NIZATIDINE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

NIZATIDINE (UNII: P41PML4GHR) (NIZATIDINE - UNII:P41PML4GHR)

Dostupno od:

Preferred Pharmaceuticals, Inc

INN (International ime):

NIZATIDINE

Sastav:

NIZATIDINE 150 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NIZATIDINE- NIZATIDINE CAPSULE
PREFERRED PHARMACEUTICALS, INC
----------
NIZATIDINE CAPSULES USP
RX ONLY
DESCRIPTION:
Nizatidine, USP is a histamine H -receptor antagonist. Chemically, it
is N-[2-[[[2-
[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N
-methyl-2-nitro-1,1-ethenediamine.
The structural formula is as follows:
Nizatidine USP has the empirical formula C
H N O S representing a molecular weight of 331.46. It
is an off-white to buff crystalline solid that is sparingly soluble in
water. Nizatidine USP has a bitter
taste and mild sulfur-like odor. Each nizatidine capsule USP contains
for oral administration corn starch,
magnesium stearate, povidone, pregelatinized starch, sodium starch
glycolate and 150 mg (0.45 mmol)
or 300 mg (0.91 mmol) of nizatidine USP. The 150 mg capsule shell
contains ferric oxide yellow,
titanium dioxide, sodium lauryl sulphate and gelatin .The 300 mg
capsule shell contains FD&C Blue 1,
FD&C Red 40, D&C Yellow 10, FD&C Yellow 6, titanium dioxide, sodium
lauryl sulphate and
gelatin.The imprinting ink for capsule shell contains shellac,
dehydrated alcohol, isopropyl alcohol,
butyl alcohol, propylene glycol, strong ammonia solution, black iron
oxide, pottasium hydroxide and
purified water.
CLINICAL PHARMACOLOGY:
Nizatidine is a competitive, reversible inhibitor of histamine at the
histamine H -receptors, particularly
those in the gastric parietal cells.
ANTISECRETORY ACTIVITY
1. Effects on Acid Secretion:
Nizatidine significantly inhibited nocturnal gastric acid secretion
for up to 12 hours. Nizatidine also
significantly inhibited gastric acid secretion stimulated by food,
caffeine, betazole, and pentagastrin
(Table 1).
TABLE 1. EFFECT OF ORAL NIZATIDINE ON GASTRIC ACID SECRETION
Time After
Dose (h)
% Inhibition of Gastric Acid Output by Dose (mg)
20-50
75
100
150
300
Nocturnal
Up to 10
57
73
90
Betazole
Up to 3
93
100
99
Pentagastrin
Up to 6
25
64
67
2
’
12
21
5
2
2
2
Meal
Up to 4
41
64
98
97
Caffeine
Up to 3
73
85
96
2. Effects on Other Gastrointestinal Secretions
_Pepsin:_