About the shortage of Presolol (labetalol hydrochloride) tablets

Pharmaceutical company Alphapharm has notified us of a shortage of Presolol 200 (labetalol hydrochloride 200 mg) tablets due to manufacturing issues.

The previous shortage of Presolol 100 tablets resolved in December 2025.

To ensure ongoing access to this essential medicine that is used to treat all grades of hypertension, we have approved the supply of an overseas-registered labetalol 200 mg tablet product under section 19A of the Therapeutic Goods Act 1989. Go to the Section 19A approvals database for information about this product (search by the ingredient name ‘labetalol’).

We have also made a new Serious Scarcity Substitution Instrument (SSSI). This will allow a pharmacist to dispense the different strength of the labetalol hydrochloride tablets prescribed in an equivalent quantity, if appropriate, without a new prescription. 

If Presolol 100 (labetalol 100 mg) is prescribed but is unavailable, Presolol 200 (labetalol 200 mg) tablets can be dispensed. If Presolol 200 (labetalol 200 mg) is prescribed but is unavailable, Presolol 100 (labetalol 100 mg) tablets can be dispensed. The overseas-registered labetalol 200 mg tablets we have approved can also be used as a substitute under this SSSI.

With the substitution:

• one tablet of Presolol 100 (labetalol 100 mg) is equivalent to half a tablet of labetalol 200 mg
• one tablet of Presolol 200 (labetalol 200 mg) is equivalent to 2 tablets of labetalol 100 mg.

See below for information about the SSSI for patients, pharmacists and prescribers.

Up-to-date information about availability is published on the Medicine Shortage Reports Database. Search for ‘Presolol’.

Information for patients

If you are prescribed labetalol hydrochloride as Presolol 100 mg or Presolol 200 mg and it is not available, your pharmacist can substitute the other strength and/or an alternative brand of labetalol hydrochloride tablets without a new prescription.  

If your pharmacist gives you labetalol hydrochloride 200 mg tablets in place of the 100 mg tablet, they will explain that: 

• the tablets might look different because they are a different strength and/or brand
• you should break a 200 mg tablet in half and take only one of the halves to get a 100 mg dose
• if the tablet is not split exactly in half, you are at risk of inadvertent overdose, which could cause your blood pressure to drop suddenly.

If your pharmacist gives you Presolol 100 (labetalol hydrochloride 100 mg) tablets in place of the 200 mg tablet, they will explain that:

• the tablets might look different because they are a different strength
• you should take 2 tablets of Presolol 100 to get a 200 mg dose.

Please note that:

• the substitute medicine may cost you more, because only Presolol 100 (labetalol hydrochloride 100 mg) tablets are on the Pharmaceutical Benefits Scheme (PBS)
• once a script for 100 mg labetalol tablets is changed to private to get 200 mg tablets, it cannot be used as a PBS script for repeats in the future − the pharmacist will tell you about this
• you may still need a new prescription from your doctor if you cannot comfortably break the tablet exactly in half, if the substitute tablets are not available, or if another treatment would be better for you.

If you are unable to fill your prescription or do not consent to the substitution, speak to your doctor about other options for your situation.

Information for pharmacists

The SSSI allows you to substitute one strength of Presolol (labetalol hydrochloride) tablets for another when the strength prescribed for a patient is unavailable. The overseas-registered labetalol 200 mg tablets we have approved can also be used as a substitute under this SSSI. 

You can make the substitution without prior approval from the prescriber if you follow the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2) of the SSSI.

You are encouraged to use your professional and clinical judgement to determine whether substitution is suitable for a patient and to gain their consent. Refer patients to the prescriber if substitution is inappropriate, for example: 

• if the patient does not have the cognitive capacity needed to take 2 tablets of Presolol 100 in place of one tablet of Presolol 200, there is a risk of the patient taking the incorrect dose
• if the patient does not have the dexterity or cognitive capacity needed to comfortably break the 200 mg tablets, either because of their age or medical conditions, and the tablet is inaccurately split, the patient is at risk of inadvertent overdose, which could cause postural hypotension.

Also refer the patient to the prescriber if an appropriate substitutable medicine is not available, or if alternative treatments other than substitution may be more appropriate.

When you use the SSSI to substitute the scarce and substitutable medicine: 

• you must instruct the patient on how to take the substitute tablet, or refer them to their prescriber or GP for guidance
• you can use Consumer Medicines Information (CMI) leaflets to help explain the substitution to patients and to get their consent; you may need to use translation services, a carer or organisations such as a local Aboriginal Community Controlled Health Organisation (ACCHO) if needed to ensure the patient fully understands the situation.
• inform the prescriber by email, fax or phone as soon as is practical after you make the substitution. 

How substitution affects the PBS subsidy

Dispensing labetalol tablets under this SSSI will affect PBS subsidisation. Please consider and discuss with your patients that Presolol 200 tablets and the overseas-registered alternative are not listed on the PBS, as follows: 

• If a patient has a PBS prescription for Presolol 100 tablets and you dispense labetalol hydrochloride 200 mg tablets as a substitutable medicine, they will not get a PBS subsidy.
• If a patient has a non-PBS prescription for Presolol 200 and you dispense Presolol 100, they will not get a PBS subsidy despite 100 mg tablets being listed on the PBS.
• Dispensing a PBS prescription as ‘private’ means future repeats cannot be dispensed under the PBS. 

Information for prescribers

With the SSSI in place, a pharmacist may substitute one strength of Presolol (labetalol hydrochloride) tablets for the other, without a new prescription from you. The overseas-registered labetalol hydrochloride 200 mg tablets can also be used as a substitute under this SSSI.

When a pharmacist offers your patient the substitute strength, they may give information and guidance on how to take it, or they may recommend the patient contact you for this information. Consider checking how your patient is using the substitute strength at their next appointment. 

The pharmacist will refer the patient to you if they consider the substitution to be inappropriate, for example: 

• if the patient does not have the dexterity or cognitive function needed to comfortably break the 200 mg tablets, noting that inadvertent overdose may occur if the tablet is inaccurately split
• if the patient does not have the cognitive function needed to take 2 tablets of Presolol 100 mg in place of one tablet of Presolol 200 mg, noting there is a risk of the patient taking the incorrect dose.

The pharmacist may also refer the patient to you if an appropriate substitutable medicine is not available, the patient does not consent to the substitution, or alternative treatments other than substitution may be more appropriate.

Please note that Presolol 200 tablets and the overseas-registered alternative are not subsidised on the PBS and would not be subsidised under the SSSI. Similarly, if a patient has a non-PBS prescription for Presolol 200 and is given Presolol 100 by the pharmacist, they will not get a PBS subsidy despite 100 mg tablets being listed on the PBS. Also, if a PBS prescription is dispensed as private, future repeats cannot be dispensed under the PBS. 

In the first instance above, your patient may prefer a new prescription for a medicine that is subsidised on the PBS.

General information

We encourage you to check the Medicine shortage reports database for updates about the supply of Presolol tablets.

Please also keep in mind that we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the PBS.

While we can suggest approaches to manage the supply of medicines during shortages, we do not have the power to regulate the clinical decisions of health professionals.

We will continue to monitor the supply of Presolol tablets and work with the supplier to update this advice if needed.

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.