LIDOCAINE ointment

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Osta se nyt

Lataa Valmisteyhteenveto (SPC)
01-11-2019

Aktiivinen ainesosa:

Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)

Saatavilla:

Proficient Rx LP

INN (Kansainvälinen yleisnimi):

Lidocaine

Koostumus:

Lidocaine 50 mg in 1 g

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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%.

Tuoteyhteenveto:

Lidocaine Ointment USP, 5% is available in: 30 g tubes with a child resistant cap (NDC 63187-836-30) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

                                LIDOCAINE- LIDOCAINE OINTMENT
PROFICIENT RX LP
----------
LIDOCAINE
OINTMENT USP, 5%
RX ONLY
DO NOT USE IN THE EYES.
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%: Each gram contains
lidocaine USP, 5% in a water soluble
base containing polyethylene glycol 400, polyethylene glycol 3350, and
propylene glycol.
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
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
hydroxylation, cleavage of 
                                
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