DICLOFENAC SODIUM tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)

זמין מ:

Rebel Distributors Corp

INN (שם בינלאומי):

diclofenac sodium

הרכב:

diclofenac sodium 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Diclofenac Sodium Delayed-Release Tablets, USP are available as follows: 50 mg — Each white, round, enteric-coated tablet printed with   on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 30 (NDC 21695-038-30) and 60 (NDC 21695-038-60). 75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 20 (NDC 21695-039-20), 30 (NDC 21695-039-30), 60 (NDC 21695-039-60) and 90 (NDC 21695-039-90). 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 Repackaged by: Rebel Distributors Corp 3607 Old Conejo Rd., Thousand Oaks, CA 91320

מצב אישור:

Abbreviated New Drug Application

עלון מידע

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Rebel Distributors Corp
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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 used b

מאפייני מוצר

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
REBEL DISTRIBUTORS CORP
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
BOXED WARNING
Cardiovascular Risk
Gastrointestinal Risk
DESCRIPTION
Diclofenac sodium delayed-release is a benzene-acetic 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 enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium. In
addition, each tablet contains the following inactive ingredients:
aluminum hydrate, colloidal silicon
dioxide, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate,
propylene glycol, silica, sodium
alginate, sodium starch glycolate (Type A), stearic acid, synthetic
black iron oxide, talc, and titanium
dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
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 are contraindicated for the
treatment of peri-
operative pain in the setting of coronary artery bypass graft (CABG)
surgery (see
WARNINGS).
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).
14
10
2
2
Diclofenac sodium delayed-release tablets are a nonsteroidal
anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities in
animal