LIDOCAINE patch

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Cardinal Health 107, LLC

投与経路:

CUTANEOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

LIDOCAINE PATCH 5% 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.

製品概要:

LIDOCAINE PATCH 5% is available as the following: Packaged into individual child-resistant envelopes, overbagged with 5 patches per bag, NDC 55154-7228-5 Store at 25o C (77o F); excursions permitted to 15o -30o C (59o -86o F).  [See USP Controlled Room Temperature]. For more information, call Par Pharmaceutical at 1-800-828-9393. Manufactured for:                             Par Pharmaceutical Chestnut Ridge, NY 10977 Distributed by: Cardinal Health Dublin, Oh 43017 L50718400124 Revised: January 2019

認証ステータス:

New Drug Application Authorized Generic

製品の特徴

LIDOCAINE- LIDOCAINE PATCH
CARDINAL HEALTH 107, LLC
----------
LIDOCAINE PATCH 5%
R ONLY
DESCRIPTION
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 x 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
LIDOCAINE PATCH 5% 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 LIDOCAINE PATCH 5%
is directly
related to both the duration of application and the surface area over
which it is applied.
In a pharmacokinetic study, three LIDOCAINE PATCH 5% patches were
applied over an
area of 420 cm of intact skin on the back of normal volunteers for 12
hours. Blood
X
2
samples were withdrawn for determination of lidocaine concentration
during the
application and for 12 hours after removal of patches. The results are
summarized in
Table 1.
TABLE 1
ABSORPTION OF LIDOCAINE FROM LIDOCAINE PATCH 5%
NORMAL VOLUNTEERS