LIDOCAINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Available from:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

Lidocaine Hydrochloride

Composition:

Lidocaine Hydrochloride Anhydrous 40 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Topical Solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of Lidocaine Hydrochloride Topical Solution.

Product summary:

Lidocaine Hydrochloride Topical Solution, USP 4% is supplied in 50 mL bottle (NDC 60432-465-50) and packaged in a carton (NDC 60432-465-51). An aqueous solution for topical application. NOT FOR INJECTION. Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. AVOID FREEZING Rx Only Product No.: 8465 Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 28465 REV. 06-20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
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LIDOCAINE
HYDROCHLORIDE
TOPICAL SOLUTION,
USP 4%
RX ONLY
DESCRIPTION
Lidocaine Hydrochloride Topical Solution, USP 4% contains a local
anesthetic agent and
is administered topically. See INDICATIONS for specific uses.
Lidocaine Hydrochloride Topical Solution USP 4% contains lidocaine
hydrochloride
monohydrate, which is chemically designated as
2-(Diethylamino)-2',6'-acetoxylidide
monohydrochloride monohydrate and has the following structural
formula:
C
H N O ∙ HCL ∙ H 0
M.W. 288.81
EACH ML CONTAINS:
Lidocaine Hydrochloride Monohydrate, 40
USP mg
INACTIVE INGREDIENTS: methylparaben, propylene glycol and purified
water. IT MAY
ALSO CONTAIN sodium hydroxide for pH adjustment. The pH range is
between 5.0 and
7.0.
An aqueous solution for topical use only. NOT FOR INJECTION.
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.
14
22
2
2
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. The net effect is normally a modest hypotension when the
recommended
dosages are not exceeded.
PHARMACOKINETICS AND METABOLISM
Information derived from other formulations, concentrations and usages
reveals that
lidocaine is completely absorbed following parenteral administration,
its rate of
absorption depending, for example, upon such factors such as the site
of administration
and the presence or absence of a vasoconstrictor agent. Lidocaine may
be absorbed
following topical administration to mucous membranes, its rate of
absorption and
percent of dose absorbed depending upon concentration and total dose
administered,
the specific site of applicatio