Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
NCS HealthCare of KY, Inc dba Vangard Labs
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 10 mg
ORAL
PRESCRIPTION DRUG
The use of metoclopramide tablets, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux: Metoclopramide tablets, USP 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 G
Metoclopramide Tablets, USP: 5 mg - Light green, round, unscored tablets. Debossed: WPI on one side and 2228 on the other side. 10 mg - White, round, scored tablets in blister cards of 30 (NDC 0615-8071-39) and Unit dose boxes of 30 (NDC 0615-8071-30). Debossed: WPI on one side and 2229 on the other side. Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE Metoclopramide Tablets, USP Read the Medication Guide that comes with metoclopramide tablets 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 solution), 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 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. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking metoclopramide tablets. Your chances for getting tardive dyskinesia go up: • the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide tablets 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. 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 is a prescription medicine used: • in adults for Lesen Sie das vollständige Dokument
METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE TABLETS, USP Revised: May 2016 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 S TOPPED. 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 DYS KINES IA. SEE WARNINGS DESCRIPTION Metoclopramide hydrochloride, USP 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, practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino) ethyl]-2- methoxybenzamide monohydrochloride monohydrate. Its structural formula is as follows: Each tablet for oral administration contains metoclopramide hydrochloride, equivalent to either 5 mg or 10 mg metoclopramide. Tablets also contain as inactive ingredients anhydrous lactose, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate and (5 mg only) D&C Yellow #10 and FD&C Blue #1. 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 Lesen Sie das vollständige Dokument