FLECTOR- diclofenac epolamine patch

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Rebel Distributors Corp

INN (International ime):

DICLOFENAC EPOLAMINE

Sastav:

DICLOFENAC EPOLAMINE 180 mg

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 resulting fr

Proizvod sažetak:

The Flector® Patch is supplied in resealable envelopes, containing 1 patch (10 cm x 14 cm) (NDC 21695-707-01). It is also supplied in boxes of 30 patches (NDC 21695-707-30). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”. Manufacturer:  Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan Distributor: Alpharma Pharmaceuticals LLC, One New England Avenue, Piscataway, NJ 08854 (Telephone: [phone]) Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320 Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Do not take an NSAID medicine: Tell your healthcare provider: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. NSAID medicines that need a prescription This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by:  Alpharma Pharmaceuticals LLC                          One New England Avenue, Piscataway, NJ 08854 USA                          (Telephone:[phone]) • www.FlectorPatch.com Manufactured for:  IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland Manufactured by:  Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320

Status autorizacije:

New Drug Application

Uputa o lijeku

Rebel Distributors Corp
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Revised: 9/2010
Document Id: 3c9f9507-8f72-4850-aa43-9ff5532f1396
Set id: e58641de-b6fd-484c-8902-b9262d7ce251
Version: 2
Effective Time: 20100927
Rebel Distributors Corp

Svojstava lijeka

FLECTOR- DICLOFENAC EPOLAMINE PATCH
REBEL DISTRIBUTORS CORP
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FLECTOR® PATCH
(DICLOFENAC EPOLAMINE TOPICAL PATCH) 1.3%
CARDIOVASCULAR RISK
Gastrointestinal Risk
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, tartaric acid, titanium dioxide, and purified water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Flector® Patch applied to intact skin provides local analgesia by
releasing diclofenac epolamine from
the patch into the skin. Diclofenac is a nonsteroidal
anti-inflammatory drug (NSAID). In pharmacologic
studies, diclofenac has shown anti-inflammatory, analgesic, and
antipyretic activity. As with other
NSAIDs, its mode of action is not known; its ability to inhibit
prostaglandin synthesis, however, may be
1
20
24
l2
2
3
involved in its anti-inflammatory activity, as well as contribute to
its efficacy in relieving pain
associated with inflammation.
PHARMACOKINETICS
_ABSORPTION_
Following a single application of the Flector Patch on the upper inner
arm, pe