LIDODERM- lidocaine patch

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Disponível em:

Lake Erie Medical DBA Quality Care Products LLC

DCI (Denominação Comum Internacional):

LIDOCAINE

Composição:

LIDOCAINE 50 mg in 1 g

Via de administração:

CUTANEOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

LIDODERM is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Resumo do produto:

LIDODERM (lidocaine patch 5%) is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes NDC 49999-419-30 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, call Endo Pharmaceuticals at 1-800-462-3636. Manufactured for: Endo Pharmaceuticals Inc. Malvern, PA 19355 LIDODERM® is a registered trademark of Hind Health Care, Inc. © 2015 Endo Pharmaceuticals Inc.  All rights reserved. 114957 / January 2015

Status de autorização:

New Drug Application

Características técnicas

LIDODERM- LIDOCAINE PATCH
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
LIDODERM®
(LIDOCAINE PATCH 5%)
R ONLY
DESCRIPTION
LIDODERM (lidocaine patch 5%) is comprised of an adhesive material
containing 5% lidocaine, which
is applied to a non-woven polyester felt backing and covered with a
polyethylene terephthalate (PET)
film release liner. The release liner is removed prior to application
to the skin. The size of the patch is
10 cm × 14 cm.
Lidocaine is chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl), has an
octanol: water partition ratio of 43 at pH 7.4, and has the following
structure:
Each adhesive patch contains 700 mg of lidocaine (50 mg per gram
adhesive) in an aqueous base. It also
contains the following inactive ingredients: dihydroxyaluminum
aminoacetate, disodium edetate, gelatin,
glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol,
propylene glycol, propylparaben,
sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol,
tartaric acid, and urea.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Lidocaine is an amide-type local anesthetic agent and is suggested to
stabilize neuronal membranes by
inhibiting the ionic fluxes required for the initiation and conduction
of impulses.
The penetration of lidocaine into intact skin after application of
LIDODERM is sufficient to produce an
analgesic effect, but less than the amount necessary to produce a
complete sensory block.
PHARMACOKINETICS
_ABSORPTION_The amount of lidocaine systemically absorbed from
LIDODERM is directly related to both
the duration of application and the surface area over which it is
applied. In a pharmacokinetic study,
three LIDODERM patches were applied over an area of 420 cm of intact
skin on the back of normal
volunteers for 12 hours. Blood samples were withdrawn for
determination of lidocaine concentration
X
2
during the application and for 12 hours after removal of patches. The
results are summarized in Table 1.
TABLE 1
ABSORPTION OF LIDOCAINE FROM LIDODERM
NORMAL VOLUNTEERS (N =