DICLOFENAC SODIUM DELAYED RELEASE- diclofenac sodium tablet, delayed release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Bryant Ranch Prepack

INN (Mezinárodní Name):

DICLOFENAC SODIUM

Složení:

DICLOFENAC SODIUM 50 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Carefully consider the potential benefits and risks of Diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac is indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets is contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac 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). Diclofenac is contraindicated for the treatment of perioperati

Přehled produktů:

Product: 63629-1534 NDC: 63629-1534-1 30 TABLET, DELAYED RELEASE in a BOTTLE NDC: 63629-1534-5 20 TABLET, DELAYED RELEASE in a BOTTLE NDC: 63629-1534-2 60 TABLET, DELAYED RELEASE in a BOTTLE NDC: 63629-1534-4 120 TABLET, DELAYED RELEASE in a BOTTLE NDC: 63629-1534-3 90 TABLET, DELAYED RELEASE in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

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 shou

Charakteristika produktu

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
BRYANT RANCH PREPACK
----------
DICLOFENAC SODIUM
DELAYED-RELEASE TABLETS USP
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 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, 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, as the sodium salt, is a benzene-acetic acid derivative.
The chemical name is 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
molecular weight is 318.14. Its
molecular formula is C14H10Cl2NNaO2, and it has the following
structural formula
Each enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium. In
addition, each tablet contains the following inactive ingredients;
black iron oxide, hypromellose, lactose
monohydrate, magnesium stearate, methacrylic acid copolymer,
microcrystalline cellulose,
pharmaceutical glaze, polyethylene glycol, povidone, sodium starch
glycolate, talc, titanium dioxide,
triethyl citrate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium delayed-release tablets is a nonsteroidal
anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities in
animal models. The mechanism of
action of diclofenac, like that of other NSAIDs,