DESCRIPTION
id: 0ed85cc9-3abd-4032-ac50-b8f3e7318443
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) 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% (Anestacon®) contains lidocaine HCl which is chemically designated as acetamide, 2- (diethyl-amino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:
Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) also contains hydroxypropyl methylcellulose, 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% (Anestacon®) 15 mL bottle: Each mL contains 20 mg of lidocaine HCl. The formulation also contains benzalkonium chloride, hydroxypropyl methylcellulose, purified water, sodium chloride, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0–7.0.
INDICATIONS AND USAGE
id: c3e28f77-a014-41d4-8167-6bd1fcf8e389
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine hydrochloride jelly USP, 2% (Anestacon®) 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: 5674a83f-df64-47c7-9fa1-8336b8f65850
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% (Anestacon®).
WARNINGS
id: e45cc7b8-d9fe-4ee3-9ee5-2748dbc4d310
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% (Anestacon®) 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. 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: 361dfd72-7fda-4e9d-923d-4283df60a91f
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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
.)
Central Nervous System
id: ec08c084-8ee1-41cc-b50f-18e4da2f9832
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.
Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.
Cardiovascular System
id: f87e0c45-8c19-4b31-9c0e-4d17c859ce22
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
Allergic
id: 1472b814-ee5f-422f-b060-b10143c4fa55
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Allergic reactions are characterized by cutaneous lesions, urticaria, edema, or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
OVERDOSAGE
id: 858fa016-c285-42a2-b9ca-8933820273d6
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: ceb97b54-378f-4f4e-a4a8-5bf50f01063a
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
When lidocaine hydrochloride jelly USP, 2% (Anestacon®) 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% (Anestacon®) 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: 60d8016a-e326-4a38-bea9-9ec00dfb5cf4
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) is supplied in 15 mL unit-dose disposable container for SINGLE PATIENT USE.
PRINCIPAL DISPLAY PANEL – 15 mL Bottle Carton
id: 79ce155d-f682-4731-b4ff-a20643dc5ff7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 50383-772-15
Hi•Tech
PHARMACAL
Lidocaine
Hydrochloride
Jelly USP, 2%
(Anestacon
®
)
15 mL
Rx only
