LIDOCAINE patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

LIDOCAINE

Composition:

LIDOCAINE 50 mg in 1 g

Administration route:

CUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Lidocaine patch 5% is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 0591-3525-30 Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. For more information, call Actavis at 1-800-272-5525. Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA Distributed by:            Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: February 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE- LIDOCAINE PATCH
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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LIDOCAINE PATCH
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 LIDO