Cracked Tip Alert

Valeant Pharmaceuticals North America has received complaints concerning small cracks at the base of the plastic tip of some DIASTAT AcuDial applicators. View Syringe Inspection Instructions.
If you have any questions or would like to schedule a visit from a Valeant Sales Representative, please call 1-877-361-2719.

Dial, Set & Lock Instructions for DIASTAT® AcuDial™ (diazepam rectal gel)

The Food and Drug Administration has received reports of dosing errors due to DIASTAT AcuDial Syringes not being properly dialed and locked.

As the pharmacist, you will need to dial in the correct dose from the pre-filled DIASTAT AcuDial and lock it into place.

DIASTAT AcuDial is prescribed as Twin Pack because an additional dose may be required:

  • Please do not separate
  • Please be sure to dial, set and lock both doses.

Because you will be dialing the dose in the prescribed increments of 2.5 mg, we want to make sure you are comfortable with the dial and lock features of DIASTAT AcuDial.

Dial, Set and Lock

Confirm Correctly Dialed

Make sure the correct dose appears through the dose display window. This is a visual indication that the barrel of the DIASTAT AcuDial is in the correct position for the desired dose:

  • Ensure that the locking ring is engaged
  • The green “READY” band will be revealed at the base of the DIASTAT AcuDial. This allows you to see that the unit has been locked.

Now repeat steps for the second DIASTAT AcuDial in the Twin Pack

If you misdial or lock DIASTAT AcuDial before dialing the dose, please call 1-877-361-2719.

 
IMPORTANT SAFETY INFORMATION

DIASTAT® AcuDial™ (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity for patients 2 years and older.

In clinical trials with DIASTAT®, the most frequent side effect was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis (1%-5%). Please see full DIASTAT AcuDial Prescribing Information.