DIFLUNISAL- diflunisal tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIFLUNISAL (UNII: 7C546U4DEN) (DIFLUNISAL - UNII:7C546U4DEN)

Available from:

Heritage Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: - Mild to moderate pain - Osteoarthritis - Rheumatoid arthritis Diflunisal tablets are contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see DESCRIPTION ). Diflunisal tablets 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/analphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactic/Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma ). In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

Diflunisal tablets USP are supplied as follows: 500 mg tablets: Modified Capsule shaped, blue film coated tablets, Debossed "EP 170" on one side and plain on the reverse side. Bottles of 60:   NDC 23155-673-06 Bottles of 100:  NDC 23155-673-01 Bottles of 500:  NDC 23155-673-05 Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Revised: 01/2019

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Heritage Pharmaceuticals Inc.
----------
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:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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 a 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

Summary of Product characteristics

DIFLUNISAL- DIFLUNISAL TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC.
----------
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
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 ).
Diflunisal tablets are contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery (see CONTRAINDICATION and WARNINGS ).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including 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
Diflunisal is [1, 1'-Biphenyl]-3-carboxylic acid, 2',
4'-difluoro-4-hydroxy. Its structural formula is:
MOLECULAR FORMULA: C
H F O
MOLECULAR WEIGHT: 250.20 g/mol
Diflunisal is a stable, white, crystalline compound with a melting
point of 211° to 213°C. It is practically
insoluble in water at neutral or acidic pH. Because it is an organic
acid, it dissolves readily in dilute
alkali to give a moderately stable solution at room temperature. It is
soluble in most organic solvents
including ethanol, methanol, and acetone.
Each tablet, for oral administration, contains 500 mg diflunisal. In
addition, each tablet contains the
following inactive ingredients: croscarmellose sodium, FD&C Blue No.
2, hypromellose,
microcrystalline cellulose, pregelatinized starch, propylene glycol,
sodium stearyl fumarate and
titanium dioxide.
CLINICAL PHARMACOLOGY
13
8
2
3
ACTION
Diflunisal is a non-steroidal drug with analgesic, anti-inflammatory
and antipyretic properties. It is a
peripherally-acting non-narcotic analgesic drug. Habituation,
tolerance, and addiction have not been
reported.
Diflunisal is a difluorophenyl derivati