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Diastat

DIAZEPAM
Diastat

CLASS

Benzodiazepine, Sedative-hypnotic, Anticonvulsant

DOSEAGE:

Recommended for patients age 2 or greater.
0.5 mg/kg Rectal

Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip.

Diastat Description

Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, propylene glycol, ethyl alcohol (10%), hydroxypropyl methylcellulose, sodium benzoate, benzyl alcohol (1.5%), benzoic acid and water. Diazepam rectal gel is clear to slightly yellow.

ACTION

Although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and in vitro studies suggest that diazepam acts to suppress seizures through an interaction with γ-aminobutyric acid (GABA) receptors of the A-type (GABAA). GABA, the major inhibitory neurotransmitter in the central nervous system, acts at this receptor to open the membrane channel allowing chloride ions to flow into neurons. Entry of chloride ions causes an inhibitory potential that reduces the ability of neurons to depolarize to the threshold potential necessary to produce action potentials. Excessive depolarization of neurons is implicated in the generation and spread of seizures. It is believed that diazepam enhances the actions of GABA by causing GABA to bind more tightly to the GABAA receptor.

Diazepam rectal gel is well absorbed following rectal administration, reaching peak plasma concentrations in 1.5 hours. The absolute bioavailability of Diazepam rectal gel relative to Valium® injectable is 90%.

INDICATIONS

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.

CONTRAINDICATIONS

-Know drug hypersensitivity
-Acute narrow angle glaucoma

WARNINGS

Consult physician in cases where the patient has kidney disease, liver disease, lung problems such as asthma, or pneumonia or history of substance abuse.

Not recommended for patients that are pregnant or that are breast feeding.

SIDE AFFECTS

The most frequent side effect was somnolence, CNS depressant

Less frequent adverse events reported were dizziness, headache, pain, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis.

BODY AS A WHOLE: Asthenia
CARDIOVASCULAR: Hypotension, vasodilatation
NERVOUS: Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo
RESPIRATORY: Hiccup

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