LIDOCAINE patch

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

DIRECT RX

INN (Միջազգային անվանումը):

LIDOCAINE

Կազմը:

LIDOCAINE 700 mg

Կառավարման երթուղին:

CUTANEOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

- Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 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

Ապրանքի ամփոփագիր:

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 25oC (68o to 77oF) [see USP Controlled Room Temperature]. Manufactured by: Watson Laboratories, Inc. Salt Lake City, UT 84108 USA Distributed by:            Watson Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2013

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

LIDOCAINE- LIDOCAINE PATCH
DIRECT RX
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LIDOCAINE
DESCRIPTION SECTION
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 SECTION
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 cm2 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 wearing time)
Lidocain