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. d/b/a Avet 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 14539-673-06 Bottles of 100:  NDC 14539-673-01 Bottles of 500:  NDC 14539-673-05 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]. Dispense with Medication Guide available at: www.avetpharma.com. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 12/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIFLUNISAL- DIFLUNISAL TABLET, FILM COATED
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
----------
Dispense with Medication Guide available at: www.avetpharma.com.
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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o 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 longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o 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 befo

Summary of Product characteristics

DIFLUNISAL- DIFLUNISAL TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC. D/B/A AVET 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, USP 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, USP 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, USP. In addition,
each tablet contains the following inactive ingredients:
croscarmellose sodium, FD&C
13
8 2
3
Blue No. 2, hypromellose, microcrystalline cellulose, pregelatinized
starch, propylene
glycol, sodium stearyl fumarate and titanium dioxide.
CLINICAL PHARMACOLOGY
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 repor