LIDOCAINE- lidocaine ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

INN (International Name):

LIDOCAINE

Composition:

LIDOCAINE 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 USP 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%.

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 42291-379-35. 50 g (1 ¾ oz) double wall jar, with a child-resistant cap, NDC 42291-379-05. Pharmacist: If dispensed to a consumer, provide child resistant package for dispensing. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals Piscataway, NJ 08854 Mfg. Rev. 10-2018-08 AV 10/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE- LIDOCAINE OINTMENT
AVKARE, INC.
----------
LIDOCAINE OINTMENT USP, 5%
FOR TOPICAL USE
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, 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.
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