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METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
DIRECT RX
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 5 mg
ORAL
PRESCRIPTION DRUG
The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12 week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (
Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed metoclopramide tablet contains 5 mg metoclopramide (present as the hydrochloride). Available in bottles of 100 and 500. Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet contains 10 mg metoclopramide (present as the hydrochloride). Available in bottles of 100, 500 and 1000. Dispense in a tight, light-resistant container. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. N 9/2011
Abbreviated New Drug Application
DIRECT RX ---------- SPL MEDGUIDE SECTION METOCLOPRAMIDE TABLETS, USP Rx only Read the Medication Guide that comes with metoclopramide tablets, USP before you start taking them and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral syrup), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about metoclopramide tablets, USP? Metoclopramide tablets, USP can cause serious side effects, including: Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping metoclopramide tablets, USP. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking metoclopramide tablets, USP. Your chances for getting tardive dyskinesia go up: • the longer you take metoclopramide tablets, USP and the more metoclopramide tablets, USP you take. You should not take metoclopramide tablets, USP for more than 12 weeks. • if you are older, especially if you are a woman • if you have diabetes It is not possible for your doctor to know if you will get tardive dyskinesia if you take metoclopramide tablets, USP. Call your doctor right away if you get movements you can not stop or control, such as: • lip smacking, chewing, or puckering up your mouth • frowning or scowling • sticking out your tongue • blinking and moving your eyes • shaking of your arms and legs See the section "What are the possible side effects of metoclopramide tablets, USP?" for more information about side effects. What are metoclopramide tablets, USP? Metoclopramide tablets, USP are a prescription medici Läs hela dokumentet
METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET DIRECT RX ---------- METOCLOPRAMIDE BOXED WARNING 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. DESCRIPTION SECTION Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2- methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows: Each tablet for oral administration contains 5 mg or 10 mg metoclopramide (present as the hydrochloride). Inactive Ingredients Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. CLINICAL PHARMACOLOGY SECTION Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resul Läs hela dokumentet