AZAMUN Film coated tablet Ref.[50454] Active ingredients: Azathioprine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand Phone: (09) 835 0660

Product name and form

Azamun 25 mg, 50 mg, 75 mg, 100mg, Film coated tablet.

Pharmaceutical Form

Azamun 25 mg: Light yellow, circular, biconvex tablet engraved “AZA” and “25” on one side and plain on the other side.

Azamun 50 mg: Light yellow, circular, biconvex tablet engraved “AZA”' break-line “50” on one side and plain on the other side.

Azamun 75 mg: Light yellow, circular, biconvex tablet engraved “AZA” and “75” on one side and plain on the other side.

Azamun 100 mg: Light yellow, circular, biconvex tablet engraved “AZA” and “100” on one side and plain on the other side.

The scoreline on Azamun 50 mg is not intended for breaking the tablet.

Qualitative and quantitative composition

Azamun 25 mg: each tablet contains 25 mg azathioprine.

Azamun 50 mg: each tablet contains 50 mg azathioprine.

Azamun 75 mg: each tablet contains 75 mg azathioprine.

Azamun 100 mg: each tablet contains 100 mg azathioprine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Azathioprine

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

Azamun contains cellulose microcrystalline, mannitol, povidone, maize starch, croscarmellose sodium, sodium stearyl fumarate in the tablet core. The tablet coating contains Opadry clear OY7240 (macrogol 400 and hypromellose).

Pack sizes and marketing

Azamun 25 mg: 30, 60 and 100 tablets in PVC/PVDC-Aluminium foil blister strips.

Azamun 50 mg, 75 mg, 100 mg: 100 tablets in PVC/PVDC-Aluminium foil blister strips.

Not all strengths or pack sizes may be marketed.

Marketing authorization holder

Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand
Phone: (09) 835 0660

Marketing authorization dates and numbers

Date of first approval:

Azamun 50 mg: 13 August 1998

Azamun 25 mg, 75 mg, 100 mg: 26 June 2014

Drugs

Drug Countries
AZAMUN Hong Kong, New Zealand, South Africa

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