Quala Topical Anesthetic Gel

Description

The drug is a white to off-white, round, biconvex tablet imprinted with "Q" on one side and "10" on the other side. Each tablet contains 10 mg of the active ingredient Quetiapine Fumarate. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

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

Healthcare professionals are advised to apply the necessary amount of the medication directly to the oral mucosa to effectively prevent or relieve pain.

It is important to note that this medication is not recommended for use in children under 2 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

Use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This risk exists even in individuals who have previously used the product without issue. Healthcare professionals should advise patients to discontinue use and seek immediate medical attention if they or a child in their care exhibit any of the following symptoms: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue and lack of energy.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product.

The product should not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, patients should consult their physician promptly. Additionally, this product is contraindicated for teething and should not be administered to children under 2 years of age.

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 with water immediately.

Patients must adhere to the recommended dosage guidelines. In cases where more than the advised amount is ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

For individuals who are pregnant or breastfeeding, it is essential to consult a physician prior to use to ensure safety for both the mother and child.

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.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. Additionally, it is advised that the product not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients should seek medical advice promptly.

The product is contraindicated for use in children under 2 years of age and should not be used for teething. Patients are also cautioned to avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately. It is critical not to exceed the recommended dosage, and if more than the prescribed amount is accidentally ingested, medical help or contact with a Poison Control Center should be sought without delay.

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

Drug Interactions

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

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse effect can occur even in patients who have previously used the product without incident. Prompt treatment is essential if methemoglobinemia is suspected. Monitoring for signs and symptoms of this condition is advised, particularly in patients with risk factors or those receiving higher doses.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. In the event that a child develops symptoms indicative of methemoglobinemia, such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue, immediate medical attention should be sought.

Additionally, it is important to keep this medication out of reach of children to prevent accidental ingestion or misuse.

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 physician prior to using this medication. It is important for healthcare providers to assess the potential risks and benefits associated with the use of this medication in these populations. The safety of this medication during pregnancy and lactation has not been fully established, and caution is advised to ensure the well-being of both the mother and the fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a physician 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 recommending this medication to 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 event of an overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Exceeding the prescribed amount can lead to serious health complications.

Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is necessary. Healthcare professionals should advise contacting a Poison Control Center or seeking emergency medical help without delay. Prompt intervention is essential to mitigate potential risks associated with overdosage.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a physician prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding 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 monitor for include cyanosis (pale, gray, or blue colored skin), 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 the medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from areas accessible to children, to ensure their safety.

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 59° 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 physician 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 Quala Topical Anesthetic Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)