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:

Novel Laboratories, Inc.

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults. Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established. Do not use metoclopramide whenever stimulation of gastrointestinal motility may be dangerous such as in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may precipitate a hypertensive crisis, most likely due to release of catecholamines from the tumor. Such hyperte

Product summary:

Metoclopramide Hydrochloride 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 40032-581-31 Metoclopramide Hydrochloride 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 40032-580-31 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

Novel Laboratories, Inc.
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SPL MEDGUIDE
Medication Guide
Metoclopramide Hydrochloride Orally Disintegrating Tablets
Phenylketonurics:
Phenylalanine is a component of aspartame. Each 5 mg and 10 mg
Metoclopramide Hydrochloride Orally
Disintegrating Tablets contains 4.7 mg of phenylalanine.
Read the Medication Guide that comes with Metoclopramide Hydrochloride
Orally Disintegrating Tablets
before you take 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, 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 Hydrochloride Orally
Disintegrating Tablets?
Metoclopramide Hydrochloride 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
Hydrochloride Orally Disintegrating Tablets. There is no treatment for
tardive dyskinesia, but symptoms
may lessen or go away over time after you stop taking Metoclopramide
Hydrochloride Orally
Disintegrating Tablets.
Your chances for getting tardive dyskinesia go up:
•
the longer you take Metoclopramide Hydrochloride Orally Disintegrating
Tablets and the more
Metoclopramide Hydrochloride Orally Disintegrating Tablets you take.
You should not take
Metoclopramide Hydrochloride 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
Hydrochloride Orally Disintegrating Tablets.
Call your

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET,
ORALLY
DISINTEGRATING
NOVEL LABORATORIES, 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 HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE) TABLET,
ORALLY DISINTEGRATING
FOR ORAL USE.
INITIAL U.S. APPROVAL: 1976
WARNING: TARDIVE DYSKINESIA
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TREATMENT WITH METOCLOPRAMIDE CAN CAUSE TARDIVE DYSKINESIA, A SERIOUS
MOVEMENT DISORDER THAT IS OFTEN
IRREVERSIBLE. THE RISK OF DEVELOPING TARDIVE DYSKINESIA INCREASES WITH
THE DURATION OF TREATMENT AND THE
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. (5.1)
INDICATIONS AND USAGE
Metoclopramide Orally Disintegrating Tablets are a dopamine receptor
antagonist indicated for:
RELIEF OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX: short-term (4 to 12
weeks) therapy for adults with symptomatic,
documented gastroesophageal reflux who fail to respond to conventional
therapy (1.1)
DIABETIC GASTROPARESIS (DIABETIC GASTRIC STASIS): the relief of
symptoms in adults associated with acute and
recurrent diabetic gastroparesis (gastric stasis) (1.2)
Important Limitations:
Therapy should not exceed 12 weeks in duration (1.3)
Metoclopramide Hydrochloride Orally Disintegrating Tablets are
recommended only for adults. The safety and
effectiveness in pediatric patients have not been established (1.3)
DOSAGE AND ADMINISTRATION
GASTROESOPHAGEAL REFULX DISEASE: 10 mg to