DIFLUNISAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Lifesciences Limited

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: 1. Mild to moderate pain 2. Osteoarthritis 3. 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 ). Diflunisal tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surg

Product summary:

Diflunisal Tablets USP, 500 mg are light blue to blue color, capsule shaped, biconvex, coated tablets, debossed with "530" on one side and plain on the other side and are supplied as follows: NDC 70771-1083-3 in bottle of 30 tablets NDC 70771-1083-6 in bottle of 60 tablets NDC 70771-1083-9 in bottle of 90 tablets NDC 70771-1083-1 in bottle of 100 tablets NDC 70771-1083-5 in bottle of 500 tablets NDC 70771-1083-0 in bottle of 1000 tablets NDC 70771-1083-8 in unit-dose blister cartons of 100 (10 X 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Manufactured by: Cadila Healthcare Ltd. Baddi, India Rev.: 06/17

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(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)?
Increased risk of a heart attack or stroke that can lead to death. The
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.
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
•
right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact w

Summary of Product characteristics

DIFLUNISAL - DIFLUNISAL TABLET
ZYDUS LIFESCIENCES LIMITED
----------
DIFLUNISAL TABLETS, USP
CARDIOVASCULAR RISK
• 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 CONTRAINDICATIONS 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 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid. Its
structural formula is:
C
H F O M.W. 250.20
Diflunisal is a stable, white to off-white, crystalline compound with
a melting point of
211° to 213°C. It is practically insoluble in hexane and water. It
is soluble in most organic
solvents including acetone and ethyl acetate and it is slightly
soluble in chloroform,
carbon tetrachloride and methylene chloride.
13
8 2
3
Each diflunisal tablet intended for oral administration contains 500
mg of diflunisal. In
addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, hypromellose, microcrystalline cellulose,
pregelatinised starch
and sodium stearyl fumarate. Additionally each diflunisal tablets
contain opadry blue
03B505010 which contains FD&C blue #2, FD&C yellow #6, hypromellose,
polyethylene
glycol 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 addicti