Safety Advisory Update

 

Further to DrugAlert Volume 275, HPS Pharmacies wish to advise that Arrow Pharmaceuticals, in consultation with the Therapeutic Goods Administration (TGA), has confirmed a safety issue concerning:

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

Laboratory testing has confirmed that 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. If only the new formulation is available, patients should be advised that the tablets may not work within the expected timeframe. This is also a timely opportunity to remind patients that the medication must not be swallowed. The tablet should be allowed to dissolve under the tongue. If symptom relief is not achieved, urgent medical attention should be sought.

Nitrolingual®, the spray-based formulation of glyceryl trinitrate, is not affected by this issue and offers the advantage of continued potency up to the manufacturer’s expiry date. Nitrolingual® delivers 400µg of glyceryl trinitrate per spray, while Anginine® and Lycinate® tablets contain 600µg.

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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