METOCLOPRAMIDE- metoclopramide injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Teva Parenteral Medicines, Inc.

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Metoclopramide injection USP is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. Metoclopramide injection USP is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. Metoclopramide injection USP is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. 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. Metoclopramide injection USP 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. Metoclopram

পণ্য সারাংশ:

Metoclopramide injection USP is supplied in 2 mL single-use vials packaged 25 per shelf pack. 0703-4502-84 5 mg/mL 2 mL in a 2 mL single-use 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-use vials for later use, as they contain no preservative. Discard unused portion. Iss. 5/2015 Manufactured By: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 PREMIERProRxTM is a trademark of Premier, Inc., used under license.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Teva Parenteral Medicines, Inc.
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MEDICATION GUIDE
Metoclopramide (met” oh kloe’ pra mide)
Injection USP
Rx only
You or your caregiver should read the Medication Guide before you
start receiving metoclopramide
injection USP and before you get another dose of metoclopramide
injection USP. 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 metoclopramide?
Metoclopramide is a prescription medicine used to:
•
relieve symptoms of slow stomach emptying in people with diabetes
•
pr

পণ্য বৈশিষ্ট্য

METOCLOPRAMIDE- METOCLOPRAMIDE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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METOCLOPRAMIDE INJECTION USP
4502
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
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 2.5-6.5 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-use 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 and/or sodium hydroxide if
necessary.
CLINICAL PHARMACOLOGY
14
22
3
2
2
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,
b