LIDOCAN IV- lidocaine 5% patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PURETEK CORPORATION

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocan™ IV is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. Lidocan™ IV 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:

Lidocan™ IV is available as the following: Package of 30 patches .................................................................................... NDC 59088-910-54 (packaged into individual child-resistant envelope) Single patch ............................................................................................. NDC 59088-910-84 (packaged into individual child-resistant envelope) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAN IV- LIDOCAINE 5% PATCH
PURETEK CORPORATION
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LIDOCAN IV
RX ONLY
DESCRIPTION
LIDOCAN™ IV is comprised of an adhesive material containing 5%
lidocaine, which is
applied to a non-woven polyester felt backing and covered with a
polyethylene
terephthalate (PET) film 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:
purified water, glycerin,
sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium
polyacrylate, propylene
glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol,
dihydroxyaluminum
aminoacetate, edetate disodium, methylparaben, and propylparaben.
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 a 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 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 WEARI