LIDOCAINE AND PRILOCAINE CREAM cream

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

SOLA Pharmaceuticals

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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.

Prehľad produktov:

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.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

LIDOCAINE AND PRILOCAINE CREAM- LIDOCAINE AND PRILOCAINE CREAM CREAM
SOLA PHARMACEUTICALS
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LIDOCAINE AND PRILOCAINE CREAM 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:
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 and prilocaine
cream, 2.5%/2.5% depend primarily on the duration of application. To
provide sufficient analgesia for
clinical procedures such as intrave