FLECTOR- diclofenac epolamine system

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

DICLOFENAC EPOLAMINE (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1)

MAH:

IBSA Pharma Inc.

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. FLECTOR is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see Warnings and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions (5.7, 5.8) ] - In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions (5.1) ] - FLECTOR is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczem

leaflet_short:

Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

authorization_status:

New Drug Application

PIL

FLECTOR- DICLOFENAC EPOLAMINE SYSTEM
IBSA Pharma 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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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 yo

SPC

FLECTOR- DICLOFENAC EPOLAMINE SYSTEM
IBSA PHARMA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLECTOR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLECTOR.
FLECTOR (DICLOFENAC EPOLAMINE) TOPICAL SYSTEM
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 ( 5.1)
FLECTOR IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG)
SURGERY ( 4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS ( 5.2)
RECENT MAJOR CHANGES
Warning and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS) ( 5.10)
04/2021
Warning and Precautions, Fetal Toxicity ( 5.11)
04/2021
INDICATIONS AND USAGE
FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is
indicated for the topical treatment of
acute pain due to minor strains, sprains, and contusions in adults and
pediatric patients 6 years and
older. ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consist with the
individual patient treatment
goals. ( 2.1)
The recommended dose of FLECTOR for adults and pediatric patients 6
years and older is one (1)
topical system to the most painful area twice a day. ( 2)
FLECTOR should not be applied to damaged or non-intact skin. ( 2)
DOSAGE FORMS AND STRENGTHS
FLECTOR
(diclofenac epolamine) to