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  • Mezavant 1200 mg
    / Medison


    Active Ingredient
    Mesalazine 1200 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Prolonged-Release Tablets

    60 X 1200 mg

    not in the basket chart 55503

    Related information


    Dosage

    Mezavant is intended for once daily, oral administration. The tablets must not be
    crushed or chewed and should be taken with food.
    Adults, including the elderly (>65 years)
    For induction of remission: 2.4 to 4.8g (two to four tablets) should be taken once daily. The highest dose of 4.8g/day is recommended for patients not responding to lower doses of mesalazine. When using the highest dose (4.8g/day), the effect of the treatment should be evaluated at 8 weeks.
    For maintenance of remission: 2.4g (two tablets) should be taken once daily.
    Children and adolescents:  Mezavant is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
    Specific studies have not been performed to investigate Mezavant in patients with hepatic or renal impairment.


    Indications

    For the induction of clinical and endoscopic remission in patients with mild to
    moderate, active ulcerative colitis. For maintenance of remission.


    Contra-Indications

    History of hypersensitivity to salicylates (including mesalazine) or any of the
    excipients of Mezavant.
    Severe renal impairment (GFR <30ml/min/1.73m²) and/or severe hepatic impairment.


    Special Precautions

    Reports of renal impairment, including minimal change nephropathy, acute/chronic interstitial nephritis and renal failure have been associated with preparations containing mesalazine and pro-drugs of mesalazine. Mezavant should be used with caution in patients with confirmed mild to moderate renal impairment. It is recommended that all patients have an evaluation of renal function prior to initiation of therapy and at least twice a year, while on treatment.
    Patients with chronic lung function impairment, especially asthma, are at risk of
    hypersensitivity reactions and should be closely monitored.
    Following mesalazine treatment, serious blood dyscrasias have been reported rarely.
    If the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat, haematological investigations should be performed. If there is suspicion of blood dyscrasia, treatment should be terminated.
    Mesalazine induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely with Mezavant and with other mesalazine containing
    preparations. Caution should be used in prescribing this medication to patients with conditions predisposing to the development of myo- or pericarditis. If such
    hypersensitivity reaction is suspected, products containing mesalazine must not be reintroduced.
    Mesalazine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalazine or sulphasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhoea, sometimes fever, headache and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required and products containing mesalazine must not be reintroduced.
    There have been reports of increased liver enzyme levels in patients taking
    preparations containing mesalazine. Caution is recommended if Mezavant is
    administered to patients with hepatic impairment.
    Caution should be exercised when treating patients allergic to sulphasalazine due to the potential risk of cross sensitivity reactions between sulphasalazine and mesalazine.
    Organic or functional obstruction in the upper gastrointestinal tract may delay onset of action of the product.
    Interference with Laboratory Tests: Use of mesalazine may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalazine’s main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective
    assay for normetanephrine should be considered.


    Side Effects

    The most frequently reported adverse drug reactions (ADRs)within the pooled safety analysis of clinical studies with Mezavant, including 3,611 patients, were colitis (including ulcerative colitis) 5.8%, abdominal pain 4.9%, headache 4.5%, liver function test abnormal, 2.1%, diarrhoea 2.0%, and nausea 1.9%.
    See prescribing information for full details.


    Drug interactions

    Drug-drug interaction studies in healthy adult subjects have been conducted with Mezavant to investigate any effect of Mezavant on the pharmacokinetics and safety of three commonly used antibiotics. There were no clinically significant interactions of Mezavant with amoxicillin, metronidazole or sulfamethoxazole.
    However, the following drug-drug interactions have been reported for products
    containing mesalazine.
    – Caution is recommended for the concomitant use of mesalazine with known
    nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine as these may increase the risk of renal adverse reactions.
    – Mesalazine inhibits thiopurine methyltransferase. In patients receiving
    azathioprine or 6-mercaptopurine, caution is recommended for concurrent use
    of mesalazine as this can increase the potential for blood dyscrasias.
    – Administration with coumarin-type anticoagulants e.g. warfarin, could result
    in decreased anticoagulant activity. Prothrombin time should be closely monitored if this combination is essential.
    Mezavant is recommended to be administered with food.


    Pregnancy and Lactation

    Pregnancy: Limited experience with mesalazine in pregnancy does not indicate an increased risk of drug induced congenital malformations. Mesalazine crosses the placental barrier, but provides foetal concentrations much lower than those seen with adult therapeutic use. Mesalazine should be used during pregnancy only when clearly indicated. Caution should be exercised when using high doses of mesalazine.
    Breast-feeding: Mesalazine is excreted in breast milk at low concentration. Caution should be exercised if using Mesalazine while breast-feeding and only if the benefit outweighs the risks. Sporadically acute diarrhoea has been reported in breast fed infants.
    See prescribing information for full details.


    Overdose

    Mezavant is an aminosalicylate, and signs of salicylate toxicity include tinnitus,
    vertigo, headache, confusion, drowsiness, pulmonary oedema, dehydration as a result of sweating, diarrhoea and vomiting, hypoglycaemia, hyperventilation, disruption of electrolyte balance and blood-pH and hyperthermia.
    Conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. Hypoglycaemia, fluid and electrolyte imbalance should be corrected by the administration of appropriate therapy. Adequate renal function should be maintained.


    Manufacturer
    Cosmo SpA, Italy
    Licence holder
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