Rx only
id: 721dbecf-10fa-431f-9eee-a8799a261c32
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
A topical anesthetic for the mucous membranes of the mouth and pharynx.
WARNING: Life-threatening and fatal events in infants and young children
id: 4d0f7bfc-7406-48d7-801d-c6038d010900
displayName: Boxed Warning section
FDA Article Code: 34066-1
Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Lidocaine Viscous 2%, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.
Description
id: f3d97494-8377-45a1-be3a-357fa803e1c2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP) contains a local anesthetic agent and is administered topically. Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride, and has the following structural formula:
The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.
Composition of Solution:
Each mL contains 20 mg (2%) of lidocaine hydrochloride USP and the following inactive ingredients: carboxymethylcellulose sodium, flavoring, methylparaben, propylparaben, purified water and saccharin sodium.
INDICATIONS AND USAGE
id: 2e0b23fd-0778-4fc0-8c3f-7cf33970e79d
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
CONTRAINDICATIONS
id: 6f4c835e-562f-4031-9734-db86d2c15af9
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 the solution.
WARNINGS
id: f171456d-53e4-454a-a8d8-cfaa39d6af57
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 should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.
Life-threatening and fatal events in infants and young children
Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
ADVERSE REACTIONS
id: 447ad10e-7f6f-4fca-8695-0d6dfc15c0fe
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:
OVERDOSAGE
id: fc8cd350-9f96-4d25-8297-2c5de7614f44
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)
HOW SUPPLIED
id: 2019607d-5562-451a-932c-14c284452249
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)
The 2% oral topical solution is supplied as a clear, colorless, viscous solution.
NDC 55700-632-00: Squeeze Bottle of 100 mL
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Dispense in a child-resistant container as defined in the USP/NF.
SHAKE WELL BEFORE USE.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
4055408//10
Revised September 2017
