RiteMED Glucosamine Sulfate

Each sachet contains: Glucosamine Sulfate 1.5 g (Equivalent to 1.99 g Glucosamine Sulfate Potassium Chloride).
Each sachet also contains 262.14 mg (6.72 mEq) of potassium.

Pharmacology: Pharmacodynamics: 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 is synthesized in the body but its ability to do so declines with age. Thus, Glucosamine and its salts have been given for their chondroprotective action in musculoskeletal and joint disorders including osteoarthritis. Glucosamine also acts to improve viscosity of by increasing synovial fluid production, thereby providing lubricant activity.
In addition to the primary role of Glucosamine itself, inorganic sulfates may contribute to the pharmacological effect of Glucosamine since they are essential for controlling the rate of glycosaminoglycan and proteoglycan synthesis.
Pharmacokinetics: Following oral administration, about 90% of Glucosamine (as Glucosamine salt) is absorbed from the small intestine. The maximum concentration (C_max) after oral administration of Glucosamine Sulfate to healthy adults is 31 mcM/L. The bioavailability of oral Glucosamine Sulfate is 26% and the volume of distribution is 2.5 liters. Glucosamine is incorporated into plasma glycoproteins and is distributed into liver, kidney and skeletal tissues. It is not currently known how much of an ingested dose is taken up in human joints. However, some uptake in articular cartilage was seen in animal studies; approximately 30% of Glucosamine is taken up in skeletal tissues of the rat. A significant amount (70%) of Glucosamine Sulfate is catabolized by first-pass metabolism in the liver and ultimately to carbon dioxide, water and urea. Glucosamine is excreted mainly in the urine with only small amounts excreted in feces. Notable amounts are also metabolized to carbon dioxide and excreted via expired air. Elimination is delayed in renal insufficiency.

Adjunctive therapy for osteoarthritis.

Glucosamine Sulfate should be taken with meals.
Directions for Use: Dissolve entire contents of one sachet (1.5 g) in a full glass of warm water (250 mL) and stir. Drink the full dose.
Usual Adult Dose: Contents of one sachet (1.5 g) once a day, or, as directed by a physician.
Glucosamine Sulfate is not indicated for the treatment of acute painful syndromes.
Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment or sometimes even longer. If no relief of symptoms is experienced after 2 to 3 months, continued treatment with Glucosamine should be re-evaluated.

No case of overdose has been reported.

Hypersensitivity to Glucosamine or to any ingredient in the product.
Patients who are allergic to shellfish since Glucosamine is obtained from shellfish.
Patients who suffer from phenylketonuria since this product contains Aspartame, a source of Phenylalanine.
Patients in the first 3 months of pregnancy.

This product contains potassium, thus, it should be given with caution to patients with congestive heart failure or renal failure. Caution should also be exercised when administering to patients taking potassium supplements and potassium-sparing diuretics (e.g., Spironolactone, Triamterene).
A physician should be consulted to rule out the presence of other joint diseases for which other treatments should be considered.
Glucosamine treats the underlying cause of osteoarthritis and the therapeutic effect can only be seen after 2 to 3 weeks. An analgesic/anti-inflammatory drug may be advised by a physician during the first 2 to 3 weeks of glucosamine therapy.
Administration to patients with severe hepatic or renal disease should be made under medical supervision.
Patients with type 2 diabetes and those who are overweight and have problems with glucose tolerance should have their blood glucose levels carefully monitored if they use Glucosamine since Glucosamine may increase insulin resistance.
A case of exacerbated asthma symptoms triggered after initiation of Glucosamine has been reported, although symptoms resolved after Glucosamine withdrawal. Asthmatic patients starting on Glucosamine therapy should be aware of possible worsening of asthma symptoms.
Use in Children: Glucosamine should not be administered to children and adolescents under 18 years old since safety and efficacy have not been established in this age group.
Use in the Elderly: Glucosamine should be administered with caution in elderly patients with hepatic or renal disease.

Pregnancy: There are no adequate data on the use of Glucosamine in pregnant women. This product should not be used during pregnancy.
Lactation: There are no available data on the excretion of Glucosamine into human milk. Thus, Glucosamine is not recommended for use by breastfeeding women since there are no data on the safety for the newborn.

Cardiovascular: peripheral edema, tachycardia.
Central Nervous System: drowsiness, headache, somnolence, insomnia.
Gastrointestinal: nausea, vomiting, diarrhea, constipation, flatulence, dyspepsia, epigastric pain, heartburn, anorexia.
Skin: rash, erythema, pruritus, urticaria, angioedema, hair loss.
Special Senses: visual disturbances.
Immune System: allergic reactions.
Sporadic, spontaneous cases of hypercholesterolemia have been reported, but causality has not been established.

As the possibility of interactions cannot be excluded, caution should be exercised when Glucosamine is used with other medicines.
Elevations in International Normalized Ratio (INR) serum values and potentiation of anticoagulant effects have been observed following concomitant use of Glucosamine and Warfarin. If concomitant therapy is necessary the patient's INR should be closely monitored.
Glucosamine may increase insulin resistance and consequently affect glucose tolerance. Diabetics, who under medical advice, decide to use Glucosamine supplements will need their blood glucose monitored and doses of antidiabetic medications adjusted.
Glucosamine may reduce the effect of chemotherapy drugs such as Doxorubicin, Etoposide and Teniposide.

Store at temperatures not exceeding 30°C.

Other Drugs Acting on Musculo-Skeletal System

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

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