Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
McKesson Contract Packaging
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
METOCLOPRAMIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET MCKESSON CONTRACT PACKAGING ---------- METOCLOPRAMIDE TABLETS, USP 2204 2203 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 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: C H ClN O •HCl•H O M.W. 354.3 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 14 22 3 2 2 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 sphincte Lire le document complet