METOCLOPRAMIDE solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

ANI Pharmaceuticals, Inc.

INN (Isem Internazzjonali):

METOCLOPRAMIDE HYDROCHLORIDE

Kompożizzjoni:

METOCLOPRAMIDE 5 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide Oral Solution 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 post-prandial 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 12-week trial using doses of 15 mg 4 times daily. 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

Sommarju tal-prodott:

Metoclopramide Oral Solution USP, 5 mg metoclopramide base (as the monohydrochloride monohydrate) per 5 mL (teaspoonful) is available as an orange-colored, vanilla-flavored, palatable, aromatic, sugar-free and alcohol-free liquid for oral administration and is available in the following size: NDC 62559-190-16 – bottle of 16 fl. oz. (473 mL) Dispense in a tight, light-resistant container. Store at controlled room temperature, between 20°C and 25°C (68° to 77°F) (see USP). Protect from freezing. Manufactured by ANI Pharmaceuticals, Inc. Baudette, MN 56623 9643 Rev 09/14

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

METOCLOPRAMIDE- METOCLOPRAMIDE SOLUTION
ANI Pharmaceuticals, Inc.
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MEDICATION GUIDE
Metoclopramide (met-o-KLO-pra-mide) Oral Solution
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:
Tardive dyskinesia (abnormal muscle movements). 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 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 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:
•
in adults for 4 to 12 weeks to relieve heartburn symptoms with
gastroesophageal reflux disease
(GERD) when certain other treatment

Karatteristiċi tal-prodott

METOCLOPRAMIDE- METOCLOPRAMIDE SOLUTION
ANI PHARMACEUTICALS, INC.
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METOCLOPRAMIDE ORAL SOLUTION USP 5 MG/5 ML
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,
vanilla-flavored, palatable, aromatic, sugar-
free liquid for oral administration.
Each 5 mL (teaspoonful) contains: Metoclopramide base (as the
monohydrochloride monohydrate) 5 mg.
Inactive ingredients: Citric Acid Anhydrous, FD&C Yellow No. 5
(tartrazine), FD&C Red No. 40,
Glycerin, Methylparaben, Propylparaben, Purified Water, Sorbitol
Solution 70%, Vanilla Flavor.
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, with a molecular
weight of 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.
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22
3
2
2
Metoclopramide increases the tone and amplitude of ga