"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).
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.
For oral administration, reglan® tablets (metoclopramide tablets, USP) 10 mg are white, scored, capsule-shaped tablets engraved REGLAN (metoclopramide) on one side and SP 10 on the opposite side.
Each tablet contains
Metoclopramide base .................................................. 10 mg (as the monohydrochloride monohydrate)
Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Stearic Acid.
reglan® tablets (metoclopramide tablets, USP) 5 mg are green, elliptical-shaped tablets engraved REGLAN (metoclopramide) 5 on one side and SP on the opposite side.
Each tablet contains
Metoclopramide base .................................................... 5 mg (as the monohydrochloride monohydrate)
Corn starch, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, Lactose, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid.
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 C14H22CIN3O2•HCl•H2O. Its molecular weight is 354.3.
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...
What are the precautions when taking metoclopramide (Reglan)?
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,...
Last reviewed on RxList: 12/17/2010
This monograph has been modified to include the generic and brand name in many instances.
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