Ostigold 1500

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COMPOSITION:

Glucosamine sulfate (as Glucosamine sulfate.2NaCl) .......................... 1500 mg

(Equivalent to 1177.76 mg of Glucosamine)

Excipients q.s .................................................... 1 sachet

(Aspartame, PEG 6000, anhydrous citric acid, tutti frutti flavor, mannitol).

DOSAGE FORM: Granules for oral solution.

PRESENTATION: Box of 24 sachets x 3.95 g.   

PHARMACODYNAMICS:

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. In vitro and in vivo experiments have shown glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes. The mechanism of action of glucosamine is unknown.

PHARMACOKINETICS:

No pharmacokinetic documents about glucosamine sulfate on human body have been found.

INDICATIONS:

Relief of symptoms in mild to moderate osteoarthritis of the knee.

CONTRAINDICATIONS:

Pregnant women, nursing mothers, children, and the nonage aged less than 18 years should not use the drug because its safety and efficacy have not been found. 

PRECAUTIONS:

In patients with impaired glucose tolerance, monitoring of the blood glucose levels is recommended. The tight control of blood sugar is very necessary for patients with diabetes mellitus when starting treatment.

In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended since hypercholesterolemia has been observed in a few patients treated with glucosamine.

Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of asthma symptoms.

The treatment for patients with liver failure and kidney failure should be strictly controlled.

PREGNANCY AND LACTATION:

The drug is contraindicated to pregnant women and nursing mothers.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Cautions should be taken in patients with headache, dizziness, fatigue when using the drug.

INTERACTIONS:

Increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with glucosamine has been reported.

Concurrent treatment with glucosamine may increase the absorption and serum concentrations of tetracyclines, but the clinical relevance of this interaction is probably limited.

ADVERSE EFFECTS:

Common: headache, fatigue, nausea, abdominal pain, indigestion, diarrhea or constipation.

Uncommon: rash, pruritus.

Rare: dizziness, vomiting, urticaria, angioedema.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

Intentional or accidental overdose cases have not been found.

If overdose occurs, signs and symptoms including headache, dizziness, disorientation, nausea, vomiting, diarrhea or constipation may occur.

Management: Glucosamine should be discontinued. Symptomatic treatment and supportive measures should be instituted if necessary.

DOSAGE & ADMINISTRATION:

The drug should be dissolved in a sufficient amount of water (about 15 - 20 ml for per sachet). The drug can be taken with or without food.

For individuals aged more than 18 years, the recommended dose should be 1 sachet once daily. Glucosamine sulfate may be used alone or combined with other drugs e.g., chondroitine 1200 mg/ day. The treatment duration depends on each individual, but it is needed to use continuously for 2 - 3 months in order to ensure the effective treatment.

Read the directions carefully before use.

Consult the physician for more information.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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