DIFLUNISAL- diflunisal tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

PD-Rx Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

DIFLUNISAL

Komposisi:

DIFLUNISAL 500 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 ). Diflunisal tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surge

Ringkasan produk:

Diflunisal tablets USP are supplied as follows: 500 mg – light blue-purple, capsule-shaped, film-coated tablets, debossed “755/93” on one side, plain on other. Packaged in bottles of 10 (NDC 55289-460-10), 15 (NDC 55289-460-15), 20 (NDC 55289-460-20) and 30 (NDC 55289-460-30). 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) [See USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PD-Rx 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
•
older age
•
longer use
of NSAIDs
•
poor health
•
smoking
•
advanced liver
disease
•
drinking
alcohol
•
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
med

Ciri produk

DIFLUNISAL- DIFLUNISAL TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
DIFLUNISAL TABLETS USP
0755
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 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, 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 Blue #2
aluminum lake, hypromellose,
microcrystalline cellulose, pregelatinized starch, propylene glycol,
sodium stearyl fumarate, and
titanium dioxide.
CLINICAL PHARMACOLOGY
ACTION
13
8
2
3
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 derivative of sa