Glyceryl trinitrate tablets (Anginine and Lycinate)

Update - medicine shortage

9 February 2017

Further to the information provided below, the TGA anticipates that there will be a shortage of the alternative product 600 mcg (0.6 mg) Nitrostat tablets. However, the 300 mcg (0.3 mg) tablets are not expected to be in short supply and two 300 mcg tablets can be taken as an alternative to one 600 mcg tablet.

Additionally, Pfizer Australia is working to make more units of the 600 mcg tablets available as soon as possible.

See the 'Alternative product' section below for further information.


Alternative product and potential medicine shortage

3 February 2017

This alert updates information previously provided in TGA safety advisories published on 27 July 2016 and 2 June 2016 regarding a new formulation of glyceryl trinitrate (GTN) tablets for sublingual use that were taking longer than usual to disintegrate and were more difficult to break in half.

GTN tablets, which are sold in Australia under the brand names Anginine and Lycinate, are used to treat acute angina pectoris (chest or heart pain caused by coronary heart disease). The tablets are used in acute healthcare settings, such as hospitals and ambulances, but can also be used by patients at home.

Consumers and health professionals are advised that the TGA has approved an application to supply an alternative product (see the ‘Alternative product’ section below for further information).

However, the availability of this alternative product may not be sufficient to meet demand at this time, so the TGA is continuing to work with industry to address this issue.

old formulation square tablets and new formulation round tablets

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

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.

Alternative product

Alternative supply has now been approved for Nitrostat tablets, which have been sourced from the United States of America and are being supplied by Pfizer Australia. Nitrostat tablets 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. 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, health professionals are reminded 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.

Further information is provided for consumers and health professionals below.

Information for consumers

If you or someone you care for uses Anginine or Lycinate tablets, please be aware of this issue.

Alternative products have been approved for supply to help ensure you continue to have access to these medicines (see ‘Alternative product’ above). However, the availability of this alternative product may not be sufficient to meet demand at this time.

Please note that the alternative product, Nitrostat, is available in 0.6 mg (equal to 600 mcg) and 0.3 mg (equal to 300 mcg) tablets. Unlike Anginine and Lycinate, which come in 600 mcg tablets and can be broken in half, Nitrostat tablets cannot be split. If you require a half-dose of Anginine or Lycinate, you will need to use a 0.3 mg (300 mcg) tablet.

The alternative product is being relabelled with suitable instructions and should always be used in accordance with those instructions, including being dissolved under the tongue. As with Anginine and Lycinate, they must not be swallowed like normal tablets, as they will not work.

Nitrostat tablets have been listed on the Pharmaceutical Benefits Scheme (PBS) from 1 February 2017.

If you wish, you can also talk to your health professional about possible alternative treatments, such as the spray-based formulation of GTN, marketed as Nitrolingual Pump Spray.

If you are unable to get an alternative product (either Nitrostat tablets or Nitrolingual Pump Spray) you should continue to use Anginine and Lycinate if it is required. However, be aware that the tablets may not work within the expected timeframe and may be difficult to break in half. If these tablets do not relieve your symptoms, you should seek urgent medical attention (calling 000 if necessary).

If you have any questions or concerns about this issue, speak to your health professional.

Further information regarding this issue will be published as soon as it becomes available.

Information for health professionals

If you are treating a patient who uses Anginine or Lycinate tablets, particularly in a home setting, please advise them of this issue.

Ensure they are aware of the differences in dosages and labelling for the alternative product Nitrostat (600 mcg and 300 mcg tablets) and that the 600 mcg tablets cannot be broken in half like Anginine and Lycinate tablets. Therefore patients who would normally use a half-dose of Anginine or Lycinate should be prescribed the 300 mcg Nitrostat.

Also, if clinically appropriate, you may consider switching patients who use GTN tablets to the GTN spray (marketed as Nitrolingual Pump Spray), noting that the spray delivers a different dose compared to the tablets.

Please remind patients to always take GTN tablets in accordance with the instructions for those medicines, including that they are for sublingual use and should not be swallowed like normal tablets.

For further information about the alternative product, contact Pfizer Australia on 1800 629 921.

Further information regarding this issue will be published as soon as it becomes available.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.