METOCLOPRAMIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

METOCLOPRAMIDE HYDROCHLORIDE

Composição:

METOCLOPRAMIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. 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. Metoclopramide tablets, are indicated for the re

Resumo do produto:

Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in: Dispense tablets in tight, light-resistant container. Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA. by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India. To obtain the Medication Guide online please visit www.ranbaxyusa.com. October 2009 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Physicians Total Care, Inc.
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MEDICATION GUIDE
Metoclopramide Tablets, USP
Read the Medication Guide that comes with metoclopramide tablets
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 tablets, 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 tablets?
Metoclopramide tablets 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 tablets. There is no treatment for TD, but symptoms may
lessen or go away over time
after you stop taking metoclopramide tablets.
Your chances for getting TD go up:
•
the longer you take metoclopramide tablets and the more metoclopramide
tablets you take. You
should not take metoclopramide tablets 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 tablets.
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
tablets?" for more information
about side effects.
What are metoclopramide tablets?
Metoclopramide tablets are a prescription medicine used:
•
in adults for 4 to 12 weeks to relieve heartburn symptoms with
gastroesophageal r

Características técnicas

METOCLOPRAMIDE - METOCLOPRAMIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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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
S TOPPED.
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
DYS KINES IA.
SEE WARNINGS
DESCRIPTION
For oral administration, Metoclopramide tablets, USP 10 mg are white
to off white, capsule shaped,
biconvex tablets with "RF11" embossed on one side and score line on
the other side.
Each tablet contains:
10 mg of metoclopramide base as metoclopramide hydrochloride USP
INACTIVE INGREDIENTS
Microcrystalline Cellulose, Corn starch, Pregelatinized starch,
Colloidal silicon dioxide and Stearic
acid.
Metoclopramide tablets, USP 5 mg are white to off white, oval shaped,
biconvex tablets with "RF10"
embossed on one side and plain on the other side.
Each tablet contains:
5 mg of metoclopramide base as metoclopramide hydrochloride USP
Microcrystalline cellulose, Corn starch, Pregelatinized starch,
Colloidal silicon dioxide and Stearic
acid.
Metoclopramide hydrochloride is a white crystalline, odorless
substance, freely soluble in water.
Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)
ethyl]-2-methoxy benzamide
monohydrochloride monohydrate. Its molecular formula is C
H CIN O •HCI•H O. Its molecular
weight is 354.3.
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 t