Description
Instructions for medical use of
Theraflex®
Trade name:
Theraflex®
International nonproprietary name
None
Dosage form
Capsules
Composition
One capsules includes:
Active substance: D-glucosamine hydrochloride 500 mg, chondroitin sodium sulfate 400 mg;
Adjuvants: gelatin, stearic acid, magnesium stearate, manganese sulfate.
Description
Transparent, solid, gelatin capsules, size No, 00, filled with white powder with insignificant shades or light-and-beige with crystalline particles.
Pharmacotherapeutic group
Other drugs for the treatment of the musculoskeletal system diseases.
Code АТX М09АХ
Pharmacological properties
Pharmacokinetics
Chondroitin sulfate - after oral administration of a single therapeutic dose it achieves themaximal levels in blood plasma within 3-4 hours, in the synovial fluid – within 4-5 hours. Bioavailability is 13%. It is excreted mainly through the kidneys within 24 hours.
Glucosamine sulfate - after oral administration, 90 % of it is absorbed in the intestine. More than 25% comes from plasma to cartilage and synovial joint tissue.The liver metabolizes a part of the drug to urea, carbon dioxide and water. Bioavailability of glucosamine sulfate makes 25%.The liver, kidneys and cartilage have the highest concentrations of glucosamine. The bone and muscle tissue retain about 30% of the administered dose for a long period. Kidneys mainly excrete glucosamine hydrochloride in the unchanged form. The half-life is 68 hours.
Pharmacodynamics
Chondroitin sulfate is a high-molecular mucopolysaccharide involved in the construction and restoration of cartilage tissue. It reduces the activity of enzymes destroying articular cartilage and stimulates its regeneration (biosynthesis of glucosaminoglycans). Chondroitin sulfate slows destruction of cartilage at the early stages of the inflammatory process. It makes an anti-inflammatory effect, promotes reduction in the intensity of pain, and improves joint function.
Glucosamine hydrochloride has chondroprotective and osteotrophic properties, reduces the deficiency of glucosaminoglycans in the body, participates in the biosynthesis of proteoglycans and hyaluronic acid, and normalizes calcium deposition in bone tissue. Having high affinity to cartilage, glucosamine hydrochloride initiates the process of fixation of sulfur in the chondroitinase acid synthesis. Glucosamine hydrochloride inhibits formation of superoxide radicals and enzymes damaging cartilage (collagenase and phospholipase), prevents the damaging effect of glucocorticoids, non-steroidal anti-inflammatory drugs upon chondrocytes and abnormality in biosynthesis of glucosaminoglycans. The combination of chondroitin sulfate and glucosamine hydrochloride provides more pronounced and more long-lasting clinical effect.
Indications
– osteoarthrosis
– osteoporosis
– scapulohumeral periarthritis
– osteochondrosis, degenerative-dystrophic diseases of the spine
– spondylosis
– chondromalacia patellae
– fractures (for acceleration of the callus formation).
It is recommended as part of a comprehensive treatment of the musculoskeletal system, post-traumatic and other states of health, accompanied by degenerative-dystrophic changes in the tissues of articular cartilage for children older 12 years old, adults, the elderly.
Dosage and methods of use
Adults and children older 12 years old during the first three weeks are assigned to take per one capsule 3 times a day after meals; further days to take per 1 capsule 2 times a day. The minimal treatment course duration is 2 months. To repeat the courses of treatment at intervals of 3 months or on advice of the doctor.
Adverse reaction
– nausea
– stomach ache
– flatulence
– diarrhea or constipation
– allergic reaction
Contraindications
– increased individual sensitivity to any of the ingredients of the drug (allergic reaction)
– phenylketonuria
– pregnancy, lactation
– children under 12 y.o.
Drug interaction
The drug improves the absorption of tetracyclines and reduces the absorption of penicillins and chloramphenicol.
Teraflex potentizes antiplatelets, fibrinolytics, and coumarin anticoagulants (e.g. warfarin), simultaneous administration of these drugs can change the indeces of coagulogram (INR) and increase the risk of bleeding.
On the background of treatment with Tteraflex, the need for non-steroidal anti-inflammatory drugs is reduced.
Special indications
Features of the effect upon the ability to drive the vehicle or other machinery.
It does not effect.
Overdosage
There is no description of overdosage for the drug. At overdose increase of side effects is possible.
Treatment: it is recommended to make gastric lavage and symptomatic therapy.
Form of output and packing
It is packed in high-density polyethylene bottles with a screw-on lid made of white polypropylene per 30, 60, 120 capsules.200 capsules are packed in a bottle made of high-density polyethylene with a colored screw cap made of polypropylene with a thermoplastic elastomer overlay bearing the company logo. The bottleneck is sealed with a firm membrane made of the combined material: aluminum foil /paper, laminated with polyethylene; there is a protective film made of transparent polyethylene on top of the cover.
The enclosure of the cardboard box includes the bottle together with the instruction on medical use in the state and Russian languages.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf live
3 years
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Over the counter.
Name and country of the organization-manufacturer
Contract Pharmacal Corporation, USA
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name and country of the packaging company
Contract Pharmacal Corporation, USA
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax: +7 727 244 70 01
e-mail: kz.claims@bayer.com
