LIDOCAINE- lidocaine hydrochloride jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Available from:

Physicians Total Care, Inc.

INN (International Name):

Lidocaine Hydrochloride

Composition:

Lidocaine Hydrochloride 20 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine HCl 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine HCl 2% Jelly.

Product summary:

Lidocaine HCl 2% Jelly is supplied in the listed dosage forms. NDC 54868-4195-0       30 mL aluminum tube A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 LD00N Rev. 05/08 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE - LIDOCAINE HYDROCHLORIDE JELLY
PHYSICIANS TOTAL CARE, INC.
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LIDOCAINE HYDROCHLORIDE JELLY
USP,2%
RX ONLY
DESCRIPTION
Lidocaine HCl 2% Jelly is a sterile, aqueous product that contains a
local anesthetic agent and is
administered topically. (See INDICATIONS for specific uses.)
Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically
designated as acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the
following structural formula:
Its molecular formula is C
H N O • HCl and its molecular weight is 270.80.
Lidocaine HCl 2% Jelly also contains hypromellose, and the resulting
mixture maximizes contact with
mucosa and provides lubrication for instrumentation. The unused
portion should be discarded after
initial use.
Composition of Lidocaine HCl 2% Jelly 30 mL and 5 mL tubes: Each mL
contains 20 mg of lidocaine
HCl. The formulation also contains methylparaben, propylparaben,
hypromellose, and sodium hydroxide
and/or hydrochloric acid to adjust pH between 6.0 to 7.0.
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 ACTION: 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
concentration and total dose
administered, the specific site of application, and duration of
exposure. In general, the rate of
absorption of local anesthetic agents following topical application
occurs most rapidly after
intratracheal administration. Lidoc