LIDOCAINE patch

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Bryant Ranch Prepack

INN (International Nazwa):

LIDOCAINE

Skład:

LIDOCAINE 700 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% NDC 63629-7059-1: 30 in a CARTON NDC 63629-7059-2: 15 in a CARTON NDC 63629-7059-3: 5 in a CARTON NDC 63629-7059-4: 3 in a CARTON NDC 63629-7059-5: 10 in a CARTON NDC 63629-7059-6: 9 in a CARTON Store at 20  to 25 C (68  to 77 F) [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LIDOCAINE- LIDOCAINE PATCH
BRYANT RANCH PREPACK
----------
LIDOCAINE PATCH 5%
RX ONLY
DESCRIPTION
Lidocaine patch 5% is comprised of an adhesive material containing 5%
lidocaine, which
is applied to a white non-woven polyethylene terephthalate (PET)
material backing and
covered with a transparent PET 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:
glycerin, D-sorbitol,
propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate,
carboxymethylcellulose
sodium, gelatin, polyacrylic acid, kaolin, tartaric acid,
dihydroxyaluminum aminoacetate,
methylparaben, propylparaben, and edetate disodium.
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 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 is
directly related to both the duration of application and the surface
area over which it is
applied. In a pharmacokinetic study, three lidocaine 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 NORMAL VOLUNTEERS (N = 15, 12-HOUR WE