TERAFLEKS ADVANCE

Active material: Chondroitin sulfate, Glucosamine, Ibuprofen
When ATH: M01AE51
CCF: Preparation, stimulates the regeneration of cartilage tissue, with anti-inflammatory action
ICD-10 codes (testimony): M15, M42
When CSF: 05.01.01.06
Manufacturer: SAGMEL, Inc. (United States)

Pharmaceutical form, composition and packaging

Capsules hard gelatin, size №0, opaque, consisting of a blue cap and white body, with the inscription in blue “TERAFLEX ADVANCE”; contents of capsules – patchy white powder with slight shades.

Excipients: microcrystalline cellulose, corn starch, pre-gelatinized starch, stearic acid, sodium carboxymethyl, krospovydon, magnesium stearate, silicon dioxide, povidone.

Composition of a gelatin capsule: gelatin, Titanium dioxide, FD&C Blue nail №1.

60 PC. – plastic bottles (1) – packs cardboard.
120 PC. – plastic bottles (1) – packs cardboard.

Pharmacological action

Preparation, stimulates the regeneration of cartilage tissue, with anti-inflammatory action.

Chondroitin sulfate is an additional substrate for the formation of healthy cartilage matrix. It stimulates the production gialuronona, synthesis of proteoglycans and type II collagen, and protects it from enzymatic cleavage gialuronon (by inhibiting the activity of hyaluronidase); It maintains the viscosity of synovial fluid, It stimulates cartilage repair mechanisms and inhibits the activity of the enzymes (elastase, gialuronidaza), that break down cartilage. At treatment of osteoarthritis It alleviates the symptoms of the disease and reduces the need for NSAIDs.

Glucosamine sulfate activates the synthesis of proteoglycans, hyaluronic, chondroitin acids and other substances, members of the joint shells, synovial fluid and cartilage.

Ibuprofen is a propionic acid derivative and has analgesic, antipyretic and anti-inflammatory action due to non-selective blockade of COX-1 and COX-2.

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

Pharmacokinetics

Glucosamine sulfate

Absorption

The bioavailability of glucosamine ingestion of 25% (due to the effect “first pass” through the liver), highest concentrations found in the liver, kidneys and articular cartilage. About 30% the dose persists in the long bone and muscle tissue.

Deduction

Write mainly with urine in unchanged form, partly with feces. T_1/2 – 68 no.

Chondroitin sulfate

Absorption

More 70 % Chondroitin sulfate is absorbed in the digestive tract. Bioavailability is about 13%. With a single oral administration of therapeutic doses of C_max plasma achieved through 3-4 no, synovial fluid – through 4-5 no.

Distribution and excretion

Absorbed in the gastrointestinal tract drug accumulates in synovial fluid. Report the news.

Ibuprofen

Absorption and distribution

Ibuprofen is well absorbed from the stomach. C_max plasma achieved through 1 no. Priblizitelyno of ibuprofen 99% bound to plasma proteins. Slowly distributed in the synovial fluid and derived from it slower, than from plasma.

Metabolism

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

Deduction

Ibuprofen has a biphasic elimination kinetics. T_1/2 from plasma is 2-3 no. To 90% doses may be found in urine as metabolites and their conjugates. Less 1% excreted unchanged in the urine and, less, the bile. Ibuprofen is fully displayed over 24 no.

Testimony

- Osteoarthritis of large joints;

- Osteochondrosis, accompanied by mild pain.

Dosage regimen

Adults appoint 2 capsules 3 times / day after meals. Capsules taken orally, with a little water. The duration of the reception without consulting a doctor should not exceed 3 weeks. Continued use of the drug should be approved by your doctor.

Side effect

In applying the drug Teraflex^® Advance possible nausea, abdominal pain, flatulence, diarrhea, constipation, allergic reactions. These reactions disappear after drug withdrawal.

Keep in mind the possibility of adverse reactions, related part of the drug ibuprofen. When using the formulations of ibuprofen in higher doses, than is contained in the product Teraflex^® Advance, can meet the following adverse events.

From the digestive system: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased 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, ulceration of the mucous membrane of the gums, thrush, pancreatitis, hepatitis, increase in transaminases.

The respiratory system: breathlessness, bronchospasm.

CNS: headache, dizziness, insomnia, anxiety, nervousness, irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations; rarely – aseptic meningitis (more frequently in patients with autoimmune diseases).

From the senses: hearing loss (hearing loss, ringing or noise in the ears), visual impairment (toxic damage of the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids allergic genesis).

Cardio-vascular system: heart failure, tachycardia, increased blood pressure.

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

From the hematopoietic system: anemia (incl. hemolytic, aplastic), thrombocytopenia, trombotsitopenicheskaya purpura, agranulocytosis, leukopenia, possible reduction of hemoglobin or hematocrit.

From the blood coagulation system: may increase bleeding time.

Allergic reactions: skin rash (usually erythematous), hives, itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme exudative (incl. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eozinofilija, nasal allergy.

Laboratory findings: may reduce serum glucose concentrations, a decrease in creatinine clearance, increase in serum creatinine.

Contraindications

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

- “Aspirin” asthma;

- Hemophilia and other bleeding disorders (incl. hypocoagulation);

- Hemorrhagic diathesis;

- Gastrointestinal bleeding and intracranial hemorrhage;

- Pregnancy;

- Lactation (breast-feeding);

- Children up to age 12 years;

- Hypersensitivity to any of the ingredients, members of the drug;

- Hypersensitivity to aspirin or other NSAIDs history.

FROM caution should be prescribed the drug for heart failure, hypertension, liver cirrhosis with portal hypertension, hepatic and / or renal failure, nephrotic syndrome, giperʙiliruʙinemii, gastric ulcer and duodenal ulcer (history), gastritis, enteritis, cars, blood diseases of unknown etiology (leukopenia and anemia), asthma, diabetes, and elderly patients. When intolerance seafood (shrimp, clams) the likelihood of allergic reactions to the drug increases.

Pregnancy and lactation

The drug is contraindicated in pregnancy and during breastfeeding.

Cautions

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

When symptoms of gastropathy shows careful monitoring, comprising carrying out esophagogastroduodenoscopy, blood tests, hemoglobin, gematokrita, fecal occult blood test.

If necessary, simultaneous reception of additional NSAID analgesic drugs the physician should consider the presence in the formulation of ibuprofen. If necessary, additional long-term use of NSAIDs should be used drug Teraflex^®, which contains ibuprofen.

If you want to determine the 17-ketosteroids drug should be discontinued for 48 h before the test.

During the period of treatment is not recommended alcohol intake.

Effects on ability to drive vehicles and management mechanisms

Patients should refrain from activities, requiring attention, rapid mental and motor responses.

Overdose

Symptoms (associated with ibuprofen): abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, noise in ears, metabolic acidosis, coma, acute renal failure, decrease in blood pressure, hyperkalemia, bradycardia, tachycardia, Atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (It is effective only for 1 h after administration), Activated carbon, alkaline water, diurez, simptomaticheskaya therapy (Correction of acid-base status, FROM).

Drug Interactions

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

Inhibitors of microsomal oxidation reduce the risk of hepatotoxicity.

The drug reduces the hypotensive effect of vasodilators (incl. blockers of slow calcium channels, and ACE inhibitors).

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

Reduces the effectiveness of drugs urikozuricheskih.

It enhances the effect of indirect anticoagulants, antiagregantov, fibrinolitikov (increase the risk of bleeding complications).

Enhances ulcerogenic action (with the development of bleeding) GCS, NSAIDs, colchicine, estrogen, ethanol.

Do effect of oral hypoglycemic drugs and insulin.

Antacids reduce the absorption of cholestyramine and ibuprofen.

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

Caffeine increases the analgesic effect Teraflex^® Advance.

When concomitant administration of ibuprofen reduces inflammatory and antiplatelet effect of aspirin (may increase the incidence of acute coronary insufficiency in patients, receiving means angiagregantnogo as low doses of aspirin after starting ibuprofen).

In the appointment of anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase) also increase the risk of bleeding.

Цefamandol, cefoperazone, cefotetan, valproic acid, plicamycin increase the frequency of gipoprotrombinemii.

Myelotoxicity drugs increase the expression gematotoksichnosti.

Cyclosporine and drugs enhance the effect of ibuprofen gold on the synthesis of prostaglandins in the kidneys, that is manifested by increased nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporin and the probability of its hepatotoxic effects.

Drugs, block tubular secretion, reduce excretion and increase plasma concentrations of ibuprofen.

In connection with the contents of the preparation may decrease the effectiveness of glucosamine hypoglycemic agents, doxorubicin, Teniposide, etoposide.

Glucosamine povыshaet absorbtsiyu tetracycline, reduces the effect of semi-synthetic penicillins, chloramphenicol.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 2 year.