DICLOFENAC SODIUM tablet, film coated, extended release

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

INN (Alþjóðlegt nafn):

DICLOFENAC SODIUM

Samsetning:

DICLOFENAC SODIUM 100 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 )

Vörulýsing:

Diclofenac Sodium Extended-release Tablets unscored, pink, round film coated tablets, engraved with "93" on one side and "1041" on the other side. NDC 68071-4158-2 Bottles of 20 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).

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE FOR NON-
STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
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 pregna

Vara einkenni

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS
RX ONLY
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).
DESCRIPTION
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 C
H
Cl
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:
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.
14
10
2
2
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac Sodium Extended-release Tablets are 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