Safety Advisory Update

 

Further to DrugAlert Volume 284, HPS Pharmacies wish to provide an update on the availability of:

Glyceryl Trinitrate 600µg Tablets
Anginine® ARTG 227783
Lycinate® ARTG 227784

The new round tablet formulation of glyceryl trinitrate tablets are taking longer to disintegrate and are more difficult to break in half than the previous square tablet formulation. Arrow Pharmaceuticals is in the process of reformulating the product to improve dissolution times. The previous formulation may still be relied upon as long as the tablets are within the manufacturer’s expiry date and are discarded three months after opening the bottle.

The Therapeutic Goods Administration (TGA) has approved an application to supply an alternative product, Nitrostat® which is now also available on the Pharmaceutical Benefits Scheme (PBS). It is important to note that there are some differences between Nitrostat® , and Anginine® and Lycinate® . Nitrostat® tablets are not scored and cannot be broken in half to deliver a 300μg dose. However, Nitrostat® tablets are available in both a 300μg tablet and a 600μg tablet.

The TGA has advised that supplies of Nitrostat® 600µg tablets are unlikely to meet the current demand. However, two of the 300µg Nitrostat® tablets may be used as an alternative to one 600µg tablet.

Nitrolingual® , the spray-based formulation of glyceryl trinitrate, is not affected by this issue and may also be considered as an alternative. Nitrolingual® delivers 400µg of glyceryl trinitrate per spray.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Arrow Pharmaceuticals on 1300 927 769.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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