DIFLUNISAL tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Physicians Total Care, Inc.

INN (আন্তর্জাতিক নাম):

DIFLUNISAL

রচনা:

DIFLUNISAL 500 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 for the treatment of peri-operative pain in the sett

পণ্য সারাংশ:

Diflunisal tablets USP are supplied as follows: 500 mg tablets: blue, unscored, oblong, film-coated tablets, debossed "755"‑"93". Packaged in 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]. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. N 5/2008 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Physicians Total Care, Inc.
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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)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
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
•
for pain 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 with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSA

পণ্য বৈশিষ্ট্য

DIFLUNISAL - DIFLUNISAL TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see ).
Diflunisal tablets are contraindicated for the treatment of
peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (see ).
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 ).
1
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-
inflammatory drug.
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. 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.
1
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