Teraflex Advance capsules №120 №1

Name:
Teraflex advance caps. in vial #120 in pack #1
Description:
Zero size hard gelatin capsule with a blue cap and a white body with the inscription “THERAFLEX ADVANCE”, filled with a white or almost white powder with a slight odor. The main active ingredient Chondroitin sulfate + glucosamine + ibuprofen Release form Capsules Pharmacological properties Pharmacodynamics Glucosamine sulfate – the active component of the drug, is a salt of natural amino-monosaccharide glucosamine, which is physiologically found in the body. Glucosamine, derived from glucose, is used for the biosynthesis of articular cartilage proteoglycans. Exogenous glucosamine plays a major role in the biosynthesis of cartilage glycosaminoglycans and stimulates chondrocytes to produce proteoglycans. Glucosamine sulfate inhibits the action of some of the main mediators of the inflammatory process and the activity of enzymes that destroy the cartilage base, such as collagenase and phospholipase A2, as well as other substances that lead to tissue damage: superoxide radicals, lysosomal enzymes. Chondroitin sulfate is an integral component of the basic substance of bone and cartilage. Ibuprofen has antipyretic, analgesic and anti-inflammatory effects. The mechanism of action is associated with non-selective blocking of cyclooxygenase (COX) types 1 and 2 (the main enzyme of arachidonic acid metabolism), which leads to a decrease in the synthesis of prostaglandins, a decrease in their concentration in the cerebrospinal fluid. Reduces internal stiffness, increases the range of motion in the joints and spine. The combined use of glucosamine, chondroitin sulfates and ibuprofen leads to an increase in the level of analgesic activity of the latter. Pharmacokinetics Glucosamine sulfate. Absorption in the gastrointestinal tract 90%, bioavailability 26%, half-life 70 hours. After oral administration, the drug is rapidly distributed in extravascular fluids, including synovial fluid. Protein binding of glucosamine is unknown. The fraction of glucosamine that is not metabolized or bound to plasma proteins is excreted predominantly in the urine and feces. Chondroitin sulfate. Pharmacokinetics not described. Ibuprofen. When taken orally, ibuprofen is partially absorbed in the stomach, and then completely – already in the small intestine. After metabolic transformations in the liver (hydroxylation and carboxylation), pharmacologically inactive metabolites are completely excreted, mainly in the urine (90%), as well as in the bile. The half-life in healthy and patients suffering from diseases of the liver and kidneys is 1.8-3.5 hours, the relationship with plasma proteins is about 99%. When taken orally, the maximum plasma concentration is reached after 1-2 hours. Renal impairment It was reported that in patients with impaired renal function of mild severity, the level of unbound (S)-ibuprofen, the AUC of (S)-ibuprofen and the ratio of AUC of enantiomers (S / R) was higher than in healthy volunteers. In patients with end-stage kidney disease on hemodialysis, the average value of the free fraction of ibuprofen was about 3%, and in healthy volunteers – about 1%. Severe impairment of renal function may lead to accumulation of ibuprofen metabolites. The significance of this effect is unknown. Metabolites can be removed by hemodialysis. Indications for use For short-term relief of pain and other symptoms of inflammation during exacerbation of osteoarthritis, osteoarthritis, degenerative-dystrophic diseases of the knee and hip joints and spine. Dosing and Administration For adults, take 1-2 capsules 2-3 times a day after meals. Capsules are taken orally with a small amount of water. The maximum duration of admission should not exceed 20 days. After a decrease in severe pain, the patient can continue treatment with combined preparations containing glucosamine and chondroitin sulfate. Use during pregnancy and lactation Use is contraindicated. Fertility: There is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis can adversely affect the reproductive capacity of women by affecting the ovulation process. After discontinuation, this effect is reversible. Influence on the ability to drive a car or other mechanisms Teraflex Advance contains low doses of ibuprofen. However, you should be aware that when taking ibuprofen in high doses, especially in combination with alcohol, a decrease in reaction is possible. Since in high doses the drug can cause side effects from the central nervous system, such as fatigue and dizziness, in some cases it is possible to reduce the reaction to the ability to drive a car or other mechanisms. These phenomena are aggravated by the combination of the drug with the intake of alcohol. Precautions: Patients with a known seafood allergy are advised to take Teraflex Advance with caution. Glucosamine sulfate Before use, you should consult your doctor to exclude the presence of joint diseases for which other methods of treatment are provided. In patients with impaired glucose tolerance, monitoring of blood glucose levels is necessary and, if necessary, it is recommended to determine the need for insulin before starting treatment and periodically during treatment. In patients with known risk factors for cardiovascular disease, it is recommended to monitor blood lipid levels, as in some cases hypercholesterolemia was observed in patients treated with glucosamine. Exacerbation of asthma symptoms due to glucosamine administration has been reported (symptoms disappeared shortly after glucosamine administration was discontinued). Patients with asthma should be aware of the possible worsening of symptoms. Use the drug with caution in bronchial asthma and diabetes mellitus. When using the drug in patients with impaired glucose tolerance, severe hepatic and renal insufficiency, medical supervision is necessary. Ibuprofen Gastrointestinal Precautions: The use of Teraflex Advance in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors, should be avoided. The manifestation of side effects can be minimized by using the lowest effective dose for the shortest duration of use necessary to improve the condition. Elderly Patients Elderly patients are particularly prone to developing side effects with NSAIDs and careful monitoring is recommended. Gastrointestinal Bleeding, Peptic Ulcers, and Ulcer Perforation Gastrointestinal bleeding, ulcers, or perforated ulcers have been reported with NSAIDs. The risk of gastrointestinal bleeding, ulcer formation or perforation increases with increasing dose of NSAIDs in patients with a history of peptic ulcer, especially complicated by bleeding or perforation, as well as in elderly patients. NSAIDs should be started at the lowest possible dose. For these patients, as well as concomitant therapy with low doses of aspirin or other drugs that increase the risk of gastrointestinal disorders, combination therapy with agents that have a protective effect (for example, misoprostol or proton pump inhibitors) should be considered. When taken concomitantly with drugs that can increase the risk of ulcers or bleeding, special care should be taken. These drugs include oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. In the event of gastrointestinal bleeding or ulcers while using Teraflex Advance, treatment with the drug should be discontinued. NSAIDs can exacerbate ulcerative colitis, Crohn’s disease. Effects on the cardiovascular system and cerebral circulation The drug should be used with caution in patients with arterial hypertension and / or heart failure in history, since in the treatment of NSAIDs there were facts of fluid retention in the tissues, arterial hypertension and the development of edema. In patients with uncontrolled hypertension, congestive heart failure, confirmed coronary artery disease, peripheral arterial and/or cerebrovascular disease, ibuprofen should only be given after a thorough assessment of the situation. The same questions should be addressed before initiating long-term treatment in patients with cardiovascular risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). Skin reactions In very rare cases, the development of severe skin reactions, sometimes leading to death (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). At the first appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity, the drug should be discontinued. Other indications Teraflex Advance can be used only after a thorough assessment of the benefit / risk ratio in the following cases: with systemic lupus erythematosus (SLE) and mixed collagenoses – the risk of aseptic meningitis increases. Particularly careful medical supervision is required: in case of violations of the gastrointestinal tract or in the presence of a history of chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease); with high blood pressure or heart failure; in case of impaired renal function (because patients with pre-existing kidney disease may develop acute renal dysfunction); with dehydration; with violations of liver function; immediately after major surgery; with allergies to pollen, nasal polyps and chronic obstructive respiratory diseases, since these patients are at increased risk of allergic reactions (these reactions can manifest as asthma attacks (so-called analgesic asthma), Quincke’s edema or urticarial rash); with allergies to other drugs, since such patients have an increased risk of hypersensitivity reactions, including during treatment with Teraflex Advance. Ibuprofen can temporarily suppress platelet function (platelet aggregation), so careful medical monitoring of patients with bleeding disorders is necessary. With prolonged use of the drug Teraflex Advance, regular monitoring of liver function, kidney function, as well as a complete blood count is necessary. With prolonged use of painkillers, headaches may occur, which cannot be treated by increasing the dose of these drugs. In general, frequent, “habitual” use of painkillers, especially the use of combinations of several painkillers, can lead to the development of irreversible kidney damage, accompanied by a risk of kidney failure (“analgesic” nephropathy). In special cases, against the background of chickenpox, severe infectious complications from the skin and soft tissues can develop. To date, it is impossible to completely exclude the possibility of an association between NSAIDs and the development of such infectious complications. Therefore, with chicken pox, it is recommended to avoid taking Teraflex Advance. When drinking alcohol during treatment with NSAIDs, there may be an increased risk of side effects, in particular, from the gastrointestinal tract or the central nervous system. Interaction with other drugs Glucosamine sulfate is compatible with non-steroidal anti-inflammatory drugs, paracetamol and glucocorticosteroids. Increased prothrombotic time has been reported with coumarin anticoagulants (eg warfarin and acetocoumarol). Therefore, in patients receiving coumarin anticoagulants, it is necessary to carefully monitor the start and end of glucosamine therapy. Chondrosamine sulfate. Interactions are not described. Ibuprofen (like other NSAIDs) requires special care when taken with the following drugs: Other NSAIDs, including salicylates: Concomitant use of several different NSAIDs may increase the risk of gastrointestinal ulcers and bleeding. Digoxin, phenytoin, lithium: concomitant use with Teraflex Advance may increase plasma concentrations of these drugs. Diuretics, ACE inhibitors, beta-blockers and angiotensin II antagonists: NSAIDs may reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function, the co-administration of these drugs may cause a further decrease in renal function (up to acute renal failure), which is usually reversible. Co-administration should be used with caution, especially in elderly patients. Patients should receive sufficient fluids. With the simultaneous administration of ibuprofen and potassium-sparing diuretics, hyperkalemia may develop. Corticosteroids: increased risk of gastrointestinal ulcers or bleeding. Platelet aggregation inhibitors and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Acetylsalicylic acid in small doses: when used simultaneously with ibuprofen, there may be an effect of inhibiting the effect of small doses of acetylsalicylic acid on platelet aggregation. However, with regard to irregular intake, any clinically significant effects are considered unlikely. Methotrexate: Taking ibuprofen within 24 hours before and after taking methotrexate may lead to an increase in the concentration of methotrexate and an increase in its toxic effect. Cyclosporine: The simultaneous use of certain NSAIDs increases the risk of renal dysfunction due to the action of cyclosporine. The appearance of this effect is not excluded in the combination of cyclosporine with ibuprofen. Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin. Sulfonylureas: It is recommended that you monitor your blood sugar levels while taking these medicines as a preventative measure. Tacrolimus: concomitant use increases the risk of nephrotoxicity. Zidovudine: when used simultaneously with ibuprofen in HIV-infected patients with hemophilia, the risk of developing hemarthroses and hematomas increases. Probenecid and sulfinpyrazone: able to delay the excretion of ibuprofen from the body. Contraindications Hypersensitivity to any of the active or excipients; a history of bronchospasm, asthma, rhinitis or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); hematopoietic disorders of unknown origin; present or past recurrent peptic ulcer/bleeding (two or more separate episodes of confirmed peptic ulcer or bleeding); a history of gastrointestinal bleeding or ulcer perforation associated with previous NSAID therapy; cerebrovascular bleeding or other bleeding currently present; severe impairment of liver or kidney function (creatinine clearance < 30 ml / min); severe heart failure; last trimester of pregnancy; children and adolescents under 18 years of age. Ingredients: glucosamine sulfate potassium chloride 250 mg, chondroitin sulfate sodium 200 mg; ibuprofen* 100 mg. Excipients: microcrystalline cellulose (E460), corn starch, stearic acid (E570), sodium starch glycolate, crospovidone, magnesium stearate (E572), polyvinylpyrrolidone, silicon dioxide (E551); capsule: gelatin (E441), titanium dioxide (E171), FD&C Blue No. 1 (E133). The composition of the ink with which the inscription is applied to the capsule: shellac, dehydrogenated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, FD&C Blue No. 2 Aluminum Lacquer (E132), titanium dioxide (E171). *Ibuprofen includes: corn starch, polyvinylpyrrolidone, pregelatinized starch, microcrystalline cellulose, silicon dioxide, croscarmellose sodium, stearic acid. Overdose For glucosamine and chondroitin sulfate, overdose symptoms are unknown. With an established overdose, treatment is symptomatic. Ibuprofen. Overdose symptoms: disorders of the nervous system - headache, dizziness, fainting and loss of consciousness (with myoclonic convulsions in children), as well as abdominal pain, nausea and vomiting. Perhaps the development of gastrointestinal bleeding, as well as functional disorders of the liver and kidneys. Decreased blood pressure, respiratory depression, and cyanosis are also possible. Therapeutic measures in case of overdose. There is no specific antidote for ibuprofen. Treatment depending on the degree, level and clinical symptoms of intoxication in accordance with generally accepted practice in intensive care. Side effect The frequency of adverse reactions indicated below was determined using the following note: very often (? 1/10), often (? 1/100 - <1/10), infrequently (? 1/1000 - <1/100), rarely (? 1/10000 - <1/1000), very rare (<1/10000), unknown (cannot be determined from the available data). Glucosamine sulfate Gastrointestinal disorders. Often: discomfort and pain in the abdomen, dyspepsia, constipation, nausea, flatulence, diarrhea. Skin and subcutaneous tissue disorders. Infrequently: itching, erythema, skin rash. Not known: hair loss. Immune system disorders. Uncommon: allergic reactions, bronchial asthma. Nervous system disorders. Often: headache, drowsiness, fatigue. Not known: dizziness. Violations of the organs of vision. Uncommon: blurred vision. Blood disorders. Infrequently: elevated blood glucose levels. Chondroitin sulfate From the skin and subcutaneous tissue: there are reports of isolated cases of erythema, urticaria, dermatitis, maculopapular rash with or without itching, and / or edema. From the gastrointestinal tract: rare cases of nausea, vomiting. Ibuprofen The following side effects have been observed during treatment with ibuprofen, including during long-term treatment with high doses in patients suffering from rheumatism. The established frequency, including very rare cases, refers to short-term treatment in daily doses up to 1200 mg of ibuprofen for oral dosage form and up to 1800 mg for suppositories. The most common are from the gastrointestinal tract. Thus, it is possible to develop peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients. There are reports of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, ulcerative stomatitis, as well as exacerbation of ulcerative colitis and Crohn's disease after taking ibuprofen. Rarely, gastritis has been reported. The risk of gastrointestinal bleeding depends on the dose and duration of ibuprofen use. Edema, increased blood pressure, and heart failure have been reported during treatment with NSAIDs. The use of ibuprofen, especially at high doses (2400 mg per day / 24 capsules), as well as during long-term therapy, may be associated with a slight increase in the risk of developing conditions caused by arterial thrombosis (for example, myocardial infarction or stroke). Heart disorders. Very rare: palpitations, heart failure, myocardial infarction. Blood and lymphatic disorders. Very rarely: hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). With long-term treatment with the drug, a complete blood count should be performed regularly. Nervous system disorders. Uncommon: central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue. Violations of the organs of vision. Sometimes: visual disturbances. Ear and labyrinth disorders. Rare: tinnitus. Gastrointestinal disorders. Often: complaints of heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding, which in some cases can lead to the development of anemia. Uncommon: gastric/duodenal ulcers with a risk of bleeding and perforation. Ulcerative stomatitis, exacerbation of nonspecific ulcerative colitis or Crohn's disease, gastritis. Very rarely: esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures. In the event of severe pain in the upper abdomen, tarry stools or bloody vomiting, stop taking Teraflex Advance immediately and consult a doctor. Renal and urinary tract disorders. Very rarely: the appearance of edema, especially in patients with arterial hypertension or renal insufficiency; nephrotic syndrome; interstitial nephritis, which may be accompanied by acute renal failure. In rare cases, damage to the renal tissue (necrosis of the renal papillae) with an increase in the concentration of uric acid in the blood. Therefore, regular monitoring of kidney function is necessary. Violations of the skin and subcutaneous fat. Very rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. With chickenpox, in exceptional cases, the development of severe skin infections and complications from the soft tissues is possible. Infectious and parasitic diseases. Very rarely - exacerbations of inflammatory processes of infectious origin (for example, the development of necrotizing fasciitis) associated with the use of NSAIDs. If signs of infection or their increase appear during treatment with Teraflex Advance, it is recommended to immediately consult a doctor. In this case, it is necessary to check whether there are indications for antibiotic therapy of the infection. Very rarely, during treatment with ibuprofen, symptoms of aseptic meningitis were observed: stiff neck, headache, nausea, vomiting, fever or clouding of consciousness. Patients with autoimmune diseases (systemic lupus erythematosus, mixed collagenosis) are predisposed to the occurrence of such conditions. vascular disorders. Very rare: arterial hypertension. Immune system disorders. Sometimes: hypersensitivity reactions, accompanied by skin rash and itching, as well as asthma attacks (in some cases with a drop in blood pressure). Very rare: severe general hypersensitivity reactions in the form of swelling of the face, tongue and larynx with narrowing of the airways, respiratory distress syndrome, palpitations, drop in blood pressure up to life-threatening shock. If any of these symptoms occur, even when using the drug for the first time, it is necessary to stop taking the drug and consult a doctor immediately. Liver and biliary tract disorders. Very rare: abnormal liver function, liver damage, especially with long-term therapy, liver failure, acute hepatitis. Psychiatric disorders: Very rare: psychotic reactions, depression. Storage conditions At a temperature not exceeding 25 ° C, out of the reach of children. Buy Teraflex Advance capsules No. 120 No. 1 Price for Teraflex Advance capsules No. 120 No. 1 Instructions for use for Teraflex Advance capsules No. 120 No. 1