METOCLOPRAMIDE- metoclopramide hydrochloride solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

PAI Holdings, LLC

INN（国際名）:

METOCLOPRAMIDE HYDROCHLORIDE

構図:

METOCLOPRAMIDE 5 mg in 5 mL

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Metoclopramide is indicated for the: - 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. Limitations of Use : Metoclopramide is 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 gastrointestinal hemorrhage,

製品概要:

Metoclopramide Oral Solution USP, 5 mg metoclopramide base (as the monohydrochloride monohydrate) per 5 mL (teaspoonful) is available as an orange-colored, berry-citrus flavored, sugar-free solution and is supplied in the following oral dosage forms: STORAGE Dispense in a tight, light-resistant container. Store at controlled room temperature between 20°C to 25°C (68°F to 77°F).

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

PAI Holdings, LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: September
2017
MEDICATION GUIDE
Metoclopramide (met-o-KLO-pra-mide) Oral Solution USP
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 REGLAN
injection, REGLAN 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

製品の特徴

METOCLOPRAMIDE- METOCLOPRAMIDE HYDROCHLORIDE SOLUTION
PAI HOLDINGS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOCLOPRAMIDE ORAL
SOLUTION USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR METOCLOPRAMIDE
ORAL SOLUTION USP.
METOCLOPRAMIDE ORAL SOLUTION USP, FOR ORAL USE INITIAL U.S. APPROVAL:
1979
WARNING: TARDIVE DYSKINESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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)
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 is 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 is 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)
Admin