LIDOCAINE AND PRILOCAINE cream

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Actavis Pharma, Inc.

SNN (starptautisko nepatentēto nosaukumu):

LIDOCAINE

Kompozīcija:

LIDOCAINE 25 mg in 1 g

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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.

Produktu pārskats:

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following: NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Storage: Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx Only Keep out of the reach of children. For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: July 2019                                                                    

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
ACTAVIS PHARMA, INC.
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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:
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,
polyoxyethylene fatty acid esters (as emulsifiers),
carboxypolymethylene (as a
thickening agent), sodium hydroxide to adjust to a pH approximating 9,
and purified
water to 1 gram. 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.
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.
The onset, depth and duration of dermal analgesia on intact skin
provided by lidocaine
and prilocaine cre