IMURAN Tablet

Active ingredients: Azathioprine

Product name and form

Imuran Tablets 25 mg.

Pharmaceutical Form

Tablet.

Qualitative and quantitative composition

Orange, round, biconvex, film-coated tablets, unscored, branded ‘IM 2’ and containing 25 mg Azathioprine BP in each tablet

Each tablet contains 25 mg of the active substance azathioprine.

Excipient(s) with known effect: Each 25 mg tablet contains 37 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Azathioprine is a pro-drug of 6-mercaptopurine (6-MP). 6-MP is inactive but acts as a purine antagonist and requires cellular uptake and intracellular anabolism to thioguanine nucleotides (TGNs) for immunosuppression. The TGNs and other metabolites (e.g. 6-methyl-mecaptopurine ribonucleotides) inhibit de novo purine synthesis and purine nucleotide interconversions.

List of Excipients

Lactose
Pregelatinised starch
Maize starch
Stearic acid
Magnesium stearate
Methylhydroxylpropyl cellulose
Polyethylene glycol 400
Titanium dioxide (E171)
Iron oxide, yellow (E172)
Iron oxide, red (E172)

Pack sizes and marketing

Blister strips in a pack.

Pack sizes: 28, 30, 56, 60 and 100 tablets.

Marketing Authorization Holder
Authorization Dates

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

20 March 1992

Marketing authorization number:

PL 39699/0004

Drugs

Drug
Countries
Australia, Canada, Cyprus, Hong Kong, Lithuania, Netherlands, Singapore, United Kingdom, United States