Teraflex - instructions for use, dose, side effects, contraindications

Description:Transparent hard gelatin capsules No. 00. Capsule contents - white or white powder with a yellowish tint of color with crystalline particles.

Pharmacotherapeutic group:Reparation of tissue stimulant

ATX: & nbsp

M.01.A.X Other non-steroidal anti-inflammatory drugs

Pharmacodynamics:

Stimulates the regeneration of cartilaginous tissue. Glucosamine and chondroitin sulfate participate in the synthesis of connective tissue, contributing to the prevention of cartilage destruction processes and stimulating the regeneration of tissue. The introduction of exogenous glucosamine enhances the production of the cartilaginous matrix and provides non-specific protection against chemical damage to the cartilage. Another possible action of glucosamine is the protection of damaged cartilage from metabolic destruction caused by non-steroidal anti-inflammatory drugs (NSAIDs) and glucocorticosteroids (GCS), as well as its own moderate anti-inflammatory effect.

Chondroitin sulfate serves as an additional substrate for the formation of a healthy cartilage matrix. Stimulates the formation of hyaluronone, the synthesis of proteoglycans and collagen type II, and also protects hyaluronone from enzymatic cleavage (by suppressing the activity of hyaluronidase); maintains the viscosity of the synovial fluid, stimulates mechanisms of cartilage repair and inhibits the activity of those enzymes that break down cartilage (elastase, hyaluronidase). In the treatment of osteoarthritis, it alleviates the symptoms of the disease and reduces the need for NSAIDs.

Pharmacokinetics:

Glucosamine

Absorption. Bioavailability of glucosamine with oral administration is 25% (the effect of "first passage" through the liver).

Metabolism. After absorption of the oral dose, radiolabeled glucosamine initially found in the plasma and later penetrates into the tissue. The highest concentrations are found in the liver, kidneys and articular cartilage. About 30% of the dose is persistently persistent in the tissues of bones and muscles.

Elimination. It is excreted mainly by the kidneys in unchanged form; partially through the intestine. The half-life of the drug is 68 h.

Chondroitin sulfate

Absorption. When chondroitin sulfate is administered orally at a dose of 0.8 g (or twice a day 0.4 g), the plasma concentration increases for 24 hours. Absolute bioavailability is 12%.

Metabolism. It is metabolized by desulfurization.

Elimination. It is excreted by the kidneys. The half-life is 310 min.

Indications:

Degenerative and dystrophic diseases of the joints and spine: osteoarthritis of I-III stage, osteochondrosis.

Contraindications:

Hypersensitivity, severe chronic renal failure, pregnancy, lactation, age 15 years.

Carefully:

Diabetes mellitus (it is recommended to periodically check the blood glucose level, especially at the beginning of treatment), bronchial asthma, cardiac and / or renal insufficiency (with single chondroitin cases, edema development), hypersensitivity to seafood.

Pregnancy and lactation:

Clinical data on the efficacy and safety of Teraflex® during pregnancy and lactation (breastfeeding) are not available.

Dosing and Administration:

Inside. For adults and children over 15 years, the first three weeks are prescribed 1 capsule 3 times a day; in the following days - 1 capsule 2 times a day, regardless of food intake, with a small amount of water. The recommended duration of treatment is from 3 to 6 months. If necessary, it is possible to conduct repeated courses of treatment, the duration of which is set individually.

Side effects:

Teraflex^® well tolerated by patients. Possible dysfunction of the gastrointestinal tract (pain in epigastrium, flatulence, diarrhea, constipation), dizziness, headache, leg pain and peripheral edema, drowsiness, insomnia, tachycardia,allergic reactions.

Overdose:

Symptoms: cases of overdose are unknown. When an overdose of chondroitin sulfate, hemorrhagic rash, nausea, vomiting are possible.

Treatment: gastric lavage, symptomatic therapy.

Interaction:

Improves the absorption of tetracyclines, reduces the effect of semisynthetic penicillins and chloramphenicol. The drug is compatible with NSAIDs and glucocorticosteroids.

There are limited data on the possible interaction of glucosamine and warfarin, which can lead to an increase in INR and a risk of bleeding. Therefore, with simultaneous admission, blood coagulation should be monitored.

Special instructions:If there are undesirable effects from the gastrointestinal tract, the dose of the drug should be reduced 2 times, and in the absence of improvement - cancel the drug.

Form release / dosage:Capsules 500 mg + 400 mg.

Packaging:

30, 60, 100 or 120 capsules are placed in a high-density polyethylene bottle with a screw cap made of the same material.

200 capsules are placed in a high-density polyethylene bottle with a color screw cap made of polypropylene with a thermoplastic elastomer lining with the company logo.

A diaphragm made of a combined material is glued onto the vial: aluminum foil / paper, laminated with polyethylene. The lid and the neck of the bottle are sealed with a transparent film. Each vial with the instruction for 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:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N015287 / 01

Date of registration:08.08.2008 / 30.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

CONTRACT PHARMACAL CORPORATION USA

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp22.01.2018

Illustrated instructions

Instructions

Teraflex® (Theraflex®)