Psycho-Babble Medication Thread 568520

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For those of you that were eagerly awaiting this..

Posted by jrbecker on October 18, 2005, at 11:24:27

Valium (Diazepam) now comes in an easy rectal gel version!

Diazepam Rectal Gel Delivery System (Diastat AcuDial) for at-Home Use

On Sept. 15, the FDA approved a new delivery system for diazepam rectal gel (Diastat AcuDial, made by Valeant Pharmaceuticals International) that enables immediate in-home treatment of emergency seizures by a non–medically trained caregiver.

Using the system, pharmacists can dial, set, and lock in specific doses ranging from 5 to 20 mg using one of two configurations: one with a 4.4-cm tip that delivers doses of 5, 7.5, and 10 mg, and the other having a 6.0-cm tip for delivery of 10-, 12.5-, 15-, 17.5-, and 20-mg doses.

No refrigeration or special handling is required, allowing the device to be stored in the home or office, and taken along when traveling.

The approval was based on data from clinical studies showing that use of the system was effective in resolving seizures in 85% of patients; 71% remained seizure-free for 12 hours after diazepam administration.

Home use of the system was also linked to a 67% decrease in emergency-department visits, and 82% of patients treated with the device in clinical trials were assessed by their caregivers as better compared with 33% of placebo-treated patients (P < .0001).

Diazepam rectal gel is indicated for the management of selected refractory patients with epilepsy who are on stable anti-epileptic drug regimens and who require intermittent use of diazepam to control bouts of increased seizure activity.

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