DICLOFENAC SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: Diclofenac sodium delayed-release tablets, USP 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). Diclofenac sodium delayed-release is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Product summary:

Diclofenac Sodium Delayed-Release Tablets, USP are available as follows: 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 15(NDC 63187-761-15), 30 (NDC 63187-761-30), 60 (NDC 63187-761-60), and 90 (NDC 63187-761-90). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59ºto 86ºF). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320 40-9184 Revised —  August 2015

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Proficient Rx LP
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o older age
o longer use of NSAIDs
o poor health
o smoking
o advanced liver disease
o drinking alcohol
o bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs? Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including if
you

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
40-9184
REVISED – AUGUST 2015
RX ONLY
PRESCRIBING INFORMATION
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac sodium delayed-release tablets, USP 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 C NNaO , and it has the following structural formula
Each enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium, USP.
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
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction, and
stroke, which can be
fatal. This risk may occur early in treatment and may increase with
duration of use (see
WARNINGS and PRECAUTIONS).
Diclofenac sodium delayed-release tablets are contraindicated in the
setting of coronary
artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
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
l2
2
dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium delayed-release tablets, USP are a non-steroidal
anti-inflammatory drug (NSAID)
that exhibits anti-i