FLECTOR- diclofenac epolamine patch

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Preferred Pharmaceucitalc Inc.

INN (International Name):

Diclofenac Epolamine

Sammensetning:

Diclofenac Epolamine 180 mg

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

FLECTOR® PATCH is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. FLECTOR PATCH is contraindicated in the following patients: Risk Summary Published literature reports that use of NSAIDs, including FLECTOR PATCH, after 30 weeks' gestation increases the risk of premature closure of the fetal ductus arteriosus. Data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in the first or second trimester of pregnancy are inconclusive. Avoid use of NSAIDs, including FLECTOR PATCH, in pregnant women starting at 30 weeks of gestation (third trimester) (see Clinical Considerations and Data) . In animal reproduction studies, diclofenac epolamine administered orally to pregnant rats and rabbits during the period of organogenesis produced embryotoxicity at approximately 3 and 7 times, respectively, the topical exposure from the maximum recommended human dose (MRHD) of FLECTOR PATCH. In rats, increased incidences of

Produkt oppsummering:

The FLECTOR PATCHis supplied in resealable envelopes, each containing 5 patches (10 cm × 14 cm), with 6 envelopes per box (NDC 68788-6396-3). Each individual patch is embossed with "FLECTOR PATCH 1.3%". Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Preferred Pharmaceucitalc Inc.
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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: 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.
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:The risk of getting an
ulcer or bleeding increases with:
•
anytime during use
•
without warning symptoms
•
that may cause death
•
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 your
medical conditions, i

Preparatomtale

FLECTOR- DICLOFENAC EPOLAMINE PATCH
PREFERRED PHARMACEUCITALC INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLECTOR® PATCH SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FLECTOR PATCH.
FLECTOR® PATCH (DICLOFENAC EPOLAMINE 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._
•
•
•
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
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
FLECTOR® PATCH (diclofenac epolamine patch) 1.3%, for topical use.
Each individual patch is embossed. (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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 PATCH 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)
FLECTOR PATCH 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)
Use the lowest effective dosage for shortest duration consist with the
individual patient treatment goals (2.1)
The re