Metozolv ODT (Metoclopramide Hydrochloride Orally Disintegrating Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

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GERD is a condition in which the acidified liquid content of the stomach up into the esophagus.
The causes of GERD include an abnormal lower esophageal sphincter, hiatal hernia, abnormal esophageal contractions, and slow emptying of the stomach.
GERD may damage the lining of the esophagus, thereby causing inflammation (esophagitis), although usually it does not.
The symptoms of uncomplicated GERD are heartburn, regurgitation, and nausea.
Complications of GERD include ulcers and strictures of the esophagus, Barrett's esophagus, cough and asthma, throat and laryngeal inflammation, inflammation and infection of the lungs, and collection of fluid in the sinuses and middle ear.
Barrett's esophagus is a pre-cancerous condition that requires periodic endoscopic surveillance for the development of cancer.
GERD may be diagnosed or evaluate...

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Metozolv ODT

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METOZOLV ODT
(metoclopramide hydrochloride) Orally Disintegrating Tablets

WARNING: TARDIVE DYSKINESIA

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and 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. [see WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION

METOZOLV ODT is an orally disintegrating tablet formulation of metoclopramide hydrochloride. The 5 mg strength is a round white tablet debossed on one side with a "5" and plain on the other side; it is comprised of 5 mg metoclopramide (as 5.91 mg of metoclopramide hydrochloride ) with gelatin, mannitol, mint flavoring, and Acesulfame K (artificial sweetener). The 10 mg strength is a round white tablet debossed on one side with a "10" and plain on the other side; it is comprised of 10 mg metoclopramide (as 11.82 mg of metoclopramide hydrochloride) with gelatin, mannitol, mint flavoring, and Acesulfame K.

The active ingredient, metoclopramide hydrochloride, is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C₁₄H₂₂ClN₃O₂•HCl•H₂O. Its molecular weight is 354.3. The structural formula is shown in Figure 1.

Figure 1

METOZOLV ODT
(metoclopramide hydrochloride) Structural Formula Illustration

METOZOLV ODT includes the following inactive ingredients: gelatin, mannitol, mint flavoring, Acesulfame potassium (artificial sweetener), and trace amounts of sodium chloride and sodium hydroxide.

What are the precautions when taking metoclopramide hydrochloride orally disintegrating tablets (Metozolv ODT)?

Before taking metoclopramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blockage/hole in the intestines/stomach, breast cancer, diabetes, high blood pressure, kidney problems, heart failure, mental/mood problems (such as depression, thoughts of suicide), Parkinson's disease, liver problems (such as cirrhosis, porphyria), pheochromocytoma, seizures, a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency).

This drug may make you dizzy or drowsy. Do not drive,...

Read All Potential Precautions of Metozolv ODT »

Last reviewed on RxList: 10/17/2011
This monograph has been modified to include the generic and brand name in many instances.