LIDOCAINE AND PRILOCAINE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R)

Tilgjengelig fra:

NuCare Pharamceuticals,Inc.

INN (International Name):

LIDOCAINE

Sammensetning:

LIDOCAINE 25 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine 2.5% and prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS). lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) 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.

Produkt oppsummering:

Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following: NDC 68071-1625-3 Box of 30g NOT FOR OPHTALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP]. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 667:02 7/09 MG #16518

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
NUCARE PHARAMCEUTICALS,INC.
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LIDOCAINE 2.5% AND PRILOCAINE 2.5% CREAM
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Lidocaine 2.5% and Prilocaine 2.5%, a topical anesthetic agent, is an
emulsion in which
the oil phase is a eutectic mixture of lidocaine and prilocaine 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 15 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 2.5% and prilocaine 2.5% cream contains
lidocaine 25 mg,
prilocaine 25 mg, carboxypolymethylene (as a thickening agent),
polyoxyethylene fatty
acid esters (as emulsifiers), purified water to 1 gram, and sodium
hydroxide to adjust pH
(pH range 9.0-9.4). Lidocaine 2.5% and prilocaine 2.5% cream contains
no preservative,
however it passes the USP antimicrobial effectiveness test due to the
pH. The specific
gravity of lidocaine 2.5% and prilocaine 2.5% cream is 1.00.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Lidocaine 2.5% and prilocaine 2.5% 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.
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