DERMACINRX LIDO V PAK- lidocaine kit

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

MAH:

PureTek Corporation

INN:

LIDOCAINE

composition:

LIDOCAINE 50 mg in 1 g

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment USP, 5%.

leaflet_short:

Lidocaine Ointment USP, 5% is available in 35.44 g (1 ¼ oz) laminate tubes with a child-resistant cap, NDC 52565-008-14. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 01/16

authorization_status:

unapproved drug other

SPC

DERMACINRX LIDO V PAK- 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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DERMACINRX LIDO V PAK™
(LIDOCAINE OINTMENT USP 5%, FRAME STYLE TRANSPARENT FILM DRESSING)
FOR TOPICAL USE ONLY
DO NOT USE IN THE EYES
RX ONLY
DESCRIPTION
Lidocaine Ointment USP, 5% contains a local anesthetic agent and is
administered topically. See
INDICATIONS AND USAGE for specific uses.
Lidocaine Ointment USP, 5% contains lidocaine, which is chemically
designated as acetamide, 2-
(diethylamino)- _N_-(2,6-dimethylphenyl)-, and has the following
structural formula:
Composition of Lidocaine Ointment USP, 5%: acetamide,
2-(diethylamino)- _N_-(2,6-dimethylphenyl)-,
(lidocaine) 5% in a water miscible ointment vehicle containing
polyethylene glycol 300 and
polyethylene glycol 1450.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation and
conduction of impulses, thereby effecting local anesthetic action.
ONSET OF ANESTHESIA
Lidocaine Ointment USP, 5% effects local, topical anesthesia. The
onset of action is 3-5 minutes. It is
ineffective when applied to intact skin.
HEMODYNAMICS
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance, and mean
arterial pressure. These changes may be attributable to a direct
depressant effect of the local anesthetic
agent on various components of the cardiovascular system.
PHARMACOKINETICS AND METABOLISM
Lidocaine may be absorbed following topical administration to mucous
membranes, its rate and extent of
absorption depending upon the specific site of application, duration
of exposure, concentration, and
®
total dosage. In general, the rate of absorption of local anesthetic
agents following topical application
occurs most rapidly after intratracheal administration. Lidocaine is
also well-absorbed from the
gastrointes