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:

Teva Pharmaceuticals USA, 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) s

Ringkasan produk:

Diflunisal Tablets, USP are supplied as follows: 500 mg – light blue-purple, capsule-shaped, film-coated tablets, debossed “L77” on one side, and “TV” on the other. Packaged in bottles of 100 (NDC 0093-9222-01), 500 (NDC 0093-9222-05), and 60 unit-of-use (NDC 0093-9222-06). 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]. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. U 10/2021

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
Dispense with Medication Guide available at: www.tevausa.com/medguides
Rx only
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

Ciri produk

DIFLUNISAL- DIFLUNISAL TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
DIFLUNISAL TABLETS, USP
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, USP is 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid.
Its structural
formula is:
C
H F O M.W. 250.20
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 Blue #2
aluminum lake, hypromellose, microcrystalline cellulose, polyethylene
glycol, polyvinyl
alcohol, pregelatinized starch, sodium stearyl fumarate, talc, and
titanium dioxide.
13
8 2
3
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 reported.
Diflunisal