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MEZAVANT is a brand name for Mesalamine (also known as Mesalazine), supplied as a tablet (delayed and extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics, Absorption). 2 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.
For a complete listing (see 6 Dosage Forms, Strengths, Composition and Packaging). 73 m2) and/or severe hepatic impairment (see 7 Warnings and Precautions, Hepatic/Biliary/Pancreatic). 8 g with a high-fat meal in healthy volunteers increased systemic exposure of mesalamine compared to results in the fasted state; consideration should be given to this observation when prescribing to patients expected to consume high fat meals.
3 Clinical Pharmacology, Pharmacokinetics, Absorption). • In patients with mild to moderate renal impairment, mesalamine products should be used only if the benefits outweigh the risks. Therefore, caution should be exercised, and it is MEZAVANT® (mesalamine) Page 5 of 37 recommended that all patients have an evaluation of renal function prior to initiation of therapy, and periodically while on treatment (see 7 Warnings and Precautions, Renal).
2 Recommended Dose and Dosage Adjustment MEZAVANT is intended for once daily, oral administration with food. 8 g. 4 g. As for tablets needing to be swallowed whole, consideration should be given to the ability to swallow the intact tablet.
Pediatrics:
Health Canada has not authorized an indication for pediatric use.
Geriatrics:
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy.
Systemic exposures in individual subjects were inversely correlated with renal function as assessed by estimated creatinine clearance. 3 Pharmacokinetics Special Populations and Conditions). 4 Administration 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. 5 Missed Dose If a dose of this medication has been missed, it should be skipped and taken as usual the next day.
5 Overdose MEZAVANT is an aminosalicylate, and symptoms of salicylate toxicity may include confusion, diarrhea, drowsiness, headache, hyperventilation, sweating, tinnitus, vertigo, and vomiting. Severe intoxication may lead to disruption of electrolyte balance and blood-pH, hyperthermia, and dehydration.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mesalamine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy. Maintain adequate renal function. For the most recent information in the management of a suspected drug overdose, contact your MEZAVANT® (mesalamine) Page 6 of 37 regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764- 7669).
6 Dosage Forms, Strengths, Composition and Packaging Table 1: Dosage Forms, Strengths, Composition and Packaging. 2 g of mesalamine, and debossed on one side with S476. The MEZAVANT delayed- and extended-release tablet contains a core of 1200 mg mesalamine (5-aminosalicylic acid; 5-ASA), formulated with a matrix of lipophilic and hydrophilic excipients.
The tablet is coated with a gastro-resistant film of methacrylic acid – methyl methacrylate copolymer (1:1) and methacrylic acid – methyl methacrylate copolymer (1:2) (MMX Multi Matrix System®), which are designed to delay the initial release of mesalamine until exposure to approximately pH 7 and above, normally in the terminal ileum.
2. The combination of the matrix of lipophilic and hydrophilic excipients (MMX Multi Matrix System®) and gastro-resistant coating facilitate the delayed and extended delivery of effective concentrations of mesalamine through the entire colon with limited systemic absorption.
MEZAVANT tablets do not contain gluten, lactose or phthalates. MEZAVANT tablets are supplied in opaque high-density polyethylene (HDPE) bottle of 120 tablets with child-resistant closure. 7 Warnings and Precautions General 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 Route of Administration Dosage Form/ […]