METOCLOPRAMIDE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

RedPharm Drug, Inc.

DCI (Dénomination commune internationale):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 Gastr

Descriptif du produit:

Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 5 mg metoclopramide. Available in bottles of 100 (NDC 0093-2204-01) and 500 (NDC 0093-2204-05). Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1000 (NDC 0093-2203-10). Dispense in a tight, light-resistant container. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. P 9/2015

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
REDPHARM DRUG, INC.
----------
METOCLOPRAMIDE 10MG TABS
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.
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 and practically insoluble in ether. Chemically,
it is 4-amino-5-chloro-
N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride
monohydrate. Its
structural formula is as follows:
[metoclopramide hydrochloride structural formula]
C14H22ClN3O2 •HCl•H2O M.W. 354.3
Each tablet for oral administration contains metoclopramide
hydrochloride, USP
equivalent to 5 mg or 10 mg metoclopramide.
Inactive Ingredients
Corn starch, dibasic calcium phosphate, magnesium stearate,
microcrystalline cellulose
and sodium starch glycolate.
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,