LIDOCAINE AND PRILOCAINE- lidocaine and prilocaine cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Preferred Pharmaceuticals, Inc.

INN (nume internaţional):

LIDOCAINE

Compoziție:

LIDOCAINE 25 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Lidocaine and prilocaine cream USP, 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 is not recommended in any clinical situation in which 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.

Rezumat produs:

Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following: NDC 0115-1468-60: 5 gram tube (NDC 68788-9320-3) Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc. NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. 44942 Rev. 1 09/15 Manufactured by: TOLMAR Inc. Fort Collins, CO 80526 Distributed by: Impax Generics Hayward, CA 94544 Repackaged By: Preferred Pharmaceuticals Inc.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
PREFERRED PHARMACEUTICALS, INC.
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LIDOCAINE AND PRILOCAINE CREAM USP, 2.5%/2.5%
RX ONLY
DESCRIPTION
Lidocaine and prilocaine cream USP, 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 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:
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 contains lidocaine 25 mg,
prilocaine 25 mg, purified
water, PEG-60/hydrogenated castor oil, carbopol 5984 and sodium
hydroxide to adjust pH to
approximately 9. Lidocaine and prilocaine cream contains no
preservative, however it passes the USP
antimicrobial effectiveness test due to the pH. The specific gravity
of lidocaine and prilocaine cream is
1.00.
The therapeutic class is topical anesthetic agent.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Lidocaine and prilocaine cream, applied to intact
skin under occlusive dressing,
C
H N O M.W. 234.3
14
22
2
C
H N O M.W. 220.3
13
20
2
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.
The onset, depth and duration of dermal analg