LIDOCAINE patch

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Mylan Pharmaceuticals Inc.

INN (International Nazwa):

LIDOCAINE

Skład:

LIDOCAINE 140 mg

Droga podania:

CUTANEOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Lidocaine Patch 5% is available containing 140 mg of lidocaine, USP (50 mg per gram adhesive in polyisobutylene adhesive matrix). The rectangular patch consists of a pigmented backing film randomly printed with “Lidocaine Patch 5%” in brown ink, an adhesive matrix layer and a clear removable release liner. They are available as follows: NDC 0378-9055-93 carton containing 30 patches, packaged into individual child-resistant pouches Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2018 LIDO:R4

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LIDOCAINE- LIDOCAINE PATCH
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Lidocaine patch 5% is comprised of an adhesive material containing 5%
lidocaine, USP, which is
applied to a pigmented polyethylene/polyester backing film printed
with brown ink and covered with a
silicone coated polyester 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
2-(Diethylamino)-2’,6’-acetoxylidide, has an octanol: water
partition ratio of 43 at pH 7.4, and has the following structure:
Each adhesive patch contains 140 mg of lidocaine, USP (50 mg per gram
adhesive) in a polyisobutylene
adhesive matrix.
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: ABSORPTION OF LIDOCAINE FROM LIDOCAINE PATCH 5%
Normal volunteers (n = 15, 12-hour wearing time)
Lidocaine
Patch 5%
Application
Site
Area
(cm )
Dose
Absorbed
(mg)
C
(mcg/mL)
T
(hr)
3 patches
Back
420
64 ± 32
0.13 ± 0.06
11 hr
When lidocaine patch 5% is used according to the recommended dosing
instructions, only 11 ± 4% of
2
2
max
max
the dose applied is e