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:

International Medication Systems, Limited

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Jelly USP, 2% 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 Hydrochloride Jelly USP, 2%.

Product summary:

Lidocaine Hydrochloride Jelly USP, 2% Box of 25 In unit use packages containing one single use vial and a URO-JET® vial injector. In unit use packages containing one single use vial and a URO-JET® AC (Anatomically Constricted) vial injector. Box of 25 USE ASEPTIC TECHNIQUE Do not assemble until ready to use. Store at controlled room temperature 15° to 30°C (59° to 86°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE JELLY
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
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LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
A STERILE, WATER-SOLUBLE, TOPICAL ANESTHETIC
DESCRIPTION
Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product
that contains a local
anesthetic agent and is administered topically (see INDICATIONS AND
USAGE for
specific uses).
Lidocaine Hydrochloride Jelly USP, 2% contains lidocaine hydrochloride
which is
chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the following structural formula:
Lidocaine Hydrochloride Jelly USP, 2% 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 Hydrochloride Jelly USP, 2%: Each mL contains
20 mg of
lidocaine HCI. 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 varies 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 occur