"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
(metoclopramide) 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]
REGLAN ODT™ (metoclopramide orally disintegrating tablets) is an orally administered formulation of metoclopramide which disintegrates on the tongue.
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.
Each orally disintegrating tablet contains either 5 mg or 10 mg of metoclopramide base (as the monohydrochloride monohydrate) and the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, aminoalkyl methacrylate copolymer, microcrystalline cellulose, natural and artificial orange flavor and povidone.
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: 12/27/2010
This monograph has been modified to include the generic and brand name in many instances.
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