METOCLOPRAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 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. Symptomatic Gastroesophageal Reflux: 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. Diabetic Gastroparesis

Product summary:

10 mg — Each white, round tablet imprinted with “p” on one side and 685 and bisect on the other side contains 10 mg of metoclopramide (as the hydrochloride). Tablets are supplied as blisterpacks of 30 (NDC 0615-7932-39). Dispense in a tight, light-resistant container as defined in the USP. Store at 20°-25°C (68° – 77°F) (See USP Controlled Room Temperature). Distributed by: Par Pharmaceutical Companies Inc. Spring Valley, NY 10977 U.S.A. Product of Italy Manufactured by: Par Formulations Private Limited 1/58, Pudupakkam, Kelambakkam – 603 103 Made in India From Active Pharmaceutical Ingredient made in Italy I02/15 Mfg. Lic. No.: TN00002121

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
MEDICATION GUIDE
METOCLOPRAMIDE TABLETS, USP
Rx Only
Read the Medication Guide that comes with metoclopramide 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 tablet, or metoclopramide oral
syrup), 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?
Metoclopramide 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.. There is no treatment for TD, but symptoms may lessen
or go away over time after you
stop taking metoclopramide.
Your chances for getting TD go up:
•
•the longer you take metoclopramide and the more metoclopramide you
take. You should not take
metoclopramide 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.
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?” for more information about side
effects.
What is metoclopramide?
Metoclopramide is a prescription medicine used:
•
•in adults for 4 to 12 weeks to relieve heartburn symptoms with
gastroesophageal reflux disease
(GERD) when ce

Summary of Product characteristics

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
METOCLOPRAMIDE TABLETS, USP
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 is a white, crystalline, odorless
substance, freely soluble in water.
Chemically, it is 4-amino-5-chloro-_N_-[2-(diethylamino)ethyl]
-_o-anisamide_ monohydrochloride
monohydrate. Its molecular formula is C
H CIN O •HCl•H O. Its molecular weight is 354.27.
Each tablet, for oral administration, contains metoclopramide
hydrochloride, equivalent to 10 mg of
metoclopramide. In addition each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, corn starch, magnesium stearate, mannitol and pregelatinized
starch.
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 amplitude of gastric (especially
antral) contractions, relaxes the
pyloric sphincter and the duodenal bulb, and increases peristalsis of
the duodenum and jejunum resulting
in accelerated gastric emptying an