Made by Dentists, Inc. Total Care

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of 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 should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize swallowing. A pea-sized amount of toothpaste should be used, and supervision is recommended until the child is capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use.

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

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of the patient.

Currently, there are no specific warnings or general precautions outlined for the use of this product. Additionally, no laboratory tests have been recommended for monitoring during its use. Healthcare professionals should remain vigilant and exercise clinical judgment in the management of any adverse events or concerns that may arise during treatment.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects, while infrequent, can occur and should be monitored closely.

Common adverse reactions reported in clinical trials include symptoms that may affect the cardiovascular, neurological, and dermatologic systems. These reactions are typically mild to moderate in severity and may resolve with continued treatment or upon discontinuation of the medication.

Less common adverse reactions have also been observed, which may require further evaluation and management. These reactions, while not as frequently reported, can still impact patient well-being and should be taken into consideration during treatment.

Rare adverse reactions have been documented, although they occur at a significantly lower frequency. These reactions may necessitate immediate medical attention and should be reported to healthcare providers.

Allergic reactions, while not common, have been noted in some patients. Symptoms may vary and can include rash, itching, or more severe manifestations that require urgent care.

Postmarketing experience has provided additional insights into the safety profile of the medication, highlighting the importance of ongoing surveillance for adverse reactions in the broader patient population.

Healthcare professionals are encouraged to report any adverse reactions observed in patients to contribute to the overall understanding of the medication's safety and efficacy.

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 Made by Dentists, Inc. Total Care (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, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is necessary until children are capable of brushing without assistance.

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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Total Care Sodium Fluoride Paste during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that women of childbearing potential discuss their individual circumstances with their healthcare provider to weigh the potential benefits and risks associated with the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants from the use of this product during lactation.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating careful consideration of dosage adjustments. It is essential that these patients are monitored closely for any adverse effects throughout the course of treatment.

Prior to initiating therapy, liver function tests should be conducted to establish a baseline. Additionally, ongoing monitoring of liver function is recommended during treatment to ensure patient safety and to facilitate timely adjustments to the dosage if required.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved, the amount ingested, and the individual patient's characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of a suspected overdose, immediate assessment of the patient's condition is critical. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and level of consciousness. Monitor for any signs of distress or abnormal physiological responses.

2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids to maintain hemodynamic stability.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

4. Symptomatic Treatment: Administer symptomatic treatment as indicated, which may involve the use of antidotes if available and appropriate for the specific overdose scenario.

5. Monitoring: Continuous monitoring of the patient is essential to detect any changes in their condition and to adjust treatment protocols accordingly.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to act swiftly and effectively in the event of an overdose, utilizing established protocols and resources to ensure optimal patient outcomes.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the 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 information is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize swallowing, recommending the use of only a pea-sized amount. It is important for parents to supervise children until they are capable of using the product without assistance. For children under 2 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Made by Dentists, Inc. Total Care, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)