LIDOCAINE HYDROCHLORIDE JELLY USP, 2%, A STERILE, WATER-SOLUBLE, TOPICAL ANESTHETIC

/LIDOCAINE HYDROCHLORIDE JELLY USP, 2%, A STERILE, WATER-SOLUBLE, TOPICAL ANESTHETIC
LIDOCAINE HYDROCHLORIDE JELLY USP, 2%, A STERILE, WATER-SOLUBLE, TOPICAL ANESTHETIC2018-09-06T09:12:40+00:00

Prescription Drug Name:

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%, A STERILE, WATER-SOLUBLE, TOPICAL ANESTHETIC

ID:

bf08d347-dd75-4cad-acbc-d76c225bac14

Code:

34391-3

DESCRIPTION


id: e9808973-d9b1-425d-8a08-4ad065254696
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically. See INDICATIONS 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:

INDICATIONS AND USAGE


id: 2707d1db-21df-4116-a9d6-30e002a007d9
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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).

CONTRAINDICATIONS


id: 9998be45-2dae-4e1c-a319-807212a3a4ad
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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%.

WARNINGS


id: 9dc57133-dc6c-477b-bdbd-94c59528bafd
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS. Lidocaine Hydrochloride Jelly USP, 2% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption. When used for endotracheal tube lubrication, care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate the endotracheal stylettes. lf allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. There have been rare reports in which this residue has caused the lumen to occlude. See also ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS


id: 706385c9-9a15-4bfa-8feb-4bae50fa101a
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube. See also WARNINGS and DOSAGE AND ADMINISTRATION.

OVERDOSAGE


id: 068cd218-ca56-42e8-a2b6-37648778f0f8
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.)

DOSAGE AND ADMINISTRATION


id: f9628468-0ac1-49b7-9926-fb2811b9d4a3
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

When Lidocaine Hydrochloride Jelly USP, 2% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine Hydrochloride Jelly USP, 2% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

HOW SUPPLIED


id: b793f8ad-510c-4930-8986-864a62b1beb8
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lidocaine Hydrochloride Jelly USP, 2% Box of 25 In unit use packages containing one single use vial and a URO-JET® vial injector.

Stock No.
5 mL size NDC 76329-3012-5 3012-SP
10 mL size NDC 76329-3013-5 3013-SP
20 mL size NDC 76329-3015-5 3015-SP
In unit use packages containing one single use vial and a URO-JET® AC (Anatomically Constricted) vial injector. Box of 25
Stock No.
5 mL size NDC 76329-3011-5 3011-SP

PRINCIPAL DISPLAY PANEL


id: 6e83378a-772b-42bb-b299-19b4cb69c929
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%

100 mg (20 mg/mL) 1 x 5 mL STERILE PAK URO-JET

PRINCIPAL DISPLAY PANEL


id: a92d8bb9-4565-4d76-908d-7efea6249df1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%

200 mg (20 mg/mL) 1 x 10 mL STERILE PAK URO-JET