LIDOCAINE patch

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Par Pharmaceutical

INN (Международно Name):

LIDOCAINE

Композиция:

LIDOCAINE 50 mg in 1 g

Начин на приложение:

CUTANEOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

LIDOCAINE PATCH 5% is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes NDC 0603-1880-16 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 Pharmacutical at 1-800-828-9393. Manufactured for:                             Par Pharmaceutical Chestnut Ridge, NY 10977 Printed in U.S.A. Revised: January 2019

Статус Оторизация:

New Drug Application Authorized Generic

Данни за продукта

LIDOCAINE- LIDOCAINE PATCH
PAR PHARMACEUTICAL
----------
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 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
X
2
ABSORPTION OF LIDOCAINE FROM LIDOCAINE PATCH 5%
NORMAL VOLUNTEERS (N = 15, 12-HOUR