LIDOCAINE ointment

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Alembic Pharmaceuticals Inc.

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 5%.

Ringkasan produk:

Lidocaine Ointment USP, 5% is available in below presentations: 30 g laminate tubes with a child-resistant cap; NDC 62332-424-30 35.44 g (1¼ Oz) laminate tubes with a child-resistant cap; NDC 62332-424-35 50 g (1¾ Oz) Jar with a child-resistant cap; NDC 62332-424-50 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 10/2023

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LIDOCAINE- LIDOCAINE OINTMENT
ALEMBIC PHARMACEUTICALS INC.
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LIDOCAINE OINTMENT USP, 5%
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 glycols.
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 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 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
hydr