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. Maintenance of remission.
Dosage/Direction for Use
Adult including elderly (>65 yr) Induction of remission 2.4-4.8 g once daily. Patient not responding to lower doses: Max 4.8 g/day; evaluate effect at 8 wk. Maintenance of remission 2.4 g once daily.
Administration
Should be taken with food: Do not crush/chew.
Contraindications
Hypersensitivity to salicylates (including mesalazine). Severe renal impairment (GFR <30 mL/min/1.73 m2) &/or severe hepatic impairment.
Special Precautions
Closely monitor patients w/ chronic lung function impairment, especially asthma, for risk of hypersensitivity. Potential risk of cross sensitivity reactions w/ sulphasalazine. Possible severe photosensitivity reactions in patients w/ pre-existing skin conditions (eg, atopic dermatitis & eczema). Perform haematological investigations if patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Terminate treatment if there is blood dyscrasia suspicion. Patients w/ conditions predisposing to myo- or pericarditis development. W/draw promptly if acute intolerance syndrome is suspected. Increased liver enzyme levels. May delay onset of action by organic or functional obstruction in the upper GIT. May lead to falsely elevated test results when measuring urinary normetanephrine by liqd chromatography w/ electrochemical detection. Nephrolithiasis; ensure adequate fluid intake during treatment. Patients w/ confirmed mild to moderate renal impairment. Evaluate renal function prior to initiation of therapy & at least twice a yr, while on treatment. Hepatic impairment. 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 (eg, ALT, AST, bilirubin); pruritus, rash; arthralgia, back pain; asthenia, fatigue, pyrexia.
Drug Interactions
May increase risk of renal AR w/ known nephrotoxic agents including NSAIDs & azathioprine. May increase potential for blood dyscrasias, bone marrow failure, & associated complications in concurrent use w/ azathioprine or 6-mercaptopurine &/or known myelotoxicity-causing drugs. May decrease anticoagulant activity of coumarin-type anticoagulants (eg, warfarin). May lead to falsely elevated test results when measuring urinary normetanephrine by liqd chromatography w/ electrochemical detection.
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 gastro-resistant PR tab 1,200 mg
Packing/Price
5 × 12's
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