Teraflex Advance, capsules for acute pain in the joints, 120 pcs., Bayer

Description

Composition
Active substance:
1 capsule contains: glucosamine sulphate in the form of D-glucosamine sulfate 250 mg of potassium chloride, sodium chondroitin sulfate 200 mg, ibuprofen 100 mg.
Opaque hard gelatine capsules size 0 № consisting of two parts: cap blue and white body, labeled blue «THERAFLEX
ADVANCE », filled with a white or almost white powder with a faint odor.
Excipients:
Microcrystalline cellulose, corn starch (pregelatinized starch), stearic acid, sodium carboxymethyl starch, crospovidone, magnesium stearate, silicon dioxide, povidone.
The gelatin capsule: gelatin, titanium dioxide, aluminum brilliant blue dye LACAC.
Composition of Ink: shellac NF, USP dehydrated ethyl alcohol, isopropyl alcohol, USP, NF butyl alcohol, propylene glycol USP, NF ammonia solution, indigo carmine aluminum lake, titanium dioxide USP.
Description:
Stronger structure – healthy joint (1).
Teraflex №1 drug for the treatment of osteoarthritis and osteoarthritis (2).
Advanced Teraflex unique modern chondroprotector (3), which is produced in the United States in accordance with the high quality standards of the company Bayer.
Unlike other drugs (4) comprises Teraflex Advanced analgesic component Ibuprofen and Glucosamine Chondroitin with – a substance affecting the cartilage structure. The drug not only helps to reduce umerennoyboli in the joints, but also the removal of inflammation.
Advanced Teraflex also contains a daily dose confirmed some of the glucosamine and chondroitin (5) Study of active substances that contribute to the restoration of cartilage of joints and improve their mobility.
The combination of active components in the combined preparation Teraflex Advanced reduces the daily dose of ibuprofen in 2 times, while retaining the efficacy in reducing pain (6). This reduces the likelihood of side effects that are often experienced by patients with prolonged use of analgesics (7).
Teraflex Advanced produced in the ideal form of capsules (8), so that:
– it includes only the necessary active ingredients without unnecessary additional impurities;
– easily digested.
Teraflex Advanced advised to take 2 capsules 3 times a day after meals. To restore the cartilage of the joints doctor recommended to continue the treatment with the transition to Teraflex medication for 3 months.
Maintain joint health by means of capsules Teraflex courses 2 times and joints will thank you (9).
(1). Capsules Teraflex Advanced further contain ibuprofen, which provides significant relief of pain and stiffness after 2 weeks of treatment, compared with conventional capsules Teraflex (2 months). Povoroznyuk VV The effectiveness of the drug Teraflex Advance in the treatment of pain in osteoarthritis of the knee. Health Protection of Ukraine. 2007; thirteen.
(2). According to the company I Am Es Hals obtained from the database Retail Audit of Drugs and dietary supplements in Russia, Teraflex is a leader in terms of sales of drugs group 02G2C preparations for joints, system, 02E2S drugs in muscular pain, systemic and 02E1O drugs in muscular pain for topical application (classification UTS) for the period September 2016 August 2017.
(3). It has no analogues on the composition according to the base GRLS from 27.07.2018g.
(4). Refers to non-steroidal antiinflammatory drugs without hondroprotektivnoe component.
(5). Kadurin TN, LN Abbakumova Principles of rehabilitation of patients with connective tissue dysplasia // attending physician. Number 2010. 4. S. 1719.
(6). Tallarida RJ., Cowan A., Raffa RB. Antinociceptive synergy, additivity, and subadditivity with combinations of oral glucosamine plus nonopioid analgesics in mice. J Pharmacol Exp Ther. 2003 Nov; 307 (2): 699-704. (7). Castellsague J. et al. Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS) Project. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012 Dec 1; 35 (12): 1127-46.
(8). For the combined drugs. Cole G. Evaluating Development and Production Costs: Tablets Versus Capsules. Pharmaceutical Technology Europe; Vol. 5, Pgs. 17, 26 (1998).
(9). Federal guidelines for the diagnosis and treatment of osteoarthritis, the Association of Rheumatology Russia, 2016, 19 pages. ”
Product form:
Capsules 250 mg + 100 mg + 200 mg. 30, 60, 120 capsules were placed in a bottle of high-density polyethylene with polypropylene screw cap. The neck of the bottle seal the protective membrane. Cover and seal the neck of the vial transparent film.
Each vial together with instructions for medical application is placed in a cardboard box.
Contraindications
Hypersensitivity to any of the ingredients in the preparation.
Hypersensitivity to aspirin or other NSAIDs history.
Erosive and ulcerative diseases of the gastrointestinal (including gastric ulcer and duodenal ulcer in the acute stage, Crohn’s disease, ulcerative colitis).
Full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses.
Confirmed hyperkalemia.
Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
Gastrointestinal bleeding and intracranial hemorrhage.
Severe renal impairment (creatinine clearance less than 30 mL / min), progressive renal disease.
Severe hepatic insufficiency or active liver disease.
Severe heart failure, the post-coronary artery bypass grafting.
Pregnancy, lactation.
Children up to age 18 years.
Carefully:
Advanced age, heart failure, arterial hypertension, liver cirrhosis with portal hypertension, liver and / or renal failure, nephrotic syndrome, hyperbilirubinemia, gastric ulcer and duodenal ulcer (history), gastritis, enteritis, colitis, blood diseases of unknown etiology (leukopenia and anemia), asthma, diabetes, concomitant therapy with anticoagulants, antiplatelet agents, corticosteroids, selective serotonin reuptake inhibitors, peri disease fericheskih arteries moderate renal impairment (creatinine clearance of 30-60 ml / min), smoking, alcoholism, dyslipidemia / hyperlipidemia, coronary heart disease, cerebrovascular disease, the presence of Helicobacter pilori infection, prolonged use of NSAIDs, tuberculosis, severe somatic disorders. Intolerance of seafood (shrimp, clams), the probability of allergic reaction to the drug increases.
Dosage
250 mg + 100 mg + 200 mg
Indications
Osteoarthritis of large joints, osteochondrosis, accompanied by mild pain.
Interaction with other drugs
Inductors microsomal oxidation (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 hepatotoxicity.
Decreases hypotensive activity vasodilators (including calcium channel blockers slow and ACE inhibitors..), Natriuretic and diuretic – furosemide and hydrochlorothiazide.
Reduces the efficiency of uricosuric drugs enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of bleeding complications), ulcerogenic action bleeding corticosteroids, NSAIDs, colchicine, estrogens, ethanol; enhances the effect of oral hypoglycemic drugs and insulin.
Antacids colestyramine and reduce the absorption of ibuprofen.
Increases the blood concentration of digoxin, drugs lithium and methotrexate.
Caffeine increases the analgesic effect.
When concomitant administration of ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving antiplatelet agents as low-dose acetylsalicylic acid, after you start taking ibuprofen).
Simultaneous application of preparations containing glucosamine and coumarin anticoagulant (e.g., warfarin) may increase the risk of bleeding and the INR is necessary to control blood coagulation parameters.
In the appointment of anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase) also increase the risk of bleeding.
Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence hypoprothrombinemia.
Myelotoxicity drugs increase the expression gematotoksichnosti.
Cyclosporine and preparations of gold enhance the effect of ibuprofen on prostaglandin synthesis 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 preparation of glucosamine content may decrease the effectiveness of hypoglycemic drugs, doxorubicin, teniposide, etoposide. Glucosamine increases the absorption of tetracycline, reduces the effect of semi-synthetic penicillins, chloramphenicol.
Co-administration with potassium-sparing diuretics increase the risk of hyperkalemia.
NSAIDs may reduce the effect of mifepristone.
Co-administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Co-administration of zidovudine increases the risk of hematologic toxicity of NSAIDs.
Co-administration of quinolones and NSAIDs increases the risk of seizures.
Overdose
Symptoms (associated with ibuprofen): abdominal pain, nausea, vomiting, lethargy, sleepiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, pochechnokanaltsevy acidosis, hypokalemia, hyperkalemia, bradycardia, tachycardia , atrial fibrillation, respiratory arrest.
Treatment: gastric lavage (only effective within 1 hour after administration), activated carbon, alkaline water, diuresis, symptomatic therapy (correction of acid-base balance, blood pressure).
pharmachologic effect
Pharmacological group:
Tissue repair promoter + nonsteroidal anti-inflammatory drug.
Pharmacological properties:
Teraflex Advanced is a combined preparation comprising as active components of chondroitin sulfate, glucosamine sulfate and ibuprofen.
Chondroitin sulfate is involved in the construction and reconstruction of cartilage tissue, protects it from destruction and improves joint mobility.
Glucosamine sulfate activates the synthesis of proteoglycans, hyaluronic, chondroitin acids and other substances included in the joint membranes, synovial fluid and cartilage.
Ibuprofen is a propionic acid derivative and has analgesic, antipyretic and anti-inflammatory action due to non-selective blockade of cyclooxygenase 1 and 2. Contained in the preparation of glucosamine sulphate and chondroitin sulphate potentiate the analgesic effect of ibuprofen.
Pharmacokinetics:
glucosamine oral bioavailability – 25% (the effect of “first pass” through the liver), the highest concentrations found in the liver, kidney, and articular cartilage. About 30% of the dose is long persists in bone and muscle tissue. Excreted predominantly in the urine in an unmodified form, partly in the feces.
The half-life – 68 hours.
Over 70% of chondroitin sulfate absorbed in the digestive tract. The bioavailability is about 13%. In single ingestion sredneterapevticheskih dose maximum plasma concentration observed after 3 – 4 hours in the synovial fluid after 4 – 5 hours. The absorbed in the gastrointestinal tract the drug is accumulated in the synovial fluid.
Excreted by the kidneys.
Ibuprofen is well absorbed from the stomach. Tmax – about 1 hour. Ibuprofen is approximately 99% bound to plasma proteins. He slowly spread in the synovial fluid and is derived from it more slowly than from plasma. Ibuprofen is metabolized mainly in the liver by hydroxylation and carboxylation isobutyl group. The metabolism of the drug is involved isoenzyme CYP2C9. After absorption of about 60% pharmacologically inactive R-ibuprofen form is slowly converted into the active S-shape. Ibuprofen imeet3 biphasic elimination kinetics. The half-life (T 1/2) of the plasma is 2 – 3 h. Up to 90% of the dose can be found in urine as metabolites and their conjugates.
Less than 1% excreted unchanged in the urine, and, to a lesser extent in the bile.
Ibuprofen is completely eliminated within 24 hours.
Pregnancy and breast-feeding
Not recommended for use during pregnancy and lactation.
Conditions of supply of pharmacies
Without recipe.
side effects
In applying the drug Terafleks® Advanced possible: nausea, abdominal pain, bloating, diarrhea, constipation, allergic reactions; These reactions disappeared after drug withdrawal.
It should consider the possibility of adverse reactions associated with the presence of the drug ibuprofen.
Gastrointestinal tract (GIT): NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, rarely – ulceration of the gastrointestinal mucosa, which in some cases are complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, gums ulcerated mucous membranes, aphthous stomatitis, pancreatitis, colitis and Crohn’s disease exacerbation.
Hepatobiliary: hepatitis.
Respiratory system: dyspnea, bronchospasm.
Senses: hearing loss (hearing loss, ringing or noise in the ears); visual impairment (toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelid allergic genesis).
Central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, agitation, drowsiness, depression, confusion, hallucinations, rare – aseptic meningitis (usually in patients with autoimmune diseases).
Cardiovascular system: development or exacerbation of congestive 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 (typically erythematous or urticaria), itching, angioedema, anaphylactoid reactions, anaphylaxis, dyspnea, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), eosinophilia allergic rhinitis.
Agencies blood: anemia (including haemolytic, aplastic..), And thrombocytopenia thrombocytopenic purpura, agranulocytosis, leukopenia.
Other: increased sweating.
Laboratory parameters: bleeding time (may be increased), the concentration of glucose in serum (may be reduced), creatinine clearance (may decrease), hematocrit or hemoglobin (may be reduced), serum creatinine concentration (may be increased) activity “liver” transaminases (may increase ), blood urea concentration (may be increased), the concentration of bilirubin in the blood (may be increased).
special instructions
During long-term treatment is required to monitor patterns of peripheral blood and functional state of the liver and kidneys.
When the symptoms of gastropathy shows careful monitoring, including the holding of esophagogastroduodenoscopy, a blood test with the hemoglobin, hematocrit, analysis of stool for occult blood.
If necessary, the simultaneous reception of other NSAIDs and analgesic drugs physician should take into account the presence in the formulation of ibuprofen. If you need more long-term use of NSAIDs should be used drug Teraflex not containing ibuprofen.
If necessary, the definition of 17-ketosteroids drug should be discontinued 48 hours prior to the study.
During the period of treatment is not recommended alcohol intake.
Effects on ability to management mechanisms and other means of transport:
The treatment should refrain from driving and performing actions that require concentration or psychomotor reactions.
Storage conditions
At a temperature above 25 degrees Celsius.
Keep out of the reach of children.
Dosing and Administration
Inside. Adults used 2 capsules 3 times a day after meals. The capsules are taken orally, with a little water. Duration of reception without consulting a doctor should not exceed 3 weeks. Further use of the drug should be agreed with your doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist