1 INDICATIONS AND USAGE 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 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 )

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions ( 5.1 )] Other extrapyramidal effects [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Depression [see Warnings and Precautions ( 5.4 )] Hypertension [see Warnings and Precautions ( 5.5 )] Fluid retention [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8) ] Metoclopramide The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude.

In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration.

Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches.

Central Nervous System Disorders Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms Convulsive seizures Hallucinations Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily.

Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents) Endocrine Disorders : Fluid retention secondary to transient elevation of aldosterone.

Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Cardiovascular Disorders : Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention Gastrointestinal Disorders : Nausea, bowel disturbances (primarily diarrhea) Hepatic Disorders : Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential Renal and Urinary Disorders : Urinary frequency, urinary incontinence Hematologic Disorders : Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia Hypersensitivity Reactions : Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema Eye Disorders : Visual disturbances Metabolism Disorders : Porphyria Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude.

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.

at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.