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:

Fresenius Kabi USA, LLC

INN (International Name):

Metoclopramide Hydrochloride

Composition:

Metoclopramide 10 mg in 2 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoclopramide Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. Metoclopramide Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. Metoclopramide Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. Metoclopramide Injection 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. Metoclopramide Injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine. Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g. in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforati

Product summary:

Metoclopramide Injection, USP, 5 mg/mL metoclopramide base (as the monohydrochloride monohydrate) is available as: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation. Discard unused portion. Benadryl® is a registered trademark of McNeil Consumer. Cogentin® is a registered trademark of MS&D. Do not place syringe on a sterile field.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Fresenius Kabi USA, LLC
----------
MEDICATION GUIDE
Metoclopramide Injection
(MET oh KLOE pra mide)
You or your caregiver should read the Medication Guide before you
start receiving Metoclopramide
Injection and before you get another dose of Metoclopramide Injection.
There may be new information. If
you take another product that contains metoclopramide (such as
Metoclopramide Tablets,
Metoclopramide ODT, 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 to your doctor about your medical condition or your
treatment.
What is the most important information I should know about
Metoclopramide Injection?
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 Injection?
Metoclopramide Injection is a prescription medicine used to:
•
relieve symptoms of slow stomach emptying in people with diabetes
•
prevent nausea and vomiting that c

Summary of Product characteristics

METOCLOPRAMIDE- METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
METOCLOPRAMIDE INJECTION, 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 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 crystalline, odorless
substance, freely soluble in
water. Chemically, it is
4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide
monohydrochloride monohydrate. Molecular weight: 354.3.
C
H
ClN O ⋅HCl⋅H O
Metoclopramide Injection, USP is a clear, colorless, sterile solution
with a pH of 4.5 to 6.5
for intravenous (IV) or intramuscular (IM) administration.
This product is light sensitive. It should be inspected before use and
discarded if either
color or particulate is observed.
Each mL contains: metoclopramide base 5 mg (as the monohydrochloride
monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP
q.s. pH adjusted,
when necessary with hydrochloric acid and/or sodium hydroxide.
14
22
3
2
2
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 a