LIDOCAINE AND PRILOCAINE cream

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987), Prilocaine (UNII: 046O35D44R) (Prilocaine - UNII:046O35D44R)

Dostupné s:

MAJOR Pharmaceuticals

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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: 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 effect 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.

Přehled produktů:

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is a white to off-white cream supplied 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) [see USP Controlled Room Temperature].  Do Not Freeze. Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 Distributed by: MAJOR PHARMACEUTICALS Livonia, MI 48152 Rev 05/2019

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
MAJOR PHARMACEUTICALS
----------
LIDOCAINE AND PRILOCAINE USP, 2.5%/2.5%
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:
C
H N O
M.W. 234.3
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:
C
H N O
M.W. 220.3
Each gram of lidocaine and prilocaine cream, 2.5%/2.5% contains
lidocaine 25 mg, prilocaine 25
mg, PEG-60 hydrogenated castor oil (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, 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
1.00.
CLINICAL PHARMACOLOGY
14
22
2
13
20
2
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
anesthetic action.
The onset, dept