Brisa

Description

brisa™ is a fluoride toothpaste formulated for effective dental care. It is presented in a Tropical Fresh flavor and is packaged in a net weight of 4.1 ounces (116 grams).

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of children's teeth until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use is contraindicated in the event of accidental ingestion of amounts exceeding those recommended for brushing. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

There are no specific adverse reactions, warnings, or clinical trial experiences reported for this product. Additionally, postmarketing experiences and any other important notes regarding adverse reactions are not available. As such, healthcare professionals should remain vigilant and report any unexpected events or reactions that may arise during the use of this product.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years.

Supervision of children's brushing is essential until proper oral hygiene habits are established. For children under 2 years of age, consultation with a dentist is recommended prior to use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Brisa Tropical Fresh (sodium fluoride paste, dentifrice) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with a reduced dose recommended for those with moderate to severe renal impairment. Additionally, renal function tests should be conducted prior to initiating therapy and periodically thereafter to assess any changes in kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to assess the degree of impairment and to guide treatment decisions. Specifically, patients with severe hepatic impairment may necessitate a reduced dose to ensure safety and efficacy. Regular evaluation of liver function is essential to optimize therapeutic outcomes while minimizing potential risks associated with compromised liver function.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage data.

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

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing.

To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame, although this duration is not detailed in the provided information.

Additional Clinical Information

The product is administered orally, with recommendations for adults and children aged 2 years and older to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important that the product is not swallowed; to minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. Clinicians are advised to supervise children's brushing until proper habits are established, and for children under 2 years, consultation with a dentist is recommended.

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

Drug Information (PDF)

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

View product document (PDF)