HIGHLIGHT
Mezavant XL

Mezavant XL

mesalazine

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Induction of clinical & endoscopic remission in patients w/ mild to moderate, active ulcerative colitis; for maintenance of remission.
Dosage/Direction for Use
Adult, including the elderly (>65 yr) Induction of remission 2.4 g (2 tab) to 4.8 g (4 tab) once daily. Highest dose of 4.8 g/day is recommended for patients unresponsive to lower doses. For maintenance of remission 2.4 g (2 tab) once daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to mesalazine or salicylates. Severe renal (GFR <30 mL/min/1.73 m2) &/or severe hepatic impairment.
Special Precautions
Allergy to sulphasalazine. Closely monitor patients w/ chronic lung function, especially asthma due to risk of hypersensitivity reactions. Patients w/ conditions predisposing to the development of myo- or pericarditis; do not reintroduce treatment if hypersensitivity reaction is suspected. Perform haematological investigations if patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Terminate treatment if blood dyscrasia is suspected. W/draw promptly in suspected acute intolerance syndrome. May delay onset of action in organic or functional obstruction in upper GIT. May lead to false elevated results when measuring urinary normetanephrine by liqd chromatography w/ electrochemical detection. Ensure adequate fluid intake during treatment. Hepatic impairment. Patients w/ confirmed mild to moderate renal impairment. Evaluate renal function prior to initiation of therapy & at least twice a yr while on treatment. Pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Headache; HTN; abdominal distension & pain, colitis, diarrhoea, dyspepsia, vomiting, flatulence, nausea; abnormal liver function test; pruritus, rash; arthralgia, back pain; asthenia, fatigue, pyrexia. Stevens-Johnson syndrome.
Drug Interactions
May increase the risk of renal adverse reactions w/ nephrotoxic agents (eg, NSAIDs & azathioprine). Increased potential for blood dyscrasias w/ azathioprine or 6-mercaptopurine. Decreased anticoagulant activity w/ coumarin-type anticoagulants (eg, warfarin).
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 tab 1200 mg
Packing/Price
60's
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