LIDOCAINE AND PRILOCAINE cream

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

lidocaine

Samsetning:

lidocaine 25 mg in 1 g

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream, 2.5%/2.5% 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, 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.

Vörulýsing:

Lidocaine and prilocaine cream, 2.5%/2.5% is supplied as follows: NDC 0168-0357-30      30 gram tube. Available in a child resistant tube NDC 0168-0357-55      5 gram tube, FOR HOSPITAL USE ONLY NDC 0168-0357-56      5 gram tube, with 12 dressings, FOR HOSPITAL USE ONLY NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. KEEP OUT OF THE REACH OF CHILDREN. Store at 20°C to 25°C (68°F to 77°F) (See USP Controlled Room Temperature). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46243078/46243709 R12/18 #42

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS 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 934P (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 1.00.
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 imp