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(diazepam rectal gel)
Diastat AcuDial is the only FDA approved at-home treatment for the management of
breakthrough seizures. Diastat AcuDialis an easy-to-use delivery system that enables a
non-medically trained caregiver to take control of a seizure. Diastat AcuDial ccan begin to
work within 15 minutes.
Diastat AcuDial is a gel formulation of diazepam and is intended for rectal administration in the
management of selected refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs
(AEDs), who require intermittent use of diazepam to control the attacks of increased seizure activity for
patients two years and older.
The reason Diastat AcuDial is given rectally is because when experiencing a seizure, taking medications
can be difficult. You may not be able to swallow a pill, or it might cause you to choke. Diastat AcuDial is given rectally because the absorption of the medication is fast - within 15 minutes. Rectal absorption of
Diastat AcuDial is rapid, safe and effective. Because of its rapid absorption, rectal administration of
medications is very common worldwide.
Valeant Pharmaceuticals is in the process of developing an intranasal diazepam for the at-home treatment of
emergency seizures.
Epilepsy is defined as a chronic neurological condition where the individual is susceptible to several
seizures. A seizure is a sudden, temporary, interruption of the normal electrical/chemical activity in the
brain, resulting in a change in sensation, awareness or behavior. A seizure can range from a brief
disruption of senses, brief stares, muscle spasms, or odd sensations, to short periods of unconsciousness,
to convulsions. Some people have just one type of seizure; others are susceptible to more than one.
Epilepsy is not a mental disorder. Epilepsy can be caused by anything that affects the brain, such as a
stroke, brain trauma, a brain tumor, degenerative disease (such as Alzheimer's), or an infection (such as
meningitis or encephalitis). Epilepsy can be genetically inherited. Sometimes, there is no cause at all.
Approximately 2.7 million Americans suffer from epilepsy, of whom, approximately 30% are not able to control
their seizures with existing maintenance therapies. Epilepsy is a physical condition that starts in the
brain. It is a symptom that disrupts the way a person's brain works. When this happens, a person may
suddenly have a seizure. Many people will have a single seizure at some time in their lives, but this does
not mean that they have epilepsy. If a person has epilepsy it means that they have had more than one seizure
that began in the brain. Epilepsy is experiencing two or more seizures of unknown cause.
Prolonged or repetitive seizures can cause neurological damage. They can also increase the risk of death,
mental handicap, memory loss and changes in neuropsychological function. Annually, approximately 42,000
deaths occur due to epilepsy.
About 300,000 American children under the age of 14 have epilepsy. Epilepsy in children may be time limited
or long term and represents the most common serious neurological problem affecting children, with overall
incidence approaching 2% for febrile seizures and 1% for idiopathic epilepsy. Seizures in children have many
causes. Common causes of childhood seizures or epilepsy include:
- fever (these are called febrile seizures)
- genetic causes
- head injury
- infections of the brain and its coverings
- lack of oxygen to the brain
- hydrocephalus (excess water in the brain cavities)
- disorders of brain development. (however, most seizures are not associated with a definite cause)
Currently there is no known cure for epilepsy. However, antiepileptic drugs can help to control seizures in
most people. These drugs do not actually "fix" the problems that cause seizures; they work by suppressing
seizures. Before choosing an antiepileptic drug, it's important to do these two things: receive an accurate
diagnosis of epilepsy and have an open discussion with your doctor about the pros and cons of the different
drugs available.
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, the most frequent side effect was sleepiness (23%). Less frequent adverse events reported were dizziness, headache, pain, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis (1%-5%).
Please see full DIASTAT AcuDial prescribing information at www.diastat.com.
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