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. 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. 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. Decreased 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.
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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