Labetalol injection 5mg/ml (20ml ampoule): Supply issue resolved

Labetalol injection is an antihypertensive used in a wide range of clinical indications, including severe hypertension in pregnancy. It is generally used in hospitals.

Trandate brand released to the market 21 April 2021

Labetalol injection 5mg per ml, 20 ml ampoules (Trandate brand p/code 256951) had been in out of stock since July 2020. 

The Trandate brand is the only labetalol injection approved by Medsafe.

This supply shortage did not apply to labetalol tablets.

Alternative treatment

While the Trandate brand was out of stock, we listed Alvogen as an alternative brand, to ensure people could continue to access this vital medication.

The Alvogen (pharmacode 2593769) labetalol injection 5mg per ml, 20ml ampoules was listed on 1 July 2020.

Alvogen is an unapproved medicine in New Zealand. As such, it needed to be supplied in accordance with section 29 of the Medicines Act 1981.

More about medicines supplied under s29

PHARMAC has received expert clinical advice from the relevant PTAC subcommittees. They advise it is not uncommon for section 29 medicines to be used in critical care and obstetrics. They note patients are carefully monitored in these settings. 

We know supplying a medicine under section 29 is not ideal. However, section 29 supply is the only alternative to an out of stock situation for this medicine.

We appreciate that this can limit the ability of non-medical prescribers to prescribe this medicine. 

Information for prescribers

Alvogen is an unapproved medicine in New Zealand. As such, it needs to be supplied in accordance with section 29 of the Medicines Act 1981. Prescribers need to be familiar with their obligations under section 29.

Labetalol on the NZ Formulary(external link)

Only medical practitioners can supply section 29 medicines.

Read more about section 29 on the Medsafe website(external link) 

What you need to know about Alvogen

Alvogen:

  • has the same concentration and volume as the Trandate injection. 
  • is an overseas-registered pharmaceutical
  • has slightly different packaging and presentation from Trandate
  • has been approved for use in the US.

In all clinical settings where labetalol injection is used, we recommend:

  • staff familiarise themselves with the packaging and presentation of Alvogen injection
  • clinical protocols and guidelines are amended to include Alvogen specific information, if needed.

Information for pharmacists

The Alvogen brand of labetalol injection 5mg per ml, 20 ml ampoules was listed in Section B of the Pharmaceutical Schedule from 1 July 2020.

It was listed on the Schedule to be supplied under section 29. 

Check the listing in the Schedule(external link)

Wastage rules will apply.

Check the wastage rules