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:

Bryant Ranch Prepack

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 USP, 2.5%/2.5% is available as the following: NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at 20° to 25°C (68° to 77°F); 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
BRYANT RANCH PREPACK
----------
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, USP 2.5%/2.5% contains
lidocaine 25 mg,
prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifier),
carbomer
homopolymer Type B (as a thickening agent), sodium hydroxide to adjust
to a pH
approximating 9, and purified water to 1 gram. Lidocaine and
Prilocaine Cream, USP
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
is 1.00.
C
H
N OM.W. 234.3
14
22
2
C
H
N OM.W. 220.3
13
20
2
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, d