Hydralazine hydrochloride (20 mg ampoule): Supply issue

Supply issue Section 29A Active

Due to delays at the factory, there is a supply issue affecting hydralazine hydrochloride 20 mg ampoule (Pharmacodes: 274550 and 2446227).

Affected product

The supplier expects to run out of the Apresoline brand during May 2026.

  • Chemical: Hydralazine hydrochloride
  • Presentation: Inj 20 mg ampoule
  • Brand: Apresoline
  • Pharmacode: 274550 and 2446227
  • Price: $25.90
  • Measure / Qty: per 5

HML Schedule listings for hydralazine hydrochloride(external link)

Alternative products

To ensure continuity of supply, Pharmac has sourced two alternatives that are listed from 1 May. These are not Medsafe approved and need to be prescribed and supplied in line with Section 29A of the Medicines Act 1981.  

Eugia brand

The Eugia product, supplied by Orspec, is a vial not an ampoule. This is a sterile, nonpyrogenic clear, colourless solution and does not require reconstitution. It is available from the supplier immediately.

Hydrapres brand

The Hydrapres product requires reconstitution, and the instructions differ from the Medsafe approved Apresoline product. This product will be available from mid-June 2026.

  • Hydrapres: dilute with 1.1 mL, then extract 1.0 mL
  • Apresoline (Medsafe approved): dilute with 1.0 mL, extract 1.0 mL

Key information/differences on alternatives

Details

Apresoline 20mg ampoule

Hydrapres 20mg ampoule

Eugia 20 mg per ml, 1 ml vial

Pharmacode

274550 and 2446227

2728176

2729563

Listing Date

Currently listed

Listed 1 May 2026

Listed 1 May 2026

Availability

Expected to run out May 2026

Expected mid‑June

Expected early May

Presentation

Ampoule

Ampoule

Vial

Medsafe Approved

Yes

No – Section 29

No – Section 29

Reconstitution

Required (1.0 mL → extract 1.0 mL)

Required (1.1 mL → extract 1.0 mL)

None required

Labelling / language

English

Spanish product, over‑labelled in English

English

Storage

  • Store below 25ºC.
  • Use reconstituted solution within 24 hours.
  • Store below 30ºC.
  • Keep in the original packaging.
  • Store below 25ºC

Inactive ingredients (Excipients) 

None

  • Mannitol (E-421)
  • Hydrochloric acid to adjust pH to 3.5-4.2
  • Methylparaben NF, 0.65 mg
  • Propylparaben NF, 0.35 mg
  • Propylene glycol USP, 103.6 mg
  • Sodium hydroxide
  • Hydrochloric acid
  • USP to adjust pH (3.4 to 4.4)
  • Water for injection.

Expected resupply

We are working with the supplier to understand when Apresoline brand will be available again.

Who to contact

If you have questions about this issue, email enquiry@pharmac.govt.nz

Please include as much information as you can about the product (presentation, brand, pharmacode) and who your wholesaler is.

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