Gelato Anestesico Topical Gel

Description

The product is a gel formulation intended for topical application. It contains an active ingredient, the specifics of which are not provided. The formulation includes various inactive ingredients, details of which are also not specified. The gel is packaged in a manner that has not been detailed in the provided information.

Uses and Indications

This drug is indicated solely for use on the oral mucosa, as directed by a dentist. It is intended for the temporary relief of pain associated with minor dental procedures.

Dosage and Administration

Healthcare professionals are advised to apply only the necessary amount of the medication to the oral mucosa to prevent or alleviate pain. It is important to note that this medication is contraindicated for use in children under the age of 2 years.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

El uso de este producto conlleva importantes advertencias y precauciones que deben ser consideradas para garantizar la seguridad del paciente.

Advertencia de Metahemoglobinemia Este producto puede inducir metahemoglobinemia, una condición grave que compromete la capacidad de la sangre para transportar oxígeno. Los síntomas pueden presentarse incluso en pacientes que han utilizado el producto previamente sin complicaciones. Se debe interrumpir el uso de inmediato y buscar atención médica si se observan los siguientes signos en el paciente o en un niño bajo su cuidado: piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o aturdimiento, y fatiga o falta de energía.

Alerta de Alergia Este producto está contraindicado en pacientes con antecedentes de reacciones alérgicas a anestésicos locales, incluyendo procaína, butacaína, benzocaína u otros anestésicos de tipo "caína".

Uso y Duración No se debe utilizar este producto por más de 7 días a menos que sea indicado por un médico. Si los síntomas de dolor en la boca no mejoran en este período, o si la irritación, el dolor o el enrojecimiento persisten o empeoran, o si se presenta hinchazón, sarpullido o fiebre, se debe consultar a un médico de inmediato. Este producto no está indicado para la dentición y no debe ser administrado a niños menores de 2 años.

Precauciones durante el Uso Se debe evitar el contacto con los ojos. En caso de contacto accidental, se recomienda enjuagar con abundante agua fresca.

Dosis Recomendada Es crucial no exceder la dosis recomendada. Si se ingiere accidentalmente una cantidad superior a la indicada para el tratamiento del dolor, se debe buscar atención médica o contactar a un Centro de Control de Envenenamiento de inmediato.

Embarazo y Lactancia Las mujeres embarazadas o en periodo de lactancia deben consultar a un médico antes de utilizar este producto.

Side Effects

El uso de este producto puede asociarse con una serie de reacciones adversas, algunas de las cuales son graves y requieren atención médica inmediata.

Una de las advertencias más significativas es la posibilidad de metahemoglobinemia, una condición que puede comprometer la capacidad de la sangre para transportar oxígeno. Esta reacción puede presentarse incluso en pacientes que han utilizado el producto anteriormente. Se recomienda que los pacientes interrumpan el uso y busquen atención médica de inmediato si experimentan síntomas como piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o aturdimiento, así como fatiga o falta de energía.

Adicionalmente, se debe tener precaución en pacientes con antecedentes de alergias a anestésicos locales, tales como procaína, butacaína, benzocaína u otros anestésicos de tipo "caína", ya que el uso del producto en estos individuos puede provocar reacciones alérgicas graves.

Se aconseja no utilizar el producto por más de 7 días a menos que sea indicado por un médico. Si los síntomas de dolor en la boca no mejoran en este período, o si la irritación, el dolor o el enrojecimiento persisten o empeoran, o si se presenta hinchazón, sarpullido o fiebre, se debe consultar a un médico de inmediato. Este producto no está indicado para su uso en la dentición ni en niños menores de 2 años.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Gelato Anestesico Topical Gel (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

El medicamento no debe ser utilizado en niños menores de 2 años. Se debe mantener fuera del alcance de los niños.

Se ha emitido una advertencia sobre el riesgo de metahemoglobinemia. Se debe interrumpir el uso y buscar atención médica inmediata si se observa en el paciente, ya sea un niño o un adulto bajo su cuidado, síntomas como piel pálida, gris o azul (cianosis), dolor de cabeza, frecuencia cardíaca rápida, dificultad para respirar, mareos o aturdimiento, fatiga o falta de energía.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients or those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

There is no relevant information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function in the provided text. Therefore, no specific recommendations can be made for patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

El uso de este medicamento debe adherirse estrictamente a la dosis recomendada. Se advierte a los profesionales de la salud que, en caso de ingestión accidental de una cantidad superior a la indicada para el tratamiento del dolor, se debe buscar asistencia médica de inmediato.

Es fundamental contactar a un Centro de Control de Envenenamiento para recibir orientación adecuada sobre la gestión de la sobredosis. La intervención oportuna es crucial para minimizar los riesgos asociados con la sobredosis y garantizar la seguridad del paciente.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

The use of this product has been associated with reports of methemoglobinemia, a serious condition that can reduce the amount of oxygen transported in the blood. This adverse event may occur even in individuals who have previously used the product without issue. Patients and caregivers are advised to discontinue use and seek immediate medical attention if symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, difficulty breathing, dizziness or lightheadedness, fatigue, or lack of energy are observed.

Additionally, there is a warning regarding the use of this product in patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics.

It is recommended that the product not be used for more than 7 days unless directed by a healthcare professional. Patients should consult their physician immediately if oral pain symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Patient Counseling

Advise patients to keep the medication out of the reach of children. It is important to emphasize the potential risks associated with accidental ingestion or misuse by children. Encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It must be stored at a temperature not exceeding 30°C. Additionally, it is essential to protect the product from freezing to maintain its integrity and efficacy. Proper adherence to these storage conditions is crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients to avoid contact with the eyes; in the event of contact, they should rinse thoroughly with plenty of fresh water. Patients are advised not to exceed the recommended dosage. In cases of accidental ingestion of more than the recommended amount for pain relief, immediate medical assistance or contact with a poison control center is necessary. Pregnant or breastfeeding patients should consult a physician prior to use. Additionally, the product should be kept out of reach of children.

Drug Information (PDF)

This file contains official product information for Gelato Anestesico Topical Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)