HPS Pharmacies wish to advise that Upjohn Australia, in consultation with the Therapeutic Goods Administration (TGA), has communicated a product safety issue regarding Dilantin® as follows:

Dilantin® Paediatric Suspension
Phenytoin 30mg / 5mL
ARTG 14309

This product safety issue relates to the identification of higher than acceptable levels of lead in some batches. The recently updated International Conference on Harmonization (ICH) permitted daily exposure (PDE) for lead is 5 micrograms per day.

The amount of lead a patient is exposed to will depend upon the dose of Dilantin® Paediatric Suspension that the patient receives:

  • In paediatric patients, the maximum daily dose is 300mg (50mL). While previous batches of Dilantin® suspension have been found to exceed the ICH PDE for lead at the maximum daily dose, current batches do not.
  • In adult patients, the maximum daily dose is 600mg (100mL). At the maximum adult dose, all batches of the suspension have been found to exceed the ICH PDE for lead.
  • Daily doses up to 486mg (80.98mL) do not exceed the ICH PDE for lead.

Upjohn Australia makes the following recommendations:

  • For paediatric patients, carefully consider the overall risk/benefit of this product when initiating or continuing maintenance treatment.
  • For adult patients, initiation of this product is not recommended. Carefully consider the overall risk/benefit of maintenance treatment.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Upjohn Australia on 1800 314 527 or your pharmacist at HPS Pharmacies.

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