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 bubble gum flavor, enhancing its application experience.

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.

There are no teratogenic or nonteratogenic effects reported for this drug.

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 exercise caution and adhere to these guidelines to ensure safe and effective use of the product.

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

The use of this product carries specific warnings and precautions that healthcare professionals must be aware of to ensure patient safety.

Methemoglobinemia Warning This product may induce methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Symptoms 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 is contraindicated in patients with a known history of hypersensitivity to local anesthetics, including benzocaine or other "caine" anesthetics. Healthcare professionals should carefully review patient histories to avoid potential allergic reactions.

Sore Throat Warning In cases of severe sore throat that persists beyond two days, or if accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a physician promptly. Additionally, if symptoms of sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, referral to a dentist or physician is recommended.

Overdose Management In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt intervention is crucial to mitigate potential adverse effects.

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, there is an allergy alert for patients with a known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics. Such individuals should avoid using this product to prevent potential 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 these cases, it is advisable to consult a healthcare professional promptly. Furthermore, if symptoms related to 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 identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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

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 efficacy, 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. 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 regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should carefully consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

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. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary. The use of specific antidotes or treatments should be guided by the clinical scenario and the substances involved.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for further guidance on the management of overdose cases. Prompt recognition and intervention are critical to optimizing patient outcomes in such situations.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

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

Healthcare professionals are advised to instruct patients to discontinue use and seek immediate medical attention 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, there is a caution regarding the use of this product in patients with a known history of allergies to local anesthetics, including benzocaine or other "caine" anesthetics.

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 help 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)