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:

Physicians Total Care, Inc.

INN (International Name):

DICLOFENAC EPOLAMINE

Sammensetning:

DICLOFENAC EPOLAMINE 180 mg

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS ). Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. Flector® Patch is contraindicated in patients with known hypersensitivity to diclofenac. Flector® Patch 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-like reactions to NSAIDs have been reported in such patients (seeWARNINGS - Anaphylactoid Reactions , andPRECAUTIONS - Preexisting Asthma ). Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS ). Flector® Patch should not be applied to non-intact or damaged skin r

Produkt oppsummering:

The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (NDC 54868-5962-0 ).  Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”. Each patch contains 180 mg of diclofenac epolamine in an aqueous base (13 mg of active per gram of adhesive or 1.3%). The product is intended for topical use only Keep out of reach of children and pets. The ENVELOPES SHOULD BE SEALED AT ALL TIMES WHEN NOT IN USE. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF).  [See USP Controlled Room Temperature]. Manufacturer :  Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan Distributor : Alpharma Pharmaceuticals LLC, One New England Avenue, Piscataway, NJ 08854 (Telephone: [phone]) Version June 2008 8283 Ed II/06.08 Relabeling of "Additional Barcode" by Physicians Total Care, Inc. Tulsa, OK      74146

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Physicians Total Care, Inc.
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(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 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. NSAID medicines s

Preparatomtale

FLECTOR - DICLOFENAC EPOLAMINE PATCH
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. (SeeWARNINGS andCLINICAL TRIALS).
Flector® Patch is contraindicated for the treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (seeWARNINGS).
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. (SeeWARNINGS).
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-
inflammatory drug.
DESCRIPTION
Flector® Patch (10 cm x 14 cm) is comprised of an adhesive material
containing 1.3% diclofenac
epolamine which is applied to a non-woven polyester felt backing and
covered with a polypropylene
film release liner. The release liner is removed prior to topical
application to the skin.
Diclofenac epolamine is a non-opioid analgesic chemically designated
as 2-[(2,6-dichlorophenyl)
amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a
molecular formula of
C
H C N O (molecular weight 411.3), an n-octanol/water partition
coefficient of 8 at pH 8.5, and
the following structure:
Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per
gram adhesive) in an aqueous
base. It also contains the following inactive ingredients:
1,3-butylene glycol, dihydroxyaluminum
aminoacetate, disodium edetate, D-sorbitol, fragrance (Dalin PH),
gelatin, kaolin, methylparaben,
polysorbate 80, povidone, propylene glycol, propylparaben, sodium
carboxymethylcellulose, sodium
polyacrylate, t