Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
NuCare Pharmaceuticals,Inc.
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 10 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
10 mg — Each white, round tablet imprinted with p on one side and 685 and bisect on the other side contains 10 mg of metoclopramide (as the hydrochloride). NDC 68071-4326-2 BOTTLES OF 20 NDC 68071-4326-3 BOTTLES OF 30 NDC 68071-4326-9 BOTTLES OF 90 Dispense in a tight, light-resistant container as defined in the USP. Store at 20°-25°C (68° – 77°F) (See USP Controlled Room Temperature). Distributed by: Par Pharmaceutical Companies Inc. Spring Valley, NY 10977 U.S.A. Product of Italy Manufactured by: Par Formulations Private Limited 1/58, Pudupakkam, Kelambakkam – 603 103 Made in India From Active Pharmaceutical Ingredient made in Italy I02/15 Mfg. Lic. No.: TN00002121
Abbreviated New Drug Application
NuCare Pharmaceuticals,Inc. ---------- MEDICATION GUIDE MEDICATION GUIDE METOCLOPRAMIDE TABLETS, USP Rx Only Read the Medication Guide that comes with metoclopramide before you start taking it 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 tablet, 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? Metoclopramide can cause serious side effects, including: Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping metoclopramide.. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking metoclopramide. Your chances for getting TD go up: • the longer you take metoclopramide and the more metoclopramide you take. You should not take metoclopramide 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 TD if you take metoclopramide. 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?” for more information about side effects. What is metoclopramide? Metoclopramide is a prescription medicine used: • in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metocl Прочетете целия документ
METOCLOPRAMIDE- METOCLOPRAMIDE TABLET NUCARE PHARMACEUTICALS,INC. ---------- METOCLOPRAMIDE TABLETS, USP RX ONLY 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 DESCRIPTION Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro- _N_-[2-(diethylamino)ethyl] - _o-anisamide_ monohydrochloride monohydrate. Its molecular formula is C H CIN O •HCl•H O. Its molecular weight is 354.27. Each tablet, for oral administration, contains metoclopramide hydrochloride, equivalent to 10 mg of metoclopramide. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, mannitol and pregelatinized starch. 14 22 3 2 2 CLINICAL PHARMACOLOGY 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 resulting in accelerated gastric emptying and in Прочетете целия документ