DICLOFENAC EPOLAMINE patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diclofenac Epolamine (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1)

Available from:

Teva Pharmaceuticals USA Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DICLOFENAC EPOLAMINE TOPICAL PATCH 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. DICLOFENAC EPOLAMINE TOPICAL PATCH 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 PATCH 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. Risk Summary Published literature reports that use of NSAIDs, including DI

Product summary:

The DICLOFENAC EPOLAMINE TOPICAL PATCH 1.3% is supplied in resealable envelopes, each containing 5 patches (10 cm × 14 cm), with 6 envelopes per box (NDC 0093-3225-55). Each individual patch is embossed with " DICLOFENAC EPOLAMINE TOPICAL PATCH 1.3% TEVA 3225". Storage 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 Authorized Generic

Patient Information leaflet

Teva Pharmaceuticals USA Inc.
----------
Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano,
Switzerland
Distributed by
Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 (USA)
For more information call 1-866-832-8537
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised: August,
2018
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 pai

Summary of Product characteristics

DICLOFENAC EPOLAMINE- DICLOFENAC EPOLAMINE PATCH
TEVA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC EPOLAMINE TOPICAL
PATCH 1.3 % SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLECTOR PATCH.
DICLOFENAC EPOLAMINE TOPICAL PATCH 1.3, FOR TOPICAL USE
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 PATCH 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
Boxed Warning
5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1) )
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5)
5/2016
INDICATIONS AND USAGE
DICLOFENAC EPOLAMINE TOPICAL PATCH 1.3% contains diclofenac epolamine,
which is a nonsteroidal anti-
inflammatory drug (NSAID), and is indicated for the topical treatment
of acute pain due to minor strains, sprains, and
contusions. (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 PATCH 1.3% is one
(1) patch to the most painful
area twice a day. (2)
DICLOFENAC EPOLAMINE TOPICAL PATCH 1.