DICLOFENAC SODIUM E/R- diclofenac sodium tablet, film coated, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

DIRECTRX

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. 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 the signs and symptoms of osteoarthritis • For relief of the signs and symptoms of rheumatoid arthritis Diclofenac Sodium Extended-release Tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac Sodium Extended-release Tablets 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, Anaphylactic Reactions, and PRECAUTIONS, Preexisting Asthma).

Produktsammanfattning:

Diclofenac Sodium Extended-release Tablets 100 mg - unscored, pink, round film coated tablets, engraved with "93" on one side and "1041" on the other side. NDC 68682-103-01 – Bottles of 100 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

DICLOFENAC SODIUM E/R- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
DIRECTRX
----------
DICLOFENAC (dye-KLOE-fen-ak)
(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

Produktens egenskaper

DICLOFENAC SODIUM E/R- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
DIRECTRX
----------
DICLOFENAC SODIUM E/R
Cardiovascular Risk - • NSAIDs may cause an increased risk of
serious
cardiovascular thrombotic events, myocardial infarction, and stroke,
which can be
...
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 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).
Rx only
Diclofenac Sodium Extended-release Tablets 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
C14H10Cl2NNaO2, and it has
the following structural formula:
[Chemical Structure]
Each extended-release tablet for oral administration contains 100 mg
of diclofenac
sodium, USP. In addition, each tablet contains the following inactive
ingredients:
anhydrous lactose, colloidal silicon dioxide, D & C Red # 27 (phloxine
aluminum lake),
hydroxyethyl cellulose, hypromellose, isopropyl alcohol, lactose
monohydrate,
magnesium stearate, polyethylene glycol, povidone, talc, titanium
dioxide, and triacetin.
Pharmacodynamics
Diclofenac Sodium Extended-release Tablets are a nonsteroidal
anti-inflammatory drug
(NSAID) that exhibits anti-inflammatory, analg