Instructions for Teraflex capsules bottle No. 60
Composition
active ingredients: D-glucosamine hydrochloride and sodium chondroitin sulfate;
1 capsule contains 500 mg of D-glucosamine hydrochloride, 400 mg of sodium chondroitin sulfate;
excipients: gelatin, stearic acid, magnesium stearate, manganese sulfate monohydrate.
Dosage form
Capsules.
Main physicochemical properties: hard, transparent gelatin capsules containing a whitish to light beige powder with crystalline particles.
Pharmacotherapeutic group
Means used in pathologies of the musculoskeletal system. ATX code M09A X.
Pharmacological properties
Pharmacodynamics
This drug stimulates the regeneration of cartilage tissue. Chondroitin and glucosamine are effective in osteoarthritis. The drug has an anti-inflammatory effect at the cellular level, stimulates the synthesis of both endogenous proteoglycans and endogenous hyaluronic acid, reduces the catabolic activity of chondrocytes by inhibiting some enzymes that destroy cartilage, such as collagenase, elastase, proteoglycanase, phospholipase-A2, N-acetylglycosaminidase, etc., and also inhibits the formation of other substances that can damage cartilage tissue (in vitro), such as superoxide radicals; the activity of lysosomal enzymes.
Chondroitin is one of the main elements of cartilage. It reduces the activity of the inflammatory process in the early stages and, thus, slows down the degeneration of cartilage tissue. It helps reduce pain, improves joint function and reduces the need for non-steroidal anti-inflammatory drugs in osteoarthritis of the knee and hip joints.
Glucosamine is physiologically present in the human body and has chondroprotective properties. In vitro and in vivo studies have shown that glucosamine hydrochloride stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and the synthesis of hyaluronic acid by synoviocytes.
Pharmacokinetics
After a single oral dose of a therapeutic dose, peak plasma levels of chondroitin sulfate are reached within 3–4 hours. The bioavailability of the oral dose is 12%.
In the blood, 85% of chondroitin and its depolymerized derivatives bind to several plasma proteins.
At least 90% of the administered dose of chondroitin is first metabolized by lysosomal phosphatases, followed by depolymerization by hyaluronidase, β-glucuronidase, and β-N-acetylhexosaminidase in the liver, kidneys, and other organs.
Chondroitin and its depolymerized derivatives are eliminated primarily by renal excretion. The half-life is 5 to 15 hours.
After oral administration, glucosamine hydrochloride is rapidly and almost completely absorbed from the intestine. The pharmacokinetics of glucosamine are linear up to a standard dose of 1500 mg once daily, and higher doses will not result in a proportionally higher increase in maximum glucosamine concentrations.
More than 25% of the administered dose of glucosamine passes from blood plasma to cartilage tissue and synovial joint membrane.
According to the first-pass effect in the liver, more than 70% of glucosamine is metabolized to urea, carbon dioxide and water.
Excreted unchanged mainly by the kidneys in the urine and partly in the feces. The half-life is 68 hours.
Indication
Primary and secondary osteoarthritis; osteochondrosis; shoulder scapular periarthritis; fractures (to accelerate the formation of bone callus).
Contraindication
Hypersensitivity to any of the components of the drug (allergic reactions), bleeding tendency, thrombophlebitis, impaired liver or kidney function in the stage of decompensation. Do not use in patients with hypersensitivity (allergy) to seafood.
Interaction with other medicinal products and other types of interactions
No specific drug interaction studies have been conducted, however, the physicochemical and pharmacokinetic properties of glucosamine and chondroitin indicate a low likelihood of interaction.
The drug is compatible with nonsteroidal anti-inflammatory drugs and corticosteroids.
Chondroitin sulfate may enhance the effect of anticoagulants, which requires more frequent monitoring of blood coagulation parameters during concomitant use. Some sources indicate that the simultaneous use of glucosamine and warfarin may increase the international normalized ratio (INR) and the development of bleeding. Therefore, during concomitant use, it is necessary to monitor blood coagulation parameters.
The effectiveness of treatment increases when the diet is enriched with vitamins A, C and salts of manganese, magnesium, copper, zinc, and selenium.
Application features
- Do not exceed the recommended daily dose.
- Patients with diabetes should monitor their blood sugar levels more frequently, especially at the beginning of treatment.
- In rare cases, edema and/or water retention have been observed in patients with heart and/or renal failure. This may be due to the osmotic effect of chondroitin sulfate.
Use during pregnancy or breastfeeding
Due to the lack of clinical data on the efficacy and safety of the drug during pregnancy or breastfeeding, it should not be used during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the effects on the ability to drive or use machines. However, the patient should monitor changes in his reaction speed before driving or using machines.
Method of administration and doses
Take orally with a small amount of water. Adults take 1 capsule 3 times a day. The minimum duration of treatment is 2 months. The recommended course of treatment is from 3 to 6 months. If necessary, the course of treatment can be repeated with an interval of 3 months.
This medicine is not intended for the treatment of acute pain. Relief of symptoms (especially pain relief) may not be observed even after several weeks of treatment, and in some cases longer. If relief is not observed after 2-3 months of treatment, you should consult a doctor.
Patients should consult a doctor if symptoms worsen after starting this medicine.
Children
Due to the lack of experience in children, use in children is not recommended.
Overdose
No cases of overdose have been described. Based on the results of acute and chronic toxicity studies, no toxic symptoms are expected, even at high doses. However, if overdose occurs, treatment should be symptomatic. Standard supportive measures should be applied.
Adverse reactions
Available data indicate that glucosamine and chondroitin sulfate at commonly prescribed doses (1500 mg/day and 1200 mg/day, respectively) are not toxic and do not cause known patterns of adverse reactions.
The following adverse reactions have been reported during post-marketing experience with the medicinal product. As the information was provided voluntarily from a population of uncertain size, it is not always possible to estimate the frequency of these reactions.
From the gastrointestinal tract.
Epigastric pain, dyspepsia, constipation, flatulence, diarrhea, nausea and vomiting.
From the immune system.
Allergic reactions, including skin rash, urticaria, pruritus, erythema, dermatitis, maculopapular rash, edema, angioedema. If allergic reactions occur, treatment should be discontinued and specialist advice should be sought.
From the nervous system.
Dizziness, headache, drowsiness, insomnia, increased fatigue.
Other adverse reactions mentioned in literature sources.
There have been reports of extrasystoles, visual disturbances, and alopecia when taking 1200 mg of chondroitin sulfate, but they are very rare.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
Plastic bottle of 30 or 60, 120 or 200 capsules in a cardboard box.
Vacation category
Without a prescription.
Producer
Contract Pharmacal Corporation, USA
Location of the manufacturer and its business address
135 Adams Avenue, Hauppauge, New York 11788, USA/135 Adams Avenue, Hauppauge, New York 11788, USA.
