Sensicaine Tm Extra

Description

SAFCO SensiCaine™ Extra is a topical anesthetic gel formulated for professional use only. It contains 20% benzocaine as the active ingredient, providing effective local anesthesia. The gel is presented in a 1 oz. (34 g) container and features a raspberry flavor.

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.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply only the amount necessary to the oral mucosa to prevent or relieve pain. It is important to ensure that the application is limited to the affected area to achieve optimal results.

The use of this medication is contraindicated in children under 2 years of age; therefore, it should not be administered to this age group. Healthcare professionals should monitor the application to ensure safety and efficacy in the intended population.

Contraindications

Use is contraindicated in the following situations:

• The product should not be used for teething due to the potential for adverse effects in this context.

• It is contraindicated in children under 2 years of age, as safety and efficacy have not been established in this population.

Warnings and Precautions

Use of this product carries significant risks that healthcare professionals must be aware of to ensure patient safety.

Methemoglobinemia Warning The administration of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This condition can manifest even in patients who have previously used the product without incident. Immediate cessation of use and prompt medical attention are required if any of the following symptoms develop in the patient or a child under their care: cyanosis (pale, gray, or blue-colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Allergy Alert This product should not be administered to patients with a known history of hypersensitivity to local anesthetics, including benzocaine or other "caine" anesthetics. A thorough patient history should be taken to identify any potential allergic reactions prior to use.

Sore Throat Warning In cases where a patient presents with a severe sore throat that persists beyond two days, or is accompanied by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a physician without delay. Furthermore, if symptoms related to a sore mouth do not show improvement within seven days, or if there is a worsening of irritation, pain, or redness, referral to a dentist or physician is strongly advised.

Overdose Management In the event of an overdose, immediate medical assistance should be sought, or the patient should be directed to contact a Poison Control Center without delay. Prompt intervention is crucial in managing potential overdose scenarios effectively.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Additionally, patients with a history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics, should avoid using this product due to the risk of allergic reactions.

Patients experiencing a sore throat should be vigilant, particularly if the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. In such cases, it is advisable to consult a healthcare professional promptly. Furthermore, if symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, patients should seek evaluation from a dentist or doctor without delay.

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 Sensicaine Tm Extra (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 years and older, the recommended application is limited to the amount necessary to the oral mucosa to prevent or relieve pain. Care should be taken to ensure that the dosage is appropriate for the individual needs of the pediatric patient.

Geriatric Use

There is no specific information available 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a doctor prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when considering this medication for lactating patients.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is vital for ongoing management and potential reporting requirements.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information, and there are no details available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention. Symptoms to be aware of include pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion or misuse. In the event of an overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately for guidance.

Additionally, it is important to inform patients to avoid contact with the eyes while using this product. Should contact occur, they should be directed to flush the eyes with water thoroughly to mitigate any potential irritation or harm.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures ranging from 59 to 86ºF (15 to 30ºC). Care should be taken to protect the product from freezing to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor prior to use. It is also important to instruct patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Sensicaine Tm Extra, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)