LIDOCAINE AND PRILOCAINE cream

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987), prilocaine (UNII: 046O35D44R) (prilocaine - UNII:046O35D44R)

Διαθέσιμο από:

Physicians Total Care, Inc.

INN (Διεθνής Όνομα):

lidocaine

Σύνθεση:

lidocaine 25 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: Lidocaine and prilocaine cream, 2.5%/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.

Περίληψη προϊόντος:

Lidocaine and prilocaine cream, 2.5%/2.5% is available as follows NDC 54868-5194-2      30 gram tube NDC 54868-5194-1      5 gram tube NDC 54868-5194-0      5 x 5 gram tube NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. WARNING: Keep out of reach of children. Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). E.FOUGERA & CO. A division of Nycomed US Inc.  Melville, New York 11747 I2357/IF2357D R9/07 #42 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LIDOCAINE AND PRILOCAINE - LIDOCAINE AND PRILOCAINE CREAM
PHYSICIANS TOTAL CARE, INC.
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LIDOCAINE AND PRILOCAINE CREAM, 2.5%/2.5%
NOT FOR OPHTHALMIC USE
FOR EXTERNAL USE ONLY
RX ONLY
DESCRIPTION
Lidocaine and prilocaine cream, 2.5%/2.5% 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 30 gram tubes and 5 gram tubes for hospital use. 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, 2.5%/2.5% contains
lidocaine 25 mg, prilocaine 25 mg,
polyoxyethylene fatty acid esters (as emulsifiers), carbomer 934 (as a
thickening agent), sodium
hydroxide to adjust to a pH approximating 9, and purified water.
Lidocaine and prilocaine cream,
2.5%/2.5% contains no preservative, however it passes the USP
antimicrobial effectiveness test due to
the pH. The specific gravity of lidocaine and prilocaine cream,
2.5%/2.5% is approximately 1.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Lidocaine and prilocaine cream, 2.5%/2.5%,
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
anesthet