DIAZEPAM tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Diazepam (UNII: Q3JTX2Q7TU) (Diazepam - UNII:Q3JTX2Q7TU)

Saadav alates:

McKesson Contract Packaging

INN (Rahvusvaheline Nimetus):

Diazepam

Koostis:

Diazepam 5 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

DIAZEPAM- DIAZEPAM TABLET
MCKESSON CONTRACT PACKAGING
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DIAZEPAM TABLETS USP CIV
RX ONLY
DESCRIPTION
Diazepam is a benzodiazepine derivative. Chemically, diazepam is
7-chloro-1,3-dihydro-1-methyl-5-
phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow
crystalline compound, and is
insoluble in water. Its structural formula is:
C
H ClN O M.W. 284.75
Diazepam is available as 2 mg, 5 mg, and 10 mg tablets for oral
administration and contains the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide; colorants: 5 mg only (D&C
Yellow No. 10 and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1);
magnesium stearate,
microcrystalline cellulose, pregelatinized starch, and sodium starch
glycolate.
CLINICAL PHARMACOLOGY
Diazepam is a benzodiazepine that exerts anxiolytic, sedative,
muscle-relaxant, anticonvulsant and
amnestic effects. Most of these effects are thought to result from a
facilitation of the action of gamma
aminobutyric acid (GABA), an inhibitory neurotransmitter in the
central nervous system.
PHARMACOKINETICS
ABS ORPTION
After oral administration > 90% of diazepam is absorbed and the
average time to achieve peak plasma
concentrations is 1 to 1.5 hours with a range of 0.25 to 2.5 hours.
Absorption is delayed and decreased
when administered with a moderate fat meal. In the presence of food
mean lag times are approximately
45 minutes as compared with 15 minutes when fasting. There is also an
increase in the average time to
achieve peak concentrations to about 2.5 hours in the presence of food
as compared with 1.25 hours
when fasting. This results in an average decrease in C
of 20% in addition to a 27% decrease in AUC
(range 15% to 50%) when administered with food.
DIS TRIBUTION
16
13
2
max
Diazepam and its metabolites are highly bound to plasma proteins
(diazepam 98%). Diazepam and its
metabolites cross the blood-brain and placental barriers and are also
found in breast milk in
concentrations approximately one tenth of those in maternal plasma
(days 3 to 9 post-partum