NIZATIDINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

NIZATIDINE

Composition:

NIZATIDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nizatidine capsules USP are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine capsules USP are indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known. Nizatidine capsules USP are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Nizatidine capsules USP are indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

Product summary:

Nizatidine capsules USP are available as follows: 150 mg capsules: Dark yellow colored cap and light yellow colored body hard gelatin size "3" capsule printed with G46 on cap and 150 on body, filled with off-white to buff color granules. Bottles of 60 NDC 68462-425-60 300 mg capsules: Light brown colored cap and light yellow colored body hard gelatin size "1" capsule printed with G46 on cap and 300 printed on body, filled with off-white to buff color granules. Bottles of 30 NDC 68462-426-30

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIZATIDINE- NIZATIDINE CAPSULE
PROFICIENT RX LP
----------
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:_
Oral administ