Theraflex Advance 250mg+100mg+200mg capsules, 60pcs

Composition

1 capsule contains:

Active ingredients:

glucosamine sulfate-250 mg;

chondroitin sodium sulfate-200 mg;

ibuprofen-100 mg;

Auxiliary substances:

MCC-30.78 mg;

corn starch-19.69 mg;

pregelatinized starch-17.47 mg;

stearic acid-11.59 mg;

sodium carboxymethyl starch-10 mg;

crospovidone-10 mg;

magnesium stearate-3 mg;

silicon dioxide-4.05 mg;

povidone-2.382 mg

Pharmacological action

Theraflex Advance-stimulating the regeneration of cartilage tissue, analgesic, anti-inflammatory.

Pharmacodynamics

Theraflex Advance is a combination drug containing chondroitin sulfate, glucosamine sulfate and ibuprofen as active components.

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

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

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

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

Pharmacokinetics

Oral bioavailability of glucosamine is 25% (the effect of the first passage 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. It is excreted mainly in the urine in unchanged form, partially in the feces. T1 / 2 — 68 hours

More than 70% of chondroitin sulfate is absorbed in the digestive tract. Bioavailability is about 13%. With a single oral use of a medium-therapeutic dose, Cmax in plasma is noted in 3-4 hours, in synovial fluid – in 4-5 hours. The drug absorbed in the gastrointestinal tract accumulates in the synovial fluid. It is excreted by the kidneys.

Ibuprofen is well absorbed from the stomach. Tmax — about 1 h. Ibuprofen is approximately 99% bound to plasma proteins. It is slowly distributed in the synovial fluid and is removed from it more slowly than from the plasma. 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 converted to the active S-form. Ibuprofen has two-phase elimination kinetics. T 1/2 from plasma is 2-3 h. 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 the urine and to a lesser extent in the bile. Ibuprofen is completely eliminated in 24 hours.

Indications

Osteoarthritis of large joints; osteochondrosis of the spine, accompanied by moderate pain.

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Contraindications

• erosive and ulcerative diseases of the digestive tract (including stomach ulcer and duodenal ulcer in acute, Crohn’s disease, ulcerative colitis);
• “aspirin” asthma,
• hemophilia and other blood clotting (including anticoagulation);
• hemorrhagic diathesis;
• gastrointestinal bleeding and intracranial bleeding;
• pregnancy;
• lactation (breastfeeding);
• children up to age 12 years;
• hypersensitivity to any of the ingredients included in the composition of the drug;
• hypersensitivity to acetylsalicylic acid or other NSAIDs in history.

With caution, the drug should be prescribed for heart failure, arterial hypertension, cirrhosis of the liver with portal hypertension, hepatic and/or renal failure, nephrotic syndrome, hyperbilirubinemia, peptic ulcer of the stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis, blood diseases of unknown etiology (leukopenia and anemia), bronchial asthma, diabetes mellitus, as well as patients with elderly people. If you are intolerant to seafood (shrimp, shellfish), the likelihood of developing allergic reactions to the drug increases.

Side effects

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

The possibility of developing adverse reactions associated with the presence of ibuprofen in the drug should be taken into account. When using ibuprofen preparations in higher doses than those contained in Theraflex Advance, the following adverse events may occur.

From the gastrointestinal tract: NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation; rarely-ulceration of the gastrointestinal tract mucosa, which in some cases are complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis.

From the side of the hepatobiliary system: hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the sensory organs: hearing disorders (hearing loss, ringing or tinnitus), visual disturbances (toxic damage to the optic nerve, blurred vision or double vision, scotoma, dry and irritated eyes, swelling of the conjunctiva and eyelids of allergic origin).

From the central nervous system 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).

From the cardiovascular system: heart failure, tachycardia, increased blood pressure.

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

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), eosinophilia, allergic rhinitis.

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

Laboratory parameters: bleeding time may increase, serum glucose concentration may decrease, creatinine clearance may decrease; hematocrit or hemoglobin may decrease; serum creatinine concentration may increase; hepatic transaminase activity may increase.

Interaction

Inducers of 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.

Microsomal oxidation inhibitors reduce the risk of hepatotoxic effects.

Reduces the hypotensive activity of vasodilators (including BCC and ACE inhibitors), natriuretic and diuretic-furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increased risk of hemorrhagic complications), ulcerogenic effect with bleeding of corticosteroids, NSAIDs, colchicine, estrogens, ethanol, enhances the effect of oral hypoglycemic drugs and insulin.

Antacids and colestyramine reduce the absorption of ibuprofen.

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

Caffeine enhances the analgesic effect.

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

When prescribed simultaneously with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases.

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

Myelotoxic Drugs increase the manifestations of hematotoxicity.

Cyclosporine and gold preparations enhance the effect of ibuprofen on synthesis PH in the kidneys, which is manifested by increased nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce the 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 tetracyclines, reduces the effect of semi-synthetic penicillins, chloramphenicol.

How to take it, course of use and dosage

Inside, with a small amount of water.

Adults – 2 capsules 3 times a day after meals.

The duration of admission without consulting a doctor should not exceed 3 weeks.

Further use of the drug should be agreed with the doctor.

Description

Stronger composition-healthier joint(1). Theraflex Advans Theraflex preparation No. 1 for the treatment of osteoarthritis and osteochondrosis (2)Theraflex Advance is a unique modern chondroprotector (3), which is manufactured in the USA in accordance with Bayer’s high quality standards. Unlike other drugs(4) Theraflex Advance contains an analgesic component Ibuprofen and Chondroitin with Glucosamine-substances that affect the structure of cartilage. The drug not only helps to reduce moderate pain in the joints, but also to relieve inflammation. Theraflex Advance also contains a proven daily dose of some of the most studied active substances glucosamine and chondroitin (5), which contribute to the restoration of joint cartilage tissue and improve their mobility. The combination of active components in the combined drug Theraflex Advance allows you to reduce the daily dose of Ibuprofen by 2 times, while maintaining its effectiveness in reducing pain(6). This reduces the likelihood of side effects that patients often experience with prolonged use of painkillers(7). Theraflex Advance is available in the ideal form of capsules(8), therefore-it includes only the necessary active ingredients without unnecessary additional impurities-it is easily absorbed by the body Theraflex Advance is recommended to take 2 capsules 3 times a day after meals. To restore the cartilage tissue of the joints, doctors recommend continuing treatment with the transition to the drug Theraflex for 3 months. Keep your joints healthy with 2 courses of Theraflex capsules and your joints will thank you(9).1. Theraflex Advance capsules additionally contain ibuprofen, which provides reliable relief of pain and stiffness after 2 weeks of treatment, compared to conventional Theraflex capsules (2 months). Povoroznyuk V. V. Efficacy of Theraflex Advance in the treatment of pain syndrome in knee osteoarthritis. Zdorov & # 39;I am from Ukraine. 2007; 13.2. According to the data of Ai Em Es Health LLC obtained from the database Retail Audit of GLS and dietary supplements in the Russian Federation, Theraflex is the leader in sales of drugs from the groups 02G2C Joint preparations, systemic,02 E 2 C Drugs for muscle pain, systemic and 02 E 1 O Drugs for muscle pain for external use (classification of OTS) for the periods September 2016 August 2017.3. It has no analogues in composition according to the GRLS database of 27.07.2018.4. nonsteroidal anti-inflammatory drugs without a chondroprotective component are meant 5. Kadurina T. N., Abbakumova L. N. Principles of rehabilitation of patients with connective tissue dysplasia. 2010. No. 4. p. 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 combined medications. Cole G. Evaluating Development and Production Costs: Tablets Versus Capsules. Pharmaceutical Technology Europe; Vol. 5, Pgs. 17  26 (1998).9. Federal clinical guidelines for the diagnosis and treatment of osteoarthritis, Association of Rheumatologists of Russia,2016,19 p.

Special instructions

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

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

If it is necessary to take additional NSAIDs and analgesic medications at the same time, the doctor should consider the presence of ibuprofen in the preparation. If you need to take additional NSAIDs for a long time, you should use Theraflex, which does not contain ibuprofen.

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

During the treatment period, alcohol intake is not recommended.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Patients should refrain from activities that require increased attention, rapid mental and motor reactions.

Form of production

Capsules

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Glucosamine, Ibuprofen, Chondroitin Sulfate

Dosage form

Capsules

Purpose

For adults, Children over 12 years of age

Indications

Sciatica, Rheumatoid Arthritis, Lumbago, Osteoarthritis and Arthritis, Osteoarthritis, Sciatica, Osteochondrosis