LIDOCAINE ointment

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
07-07-2023

Aktīvā sastāvdaļa:

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

Pieejams no:

Septodont, Inc.

SNN (starptautisko nepatentēto nosaukumu):

LIDOCAINE

Kompozīcija:

LIDOCAINE 5 g in 100 g

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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%.

Produktu pārskats:

Lidocaine Ointment USP, 5% is available in 35.44 g (1¼ oz) laminate tubes with a child-resistant cap, (NDC 0362-0221-50) and 50.0 g (1 ¾ oz) jar with a child-resistant cap (NDC 0362-0221-10). Store at controlled room temperature 20°- 25°C (68°- 77°F). Do not permit to freeze.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                LIDOCAINE- LIDOCAINE OINTMENT
SEPTODONT, INC.
----------
LIDOCAINE OINTMENT USP, 5%
FOR TOPICAL USE ONLY
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 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 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 the amide linkage, and
                                
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