LIDOCAINE ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Ascend Laboratories, LLC

INN (International Name):

LIDOCAINE

Sammensetning:

LIDOCAINE 50 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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%.

Produkt oppsummering:

It is available as follows: •35.44 g laminate tubes with a child-resistant cap, NDC 67877-473-79. •50g laminate tubes with a child-resistant cap, NDC 67877-473-80. 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 : Alkem Laboratories Limited H.O.: ALKEM HOUSE, Senapati Bapat Marg, Lower Parel, Mumbai – 400 013, INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised : October, 2018 150026-01

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LIDOCAINE - LIDOCAINE OINTMENT
ASCEND LABORATORIES, LLC
----------
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 INDICAT IONS AND USAGEFOR 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 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
hydroxylation, cleavage of the amide linkage, and conju