LIDOCAINE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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%.

Product summary:

Lidocaine Ointment USP, 5% is supplied as a white to off-white color ointment. It is available as follows: 35.44 g (1 ¼ oz) laminate tubes with a child-resistant cap NDC: 80425-0324-01 Pharmacist: If dispensed to a consumer, provide child resistant package for dispensing. 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]. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2018-08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE- LIDOCAINE OINTMENT
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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LIDOCAINE 5% OINTMENT
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 USP, 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.
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 conjugation.
N-dealkylation, a major
path