METOCLOPRAMIDE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoclopramide tablets, USP are indicated for the: Limitations of Use: Metoclopramide tablets, USP 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 tablets are 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 major b

Product summary:

Metoclopramide Tablets, USP: 10 mg - White, round, scored tablets in bottles of 30 NDC 68788-6791-3 Debossed: WPI on one side and 2229 on the other side. Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METOCLOPRAMIDE HYDROCHLORIDE- metoclopramide hydrochloride tablet
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Metoclopramide (MET oh KLOE pra mide) Tablets, USP,
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?
Me

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOCLOPRAMIDE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR METOCLOPRAMIDE
TABLETS, USP.
METAOCLOPRAMIDE TABLETS, USP, 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, USP are indicated for the:
Limitations of Use:
Metoclopramide tablets, USP 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)
•
METOCLOPRAMIDE TABLETS 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 TABLETS IN PATIENTS WHO DEVELOP SIGNS OR
SYMPTOMS OF
TD (5.1)
AVOID TREATMENT WITH METOCLOPRAMIDE TABLETS 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