LIDOCAINE AND PRILOCAINE cream

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987), Prilocaine (UNII: 046O35D44R) (Prilocaine - UNII:046O35D44R)

Предлага се от:

Rhodes Pharmaceuticals L.P.

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP (a eutectic mixture) 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, USP 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 and prilocaine cream 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.

Каталог на резюме:

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is a white cream without visible foreign particulate matter in white to off-white tubes. It is available as the following NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx only Keep out of the reach of children.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
RHODES PHARMACEUTICALS L.P.
----------
LIDOCAINE 2.5% AND PRILOCAINE 2.5% CREAM, USP
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 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: C
H
N O M.W. 234.3
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: C
H
N O M.W. 220.32
Each gram of Lidocaine 2.5% and Prilocaine 2.5% Cream, USP contains
lidocaine 25 mg,
prilocaine 25 mg, polyoxyethylene fatty acid ester (as emulsifiers),
carboxypolymethylene (as a thickening agent), sodium hydroxide to
adjust to a pH
approximating 9, and purified water to 1 gram. Lidocaine 2.5% and
Prilocaine 2.5%
Cream, USP 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, USP is 1.00.
14 22 2
13 20 2
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.