NIZATIDINE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Actavis Pharma, Inc.

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 are available as follows: 150 mg - Size #2, two-piece hard-gelatin buff opaque capsules imprinted “3137 ” on cap and “WPI ” on body. Capsules are supplied in bottles of 60 (NDC 0591-3137-60). 300 mg - Size #0, two-piece hard-gelatin light brown opaque capsules imprinted with “3138 ” on cap and “WPI ” on body. Capsules are supplied in bottles of 30 (NDC 0591-3138-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].   Dispense in a tight, light-resistant container as defined in the USP.  Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 6/2022

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NIZATIDINE- NIZATIDINE CAPSULE
ACTAVIS PHARMA, 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 represented below:
It is an off-white to buff crystalline solid that is soluble in water.
Nizatidine, USP has a
bitter taste and mild sulfur-like odor. Nizatidine capsules USP, for
oral administration,
contain 150 mg or 300 mg nizatidine, USP 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
Time After
Dose (h)
% Inhibition of Gastric Acid
Output by Dose (mg)
20 to 50
75
100
150
300
Nocturnal
Up to 10
57
73
90
Betazole
Up to 3
93
100
99
2
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 reduced in proportion to t