Drug - Metozolv™ ODT (metoclopramide)
Therapeutic area - GI
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)
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
- Congestive Heart Failure and Ventricular Arrhythmia
- Withdrawal from Metoclopramide
MHCP Provider Call Center 651-431-2700 or 800-366-5411