Medicine Identification Chart

Diastat^® Acudial^™

generic name: diazepam (di-AZ-e-pam) rectal gel

Manufacturer: Valeant Pharmaceuticals

Uses: A gel preparation of diazepman for rectal administration in the treatment of cluster seizures or prolonged seizures in the patient who has refractory epilepsy.

How it works: Diastat works to stop seizure activity by acting on brain cell interactions that inhibit the seizure discharges. Diastat is rapidly absorbed from the lining of the rectum and quickly achieves therapeutic levels in the serum. It can be used in children and adults.

Forms of the medicine: syringes that are already prepared with the appropriate dose, with a rectal tip that is either pediatric or universal in size. One box contains two doses (2 syringes), lubricating jelly and patient/caregiver information.

• 2.5 mg syringes pediatric
• 5.0 mg syringes pediatric
• 10 mg syringes universal
• 15 mg syringes adult
• 20 mg syringes adult

Dosing: The dose will be prescribed by the treating physician, based on age and weight of the patient. When to give during a seizure should be discussed and decided with the treating physician. A second dose may be given within 4-12 hours after the first dose if seizures persist or return. Diastat® should not be given more frequently than every five days and no more than five times per month. The dosage may need to be readjusted when there are changes in weight or growth.

Duration: Diastat® is not intended to be used as a daily medication. Tolerance to the medication can develop when used chronically. Increases in frequency and severity of tonic-clonic seizures may occur with daily use. If Diastat® is used frequently, abrupt cessation may result in an increase in seizures.

Side Effects: The most common side effects are those of drowsiness, headache, dizziness, diarrhea, flushing, unsteady gait, agitation, and confusion. Patients who have received Diastat should not operate heavy machinery for several hours afterwards. Diastat® is a drug that can result in drug dependence if used frequently and for a long time.

Information for pregnant women and nursing mothers: Women of child bearing potential and pregnant women should be told about potential effects on the fetus. Diastat® can cross the placenta and levels have been found in cord blood. Diastat® levels have also been found in breast milk for some time after administration. It is recommended that mothers refrain from breast feeding for several hours after receiving Diastat®.

Drug Interactions: There are some drugs that may enhance the effects of the Diastat®; these drugs include phenothiazines, narcotics, barbiturates, MAO inhibitors and antidepressants. Valproate may also enhance the depressant effect of the Diastat®. There are some potential drug-drug interactions that might take place as Diastat® metabolism shares common pathways with other drugs. If symptoms develop that are unusual for the patient, these should be reported to the treating physician.

Care during treatment with Diastat®: You should give the Diastat® as prescribed and no more frequently than recommended by your treating physician. If the prescribed dose is not working or there are unacceptable side effects you should discuss this with your physician. If you or the patient has grown or become pregnant, you should also tell your physician.

Possible contraindications to the use of Diastat®: History of prior adverse effect from diazepam or Diastat® It should be used with caution in patients with chronic respiratory depression, chronic hepatic or renal disease.

Not everyone experiences side effects. There may be other side effects not appearing above. For a complete list, consult your doctor, nurse, or pharmacist. More detailed sources of information on side effects include the drug's prescribing information sheet, the Physician's Desk Reference, or pharmaceutical company which produces the drug.