METOCLOPRAMIDE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VistaPharm, LLC

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide Oral Solution is 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 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 is indicated for the relief of sympt

Product summary:

XACTDOSE™ Metoclopramide Oral Solution USP, 5 mg/5 mL, is a clear, sugar-free liquid with a butterscotch flavor. Each 5 mL contains 5 mg Metoclopramide (present as the hydrochloride) and is available as follows: NDC 66689-031-50: 10 mg/10 mL unit dose cups, packaged in cartons of 50 (5 trays of 10 unit dose cups each) Store at controlled room temperature, between 20 °C and 25 °C (68 ° to 77 °F) (see USP). Protect from freezing. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VistaPharm, LLC
----------
MEDICATION GUIDE
Metoclopramide (met-o-klo-pra-mide) Oral Solution
Rx only
VP2107
03/12
Read the Medication Guide that comes with Metoclopramide Oral
Solution, USP 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
REGLAN tablets, REGLAN ODT, or
REGLAN injection), 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 to 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 Tardive Dyskinesia but symptoms may lessen
or go away over time after you stop
taking Metoclopramide.
Your chances for getting Tardive Dyskinesia 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 Tardive
Dyskinesia if you take Metoclopramide. Call
your doctor right away if you get movements you can not stop or
control, such as:
•
Lip smaking, 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?"
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 certain other treatments do not work. Metoclopramide
relieves daytime he

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE SOLUTION
VISTAPHARM, LLC
----------
METOCLOPRAMIDE
ORAL SOLUTION,
USP
5 MG/5 ML
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 STOPPED.
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 DYSKINESIA.
SEE WARNINGS
DESCRIPTION
Metoclopramide Oral Solution, USP is a clear, butterscotch flavor,
sugar-free liquid for
oral administration.
Each 5 mL (teaspoonful) contains:
Metoclopramide, USP
5 mg (present as the hydrochloride)
Metoclopramide hydrochloride is a white or practically white,
crystalline, odorless or
practically odorless powder. Chemically, it is
4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-
o-anisamide monohydrochloride monohydrate. Its molecular formula is
C
H
ClN O •HCl•H O, with a molecular weight of 354.3. Its structural
formula is:
14
22
3
2
2
Inactive Ingredients: Methylparaben, Citric Acid Anhydrous, FD&C
Yellow #6, Sorbitol
Solution, Glycerin, Butterscotch Flavor and Purified Water.
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 pylo