Anesgerm

Description

The drug is identified by the SPL code 34089-3. Specific details regarding the chemical name, physical characteristics, and inactive ingredients are not provided. Additionally, there is no information available concerning the drug's formulation or composition.

Uses and Indications

This drug is indicated for the relief of dental discomfort associated with toothache, sore gums, teething, denture irritation, and braces irritation.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area up to four times daily, or as directed by a dentist or physician.

Teething infants aged 4 months and older may also have the product applied to the affected area up to four times daily, or as directed by a dentist or physician.

For children under 2 years of age, it is advised to consult a dentist or physician prior to use. Additionally, infants under 4 months of age should also seek guidance from a dentist or physician before application.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage guidelines. Exceeding the prescribed dosage is contraindicated and may lead to adverse effects. This product is not intended for use beyond 7 days unless specifically directed by a dentist or physician.

This product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following conditions occur: sore mouth symptoms that do not show improvement within 7 days; persistent or worsening infection, pain, or redness; development of swelling, rash, or fever; or if fever and nasal congestion are observed in teething infants aged 4 months and older.

In the event of an overdose, immediate medical assistance is required. Prompt intervention is critical to manage potential complications associated with overdose.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial to adhere to the recommended dosage guidelines. Patients are advised not to exceed the recommended dosage and to avoid using the medication for more than 7 days unless directed by a dentist or doctor.

In clinical practice, patients should discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days. Additionally, if infection, pain, or redness persists or worsens, or if symptoms such as swelling, rash, or fever develop, medical advice should be sought. In teething infants aged 4 months and older, the presence of fever and nasal congestion warrants immediate consultation with a healthcare provider.

It is important to note that these symptoms may indicate an underlying infection or a serious condition. Furthermore, patients with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this medication.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid the use of this medication due to the potential for severe allergic reactions.

No specific interactions with laboratory tests have been identified in the available data. Therefore, routine monitoring of laboratory tests is not indicated in relation to this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients experiencing sore gums due to teething may use this product starting at 4 months of age. For teething infants aged 4 months and older, the product may be applied to the affected area up to four times daily or as directed by a dentist or doctor.

Children under 12 years of age should be supervised during the use of this product. For infants under 4 months of age, consultation with a dentist or doctor is recommended prior to use. Additionally, if fever and nasal congestion are present in teething infants aged 4 months and older, these symptoms may indicate an infection or a serious condition, necessitating further medical evaluation.

For children under 2 years of age, it is advised to consult a dentist or doctor before using this product.

Geriatric Use

There is no specific information 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

The safety of benzocaine during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of benzocaine on a nursing infant are not well studied; therefore, caution is advised when considering the use of this product during lactation.

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 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

Exceeding the recommended dosage of the medication may lead to serious adverse effects. Healthcare professionals are advised to monitor patients closely for any signs of overdosage, which can manifest as a range of symptoms depending on the specific medication involved.

In the event of suspected overdosage, immediate medical attention is warranted. It is crucial to assess the patient's clinical status and initiate appropriate management procedures. This may include supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes.

Healthcare providers should ensure that patients are educated about the importance of adhering to prescribed dosages to mitigate the risk of overdosage and its potential complications. Regular follow-up and monitoring can further enhance patient safety and treatment efficacy.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

Additionally, healthcare providers should instruct patients to seek medical help immediately in the event of an overdose. Patients should be made aware of the signs of overdose and the importance of prompt action to ensure their safety and well-being.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light to prevent degradation.

To ensure safety, it should be kept out of reach of children. Once opened, the product should be discarded to avoid any potential risks associated with prolonged exposure to air or contamination.

Additional Clinical Information

The medication is administered orally, with the recommended application frequency being up to four times daily for both adults and children aged 12 years and older, as well as for teething infants aged four months and older. Applications should be directed to the affected area, following the guidance of a dentist or doctor.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)