METOCLOPRAMIDE HYDROCHLORIDE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals,Inc.

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoclopramide Orally Disintegrating Tablets is indicated in adults for the: - Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. - Relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis). Limitations of Use : Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4)] Metoclopramide Orally Disintegrating Tablets is contraindicated: - In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions (5.1, 5.2)]. - When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction,

Product summary:

Metoclopramide Orally Disintegrating Tablets 5 mg strength are round, white to off- white, flat faced beveled edge tablet debossed with 'N' on one side and "581" on the other side; it is comprised of 5 mg metoclopramide (as 5.91 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (1x10)   NDC 43386-581-31 Metoclopramide Orally Disintegrating Tablets 10 mg are round, white to off-white, flat faced beveled edge tablet debossed with 'N' on one side and "580" on the other side; it is comprised of 10 mg metoclopramide (as 11.82 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (1x10)   NDC 43386-580-31 Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lupin Pharmaceuticals,Inc.
----------
SPL MEDGUIDE
Metoclopramide Orally Disintegrating Tablets
(MET-oh-KLOE-pra-mide)
Read this Medication Guide before you start taking Metoclopramide
Orally Disintegrating Tablets 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, REGLAN injection
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 with your doctor about your
medical condition or your treatment.
What is the most important information I should know about
Metoclopramide Orally Disintegrating
Tablets? Metoclopramide Orally Disintegrating Tablets can cause
serious side effects, including:
Tardive dyskinesia (abnormal muscle movements). These movements happen
mostly in the face muscles.
You cannot control these movements. They may not go away even after
stopping Metoclopramide Orally
Disintegrating Tablets. There is no treatment for tardive dyskinesia,
but symptoms may lessen or go away
over time after you stop taking Metoclopramide Orally Disintegrating
Tablets.
Your chances for getting tardive dyskinesia go up:
•
the longer you take Metoclopramide Orally Disintegrating Tablets and
the more Metoclopramide
Orally Disintegrating Tablets you take. You should not take
Metoclopramide Orally
Disintegrating Tablets for more than 12 weeks.
•
if you are older, especially if you are an older woman.
•
if you have diabetes.
It is not possible for your doctor to know if you will get tardive
dyskinesia if you take Metoclopramide
Orally Disintegrating Tablets. Call your doctor right away if you have
movements you cannot stop or
control, such as:
•
lip smacking, chewing, or puckering of your lips
•
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 Metoc

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET,
ORALLY
DISINTEGRATING
LUPIN PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOCLOPRAMIDE HYDROCHLORIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOCLOPRAMIDE
HYDROCHLORIDE.
METOCLOPRAMIDE ORALLY DISINTEGRATING TABLETS.
INITIAL U.S. APPROVAL: 1976 WARNING: TARDIVE DYSKINESIA
Metoclopramide Orally Disintegrating Tablets can cause tardive
dyskinesia (TD), a serious movement disorder
that is often irreversible. There is no known treatment for TD. The
risk of developing TD increases with duration
of treatment and total cumulative dosage. ( 5.1)
Discontinue Metoclopramide Orally Disintegrating Tablets in patients
who develop signs or symptoms of TD. (
5.1)
Avoid treatment with Metoclopramide Orally Disintegrating Tablets for
longer than 12 weeks because of the risk
of developing TD with longer-term use. ( 5.1, 2.1, 2.2, 2.3)
INDICATIONS AND USAGE
Metoclopramide Orally Disintegrating Tablets is a dopamine-2 (D2)
antagonist indicated in adults for:
Treatment of symptomatic, documented gastroesophageal reflux disease
(GERD) in adults with who fail to respond to
conventional therapy.
Relief of symptoms associated with acute and recurrent diabetic
gastroparesis (gastric stasis).
Limitations of Use:
Metoclopramide Orally Disintegrating Tablets is not recommended for
use in pediatric patients due to the risk of
developing tardive dyskinesia (TD) and other extrapyramidal symptoms
and the risk of methemoglobinemia in neonates.
(1, 8.4)
DOSAGE AND ADMINISTRATION
GERD
The recommended dosage is 10 mg to 15 mg up to four times daily at
least 30 minutes before eating and at bedtime for 4
to 12 weeks. ( 2.2)
Diabetic Gastroparesis (Gastric Stasis)
The recommended dosage is 10 mg dose four times daily at least 30
minutes before eating and at bedtime for 2 to 8
weeks. ( 2.3)
Dosage Adjustment in Specific Populations
See Full Prescribing Information for recommen