METOCLOPRAMIDE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

RedPharm Drug, Inc.

INN (International Adı):

METOCLOPRAMIDE HYDROCHLORIDE

Kompozisyon:

METOCLOPRAMIDE 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

The use of metoclopramide tablets, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux: Metoclopramide tablets, USP 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 Gas

Ürün özeti:

Metoclopramide Tablets, USP: 5 mg - Light green, round, unscored tablets in bottles of 100 and 500. Debossed: WPI on one side and 2228 on the other side. 10 mg - White, round, scored tablets in bottles of 100, 500 and 1000. Debossed: WPI on one side and 2229 on the other side. Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious
movement disorder that is
often irreversible. The risk of developing tardive dyskinesia
increases with duration of treatment
and total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop
signs or symptoms of
tardive dyskinesia. There is no known treatment for tardive
dyskinesia. In some patients, symptoms
may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be
avoided in all but rare cases
where therapeutic benefit is thought to outweigh the risk of
developing tardive dyskinesia.
See WARNINGS
SPL UNCLASSIFIED SECTION
Metoclopramide
Tablets, USP
Revised: June 2015
Rx Only
DESCRIPTION
Metoclopramide hydrochloride, USP 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:
[Structural formula for metoclopramide hydrochloride]
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 anticholinerg