DESCRIPTION
id: b5e20526-3832-4fe0-bf6a-7f65bc0c53d8
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine HCI 2% Jelly is a sterile, aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS for specific uses.)
Lidocaine HCI 2% Jelly contains lidocaine HCI which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride and has the following structural formula:
Its molecular formula is C14H22N2O • HCI and its molecular weight is 270.80.
Lidocaine HCI 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 HCI 2% Jelly 30 mL and 5 mL tubes: 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.
INDICATIONS AND USAGE
id: 5ec3d62c-30f4-436b-afc2-14ac78bb8692
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine HCI 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).
CONTRAINDICATIONS
id: 5cbbeca4-a12e-43e3-ab58-725bf72bdbfb
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 HCI 2% Jelly.
WARNINGS
id: 14b6c73f-f19f-4415-8e3e-03a75a2d7e33
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 HCI 2% Jelly should be used in 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. If 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: 658a3355-922c-4f3f-93a9-76080b34175f
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Adverse experiences following the administration of lidocaine are similar in nature to those observed in 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: c23c4fb2-dd92-4d59-883c-5e2766233abd
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: 4736a94e-e6ea-4791-86f2-57efe19e2db2
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
When Lidocaine HCI 2% Jelly 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 HCI 2% Jelly 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.
MAXIMUM DOSAGE
id: 424e1b57-22ac-488c-a522-3d92e28224b5
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
No more than 600 mg of lidocaine HCI should be given in any 12 hour period.
HOW SUPPLIED
id: d5447418-aa28-4475-80cd-c587f263c02e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine HCI 2% Jelly is supplied in the listed dosage forms.
A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton.
5 MILLILITER in a TUBE, WITH APPLICATOR/1 TUBE in a CARTON (53217-222-01)
Relabeled by:
Aidarex Pharmaceuticals, LLC
Corona, CA 92880
PRINCIPAL DISPLAY PANEL
id: ff5e9ff1-4063-45ea-858c-38341fa9bce6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
SPL Label
