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  • Arthryl
    / Rafa


    Active Ingredient
    Glucosamine Sulfate (crystalline) 1,500 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Sachets

    30 X 1500 mg

    not in the basket chart 87901

    Related information


    Dosage

    The contents of one sachet (dissolved in a glass of water) should be taken once daily, preferably at meals.
    Pivotal proof of efficacy has been demonstrated for periods of up to three months, with a residual effect evident for two months after drug withdrawal. The safety and efficacy of the product were also confirmed in pivotal clinical trials for treatment up to three years. Continuous treatment beyond 3 years cannot be recommended as the safety has not been established beyond this period.
    Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be reevaluated by the patient’s healthcare practitioner.
    Patients should seek medical advice if their symptoms deteriorate after commencing treatment with glucosamine.
    Elderly: No specific studies have been performed in elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients.
    Patients with impaired renal and/or liver function: In patients with impaired renal and/or liver function no dose recommendations can be given, since
    no studies have been performed.
    Children and adolescents: Glucosamine should not be used in children and adolescents below the age of 18 years.


    Indications

    Treatment of osteoarthritis symptoms ( i.e. pain and function limitation).


    Contra-Indications

    Hypersensitivity to glucosamine or to any of the excipients.
    Arthryl should not be used in pregnant and breast feeding women.
    The powder for oral solution contains aspartame and is therefore contraindicated in patients with phenylketonuria.
    The product should not be given to patients who are allergic to shellfish as the active ingredient is obtained from shellfish.


    Special Precautions

    The presence of another joint disease, which would require alternative treatment, should be excluded.
    Exacerbation of asthma symptoms after initiation of glucosamine have been described. Therefore, asthmatic patients starting on glucosamine should be aware of potential worsening of symptoms.
    This medicinal product contains 151 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
    Caution is advised in treatment of patients with impaired glucose tolerance. Closer monitoring of blood sugar levels and where relevant insulin requirements may be necessary in diabetics at the beginning of treatment and periodically during treatment.
    No special studies were performed in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of the product does not indicate limitations for these patients. However, administration to patients with severe hepatic or renal insufficiency should be under medical supervision.
    The powder for oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this pharmaceutical form.
    Glucosamine should not be used in children and adolescents under the age of 18 years since safety and efficacy have not been established.
    If unusual signs or symptoms appear, or if any changes in the course of usual symptoms occur, the patient is recommended to consult the physician immediately.


    Side Effects

    The most common adverse reactions associated with oral administration are nausea, abdominal pain, dyspepsia, flatulence, constipation and diarrhea. The reported adverse reactions are usually mild and transitory.
    See prescribing information for full details.


    Drug interactions

    No specific drug interaction studies have been performed, however, the physico-chemical and pharmacokinetic properties of glucosamine sulfate suggest a low potential for interactions. In one study glucosamine was found not to be an inhibitor of the activities of the following human cytochrome P450
    enzymes: CYP1A2, CYP2E1, CYP2C19, CYP2C9, CYP2D6, CYP3A4, as tested by metabolite formation from selected substrates for each of the CYP enzymes tested.
    The compound does not compete for absorption mechanisms and, after absorption, does not bind to plasma protein, while its metabolic fate as an endogenous substance incorporated in proteoglycans or degraded independently of the cytochrome enzyme system, is unlikely to give rise to drug interactions.
    However, an increased effect of coumarinic anticoagulants during concomitant treatment with glucosamine sulfate has been reported. Therefore, a closer monitoring of the coagulation parameters may be considered in these patients when initiating or ending glucosamine therapy.
    The oral administration of glucosamine sulfate can enhance the gastrointestinal absorption of tetracyclines.


    Pregnancy and Lactation

    Pregnancy: There is no adequate data from the use of glucosamine in pregnant women. From animal studies only insufficient data are available. Glucosamine should not be used during pregnancy.
    Breast Feeding: There is no data available on the excretion of glucosamine in human milk. The use of glucosamine during breastfeeding is therefore not recommended as there is no data on the safety of the newborn.


    Overdose

    No cases of accidental or intentional overdose are known. The animal acute and chronic toxicological studies indicate that toxic effects and symptoms are unlikely to occur at doses up to 200 times the therapeutic dose. However, if overdose occurs treatment should be symptomatic and standard supportive
    measures should be adopted as required.


    Manufacturer
    Rottapharm, Ireland
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