METOCLOPRAMIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Cardinal Health 107, LLC

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Metoclopramide tablets are indicated for the: 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: Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see Clinical Considerations] . In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [see Data]. The estimated background risk of m

Termék összefoglaló:

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). Overbagged with 10 tablets per bag, NDC 55154-8196-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Cardinal Health 107, LLC
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MEDICATION GUIDE
8267601/0220
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 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 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 he

Termékjellemzők

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
CARDINAL HEALTH 107, LLC
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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._
•
•
•
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:
•
•
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)
•
•
•
Acute and Recurrent Diabetic Gastroparesis ( 2.3)
•
METOCLOPRAMIDE CAN 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 METOCLOPRAMIDE IN PATIENTS WHO DEVELOP SIGNS OR SYMPTOMS
OF TD (
5.1)
AVOID TREATMENT WITH METOCLOPRAMIDE FOR LONGER THAN 12 WEEKS BECAUSE
OF THE
RISK OF DEVELOPING TD WITH LONGER-TERM USE ( 5.1, 2.1, 2.2, 2.3)
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 a