METOCLOPRAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide tablets are 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 postprandial 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 a 12 week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Metoclopramide tablets are indicated for the relief of sympt

Product summary:

Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet contains 10 mg metoclopramide (present as the hydrochloride). Available in bottles of 30 and 60. Dispense in a tight, light-resistant container. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o . Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. N 9/2011

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
METOCLOPRAMIDE TABLETS, USP
Rx only
Read the Medication Guide that comes with metoclopramide tablets, USP
before you start taking them
and each time you get a refill. There may be new information. If you
take another product that contains
metoclopramide (such as metoclopramide injection, metoclopramide
orally disintegrating tablets, 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 with your
doctor about your medical condition or your treatment.
What is the most important information I should know about
metoclopramide tablets, USP?
Metoclopramide tablets, USP 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
tablets, USP. There is no treatment for tardive dyskinesia, but
symptoms may lessen or go away over time
after you stop taking metoclopramide tablets, USP.
Your chances for getting tardive dyskinesia go up:
•
the longer you take metoclopramide tablets, USP and the more
metoclopramide tablets, USP you
take. You should not take metoclopramide tablets, USP 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
tablets, USP.
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
tablets, USP?" for more
information about side effects.
What are metoclopramide tablets, USP?
Metoclopramide tablets, USP are a presc

Summary of Product characteristics

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
METOCLOPRAMIDE TABLETS, USP
2204
2203
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 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
and practically insoluble in ether. Chemically, it is
4-amino-5-chloro-_N_-[2-(diethylamino)ethyl]-2-
methoxy benzamide monohydrochloride monohydrate. Its structural
formula is as follows:
C
H ClN O •HCl•H O M.W. 354.3
Each tablet for oral administration contains 5 mg or 10 mg
metoclopramide (present as the
hydrochloride).
INACTIVE INGREDIENTS
Corn starch, dibasic calcium phosphate, magnesium stearate,
microcrystalline cellulose and sodium
starch glycolate.
CLINICAL PHARMACOLOGY
Metoclopramide stimulates motility of the upper gastrointestinal tract
without stimulating gastric,
14
22
3
2
2
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 amplitude of gastric (especially
antral) contractions, relaxes the
pyloric sphincter and the duodenal bul