Production problems


jar with capsules

Approval of an alternative angina treatment will not resolve potential shortages resulting from issues with an existing drug  

The TGA advised recently that it had approved an alternative product to glyceryl trinitrate  (GTN) tablets, which are sold in Australia under the brand names Anginine and Lycinate, for treating acute angina pectoris (chest or heart pain caused by coronary heart disease).

Last year there were reports that a new formulation of GTN tablets for sublingual use were taking longer than usual to disintegrate and were more difficult to break in half, leading to a search for an alternative.

The TGA has now approved an application to supply an alternative product – Nitrostat tablets – however the availability of this alternative may not be sufficient to meet demand at this time, so the TGA says it is “continuing to work with industry to address this issue”.

To avoid a potential medicine shortage, the current formulation of Anginine and Lycinate tablets are not being recalled at the present time.

Nitrostat tablets are being sourced from the USA and supplied by Pfizer Australia, and contain the same active ingredient and are designed to dissolve under the tongue like Anginine/Lycinate tablets.

“It is important to be aware that there are some differences between Nitrostat tablets and Anginine and Lycinate tablets,” the TGA advises.

“Anginine and Lycinate tablets are supplied as 600 mcg tablets that were scored and could be broken in half to deliver a 300 mcg dose. Nitrostat 600 mcg tablets are not scored and cannot be broken in half. Therefore, Nitrostat tablets are also available as 300 mcg tablets, which give an equivalent dose to half an Anginine or Lycinate tablet.

Additionally, a total of three Nitrostat tablets can be taken over 15 minutes compared with a total of two Anginine or Lycinate tablets over 10 minutes”.

The alternative product is being relabelled with suitable instructions for patients. Additionally, the packaging will contain a patient leaflet that will provide further information about the safe use of the medicine.

The TGA recommends that, where clinically appropriate, patients can use the spray-based formulation of GTN, marketed as Nitrolingual Pump Spray.

However, the agency is advising that the spray delivers a different dose (400 mcg) to the tablets (600 mcg/300 mcg) and that this should be considered, along with the patient’s ability to use the spray correctly, in any decision to switch to that product.

Please note, the previous square-shaped formulation is not affected by this issue and that the sponsor of Anginine and Lycinate tablets, Arrow Pharmaceuticals, is working to reformulate the product.

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