MEZAVANT 1.2 G

What is MEZAVANT?

MEZAVANT 1.2 G contains MESALAZINE : 1.2 G. It is listed in the Health Canada Drug Product Database under DIN 02297558, held by TAKEDA CANADA INC, supplied as TABLET (DELAYED AND EXTENDED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 22-Nov-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MEZAVANT used for?

MEZAVANT® (mesalamine delayed- and extended-release tablets) is indicated for: • Induction of remission (clinical and endoscopic) in patients with active, mild to moderate ulcerative colitis. • Maintenance of clinical and endoscopic remission (mucosal healing) in patients with ulcerative colitis.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

MEZAVANT is intended for once daily, oral administration with food. The recommended dose for the induction of remission in patients with mild to moderate ulcerative colitis is two to four 1.2 g tablets to be taken once daily for a total daily dose of 2.4 to 4.8 g. The recommended dose for the maintenance of clinical and endoscopic remission (mucosal healing) is two 1.2 g tablets to be taken once daily for a total daily dose of 2.4 g. As for tablets needing to be swallowed whole, consideration should be given to the ability to swallow the intact tablet. The tablets should be swallowed whole with liquid and should not be crushed or chewed taking care not to break the outer coating. The outer coating is designed to remain intact until at least pH 7, normally in the terminal ileum, to protect the active ingredient, mesalamine, and ensure its availability throughout the colon. If a dose of this medication has been missed, it should be skipped and taken as usual the next day.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature 15°C to 25°C; excursions permitted to 30°C. Keep out of reach and sight of children.

How is it supplied?

MEZAVANT tablets are available as red-brown ellipsoidal film-coated tablets containing 1.2 g of mesalamine, and debossed on one side with S476. MEZAVANT tablets are supplied in opaque high-density polyethylene (HDPE) bottle of 120 tablets with child-resistant closure.

Contraindications

MEZAVANT is contraindicated in: • Patients who are hypersensitive to any salicylates (including mesalamine) or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • Patients with severe renal impairment (GFR <30 mL/min/1.73 m2) and/or severe hepatic impairment.

Warnings and precautions

Mesalamine products should not be used in patients with urinary tract obstruction, unless the expected benefit outweighs the risks. Extreme caution should be exercised and renal/urinary function should be closely monitored. Mesalamine 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 mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required. In patients with mild to moderate impaired liver function, mesalamine products should be used only if the expected benefits outweigh the risks to the patient. Caution should be exercised. Mesalamine induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported rarely with MEZAVANT and other mesalamine-containing preparations. Caution should be taken in prescribing this medication to patients with conditions predisposing to the development of myocarditis or pericarditis. Mesalamine products should not be used in patients with existing gastric or duodenal ulcer, unless the expected benefit outweighs the risks. Extreme caution should be exercised and adequate care given to those patients. Following mesalamine treatment, serious blood dyscrasias (including myelosuppression) have been reported rarely. The risk is further increased when mesalamine products are used concomitantly with 6-mercaptopurine or azathioprine. 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, mesalamine treatment should be discontinued. There have been reports of hepatic failure and increased liver enzymes in patients with pre-existing liver disease when treated with mesalamine products. Therefore, mesalamine is contraindicated in patients with severe hepatic impairment. In patients with mild to moderate liver function impairment, caution should be exercised and mesalamine products should only be used if the expected benefit clearly outweighs the risks to the patients. Appropriate assessment and monitoring of liver function should be performed. Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine should be considered. Reports of renal impairment, including minimal change nephropathy, acute or chronic interstitial nephritis and renal failure have been associated with mesalamine products and pro-drugs of mesalamine. Cases of nephrolithiasis have been reported with the use of mesalazine, including stones with a 100% mesalazine content. Ensure adequate fluid intake during treatment. Patients with chronic lung function impairment, especially asthma, are at risk of hypersensitivity reactions with mesalamine products and should be closely monitored. Photosensitivity: Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Hypersensitivity: Use of mesalazine has been associated with the following serious and life-threatening skin reactions: Drug reaction with eosinophilia and systemic symptoms (DRESS), Severe cutaneous adverse reactions (SCARs), Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN). At the time of prescription, patients should be informed of the signs and symptoms of SJS, TEN and DRESS, and be advised to monitor closely for skin reactions. Discontinue mesalazine at the first signs or symptoms of

What can be used instead?

Other Canadian products sharing ATC code A07EC02 MESALAZINE. 18 of 29 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies MESALAZINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. MESALAZINE appears in 884 registered pack listings across 11 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.