LIDOCAINE ointment

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Liberty Pharmaceuticals, Inc.

ИНН (Международная Имя):

LIDOCAINE

состав:

LIDOCAINE 50 mg in 1 g

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Lidocaine Ointment 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 componentsof Lidocaine Ointment 5%.

Обзор продуктов:

It is available as follows: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Manufactured by: Alkem Laboratories 1733 Gilsinn Lane, Fenton, MO 63026 Manufactured for : LIBERTY PHARMACEUTICALS INC. CORONA, CA 92882 Distributed by: AIDAREX PHARMACEUTICALS, LLC CORONA, CA 92880   AAL831

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

LIDOCAINE- LIDOCAINE OINTMENT
LIBERTY PHARMACEUTICALS, INC.
----------
FOR EXTERNAL USE ONLY
DO NOT USE IN THE EYES
RX ONLY
DESCRIPTION
Lidocaine Ointment 5% contains a local anesthetic agent and is
administered topically. See
INDICATIONS AND USAGE for specific uses.
Lidocaine Ointment 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 5% acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-,
(lidocaine)5% in a water miscible ointment vehicle containing
polyethylene glycols.
CLINICAL PHARMACOLOGY
MECHANISM OFACTION
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 5% effects local, topical anesthesia. The onset of
action is 3 to 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 ofthe cardiovascular system.
PHARMACOKINETICSAND 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
gastrointestinal tract, but little intact drug appears in the
circulation because of biotransformation in the
liver
Lidocaine is metabolized rapidly by the liver, and metabolites and
unchanged drug are excreted by the
kidneys. Biotransformation includes oxidativeN-dealkylation, ring
hydroxylation, cleavage of the amide
linkage, and conjugation