ATMOSALAZINE

Active Ingredient

mesalazine

Capsules contain extended-release pellets 500 mg

Mechanism of Action

ATMOSALAZINE has Mesalazine which is recognised as the active moiety of sulphasalazine in the treatment of ulcerative colitis. It is thought to act locally on the gut wall in inflammatory bowel disease, although its precise mechanism of action has not been fully elucidated.

Increased leucocyte migration, abnormal cytokine production, increased production of arachidonic acid metabolites, particularly leukotriene B4 and increased free radical formation in the inflamed intestinal tissue are all present in patients with inflammatory bowel disease. Mesalazine has in-vitro and in-vivo pharmacological effects that inhibit leucocyte chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals. It is currently unknown which, if any of these mechanisms play a predominant role in the clinical efficacy of mesalazine

Pharmacotherapeutic Group

Intestinal anti-inflammatory agents.

Market Name

ATMOSALAZINE

Active Ingredient

mesalazine

Capsules contain extended-release pellets 500 mg

Dosage Form

Capsules contain extended-release pellets 500 mg of mesalazine

Indication

ATMOSALAZINE is indicated for the induction of remission and for the treatment of adult patients with mildly to moderately active ulcerative colitis.

Contraindication

ATMOSALAZINE is contraindicated in patients with known or suspected hypersensitivity to salicylates, amino salicylates, or any components of this medication

Pregnancy & Lactation

Pregnancy

There is no clear evidence that mesalazine exposure in early pregnancy is associated with an increased risk of major

ATMOSALAZINE should only be used during pregnancy if the benefits outweigh the risks.

Nursing Mothers

Data from published literature report the presence of mesalazine and its metabolite, N-acetyl-5-aminosalicylic acid in human milk in small amounts with relative infant doses (RID) of 0.1% or less for mesalazine.

The clinical significance of this has not been determined and there is limited experience of nursing women using mesalazine.

There are reports of diarrhea observed in breastfed infants exposed to mesalazine. The effect of ATMOSALAZINE on milk production is unknown.

Exercise caution if ATMOSALAZINE is administered to a nursing woman and monitor breastfed infants for diarrhea