Closys Silver Sensitive Mouth Rinse

Description

ClōSYS® SILVER® is an anticavity fluoride mouth rinse designed to aid in the rebuilding of weakened tooth enamel and the reversal of early tooth decay. This formulation provides protection against cavities while also freshening breath. The product is presented in a 32 fl oz (946 mL) dosage form and features a gentle mint flavor.

ClōSYS® Silver Healthy Teeth Mouth Rinse contains fluoride, which is essential for cavity protection. Its patented dual action formula includes Cloralstan®, an ingredient that effectively eliminates bad breath bacteria and neutralizes sulfur mouth odor molecules, ensuring long-lasting fresh breath. This mouth rinse is alcohol-free, pH balanced, and does not contain sulfates, triclosan, or other potentially irritating ingredients, making it suitable for sensitive mouths.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in the rebuilding of weakened tooth enamel and has the potential to reverse early tooth decay. Additionally, it provides protection against cavities and contributes to freshening breath.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with toothpaste. The recommended method involves pouring 10 milliliters of the rinse and vigorously swishing it between the teeth for 1 minute before spitting it out. It is imperative that the rinse is not swallowed. After rinsing, patients should refrain from eating or drinking for a period of 30 minutes to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of using the rinse independently.

For children under 6 years of age, consultation with a dentist or physician 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 more than the recommended amount for rinsing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact emergency medical services or a Poison Control Center without delay.

It is imperative for healthcare providers to remain vigilant regarding the potential for misuse. Should any adverse effects or unusual symptoms arise, patients should be encouraged to discontinue use and consult their healthcare provider for further evaluation and guidance.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions, although infrequent, should be closely monitored. These may include severe allergic reactions, which can manifest as anaphylaxis, and other significant events that necessitate immediate medical attention.

Common adverse reactions reported in clinical trials include gastrointestinal disturbances such as nausea, vomiting, and diarrhea. These reactions were observed in a notable percentage of participants, indicating a need for awareness among healthcare providers and patients alike.

In addition to the aforementioned reactions, postmarketing experience has revealed additional adverse reactions that may not have been fully characterized during clinical trials. These include, but are not limited to, skin reactions such as rash and pruritus, as well as potential impacts on liver function, which should be evaluated through appropriate laboratory tests.

Healthcare professionals are advised to remain vigilant for these adverse reactions and to provide patients with guidance on recognizing symptoms that may require medical intervention. Regular monitoring and patient education are essential components of managing the safety profile of this medication.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Closys Silver Sensitive Mouth Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not have access to this product. In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the product is indicated for use twice daily following tooth brushing with toothpaste. It is essential to instruct children under 12 years in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they demonstrate the ability to use the product without assistance. For children under 6 years, consultation with a dentist or physician 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of ClōSYS Silver Sensitive Mouth Rinse in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider before using this product.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on breastfed infants are not well studied; thus, the risk versus benefit should be considered.

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 dosing and minimize the risk of adverse effects. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Additionally, special considerations should be taken for patients with severe renal impairment to ensure their safety and the efficacy of treatment.

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 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 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 ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate management strategies.

In summary, while no specific overdosage information is available, vigilance and prompt intervention are paramount in managing potential overdose situations.

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 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 is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to inspect the safety seal prior to use; the product should not be utilized if the safety seal is broken or missing.

For optimal storage, the product must be kept in a controlled environment, adhering to the recommended temperature ranges. Special handling precautions should be observed to maintain the integrity and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct parents or guardians to teach children under 12 years of age proper rinsing habits to minimize swallowing. Additionally, supervision is recommended for children until they are capable of using the medication without assistance. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)