DICLOFENAC SODIUM tablet delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Доступна з:

St Marys Medical Park Pharmacy

ІПН (Міжнародна Ім'я):

DICLOFENAC SODIUM

Склад:

DICLOFENAC SODIUM 50 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
ST MARYS MEDICAL PARK PHARMACY
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
40-9184
REVISED – JUNE 2012
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 delayed-release tablets are 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, 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 delayed-release tablets, USP are 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 enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium, USP.
In addition, each tablet contains the following inactive ingredients:
aluminum hydrate, colloidal silicon
dioxide, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate,
propylene glycol, silica, sodium
alginate, sodium starch glycolate (Type A), stearic acid, synthetic
black iron oxide, talc, and titanium
dioxide.
14
10
l2
2
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium delayed-release tablets, USP are a non-steroidal
anti-inflammatory drug (NSAID)
tha