Drug Detail:Lidocaine viscous (Lidocaine viscous [ lye-doe-kane-vis-kus ])
Drug Class: Topical anesthetics
Related/similar drugs
aspirin, acetaminophen, tramadol, naproxen, oxycodone, Tylenol, lidocaine topicalIndications and Usage for Lidocaine Viscous
Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) 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
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
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 Hydrochloride Oral Topical Solution 2% (Viscous) when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) 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.
Methemoglobinemia
Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Adverse Reactions/Side Effects
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:
Lidocaine Viscous Dosage and Administration
Adult:
The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) for healthy adults should be such that the dose of lidocaine does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.
For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period. The dosage should be adjusted commensurate with the patient's age, weight and physical condition (see PRECAUTIONS).
Pediatric:
Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.
It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (3.7 to 5 mL of Lidocaine Hydrochloride Oral Topical Solution 2% Viscous).
For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period. Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.
How is Lidocaine Viscous supplied
Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) is a clear, colorless , viscous solution supplied in 100 mL low density polyethylene squeeze bottles.
NDC 72888-125-26
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]”.
SHAKE WELL BEFORE USE.
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride solution |
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Labeler - Advagen Pharma Ltd (051627256) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Rubicon Research Private Limited | 677604197 | manufacture(72888-125) , analysis(72888-125) , label(72888-125) |