METOCLOPRAMIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

A-S Medication Solutions

ІПН (Міжнародна Ім'я):

METOCLOPRAMIDE HYDROCHLORIDE

Склад:

METOCLOPRAMIDE 10 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. - 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 gastrointestinal hemorrhage, mechanical obstruction, or perforation). - In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma cr

Огляд продуктів:

Product: 50090-0132 NDC: 50090-0132-0 30 TABLET in a BOTTLE

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

A-S Medication Solutions
----------
MEDICATION GUIDE
Dispense with Medication
Guide available at:
www.tevausa.com/medguides
Metoclopramide (met'' oh
kloe' pra mide) Tablets
Read this Medication Guide
before you start taking
metoclopramide tablets 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 tablets?
Metoclopramide tablets 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
tablets. There is no treatment
for tardive dyskinesia, but
symptoms may decrease or go
away over time after you stop
taking metoclopramide tablets.
Your chances for getting
tardive dyskinesia increase:
•
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 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
tablets.
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 tablets?” for
more information about side
effects.
What are meto

Характеристики продукта

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
A-S MEDICATION SOLUTIONS
----------
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._
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)
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 intermittently:
Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at
bedtime (maximum of 60
mg per day) for 4 to 12 weeks.
Intermittent: Single doses up to 20 mg prior to provoking situation.
Acute and Recurrent Diabetic Gastroparesis (2.3)
Administer 10 mg, 30 minutes before each meal and at bedtime (maximum
of 40 mg per day) for 2 to
8 weeks
Dosage Adjustment in Specific Populations (2.2, 2.3)
For gastroesophageal reflux and acute and recurrent diabetic
gastroparesis, see Full Prescribing
Information f