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(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]
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.
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 possible side effects of metoclopramide (Metozolv ODT, Reglan)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking metoclopramide and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:
- tremors or shaking in your arms or legs;
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
- any new or unusual muscle movements...
Last reviewed on RxList: 10/17/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Metozolv ODT Information
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