METOCLOPRAMIDE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

NuCare Pharmaceuticals,Inc.

INN (Միջազգային անվանումը):

METOCLOPRAMIDE HYDROCHLORIDE

Կազմը:

METOCLOPRAMIDE 10 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Metoclopramide tablets are indicated for the: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: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) ].In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [ see Warnings and Precautions ( 5.1, 5.2) ]. - When stimu

Ապրանքի ամփոփագիր:

Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. NDC 66267-827-04 Bottles of 4 NDC 66267-827-06 Bottles of 6 NDC 66267-827-08 Bottles of 8 Dispense in a tight, light-resistant container. Store tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
METOCLOPRAMIDE TABLETS, USP
(MET-oh-KLOE-pra-mide), oral use
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 metoclopramide tablets?
Metoclopramide tablets are a prescr

Ապրանքի հատկությունները

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
NUCARE PHARMACEUTICALS,INC.
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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._
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 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 metocloprami