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Cartril-S™
Glucosamine HCI
COMPOSITION
Cartril-S 1500mg Powder
Each sachet contains 1417.5 mg Glucosamine equivalent to Glucosamine content
in 1500 mg Glucosamine Sulphate.
Cartril-S 500mg Capsule
Each capsule contains 472.5 mg Glucosamine equivalent to Glucosamine content
in 500 mg Glucosamine Sulphate.
Preservatives: None
DESCRIPTION
Cartril-S 1500mg Powder: Free flowing white to off white colour odourless
and tasteless powder.
Cartril-S 500mg Capsule: Size1, hard gelatin capsule with red cap and red
body containing white to off white powder.
Printed 'Cartril S' and '500'.
PHARMACODYNAMIC
Glucosamine possesses arthrophic metabolic activity by stimulating the
anabolic metabolism of osteocartilaginous tissues, through stimulation of
biosynthesis of the mucopolysaccharides (which are essential components of
the cartilage ground-substances) and the bone mesenchymal tissues and
improvement of the calcium intake. Lubricant activity through improvement of
synovial fluid production.
PHARMACOKINETIC
Absorption
Glucosamine sulfate is well absorbed (with a proportion close to 90%)
following oral administration.
Protein Binding
It is know that glucosamine and its metabolites bind to (alpha- and
beta-globulins.
Distribution
Mainly distributed to bone tissues and articular cartilages.
INDICATIONS
As adjuvant therapy in osteoarthritis.
CONTRAINDICATIONS
Hypersensitivity to Glucosamine. The powder for oral solution contains
aspartame and therefore contraindicated in patients with phenylketonuria.
Contraindicated in patients allergic to shellfish.
DRUG INTERACTION
Drug interaction with Oral Hypoglycaemic Agent, may reduce the oral
hypoglycaemic agent effectiveness. For examples; metformin, tolbutamide,
rosiglitazone and etc.
Glucosamine is likely safe in patients with well controlled diabetes (HbA1c
less than 6.5%) taking one or two oral diabetics medications or controlled
by diet only. In patients with higher hbA1c levels or those taking insulin,
monitor blood glucose levels closely.
PRECAUTIONS
The administration in patients with severe hepatic or renal insufficiency
should be made under medical supervision. Glucosamine is not meant for
replace NSAIDs in cases of intense pain, as this is acausal therapy. It is
advisable to take
an anti-inflammatory drug in the initial treatment of osteoarthritis
together with glucosamine.
WARNINGS
Pregnancy and Lactation:
The animal studies did not evidence any unfavourable effects on the
reproductive functions or on lactation. In the absence of such studies in
humans, the product during pregnancy and lactation should be used only under
medical control. Administration during the first three months of pregnancy
must be avoided. No effects on the ability to drive or to operate machines
is expected.
DOSAGE
Cartril-S 1500mg Powder:
The content of one sachet (dissolved in a glass of water) should be taken
once daily, preferably at meals.
Cartril-S 500mg Capsule:
Adult: One capsule taken twice daily for at least 6 weeks (or according to
medical prescription). Duration of treatment: 3 months.
(The treatment course may be repeated at intervals of 2 months).
OVERDOSE
No cases of accidental or intentional overdose are known. The animal acute
and chronic toxicological studies indicate that toxic effects and symptoms
of toxicity are not likely to occur, even after high overdoses.
UNDESIRABLE EFFECTS
Undesirable effects have been observed in a low proportion of patients. They
were transient, of minor entity, and included gastric discomfort and pain,
meteorism, constipation, diarrhoea. Effects of hypersensitivity have been
reported in some patients and included cutaneous rashes with pruritus and
erythema.
The patient should inform his doctor of any other undesirable effect during
the treatment.
PACKING / PACK SIZE
Powder for oral solution (sachet), package of 30 sachets. Blister pack of 10
x 10's, bottle of 60's.
STORAGE CONDITIONS, USER INSTRUCTIONS, AND PHARMACEUTICAL PRECAUTIONS
Store
in a dry place below 30°C in a dry place.
Protect from moisture and heat.
Derived from Seafood
Shelf-life: Please refer to the outer package.
Do not use the product after the expiry date indicated on the label.
Avoid exposure to excessive heat.
The expiry date applies to the correctly stored product in the intact
package.
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