DICLOFENAC SODIUM tablet, film coated, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bryant Ranch Prepack

INN (Algemene Internationale Benaming):

DICLOFENAC SODIUM

Samenstelling:

DICLOFENAC SODIUM 100 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-Release Tablets, USP and other treatment options before deciding to use Diclofenac Sodium Extended-Release Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Extended-Release Tablets, USP 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, USP is contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium extended-release tablets, USP should not be given to patients who have experienced asthma, urticaria, or 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). Diclofenac sodium extended-release

Product samenvatting:

Product: 63629-5096 NDC: 63629-5096-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 63629-5096-2 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 63629-5096-3 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 63629-5096-4 120 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Autorisatie-status:

New Drug Application Authorized Generic

Bijsluiter

Bryant Ranch Prepack
----------
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 medicines should not be use

Productkenmerken

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
DICLOFENAC SODIUM
EXTENDED-RELEASE TABLETS, USP
TABLETS OF 100 MG
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 tablets, USP 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, USP is a benzeneacetic
acid derivative. Diclofenac
sodium extended-release is available as extended-release tablets of
100 mg (light pink) for oral
administration. The chemical name is 2-[(2,6-dichlorophenyl)amino]
benzeneacetic acid, monosodium
salt. The molecular weight is 318.14. Its molecular formula is C
H Cl
NNaO , and it has the
following structural formula
The inactive ingredients in Diclofenac Sodium Extended-Release
Tablets, USP include: cetyl
alcohol, hydroxypropyl methylcellulose, iron oxide, magnesium
stearate, polyethylene glycol,
polysorbate, povidone, silicon dioxide, sucrose, talc, titanium
dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium extended-release tablets, USP is a non-steroidal
anti-inflammatory drug (NSAID)
that exhibits anti-inflammatory, analgesic, and antipyretic activities
in animal models. The mechanism of
action of diclofenac sodium extended-rel