METOCLOPRAMIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

NuCare Pharmaceuticals,Inc.

INN (International Adı):

METOCLOPRAMIDE HYDROCHLORIDE

Kompozisyon:

METOCLOPRAMIDE 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. 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

Ürün özeti:

10 mg — Each white, round tablet imprinted with p on one side and 685 and bisect on the other side contains 10 mg of metoclopramide (as the hydrochloride). NDC 68071-4326-2 BOTTLES OF 20 NDC 68071-4326-3 BOTTLES OF 30 NDC 68071-4326-9 BOTTLES OF 90 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). Distributed by: Par Pharmaceutical Companies Inc. Spring Valley, NY 10977 U.S.A. Product of Italy Manufactured by: Par Formulations Private Limited 1/58, Pudupakkam, Kelambakkam – 603 103 Made in India From Active Pharmaceutical Ingredient made in Italy I02/15 Mfg. Lic. No.: TN00002121

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
METOCLOPRAMIDE TABLETS, USP
Rx Only
Read the Medication Guide that comes with metoclopramide before you
start taking it and each time you
get a refill. There may be new information. If you take another
product that contains metoclopramide
(such as metoclopramide injection, metoclopramide orally
disintegrating tablet, or metoclopramide oral
syrup), you should read the Medication Guide that comes with that
product. Some of the information may
be different. This Medication Guide does not take the place of talking
with your doctor about your
medical condition or your treatment.
What is the most important information I should know about
metoclopramide?
Metoclopramide can cause serious side effects, including:
Abnormal muscle movements called tardive dyskinesia (TD). These
movements happen mostly in the
face muscles. You can not control these movements. They may not go
away even after stopping
metoclopramide.. There is no treatment for TD, but symptoms may lessen
or go away over time after you
stop taking metoclopramide.
Your chances for getting TD go up:
•
the longer you take metoclopramide and the more metoclopramide you
take. You should not take
metoclopramide for more than 12 weeks
•
if you are older, especially if you are a woman
•
if you have diabetes
It is not possible for your doctor to know if you will get TD if you
take metoclopramide.
Call your doctor right away if you get movements you can not stop or
control, such as:
•
lip smacking, chewing, or puckering up your mouth
•
frowning or scowling
•
sticking out your tongue
•
blinking and moving your eyes
•
shaking of your arms and legs
See the section “What are the possible side effects of
metoclopramide?” for more information about side
effects.
What is metoclopramide?
Metoclopramide is a prescription medicine used:
•
in adults for 4 to 12 weeks to relieve heartburn symptoms with
gastroesophageal reflux disease
(GERD) when certain other treatments do not work. Metocl

Ürün özellikleri

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
METOCLOPRAMIDE TABLETS, USP
RX ONLY
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 is a white, crystalline, odorless
substance, freely soluble
in water. Chemically, it is 4-amino-5-chloro-
_N_-[2-(diethylamino)ethyl] - _o-anisamide_
monohydrochloride monohydrate. Its molecular formula is C
H
CIN
O
•HCl•H
O.
Its molecular weight is 354.27.
Each tablet, for oral administration, contains metoclopramide
hydrochloride, equivalent
to 10 mg of metoclopramide. In addition each tablet contains the
following inactive
ingredients: colloidal silicon dioxide, corn starch, magnesium
stearate, mannitol and
pregelatinized starch.
14
22
3
2
2
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
in