METOCLOPRAMIDE- 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:

STAT RX USA LLC

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide tablets 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. Metoclopramide tablets are indicated for the relief of symp

Product summary:

Metoclopramide Tablets, USP are available as: 10 mg: white, scored, oblong tablets debossed "4235" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 30, 60, 100, 500, 1000 and 2500. 5 mg: white, oval tablets debossed "4234" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100, 500 and 1000. Dispense tablets in tight, light-resistant container. Tablets should be stored at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METOCLOPRAMIDE - METOCLOPRAMIDE HYDROCHLORIDE TABLET
STAT RX USA LLC
----------
MEDICATION GUIDE
Read the Medication Guide that comes with metoclopramide tablets
before you start taking it 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?
Metoclopramide tablets can cause serious side effects, including:
Abnormal muscle movements called tardive dyskinesia (TD). 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 TD, but symptoms may
lessen or go away over time
after you stop taking metoclopramide tablets.
Your chances for getting TD 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 TD 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?” for more information
about side effects.
What are metoclopramide tablets?
Metoclopramide tablets are a prescription medicine used:
•
in adults for 4 to 12 weeks to relieve heartburn symptoms wit

Summary of Product characteristics

METOCLOPRAMIDE - METOCLOPRAMIDE HYDROCHLORIDE TABLET
STAT RX USA LLC
----------
METOCLOPRAMIDE TABLETS, USP
10 MG AND 5 MG
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
For oral administration, Metoclopramide Tablets, USP 10 mg are white,
scored, oblong tablets
debossed "4235" on one side and debossed "V" on the reverse side.
Each tablet contains:
Metoclopramide base
.......................................................................................
10 mg
(as the monohydrochloride monohydrate)
Metoclopramide Tablets, USP 5 mg are white, oval tablets debossed
"4234" on one side and debossed
"V" on the reverse side.
Each tablet contains:
Metoclopramide base
.........................................................................................
5 mg
(as the monohydrochloride monohydrate)
INACTIVE INGREDIENTS
Colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, sodium
starch glycolate.
Metoclopramide hydrochloride is a white crystalline, odorless
substance, freely soluble in water.
Chemically, it is
4-amino-5-chloro-_N_-[2-(diethylamino)ethyl]-2-methoxy benzamide
monohydrochloride monohydrate. Its molecular formula is C
H CIN O •HCl•H O. Its molecular
weight is 354.3.
14
22
3
2
2
CLINICAL PHARMACOLOGY
Metoclopramide stimulates motility of the upper gastrointestinal tract
without stimulating gastr