METOCLOPRAMIDE- metoclopramide hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Metoclopramide Hydrochloride (UNII: W1792A2RVD) (Metoclopramide - UNII:L4YEB44I46)

Available from:

General Injectables & Vaccines, Inc.

INN (International Name):

Metoclopramide Hydrochloride

Composition:

Metoclopramide 5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy. Metoclopramide Injection, USP is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting. Metoclopramide Injection, USP is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation. Metoclopramide Injection, USP may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination. Metoclopramide Injection, USP may be used to stimulate gastric emptying and intestinaltransit of barium in cases where delayed emptying interferes with radiological examination of

Product summary:

PRESERVATIVE FREE. Metoclopramide Injection, USP, 5 mg/mL metoclopramide base (present as the monohydrochloride monohydrate) is supplied in the following: Protect from light by retaining in package until time of use.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Do not store open single-dose vials or ampuls for later use, as they contain no preservative. Discard unused portion. Benadryl is a registered trademark of Warner-Lambert Company. Cogentin is a registered trademark of Merck and Co. Inc Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1290-1.0 Revised: 5/2018

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

General Injectables & Vaccines, Inc.
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MEDGUIDE
Metoclopramide Hydrochloride, USP
You or your caregiver should read the Medication Guide before you
start receiving metoclopramide and
before you get another dose of metoclopramide. There may be new
information. If you take another
product that contains metoclopramide, 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 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 to:
• relieve symptoms of slow stomach emptying in people with diabetes
• prevent nausea and vomiting that can happen with cancer
chemotherapy
• prevent nausea and vomiting that may happen after surgery, if your
doctor decides that you should not
be

Summary of Product characteristics

METOCLOPRAMIDE- METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
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METOCLOPRAMIDE INJECTION 5MG/ML 2ML SDV
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 hydrochloride 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. It has
the following structural formula:
Metoclopramide Injection, USP is a sterile, nonpyrogenic solution of
metoclopramide
hydrochloride in water for injection. Each milliliter contains
metoclopramide base 5 mg
(as the hydrochloride monohydrate); 8.5 mg sodium chloride. May
contain hydrochloric
acid and/or sodium hydroxide for pH adjustment; pH 4.4 (2.5 to 6.5).
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended for use only as a single-dose injection. When smaller doses
are required, the
unused portion should be discarded.
This product is light sensitive. It should be inspected before use and
discarded if either
color or particulate is observed.
Metoclopramide Injection is intended for intravenous or intramuscular
administration.
CLINICAL PHARMACOLOGY
Metoclopramide stimula