DICLOFENAC SODIUM tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Physicians Total Care, Inc.

INN（国际名称）:

DICLOFENAC SODIUM

组成:

DICLOFENAC SODIUM 100 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Carefully consider the potential benefits and risks of diclofenac sodium extended-release and other treatment options before deciding to use diclofenac sodium extended-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium extended-release tablets are indicated: • For relief of signs and symptoms of osteoarthritis • For relief of signs and symptoms of rheumatoid arthritis Diclofenac sodium extended-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium extended-release should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Diclofenac sodium extended-release is contraindicated for the treatment of

產品總結:

Diclofenac Sodium Extended-Release Tablets, USP are available as follows: 100 mg - Each unscored, yellow, round, beveled edge, film-coated tablet imprinted with   on one side and 717 on the other side contains 100 mg of Diclofenac Sodium, USP. Tablets are supplied with a child-resistant closure in Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by : Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-8831 Revised — March 2009 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

授权状态:

Abbreviated New Drug Application

资料单张

Physicians Total Care, Inc.
----------
Medication Guide for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non- Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a
“coronary artery bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
•
different types of arthritis
•
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicin

产品特点

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
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
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 of other NSAIDs, is not
completely understood but may
be related to prostaglan