METOCLOPRAMIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

A-S Medication Solutions

Designación común internacional (DCI):

METOCLOPRAMIDE HYDROCHLORIDE

Composición:

METOCLOPRAMIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Metoclopramide tablets are indicated for the: - Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. - Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use: Metoclopramide  tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (8.4)]. Metoclopramide is contraindicated: - In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions (5.1, 5.2)]. - When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of

Resumen del producto:

Product: 50090-2221 NDC: 50090-2221-0 30 TABLET in a BOTTLE

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

A-S Medication Solutions
----------
MEDICATION GUIDE
MEDICATION GUIDE
METOCLOPRAMIDE TABLETS, USP (met-o-clo-pra-míde)
metoclopramide tablets, oral use
Read this Medication Guide before you start taking metoclopramide 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 solution), you
should read the
Medication Guide that comes with that product. Some of the information
may be
different. This information does not take the place of talking with
your healthcare
provider 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:
Tardive dyskinesia (abnormal muscle movements). These movements happen
mostly in the face muscles. You cannot control these movements. They
may not
go away even after stopping metoclopramide. There is no treatment for
tardive
dyskinesia, but symptoms may decrease or go away over time after you
stop
taking metoclopramide.
Your chances for getting tardive dyskinesia increase:
•
the longer you take metoclopramideand the more metoclopramideyou take.
You should not take metoclopramide for more than 12 weeks.
•
if you are older, especially if you are an older woman.
•
if you have diabetes.
It is not possible for your healthcare provider to know if you will
get
tardive dyskinesia if you take metoclopramide. Call your healthcare
provider right away if you get movements you cannot 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 hear

Ficha técnica

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOCLOPRAMIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METOCLOPRAMIDE
TABLETS.
METOCLOPRAMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1979 WARNING: TARDIVE DYSKINESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METOCLOPRAMIDECAN CAUSE TARDIVE DYSKINESIA (TD), A SERIOUS MOVEMENT
DISORDER
THAT IS OFTEN IRREVERSIBLE. THERE IS NO KNOWN TREATMENT FOR TD. THE
RISK OF DEVELOPING
TD INCREASES WITH DURATION OF TREATMENT AND TOTAL CUMULATIVE DOSAGE
(5.1)
DISCONTINUE METOCLOPRAMIDEIN PATIENTS WHO DEVELOP SIGNS OR SYMPTOMS OF
TD
(5.1)
AVOID TREATMENT WITH METOCLOPRAMIDEFOR LONGER THAN 12 WEEKS BECAUSE OF
THE RISK
OF DEVELOPING TD WITH LONGER-TERM USE (5.1, 2.1, 2.2, 2.3)
RECENT MAJOR CHANGES
Boxed Warning
8/2017
Indications and Usage (1)
8/2017
Dosage and Administration, Dosage for Gastroesophageal Reflux (2.2)
8/2017
Dosage and Administration, Dosage for Acute and Recurrent Diabetic
Gastroparesis (2.3)8/2017
Contraindications (4)
8/2017
Warnings and Precautions, Tardive Dyskinesia (5.1)
8/2017
Warnings and Precautions, Other Extrapyramidal Symptoms (5.2)
8/2017
Warnings and Precautions, Neuroleptic Malignant Syndrome (5.3)
8/2017
Warnings and Precautions, Hyperprolactinemia (5.7)
8/2017
INDICATIONS AND USAGE
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented
gastroesophageal reflux in adults who fail to
respond to conventional therapy. (1)
Relief of symptoms in adults with acute and recurrent diabetic
gastroparesis. (1)
Limitations of Use:
Metoclopramide tablets are not recommended for use in pediatric
patients due to the risk of tardive
dyskinesia (TD) and other extrapyramidal symptoms as well as the risk
of methemoglobinemia in
neonates. (1, 8.4)
DOSAGE AND ADMINISTRATION
Gastroesophageal Reflux (2.2)
Administer metoclopramide continuously or int