Synedent Flx

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 6 years of age and older should use the rinse once daily, following brushing with toothpaste. The method of administration involves vigorously swishing 10 milliliters (2 teaspoons) of the rinse between the teeth for 1 minute, after which the solution should be spat out. It is imperative that the rinse is not swallowed.

Post-administration, patients should refrain from eating or drinking for 30 minutes to ensure optimal effectiveness of the rinse. 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 is recommended until the child is capable of using the rinse without assistance.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

This product contains shellfish derivatives; therefore, caution is advised for individuals with shellfish allergies.

It is imperative to note that this product is not intended for use in pets.

Users should ensure that the safety seal is intact prior to use. If the safety seal is broken or missing, the product should not be used.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. In the event that more than the indicated amount is swallowed, it is imperative to seek medical attention or contact the Poison Control Center immediately. The product contains shellfish derivatives, which may pose a risk for individuals with shellfish allergies. Additionally, it is important to note that this product is not intended for use by pets. Patients should also ensure that the safety seal is intact before use; the product should not be used if the safety seal is broken or missing.

Drug Interactions

No drug interactions have been identified for the specified medication. Additionally, there are no interactions noted between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be supervised during use to ensure proper administration and minimize risks. For children aged 6 years and older, the recommended dosage is once daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in good rinsing habits to reduce the likelihood of swallowing the product.

For children under 6 years of age, consultation with a dentist or doctor is advised prior to use. Care should be taken to keep the product out of reach of children, and in the event of accidental ingestion beyond the indicated amount, medical attention or contact with a Poison Control Center is necessary.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of Synedent FLX (sodium fluoride mouthwash) during pregnancy has not been established, as no specific information regarding its use in pregnant patients is provided in the drug insert. There are no contraindications noted for the use of this product in pregnancy, nor are there any associated risks to the fetus documented. Additionally, the prescribing information does not indicate any need for dosage modifications or special precautions for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this mouthwash during pregnancy.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. The effects on nursing infants are not well studied; therefore, caution is advised when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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, it is imperative that immediate medical attention is sought. Healthcare professionals should advise patients or caregivers to contact the Poison Control Center without delay if an amount exceeding the recommended dosage is ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is essential for appropriate management.

Healthcare providers should ensure that patients are aware of the importance of adhering to prescribed dosages and the necessity of seeking help in the case of an overdose.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in a secure location.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered orally, specifically for adults and children aged 6 years and older. Patients should use the rinse once daily after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 milliliters (2 teaspoons) of the rinse between the teeth for 1 minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinse. Clinicians should instruct children under 12 years in proper rinsing techniques to minimize the risk of swallowing and supervise their use until they can perform the task independently.

Drug Information (PDF)

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

View product document (PDF)