PRIKAAN lidocaine and prilocaine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Shoreline Pharmaceuticals, Inc.

INN (International Name):

LIDOCAINE

Composition:

LIDOCAINE 25 mg in 1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PRIKAAN- LIDOCAINE AND PRILOCAINE
SHORELINE PHARMACEUTICALS, INC.
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PRIKAAN™
(LIDOCAINE 2.5% AND PRILOCAINE 2.5% CREAM, USP AND FRAME STYLE
TRANSPARENT DRESSING)
DESCRIPTION
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which
the oil phase is a eutectic
mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight.
This eutectic mixture has a
melting point below room temperature and therefore both local
anesthetics exist as a liquid oil rather
than as crystals. It is packaged in 5 gram and 30 gram tubes.
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:
Prilocaine is chemically designated as propanamide,
N-(2-methylphenyl)-2-(propylamino), has an
octanol: water partition ratio of 25 at pH 7.4, and has the following
structure:
Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg,
prilocaine 25 mg,
polyoxyethylene fatty acid esters (as emulsifiers),
carboxypolymethylene (as a thickening agent),
sodium hydroxide to adjust to a pH approximating 9, and purified water
to 1 gram. Lidocaine and
prilocaine cream contains no preservative, however it passes the USP
antimicrobial effectiveness test
due to the pH. The specific gravity of lidocaine and prilocaine cream
is 1.00.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Lidocaine and prilocaine cream applied to intact
skin under occlusive dressing,
provides dermal analgesia by the release of lidocaine and prilocaine
from the cream into the epidermal
and dermal layers of the skin and by the accumulation of lidocaine and
prilocaine in the vicinity of
dermal pain receptors and nerve endings. Lidocaine and prilocaine are
amide-type local anesthetic
agents. Both lidocaine and prilocaine stabilize neuronal membranes by
inhibiting the ionic fluxes
required for the initiation and conduction of impulses, thereby
effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact sk