

    The simultaneous use of preparations containing glucosamine and coumarin anticoagulants (eg, warfarin) may lead to an increase in INR and a risk of bleeding, it is necessary to monitor blood coagulation.When administered with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time.

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

    Myelotoxic drugs increase the manifestation of hematotoxicity. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

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

    In connection with 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 tetracyclines, reduces the effect of semisynthetic penicillins, chloramphenicol.

    Joint reception with potassium-sparing diuretics increases the risk of hyperkalemia.

    NSAIDs may reduce the effects of mifepristone.

    Joint use of NSAIDs and tacrolimus may increase the risk of developing nephrotoxicity.

    Joint zidovudine increases the risk of hematological toxicity of NSAIDs.

    The combined use of quinolones and NSAIDs increases the risk of seizures.

    Special instructions:

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

    When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.

    If you need to simultaneously take additional NSAIDs and analgesics, the doctor should take into account the presence of ibuprofen in the preparation. If prolonged intake of additional NSAIDs is necessary, use Teraflex®, which does not contain ibuprofen.

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

    During the period of treatment, alcohol intake is not recommended.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, one should refrain from driving and performing actions,requiring concentration of attention or psychomotor reactions.
    Form release / dosage:

    Capsules 250 mg + 100 mg + 200 mg.

    Packaging:

    At 30, 60, 120 capsules are placed in a bottle of high-density polyethylene with a screw cap made of polypropylene. The neck of the vial is sealed with a protective membrane. The lid and the neck of the bottle are sealed with a transparent film.

    Each bottle, along with instructions for medical use, is placed in a cardboard box.
    Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use after expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002678
    Date of registration:13.08.2010 / 04.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp20.12.2017
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