LIDOCAINE patch

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Bryant Ranch Prepack

SNN (starptautisko nepatentēto nosaukumu):

LIDOCAINE

Kompozīcija:

LIDOCAINE 50 mg in 1 g

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Lidocaine patch 5% Packaged into individual child-resistant envelopes. NDC: 63629-5094-1 1 g in a POUCH / 30 in a CARTON NDC: 63629-5094-2 1 g in a POUCH / 3 in a CARTON NDC: 63629-5094-3 1 g in a POUCH / 9 in a CARTON NDC: 63629-5094-4 1 g in a POUCH / 10 in a CARTON NDC: 63629-5094-5 1 g in a POUCH / 14 in a CARTON Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 9150

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

LIDOCAINE- LIDOCAINE PATCH
BRYANT RANCH PREPACK
----------
LIDOCAINE PATCH A200675
LIDOCAINE PATCH 5%
Revised: February 2015
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 LIDOCAI