LIDOCAINE PATCH, 5%- lidocaine patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The lidocaine patch 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 66993-342-38 Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F). [See USP Controlled Room Temperature]. For more information, call 1-866-525-0688. Manufactured for: Prasco Laboratories Mason, OH 45040 USA Manufactured by: Hisamitsu Pharmaceutical, Co., Inc. 408, Tashirodaikan-machi, Tosu, Saga, Japan 10136A-0 Revised: 12/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE PATCH, 5% - LIDOCAINE PATCH
PRASCO LABORATORIES
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LIDOCAINE PATCH 5%
RX 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
polypropylene 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 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, methylparaben,
oleic acid, partially
neutralized polyacrylate, polyacrylic acid, polyvinyl alcohol,
propylene glycol,
propylparaben, synthetic aluminum silicate, tartaric acid, titanium
dioxide and purified
water.
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 the
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 the 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.
2
TABLE 1 ABSORPTION OF LIDOCAINE FROM THE LIDOCAINE PATCH
NORMAL VOLUNT