Sodium fluoride

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children over the age of 12 should brush their teeth with their normal toothpaste at least twice daily, or as directed by their dental professional or physician. Following brushing, they should rinse their mouth thoroughly. A pea-sized portion of MI Paste Plus should be dispensed onto a finger and applied thoroughly, ensuring an even layer coats the upper teeth. This process should be repeated for the lower teeth. The paste should remain on the teeth for a duration of 3 minutes without rinsing.

For children under the age of 12, it is recommended to consult a dental professional or physician for appropriate guidance on usage.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings

This product should be kept out of reach of children under 6 years of age to prevent accidental ingestion. It is contraindicated for use in patients with known allergies to milk proteins or hydroxybenzoates. In the event of an allergic reaction, it is essential to discontinue use immediately, rinse the mouth with water, and seek medical advice promptly.

In cases of accidental ingestion of amounts exceeding the recommended dosage for brushing, immediate medical assistance should be sought. Contacting a Poison Control Center is advised in such situations.

General Precautions

No specific general precautions are provided in the insert; however, standard safety practices should be observed.

Laboratory Tests

No laboratory tests are recommended or required for the safe use of this product as per the available information.

Emergency Medical Help Instructions

Should accidental ingestion occur, particularly in amounts greater than those intended for brushing, it is crucial to obtain medical help or contact a Poison Control Center without delay.

Stop Taking and Call Your Doctor Instructions

In the event of an allergic reaction, users must stop using the product, rinse their mouth with water, and seek medical advice immediately.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. The product should not be used in patients with known allergies to milk protein or hydroxybenzoates, as this may lead to adverse reactions.

In the event of an allergic reaction, patients are advised to discontinue use immediately, rinse the mouth with water, and seek medical advice. Additionally, if a patient accidentally swallows more than the amount intended for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mipaste Plus Strawberry. 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 this medication. For children under the age of 12, it is advised to consult a dental professional or doctor prior to use to ensure safety and appropriateness of treatment.

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

There is no specific information available regarding the use of MIPaste Plus Strawberry during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients or women of childbearing potential about the use of this product. It is recommended that the potential benefits and risks be carefully weighed before use in this population.

Lactation

There are no specific warnings or precautions regarding the use of MIPaste Plus Strawberry in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, immediate medical assistance is crucial. If an individual accidentally swallows an amount greater than what is typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It should be stored at room temperature, away from direct light to maintain its stability. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients to keep the product out of reach of children under 6 years of age and to avoid use in individuals with allergies to milk protein or hydroxybenzoates. In the event of an allergic reaction, patients are advised to discontinue use, rinse their mouth with water, and seek medical advice. If more than the recommended amount is swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)