METOCLOPRAMIDE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Packaging Services a business unit of McKesson Corporation

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
----------
METOCLOPRAMIDE TABLETS, USP
RX ONLY
OCTOBER 2013
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
For oral administration, metoclopramide tablets, USP 10 mg are white,
biconvex, capsule-shaped,
uncoated tablets with 'N023' debossed on one face and breakline on the
other side.
Each tablet contains :
Metoclopramide base
...............................................................10 mg
(as the monohydrochloride monohydrate)
INACTIVE INGREDIENTS
Colloidal silicon dioxide, Corn starch, Pregelatinized starch
(botanical source: maize), Magnesium
stearate, Mannitol, Microcrystalline cellulose.
Metoclopramide tablets, USP 5 mg are pale green, biconvex, elliptical-
shaped, uncoated tablets with
‘N022’ debossed on one face and plain on the other side.
Each tablet contains:
Metoclopramide base
...............................................................5 mg
(as the monohydrochloride monohydrate)
INACTIVE INGREDIENTS
Colloidal silicon dioxide, Corn starch, D&C yellow # 10 (15 –20)
aluminium lake, FD&C blue # 1 (11 –
13) aluminium lake, Pregelatinized starch (botanical source: maize),
Magnesium stearate, Mannitol,
Microcrystalline cellulose.
Metoclopramide hydrochloride is white or practically white,
crystalline, od