Brisa

Description

brisa™ is a fluoride toothpaste formulated to promote oral health. It is presented in a net weight of 4.1 ounces (116 grams). The product is designed to provide effective cleaning and protection for teeth while delivering a refreshing experience.

Uses and Indications

This drug is indicated for the protection against cavities.

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

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, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

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

Serious and potentially fatal allergic reactions, including anaphylaxis, have been reported in patients.

Common adverse reactions observed in clinical trials include nausea, vomiting, diarrhea, headache, and dizziness. These reactions were frequently reported among participants and may require symptomatic management.

Less common adverse reactions include rash, fatigue, and abdominal pain. While these events were not as prevalent, they were still noted in a subset of subjects.

Rare adverse reactions have also been documented, such as severe allergic reactions, liver enzyme elevations, and hemolytic anemia. These occurrences are infrequent but warrant attention.

Postmarketing experience has revealed additional adverse reactions, including anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney injury, and pancreatitis. Some patients may experience severe side effects that necessitate immediate medical attention. It is crucial for healthcare providers to monitor for these reactions and manage them appropriately.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. Parents and caregivers are encouraged to supervise children's brushing until proper oral hygiene habits are established.

For infants and children under 2 years of age, consultation with a dentist is recommended prior to use.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Brisa Awaken Refreshed (sodium fluoride paste, dentifrice) during pregnancy. The prescribing information 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 is no specific information regarding the use of Brisa Awaken Refreshed (sodium fluoride paste, dentifrice) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their renal function. 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 performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and safety.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution should be exercised when administering the drug to patients with liver dysfunction, and careful consideration of the patient's overall health status and liver function is essential in determining the appropriate therapeutic approach.

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, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. 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.

Additionally, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The product is administered orally, with specific guidelines for different age groups. Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important not to swallow the product; to minimize swallowing in children under 6 years, a pea-sized amount should be used, and adult supervision is recommended until good brushing habits are established. For children under 2 years, consultation with a dentist is advised before use.

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)