Metozolv

Drug - Metozolv™ ODT (metoclopramide)

April 2010

Therapeutic area - GI

Criteria

Patients can not take metoclopramide oral tablets or oral solution.

FDA approved indication

Relief of Symptomatic Gastroesophageal Reflux: short-term therapy (4 to 12 weeks)

Diabetic Gastroparesis (Diabetic Gastric Stasis): short-term therapy (not to exceed 12 weeks)

Rationale

Metozolv is an orally disintegrating formulation of metoclopramide tablets. It was not studied in clinical trials for its FDA approved indication, but only shown to be bioequivalent to a branded tablet. The cost differential between generic and the ODT formulation is significant for no proven benefit.

Warnings and precautions

The warnings and precautions for Metozolv ODT do not differ from that of metoclopramide tablets.

• Tardive Dyskinesia
• Acute Dystonic Reactions, Drug-induced Parkinsonism and Other Extrapyramidal Symptoms
• Neuroleptic Malignant Syndrome
• Depression
• Hypertension
• Congestive Heart Failure and Ventricular Arrhythmia
• Withdrawal from Metoclopramide

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411