METOCLOPRAMIDE hydrochloride tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)

Disponible des:

McKesson Contract Packaging

Designació comuna internacional (DCI):

METOCLOPRAMIDE HYDROCHLORIDE

Composición:

METOCLOPRAMIDE 5 mg

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

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