DICLOFENAC SODIUM EXTENDED-RELEASE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)

Disponível em:

St Marys Medical Park Pharmacy

DCI (Denominação Comum Internacional):

Diclofenac Sodium

Composição:

Diclofenac 100 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DICLOFENAC SODIUM EXTENDED-RELEASE- DICLOFENAC SODIUM TABLET, EXTENDED
RELEASE
ST MARYS MEDICAL PARK PHARMACY
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
REVISED – MARCH 2009
RX ONLY
PRESCRIBING INFORMATION
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk..
(See WARNINGS).
Diclofenac sodium extended-release is contraindicated for the
treatment of perioperative pain
in the setting of coronary artery bypass graft (CABG) surgery (see
WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
inflammation, bleeding, inflammation, ulceration, and perforation of
the stomach or intestines,
which can be fatal. These events can occur at any time during use and
without warning
symptoms. Elderly patients are at greater risk for serious
gastrointestinal events (See
WARNINGS).
DESCRIPTION
Diclofenac sodium, USP extended-release, is a benzeneacetic acid
derivative. The chemical name is 2-
[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
molecular weight is 318.13. Its
molecular formula is C
H C NNaO , and it has the following structural formula:
Each extended-release tablet for oral administration contains 100 mg
of diclofenac sodium, USP. In
addition, each tablet contains the following inactive ingredients:
carnauba wax, cetyl alcohol, colloidal
silicon dioxide, hypromellose, lactose monohydrate, magnesium
stearate, povidone, synthetic yellow
iron oxide, talc, titanium dioxide, and triacetin.
CLINICAL PHARMACOLOGY
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PHARMACODYNAMICS
Diclofenac sodium extended-release is a nonsteroidal anti-inflammatory
drug (NSAID) that exhibits
anti-inflammatory, analgesic, and antipyretic activities in animal
models. The mechanism of action of
diclofenac sodium extended-release, like that