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Osteosave plus powder
(Glucosamine sulfate and Chondroitin sulfate powder)

Composition
Each Sachet Contains:
Glucosamine Sulfate Sodium Chloride USP equivalent to
Glucosamine Sulfate 1500 mg
Sodium Chondroitin Sulfate 1200 mg

Source of Glucosamine sulfate
Marine shrimp origin
Source of Sodium Chondroitin sulfate
Bovine origin

Colour
Quinoline Yellow

WARNING: Unsuitable for Phenylketonurics.

Description
Solid powder:
Yellow coloured, free flowing powder with orange flavour.
Reconstituted solution:
Hazy, yellow coloured, orange flavoured solution.

Pharmacology
Pharmacodynamics
Glucosamine sulphate is synthesized endogenous aminomonosacharide from the glucose, which is used like intermediary substrate in the synthesis of glycosaminoglycans and proteoglycans, at level of the cartilage to articulate. It is present as a natural component in almost all human weaves and has a special tropismo by the cartilaginous weave, where easily it is incorporated in molecules of proteoglycans. The salt sulphate of glucosamino forms half of the subunit disacharide of keratan sulphate, which diminishes in patients with osteoartritis, and of the hyaluronic acid, which is in the cartilage to articulate and the sinovial fluid. Chondroitin sulphate is a glycosaminoglycan (mucopolysacharide) that comprises, like a natural component, of the conective weave of all the mammals. At level to articulate, chondrotin sulphate is the main component of the cartilage, playing an important role in the metabolism, and regulation of this one, with the intention of assuring a function to articulate normal. Therefore, suitable amounts of this nutrient can be crucial for the normal operation of the joints. For pharmaceutical aims, chondroitin sulphate can be obtained from natural sources, like cartilage of shark or bovine. This glycosaminoglycan consists of a mixture of condroitin 4-sulphate (a) and condroitin 6-sulphate (c) in an approximated reason of 3:1. The molecular weights of the different fractions from chondroitin sulphate From A and C between 15,000 and 50,000 daltons, with a molecular weight average of 16, 000. Chondroitin sulphate is a biopolymer made up of long chains formed per well defined repeated sequences and of disacharides units (N-acetyl - condrosin), where each unit is monosulphated 4 or 6 of the galactosamine. The disaccharide unit is composed by an amino sugar (galactosamine, whose immediate precursor is the glucosamine) and an acid sugar (acid glucoronic).

Pharmacokinetics
Glucosamine:

The oral biodisponisibility of glucosamine in humans is of a 26%, since it undergoes an effect of metabolism of first step. Animal data indicate that the glucosamine spreads quickly towards weaves and is incorporated in plasma proteins and other biological structures within the body. The liver, kidneys and cartilage to articulate exhibit the highest concentrations of glucosamine. The glucosamine is metabolised mainly in the liver and a portion of the dose is retained in weaves. In addition to the hepatic metabolism, the glucosamine is metabolised in some degree to carbon dioxide, the one that is excreted with the breathed air. It has been reported that the average life of elimination of the glucosamine incorporated in plasma proteins is of 68 hours after the oral administration.

Chondroitin sulphate:
Absorption:
Several studies indicate that the bioavailability of chondroitin sulfate fluctuates between 15 and 24% of the dose by oral administration.
10% of the absorbed portion of chondroitin sulfate appears in the form of chondroitin sulfate and 90% in the form of depolymerase derivatives of inferior molecular weight, which suggests that it goes through a first pass effect. After oral administration of chondroitin sulfate, maximum hind levels are reached in about 4 hours.

Distribution:
In the blood, 85% of the concentration of chondroitin sulfate and the depolymerase derivatives is bound to plasma proteins. The volume of distribution of chondroitin sulfate is relatively small, around 0.3 l/kg. In humans, chondroitin sulfate shows an affinity for joint tissue. In rats, as well as joint tissue, chondroitin sulfate shows an affinity for the wall of the small intestine, liver, brain and kidneys.

Metabolism:
At least 90% of the dose of chondroitin sulfate is metabolised firstly by lysosomal sulfatases, and then is depolymerased by hyaluronidases, beta-glucuronidases and beta N-acetylhexosaminidases. The liver, the kidneys and other organs take part in the depolymerisation of chondroitin sulfate. There have been no observation interactions with other medicines at metabolisation level. Chondroitin sulfate is not metabolised by cytochrome enzyme P450.

Elimination:
The systematic clearance of chondroitin sulfate is 30.5 ml/min or 0.43 ml/min/kg. The average lifetime fluctuates between 5 and 15 hours, depending on the experimental protocol. Elimination of chondroitin sulfate and its depolymerased derivatives is chiefly through the kidneys

Indications
Adjunctive therapy in osteoarthritis

Dosage and Administration
Once in day.

Contraindications
Its use is contraindicated in the following cases:
Pregnancy and lactation; smaller children of 12 years of age, except low medical prescription. Hypersensitivity to glucosamine or chondroitin and patients who are allergic to shelfish.

Warnings and Precautions
Glucosamine may increase insulin resistance. Glucosamine increases insulin resistance in normal and experimentally diabetic animals. In these animals, intravenous glucosamine significantly decreases the rate of glucose uptake in skeletal muscle. In animals given oral glucosamine, this is not observed. Those with type 2 diabetes and those who are overweight and have problems with glucose tolerance should have their blood sugars carefully monitored if they use glucosamine supplements. Because of insufficient safety data, children, pregnant women and nursing mothers should avoid using glucosamine.

Interaction with the other Medicaments
Glucosamine may increase insulin resistance and consequently affect glucose tolerance. Diabetics who, are under medical advisement, decide to use glucosamine supplements will need to monitor their blood glucose and may need to adjust the doses of the medications they take to control blood glucose. This needs to be done under medical supervision. No other drug, nutritional supplement, food or herb interaction is known.

Chitosan may form complexes with chondroitin sulfate decreasing its absorption. Therefore, chondroitin sulfate should not be used concomitantly with chitosan.

Pregnancy and Lactation
Should be used only under medical control. Administration during the first three months of pregnancy must be avoided.

Side Effect
Side effects that have been reported are mainly mild gastrointestinal complaints such as heartburn, epigastric distress, nausea and diarrhea

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.

Overdosage
Cases of overdose with the administration of this supplement have not been reported.

Shelf life
24 months

Storage
Store below 25C.
Protect from moisture.

Presentation
Carton containing 30 sachets of 4.7 gm each.
Carton containing 100 sachets of 4.7 gm each.

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