METOCLOPRAMIDE- 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:

Unit Dose Services

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 USP 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 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 is indicated for the relief of

Product summary:

Product: 50436-0576 NDC: 50436-0576-1 1 mL in a SYRINGE, PLASTIC

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Unit Dose Services
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MEDICATION GUIDE
Metoclopramide (met-o-KLO-pra-mide)
Oral Solution USP
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 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 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. These movements
happen mostly in the face
muscles. You cannot 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 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
Your doctor may decide to stop Metoclopramide.
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

Summary of Product characteristics

METOCLOPRAMIDE- METOCLOPRAMIDE HYDROCHLORIDE SOLUTION
UNIT DOSE SERVICES
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METOCLOPRAMIDE ORAL
SOLUTION 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 Oral Solution USP is an orange-colored, berry-citrus
flavored liquid for oral
administration.
Each 5 mL (teaspoonful) for oral administration contains:
Metoclopramide base (as the
monohydrochloride monohydrate) 5 mg.
_Inactive ingredients:_ Citric acid, FD&C Yellow No. 6 (Sunset
Yellow), flavoring, glycerin,
methylparaben, propylparaben, purified water, and sorbitol solution.
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 ClN O • HCl • H O. Molecular
weight: 354.3. Its structural formula is:
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.
14
22
3
2
2
Metoclopramide increases the tone and amplitude of gastric (especially
antral) contractions,