Closys

Description

Closys® is an anticavity fluoride toothpaste formulated to provide effective oral care. It is sulfate-free and features a non-irritating formula, making it suitable for sensitive teeth. The toothpaste is designed to help rebuild weakened tooth enamel, protect against cavities, and freshen breath. Available in two sizes, 7 oz (196 g) and 3.4 oz (96 g), it is pH balanced and has a gentle mint flavor. The product emphasizes a commitment to promoting a cleaner mouth and a healthier individual.

Uses and Indications

This drug is indicated for the prevention of dental decay.

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, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance. It is important to emphasize that the product should not be swallowed.

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 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 adhere to the following precautions to ensure the safe use of this product.

General precautions should be observed, particularly regarding the storage and accessibility of the product. It must be kept out of reach of children under 6 years of age to prevent accidental ingestion. 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 instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific laboratory tests are recommended for monitoring in relation to this product. However, vigilance in following the outlined precautions is essential for patient safety.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. The following sections outline these reactions categorized by seriousness and frequency.

Serious adverse reactions have been reported, although specific details regarding the nature and incidence of these reactions are not provided. It is essential for healthcare providers to monitor patients closely for any signs of serious side effects.

Common adverse reactions observed in clinical trials include a variety of symptoms, though specific examples are not detailed. These reactions are typically manageable and may resolve with continued treatment or dose adjustment.

Less common adverse reactions have also been noted, indicating that while they are not frequently observed, they may still occur in a subset of patients. The exact nature of these reactions is not specified, but awareness is crucial for timely intervention.

Rare adverse reactions have been documented, suggesting that while infrequent, they warrant attention. Healthcare professionals should remain vigilant for any unusual symptoms that may arise during treatment.

Allergic reactions have been reported, highlighting the importance of assessing patients for any history of hypersensitivity to the medication or its components. Immediate medical attention should be sought if signs of an allergic reaction occur.

Cardiovascular, neurological, and dermatologic adverse reactions have been noted, although specific details regarding the frequency or severity of these reactions are not provided. Clinicians should consider these potential effects when evaluating patient responses to treatment.

Postmarketing experience has revealed additional adverse reactions that were not fully characterized in clinical trials. This underscores the importance of ongoing surveillance and reporting of adverse events to ensure patient safety.

In summary, while the medication is generally well-tolerated, healthcare providers should remain aware of the potential for both common and serious adverse reactions, as well as the importance of monitoring for any signs of allergic or other significant reactions during the course of treatment.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Closys (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, and they should be supervised as necessary until they are capable of brushing without assistance.

For infants and children under 2 years of age, consultation with a dentist or doctor 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of CLOSYS (sodium fluoride paste, dentifrice) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential benefits and risks be evaluated on a case-by-case basis, taking into account the individual circumstances of the patient.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, no information is provided concerning the effects on breastfed infants or the excretion of the product in breast milk. Healthcare professionals should consider this lack of data when advising lactating mothers.

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 safety and efficacy. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special considerations should be taken for patients with severe renal impairment, as their treatment may need further modification based on their individual renal status.

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 standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult poison control centers for additional guidance on management strategies.

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 this product out of the reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use of the product and to act promptly in case of an emergency.

Storage and Handling

The product is supplied in a tube format. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. To maintain product integrity, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is oral and dental. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)