METOCLOPRAMIDE HYDROCHLORIDE- 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:

The use of metoclopramide  tablets, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux:  Metoclopramide tablets, USP are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic G

Product summary:

Metoclopramide Tablets, USP: 10 mg - White, round, scored tablets in bottles of 30 -NDC 68788-9706-3       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 Tablets, USP
Read the Medication Guide that comes with metoclopramide tablets
before you start taking them 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 Medication Guide does not
take the place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about
metoclopramide tablets, USP?
Metoclopramide tablets can cause serious side effects, including:
Tardive Dyskinesia (abnormal muscle movements). These movements happen
mostly in the face muscles.
You can not control these movements. They may not go away even after
stopping metoclopramide
tablets. There is no treatment for tardive dyskinesia, but symptoms
may lessen or go away over time after
you stop taking metoclopramide tablets.
Your chances for getting tardive dyskinesia go up:
•
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 a woman
•
if you have diabetes
It is not possible for your doctor to know if you will get tardive
dyskinesia if you take metoclopramide
tablets.
Call your doctor right away if you get movements you can not 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, USP?” for more
information about side effects.
What are metoclopramide tablets, USP?
Metoclopra

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE
TABLETS, USP
Revised: June 2015
RX ONLY
WARNING: TARDIVE DYSKINESIA
TREATMENT WITH METOCLOPRAMIDE CAN CAUSE TARDIVE DYSKINESIA, A SERIOUS
MOVEMENT DISORDER THAT IS OFTEN IRREVERSIBLE. THE RISK OF DEVELOPING
TARDIVE DYSKINESIA
INCREASES WITH DURATION OF TREATMENT AND TOTAL CUMULATIVE DOSE.
METOCLOPRAMIDE THERAPY SHOULD BE DISCONTINUED IN PATIENTS WHO DEVELOP
SIGNS
OR SYMPTOMS OF TARDIVE DYSKINESIA. THERE IS NO KNOWN TREATMENT FOR
TARDIVE DYSKINESIA. IN
SOME PATIENTS, SYMPTOMS MAY LESSEN OR RESOLVE AFTER METOCLOPRAMIDE
TREATMENT IS
S TOPPED.
TREATMENT WITH METOCLOPRAMIDE FOR LONGER THAN 12 WEEKS SHOULD BE
AVOIDED IN ALL BUT RARE
CASES WHERE THERAPEUTIC BENEFIT IS THOUGHT TO OUTWEIGH THE RISK OF
DEVELOPING TARDIVE
DYS KINES IA.
SEE WARNINGS
DESCRIPTION
Metoclopramide hydrochloride, USP is a white or practically white,
crystalline, odorless or practically
odorless powder. It is very soluble in water, freely soluble in
alcohol, sparingly soluble in chloroform,
practically insoluble in ether. Chemically, it is
4-amino-5-chloro-N-[2-(diethylamino) ethyl]-2-
methoxybenzamide monohydrochloride monohydrate. Its structural formula
is as follows:
Each tablet for oral administration contains metoclopramide
hydrochloride, equivalent to either 5 mg or
10 mg metoclopramide. Tablets also contain as inactive ingredients
anhydrous lactose, magnesium
stearate, povidone, pregelatinized starch, sodium starch glycolate and
(5 mg only) D&C Yellow #10 and
FD&C Blue #1.
CLINICAL PHARMACOLOGY
Metoclopramide stimulates motility of the upper gastrointestinal tract
without stimulating gastric,
biliary, or pancreatic secretions. Its mode of action is unclear. It
seems to sensitize tissues to the action
of acetylcholine. The effect of metoclopramide on motility is not
dependent on intact vagal innervation,
but it can be abolished by anticholinergic drugs.
Metoclopramide increases the tone and a