Vistacaine Topical Anesthetic

Description

The drug is formulated as a topical wrap, designed for application to the skin. The effective date of the insert is March 29, 2018. Additionally, the insert contains a reference to an image labeled "LB.Vista Topical Wrap_R7.jpg," which provides visual representation of the product.

Uses and Indications

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

Limitations of use include the restriction to oral mucosal application and the necessity for administration under the guidance of a dental professional. There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to apply the necessary amount of the medication directly to the oral mucosa to effectively prevent or relieve pain. The specific dosage should be tailored to the individual patient's needs, ensuring that only the required amount is utilized for optimal results.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients with a known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics, should not use this product due to the risk of severe allergic reactions.

This product should not be used for more than 7 days unless specifically directed by a dentist or physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, it is imperative to seek prompt consultation with a dentist or healthcare provider. Additionally, if any signs of swelling, rash, or fever develop, immediate medical attention is warranted.

While using this product, it is crucial to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed thoroughly with water.

Users must discontinue use and consult a healthcare practitioner if they experience symptoms such as weakness, confusion, headache, difficulty breathing, or changes in skin color (pale, grey, or blue). These symptoms may indicate methemoglobinemia, a rare but serious condition that can manifest up to 2 hours after application.

It is essential not to exceed the recommended dosage. In cases where more than the advised amount is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For individuals who are pregnant or breastfeeding, it is advisable to consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Allergic reactions may occur, particularly in individuals with a history of allergies to local anesthetics, such as benzocaine or other "caine" anesthetics. It is advised that this product not be used for more than 7 days unless directed by a dentist or doctor. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, patients should seek prompt consultation with their healthcare provider. Additionally, if any swelling, rash, or fever develops, medical advice should be sought immediately.

During the use of this product, patients must avoid contact with the eyes. In the event of contact, it is crucial to flush the eyes with water.

Patients should discontinue use and consult a healthcare practitioner if they experience symptoms such as weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin. These symptoms may indicate methemoglobinemia, a rare disorder that can manifest up to 2 hours after application.

It is also important for patients to adhere to the recommended dosage. If more than the advised amount is accidentally ingested, immediate medical assistance should be sought or contact with a Poison Control Center is recommended. Pregnant or breastfeeding individuals should consult a health professional before using this product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. The use of this medication is contraindicated in patients with a history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics.

Healthcare professionals should ensure that the recommended dosage is not exceeded. In the event that more than the recommended amount is accidentally ingested for pain relief, immediate medical assistance or contact with a Poison Control Center is necessary.

For pregnant or breastfeeding patients, consultation with a healthcare professional is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and 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 the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is critical to adhere to the recommended dosage guidelines. Exceeding the prescribed amount can lead to serious health risks. Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is required.

Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a health professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

The following symptoms have been reported in the postmarketing experience, which may appear up to 2 hours after use: weakness, confusion, headache, difficulty breathing, and/or pale, grey, or blue-colored skin. These symptoms may indicate methemoglobinemia, a rare disorder.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 59º to 86°F (15 to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

Additional Clinical Information

The route of administration for the medication is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)