Advertisement
Advertisement
Mezavant XL

Mezavant XL

mesalazine

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Induction of clinical & endoscopic remission in patients w/ mild to moderate active ulcerative colitis & maintenance of remission in adult including elderly >65 yr, childn & adolescent weighing >50 kg & ≥10 yr.
Dosage/Direction for Use
Adult including elderly >65 yr, childn & adolescent weighing >50 kg & ≥10 yr Induction of remission 2.4-4.8 g once daily. Maintenance of remission 2.4 g once daily. Patients unresponsive to lower doses Recommended dose: 4.8 g daily. Evaluate treatment effect at 8 wk when using 4.8 g daily dose.
Administration
Should be taken with food: Do not chew/crush.
Contraindications
History of hypersensitivity to salicylates or mesalazine. Severe renal (GFR <30 mL/min/1.73 m2) &/or hepatic impairment.
Special Precautions
Induced cardiac hypersensitivity reactions (myo- & pericarditis). Discontinue treatment at 1st appearance of signs & symptoms of severe skin reactions eg, skin rash, mucosal lesions or any other sign of hypersensitivity; if renal function deteriorates. Terminate treatment if blood dyscrasia is suspected. Promptly w/draw & not to be reintroduced treatment if symptoms of acute intolerance syndrome (including cramping, acute abdominal pain & bloody diarrhoea, sometimes fever, headache & rash) occurs. Minimal change nephropathy, acute/chronic interstitial nephritis & renal failure; severe cutaneous adverse reactions including DRESS (eg, SJS & TEN); increased liver enzyme levels; serious blood dyscrasias. Cases of nephrolithiasis. Potential risk of cross-sensitivity reactions w/ sulphasalazine. May delay onset of action due to organic or functional obstruction in upper GIT. Patients w/ conditions predisposing to myo- or pericarditis development. Closely monitor patients w/ chronic lung function impairment, especially asthma. Perform haematological investigation if patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Evaluate renal function prior to initiation of therapy & at least twice a yr. Ensure adequate fluid intake during treatment. May lead to falsely elevated test results when measuring urinary normetanephrine by liqd chromatography w/ electrochemical detection. Mild to moderate renal impairment. Hepatic impairment. Leukopenia, thrombocytopenia & anaemia in infants born to mothers exposed to treatment during pregnancy. Lactation. Not to be used by paed patients ≤50 kg & <10 yr.
Adverse Reactions
Headache; HTN; abdominal distension & pain, colitis, diarrhoea, dyspepsia, vomiting, flatulence, nausea; abnormal LFT (eg, ALT, AST & bilirubin); pruritus, rash; arthralgia, back pain; asthenia, fatigue, pyrexia. SJS, TEN, DRESS.
Drug Interactions
May increase risk of renal adverse reactions w/ nephrotoxic agents including NSAIDs & azathioprine. Increased potential for blood dyscrasias, bone marrow failure & complications w/ azathioprine or 6-mercaptopurine. Decreased anticoagulant activity w/ coumarin-type anticoagulants eg, warfarin.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Mezavant XL PR-FC tab 1200 mg
Packing/Price
60's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement