PRILO PATCH- lidocaine and prilocaine, lidocaine kit

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:

PureTek Corporation

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 (lidocaine 2.5% and prilocaine 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. Lidocaine patch 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. - For removal of oils and residue from skin

Product summary:

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following: NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. NOT FOR OPHTHALMIC USE. Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Rx only Keep out of the reach of children. For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA Lidocaine patch 5% is available as the following: Carton of 15 patches, NDC 59088-396-82 Carton of 30 patches, NDC 59088-396-54 Each patch is packaged into an individual child-resistant envelope. Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]. For more information, call Actavis at 1-800-272-5525. Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA Distributed by: PureTek Corporation San Fernando, CA 91340 USA Rev. 37780     02/16

Authorization status:

unapproved drug other

Summary of Product characteristics

PRILO PATCH- LIDOCAINE AND PRILOCAINE, LIDOCAINE
PURETEK CORPORATION
_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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PRILO PATCH
DESCRIPTION
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which
the oil phase is a
eutectic mixture of lidocaine and prilocaine cream 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 contains lidocaine 25 mg,
prilocaine 25 mg,
polyoxyethylene fatty acid esters (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 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.
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 impulse