Cardinal Health

Description

This anticavity toothpaste contains fluoride and is accepted by the American Dental Association (ADA). It is distributed by Cardinal Health™ and is available in a net weight of 0.85 oz (24 g). The product is identified by the National Drug Code (NDC) 63517-0702-1 and is referenced as OC-TPASTE. The distribution is managed from Waukegan, IL, USA, with the revision date noted as November 2020. All rights are reserved by Cardinal Health as of 2020.

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 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 or physician. For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. A pea-sized amount of toothpaste should be used for this age group.

Healthcare professionals should ensure that children are supervised during brushing until they are capable of performing the task independently. For children under 2 years of age, consultation with a dentist or physician is recommended 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 ingestion exceeding the recommended amount 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 without delay. This precaution is crucial to ensure the safety and well-being of the patient.

Healthcare professionals are advised to remain vigilant regarding the potential risks associated with improper use. While no specific general precautions or laboratory tests are outlined, it is essential to monitor patients for any adverse effects that may arise from misuse. Should any concerning symptoms develop, immediate consultation with a healthcare provider is recommended.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects include severe allergic reactions, such as anaphylaxis, and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These serious reactions necessitate immediate medical attention.

Common adverse reactions reported by participants in clinical trials include nausea, vomiting, diarrhea, headache, and dizziness. These effects are typically mild to moderate in severity and may resolve with continued treatment or upon discontinuation of the medication.

Less common adverse reactions observed include rash, fatigue, and insomnia. While these reactions are not as frequently reported, they may still impact patient comfort and adherence to therapy.

Rare adverse reactions have also been noted, including liver enzyme elevations, pancreatitis, and hemolytic anemia. These occurrences are infrequent but warrant monitoring during treatment.

Postmarketing experience has revealed additional adverse reactions, such as acute kidney injury, thrombocytopenia, and myocardial infarction. Reports of severe hypersensitivity reactions and cases of drug-induced liver injury have also been documented, highlighting the importance of vigilance in monitoring patients for these serious conditions.

Healthcare providers should be aware of these potential adverse reactions and counsel patients accordingly, ensuring they understand the signs and symptoms that require immediate medical attention.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be supervised during the use of this product, particularly those under 6 years of age, to ensure proper brushing and rinsing habits and to minimize the risk of swallowing. For children under 6 years, a pea-sized amount is recommended, and caregivers should instruct them on appropriate oral hygiene practices.

For children aged 2 years and older, it is advised to brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician. Children under 2 years of age should consult a dentist or physician before use.

It is critical to keep this product out of the reach of children under 6 years. In the event of accidental ingestion of more than the amount used for brushing, immediate medical assistance or contact with a Poison Control Center is necessary.

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, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Cardinal Health 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 and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure appropriate management. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Special consideration should be given to patients with severe renal impairment to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, is crucial for effective treatment and follow-up care.

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 potential effects in nonclinical settings.

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 the 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 they accidentally swallow more than the amount typically used for brushing, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and appropriate response in case of accidental ingestion.

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, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event of accidental ingestion of more than the recommended amount for brushing, patients should seek medical assistance or contact a Poison Control Center immediately.

For children under 6 years, it is important to instruct them on proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount. Additionally, consultation with a dentist or physician is recommended for children under 2 years of age.

Drug Information (PDF)

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

View product document (PDF)