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 strawberry 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.

Limitations of use include the absence of teratogenic and nonteratogenic effects, as no such effects have been reported.

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 ensure that patients and caregivers are aware of this restriction to prevent potential adverse effects.

Contraindications

Use is contraindicated in the following situations:

• The product should not be used for teething due to the potential for adverse effects associated with its use 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. 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 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 obtained to identify any potential allergic reactions.

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 irritation, pain, or redness persists or worsens, 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 Poison Control Center should be contacted without delay to ensure appropriate management and intervention.

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 advised to discontinue use and seek immediate medical attention if they or a child in their care experience 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. It is important to note that methemoglobinemia can occur even in individuals who have previously used this product without incident.

Additionally, patients with a known 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 should also be cautioned regarding the potential for severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is essential to consult a healthcare professional promptly. Furthermore, if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek evaluation from a dentist or doctor.

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 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. 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 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 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

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified cases of methemoglobinemia associated with the use of this product. These cases were reported voluntarily or through surveillance programs.

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 for healthcare providers to inform patients to avoid contact with the eyes while using this product. Should contact occur, patients 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)