DIAZEPAM gel

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

Доступно од:

Teva Pharmaceuticals USA, Inc.

INN (Међународно име):

DIAZEPAM

Састав:

DIAZEPAM 2.5 mg in 0.5 mL

Пут администрације:

RECTAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but we

Резиме производа:

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 available in two lengths, designated for convenience as 10 mg delivery system and 20 mg delivery system. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg, and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam Rectal Gel delivery system is available in the following three presentations: Diazepam Rectal Gel Rectal Tip Size NDC 2.5 mg Twin Pack 4.4 cm NDC 0093-6137-32 Diazepam Rectal Gel Rectal Tip Size NDC 10 mg Delivery System Twin Pack 4.4 cm NDC 0093-6138-32 20 mg Delivery System Twin Pack 6.0 cm NDC 0093-6139-32 Each twin pack contains two Diazepam Rectal Gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diazepam Rectal Gel is also packed with Instructions for Caregivers upon receipt from pharmacy. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Diazepam Rectal Gel 10 mg delivery system and 20 mg delivery system INSTRUCTIONS FOR CAREGIVERS UPON RECEIPT FROM PHARMACY FOR EACH SYRINGE: SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS. The instructions are also available on the bottom of each drug product package. CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. Valium® is a registered trademark of Roche Pharmaceuticals. Distributed by: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Manufactured By: DPT Laboratories, LTD. San Antonio, TX 78215 9435000 Rev. A 2/2015

Статус ауторизације:

New Drug Application Authorized Generic

Карактеристике производа

DIAZEPAM- DIAZEPAM GEL
TEVA PHARMACEUTICALS USA, INC.
----------
DIAZEPAM RECTAL GEL CIV
RECTAL DELIVERY SYSTEM
RX ONLY
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 and has a
pH between 6.5 - 7.2.
Diazepam, the active ingredient of diazepam rectal gel, is a
benzodiazepine anticonvulsant with the
chemical name
7-chloro-1,3-dihydro-1-methyl-5-phenyl-2_H_-1,4-benzodiazepin-2-one.
The structural
formula is as follows:
CLINICAL PHARMACOLOGY
MECHANISM OF 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 (GABA ). 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
GABA receptor.
PHARMACOKINETICS
Pharmacokinetic information of diazepam following rectal
administration was obtained from studies
conducted in healthy adult subjects. No pharmacokinetic studies were
conducted in pediatric patients.
A
A
Therefore, information from the literature is used to define
pharmacokinetic labeling in the pediatric
population.
Diazepam rectal gel is well absorbed following rectal administration,
reaching peak plasma
concentrations in 1.