DICLOFENAC EPOLAMINE system

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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) ] - DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated for use on non-intac

Product summary:

Product: 50436-1335 NDC: 50436-1335-1 5 SYSTEM in a POUCH / 6 in a CARTON

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

DICLOFENAC EPOLAMINE- DICLOFENAC EPOLAMINE SYSTEM
Unit Dose Services
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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:
1.
with increasing doses of NSAIDs
2.
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:
1.
anytime during use
2.
without warning symptoms
3.
that may cause death
The risk of getting an ulcer or bleeding increases with:
4.
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
5.
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
6.
increasing doses of NSAIDs
7.
longer use of NSAIDs
8.
smoking
9.
drinking alcohol
10.older age
11.poor health
12.advanced liver disease
13.bleeding problems
NSAIDs should only be used:
1.
exactly as prescribed
2.
at the lowest dose possible for your treatment
3.
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

Summary of Product characteristics

DICLOFENAC EPOLAMINE- DICLOFENAC EPOLAMINE SYSTEM
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC EPOLAMINE
TOPICAL SYSTEM 1.3% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%.
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)
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% for
adults and pediatric
patients 6 years and older is one ( 1) topical syste