LIDOCAINE- lidocaine ointment

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

REMEDYREPACK INC.

DCI (Denominação Comum Internacional):

LIDOCAINE

Composição:

LIDOCAINE 5 g in 100 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Rx Only 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 components of Lidocaine Ointment 5%.

Resumo do produto:

Lidocaine Ointment USP, 5% is available in Store at controlled room temperature 20°C - 25°C (68°F - 77°F). Do not permit to freeze. Manufactured for Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev.933:02 11/18 C-INST-613B

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LIDOCAINE- LIDOCAINE OINTMENT
REMEDYREPACK INC.
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LIDOCAINE OINTMENT USP, 5%
FOR TOPICAL USE ONLY
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:
C
H
N
O M.W. 234.34
Composition of Lidocaine Ointment 5%: acetamide, 2-(diethylamino)-
_N_-(2,6-dimethylphenyl)-,
(lidocaine) 5% in a water miscible ointment vehicle containing
polyethylene glycols and peppermint oil.
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 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
14
22
2
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 oxidative N-dealkylation, ring
hy