VALLADERM-90- lidocaine and prilocaine cream cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Plum ValleyPharma LLC

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is a white to off-white cream supplied as the following: NDC 70512-030-30 30 gram tube (in a child-resistant tube) 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.

Status autoryzacji:

unapproved drug other

Charakterystyka produktu

VALLADERM-90- LIDOCAINE AND PRILOCAINE CREAM CREAM
PLUM VALLEYPHARMA LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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VALLADERM-90 KIT
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:
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
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, depth and duration of dermal analgesia on intact skin
provided by lidocaine