METOCLOPRAMIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)

Доступна з:

Rebel Distributors Corp.

ІПН (Міжнародна Ім'я):

METOCLOPRAMIDE HYDROCHLORIDE

Склад:

METOCLOPRAMIDE HYDROCHLORIDE 5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide is indicated for the relief of symptoms associated with acute and recu

Огляд продуктів:

Metoclopramide Tablets, USP: 5 mg - Light green, round, unscored tablets in bottles of 30 and 90. Debossed: PLIVA 517 10 mg - White, round, scored tablets in bottles of 15, 20, 30, 60 and 90. Debossed: PLIVA 430 Dispense in a tight, light-resistant container as defined in the USP. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Manufactured by: BARR LABORATORIES, INC. Pomona, NY 10970 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
REBEL DISTRIBUTORS CORP.
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METOCLOPRAMIDE
TABLETS, USP
DESCRIPTION
Metoclopramide hydrochloride is a white or practically white,
crystalline, odorless or practically
odorless powder. It is very soluble in water, freely soluble in
alcohol, sparingly soluble in chloroform,
practically insoluble in ether. Chemically, it is 4-amino-5-chloro-
_N_-[2-(diethylamino) ethyl]-2-
methoxybenzamide monohydrochloride monohydrate. Its structural formula
is as follows:
C
H CIN O •HCl•H O Molecular Weight: 354.3
Each tablet for oral administration contains metoclopramide
hydrochloride, equivalent to either 5 mg or
10 mg metoclopramide. Tablets also contain as inactive ingredients
anhydrous lactose, magnesium
stearate, povidone, pregelatinized starch, sodium starch glycolate and
(5 mg only) D&C Yellow #10 and
FD&C Blue #1.
CLINICAL PHARMACOLOGY
Metoclopramide stimulates motility of the upper gastrointestinal tract
without stimulating gastric,
biliary, or pancreatic secretions. Its mode of action is unclear. It
seems to sensitize tissues to the action
of acetylcholine. The effect of metoclopramide on motility is not
dependent on intact vagal innervation,
but it can be abolished by anticholinergic drugs.
Metoclopramide increases the tone and amplitude of gastric (especially
antral) contractions, relaxes the
pyloric sphincter and the duodenal bulb, and increases peristalsis of
the duodenum and jejunum resulting
in accelerated gastric emptying and intestinal transit. It increases
the resting tone of the lower
esophageal sphincter. It has little, if any, effect on the motility of
the colon or gallbladder.
In patients with gastroesophageal reflux and low LESP (lower
esophageal sphincter pressure), single
oral doses of metoclopramide produce dose-related increases in LESP.
Effects begin at about 5 mg and
increase through 20 mg (the largest dose tested). The increase in LESP
from a 5 mg dose lasts about 45
minutes and that of 20 mg lasts between 2 and 3 hours. Increased rate
of stomach em