LIDOCAINE AND PRILOCAINE- lidocaine and prilocaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

lidocaine

Composition:

lidocaine 25 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Lidocaine and prilocaine cream, 2.5%/2.5% is available as follows NDC 68788-6434-3      30 gram tube, Available in child resistant 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 Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2357F/IF2357F R06/14 #42 Relabeled By: Preferred Pharmaceuticals Inc

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
PREFERRED PHARMACEUTICALS INC.
----------
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.
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
an