Fluoxetine 20mg (Zactin®) Shortage

There is currently a shortage of fluoxetine 20mg dispersible tablets (Zactin®) due to manufacturing issues. Supply issues are expected to continue until 29th February 2024.

The TGA has published a Serious Scarcity Substitution Instrument (SSSI) to allow pharmacists to substitute fluoxetine capsules where appropriate.

There are also s19A approved fluoxetine 10mg capsules available that can be supplied for patients who require a dose less than 20mg, or a dose that cannot be made up in multiples of 20mg. It should be noted that these s19A products do not currently have a PBS listing and can only be supplied to patients privately. Information on the s19A products can be found in the TGA’s s19A approvals database.

When switching to fluoxetine capsules, patients should be advised to swallow capsules whole, however where required fluoxetine capsules may be opened, and the contents dispersed. Patients or carers of patients who use Zactin Tabs® due to difficulty swallowing, dexterity issues or health conditions requiring enteral feeding may require further information on opening fluoxetine capsules, which can be found in the SHPA’s Don’t Rush to Crush guidelines.

If you are dispensing an authority approved prescription for fluoxetine 20mg capsule, PBS Online will return warning codes 162 and 163 if substituting under the SSSI. Services Australia has advised that these codes can be disregarded in this instance.

More information on the SSSI and the shortage of fluoxetine 20mg dispersible tablets can be found here.