LIDOCAINE AND PRILOCAINE cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aidarex Pharmaceuticals LLC

INN (שם בינלאומי):

LIDOCAINE

הרכב:

LIDOCAINE 25 mg in 1 g

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following: NDC 33261-0591-01 30 gram tube, box of 1 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

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
AIDAREX PHARMACEUTICALS LLC
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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.
Th