NIZATIDINE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Rebel Distributors Corp

INN (International ime):

NIZATIDINE

Sastav:

NIZATIDINE 150 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine is 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 is 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 is 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.

Proizvod sažetak:

Nizatidine Capsules USP, 150 mg are #2, buff opaque capsules imprinted WPI and 3137 supplied in bottles of 60. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Repackaged by Rebel Distributors Corp Thousand Oaks, CA 91320

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NIZATIDINE- NIZATIDINE CAPSULE
REBEL DISTRIBUTORS CORP
----------
NIZATIDINE CAPSULES 150 MG AND 300 MG
NIZATIDINE
CAPSULES USP
Revised: June 2009
RX ONLY
190938
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 represented below:
It is an off-white to buff crystalline solid that is soluble in water.
Nizatidine has a bitter taste and mild
sulfur-like odor. Nizatidine Capsules USP, for oral administration,
contain 150 mg or 300 mg nizatidine
and the following inactive ingredients: colloidal silicon dioxide,
corn starch, croscarmellose sodium,
magnesium stearate and pregelatinized starch. The capsule shells
contain: ammonium hydroxide, black
iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac,
silicon dioxide, sodium lauryl
sulfate and titanium dioxide.
The 150 mg capsule shell also contains D&C Yellow No. 10 and FD&C
Yellow No. 6.
The 300 mg capsule shell also contains black iron oxide, red iron
oxide and yellow iron oxide.
CLINICAL PHARMACOLOGY
Nizatidine is a competitive, reversible inhibitor of histamine at the
histamine H2-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
2
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
Meal
Up to 4
41
64
98
97
Caffeine
Up to 3
73
85
96
2. Effects on Other Gastrointestinal Secretions – Pepsin: Oral
administration of 75 to 300 mg of
nizatidine did not affect pepsin activity in gastric secretions. Total
pepsin output was red