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:

Cardinal Health 107, LLC

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoclopramide injection 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 perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine. Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. Metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

Product summary:

Metoclopramide injection, USP is supplied in 2 mL single-dose vials overbagged with 5 vials per bag, NDC 55154-0450-5. 55154-0450-5 5 mg/mL 2 mL in a 2 mL single-dose vial PROTECT FROM LIGHT. Store in shelf pack until time of use. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Inspect the vial before use and discard if either color or particulate is observed. Dilutions may be stored unprotected from light under normal light conditions for up to 24 hours after preparation. Do not freeze. Do not store open single-dose vials for later use, as they contain no preservative. Discard unused portion. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Distributed By: Cardinal Health Dublin, OH 43017 L35627090124 Rev. A 1/2022

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE INJECTION,
SOLUTION
Cardinal Health 107, LLC
----------
Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Metoclopramide (met” oh kloe’ pra mide)
Injection
Rx Only
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
orally disintegrating tablets, or metoclopramide oral solution), 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 cannot 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 metocloprami

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE
HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH 107, 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, USP 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 and has the following
structural formula:
C
H
ClN O •HCl•H O M.W. 354.3
Metoclopramide injection, USP is a clear, colorless, sterile solution
with a pH of 2.5 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.
Metoclopramide injection, USP is supplied in 2 mL single-dose vials.
Each 1 mL contains: Metoclopramide base 5 mg (present as the
hydrochloride), Sodium
Chloride, USP 8.5 mg, Water for Injection, USP q.s. pH is adjusted
with hydrochloric acid
14
22
3
2
2
and/or sodium hydroxide if necessary.
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 intac