Flexijoint

Crystalline glucosamine sulphate.

Active Ingredient: Cap: Each capsule contains Crystalline Glucosamine Sulphate 628 mg (equivalent to 500 mg Glucosamine Sulphate).
Source of gelatin capsule: Bovine.
Powd for oral soln: Each sachet contains Crystalline Glucosamine Sulphate 1884 mg (equivalent to 1500 mg of Glucosamine Sulphate).

Pharmacology: Cap: Glucosamine is a natural substance found in chitin, mucoproteins, and mucopolysaccharides. It is involved in the manufacture of glycosaminoglycan, which forms cartilage tissue in the body; glucosamine is also present in tendons and ligaments. Glucosamine must be synthesised by the body but the ability to do this declines with age. Glucosamine and its salts have therefore been advocated in the treatment of rheumatic disorders including osteoarthritis.
Glucosamine also acts to improve the viscosity of synovial fluid by increasing synovial fluid production, thereby providing lubricant activity.
Absorption: After oral administration, bioavailability is low due to first-pass hepatic metabolism ~26%. The gastrointestinal absorption is close to 90%.
Distribution: Glucosamine is not protein-bound, but rather incorporates into plasma proteins (primarily globulins). Volume of Distribution: 2.5 Liters.
Metabolism: Liver, extensive. The first-pass effect in the liver in which more than 70% of glucosamine is metabolized.
Excretion: Renal Excretion, 10%. Feces, 11%. Part of a dose of glucosamine sulfate is eliminated as carbon dioxide via expired air.
Powd for oral soln: Glucosamine is a natural amino monosaccharide and a basic building block for the biosynthesis of glycoprotein, glycolipids, hyaluronic acid, glycosaminoglycans and proteoglycans, which are important constituents of the articular cartilage. Glucosamine is important for maintaining the elasticity, strength and resilience of cartilage in joints. This helps to reduce damage to the joints.
In addition to supporting cartilage and other connective tissue, Glucosamine enhances the production of hyaluronic acid and enhances the anti-inflammatory action of this molecule. The administration of Glucosamine is believed to stimulate production of cartilage components and allow rebuilding of damaged cartilage.
About 90% of Glucosamine administered orally as a Glucosamine salt gets absorbed from the small intestine, and from there it is transported via the portal circulation to the liver. It appears that a significant fraction of the ingested Glucosamine is catabolized by first-pass metabolism in the liver. Following oral administration, Glucosamine Sulphate is rapidly desulphated and metabolized to smaller molecules and ultimately to carbon dioxide, water, and urea. Glucosamine is not protein-bound but rather incorporates into plasma proteins (primarily globulins). About 10% of the oral administered dose is excreted in the urine and approximately 11% is excreted in the faeces as unabsorbed drug. Also, Glucosamine is partly eliminated as carbon dioxide in expired air via lungs. Glucosamine incorporated into plasma proteins has an elimination half-life of around 68 hours after oral administration.

Flexijoint is indicated as adjuvant therapy for osteoarthritis.

Initial: The initial therapy should be taken for at least 3 months (or as directed by a healthcare professional) to see the full benefits of this product.
Cap: Take 1 capsule 3 times a day before meals.
Powd for oral soln: Take the content of 1 sachet (dissolved in water) once daily before meal.
Maintenance: Following the initial 3 months therapy, dose can be increased or decreased based on individual response.
Cap: Take 1 capsule 2 times a day before meals.
Powd for oral soln: Take the content of 1 sachet (dissolved in water) once daily before meal.

No cases of accidental overdose are known or have been reported.

Hypersensitivity to glucosamine or to any of the excipients.
As the active ingredient is obtained from seafood (shellfish), the product should not be given to patients who are allergic to shellfish.
Powd for oral soln: Not suitable for people with Phenylketonuria.

Glucosamine treats the underlying cause of osteoarthritis and the therapeutic effect can only be seen after 1 to 3 weeks. Therefore, it is advisable to take an analgesic or anti-inflammatory drug if required during the first 2 to 3 weeks of therapy with Glucosamine.
Administration during the first three months of pregnancy must be avoided.
Safety and effectiveness have not been established in children, therefore children should avoid using Glucosamine.
The administration in patients with severe hepatic or renal insufficiency should be made under medical supervision. A doctor should be consulted in order to exclude the presence of other joint conditions/diseases for which an alternative treatment should be considered.
This product contains Glucosamine derived from seafood, therefore should not be given to patients who are allergic to shellfish.
This product contains Chondroitin from bovine source.
No effects on the ability to drive or to operate machines are expected.
Powd for oral soln: Caution should be taken for people with diabetes, impaired liver or kidney functions.

Administration during the first 3 months of pregnancy must be avoided.
Cap: Available evidence is inconclusive or inadequate for use in pregnant or lactating mothers. Until more information is available, this product should only be used under medical supervision in pregnancy and lactating mothers if the potential benefit to the mother justifies the potential risk to the fetus.
Powd for oral soln: During pregnancy and lactation, Glucosamine should not be taken unless advised by the doctor.

Cardiovascular: Peripheral oedema, tachycardia were reported in a few patients following larger clinical trials investigating oral administration in osteoarthritis. Causal relationship has not been established.
Central nervous system: Drowsiness, headache, insomnia have been observed rarely during therapy (less than 1%).
Gastrointestinal: Nausea, vomiting, diarrhoea, dyspepsia or epigastric pain, constipation, heartburn and anorexia have been described rarely during oral therapy with Glucosamine.
Skin: Skin reactions such as erythema and pruritus have been reported with therapeutic administration of Glucosamine.

Effects on glucose metabolism and antidiabetic agents: It has been hypothesized that Glucosamine may impair insulin secretion through competitive inhibition of glucokinase in pancreatic beta cells and/or alteration of peripheral glucose uptake.
Glucosamine may increase insulin resistance and consequently affect glucose tolerance. It may reduce antidiabetic agent effectiveness eg when used with these antidiabetic agents: Acarbose, Acetohexamide, Chlorpropamide, Glipizide, Glyburide, Metformin, Miglitol, Pioglitazone, Repaglinide, Rosiglitazone, Glimepiride, Tolbutamide and Troglitazone.
Glucosamine is likely safe in patients with well-controlled diabetes (HbA1c less than 6.5%) taking one or two oral antidiabetic medications or controlled by diet only. In patients with higher HbA1c levels or those taking insulin, monitor blood glucose levels closely or more frequently.
Reduced effectiveness when used with Glucosamine: Doxorubicin, Etoposide and Teniposide.
Warfarin: Elevations of International Normalized Ratio (INR) serum values and potentiation of anticoagulant effects. If concomitant therapy is necessary, the patient's INR should be more closely monitored.

Store below 30°C. Protect from light and moisture.
Shelf Life: 3 years from the date of manufacture.

Other Drugs Acting on Musculo-Skeletal System

M01AX05 - glucosamine ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products.

NP