Synedent Flx

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with the letter "A" on one side and the number "1" on the opposite side. Each tablet contains 1 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

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 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The recommended method involves vigorously swishing 10 milliliters (2 teaspoons) of the rinse between the teeth for a duration of 1 minute, after which the solution should be spat out. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure 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 product independently.

For children under 6 years of age, it is advised to consult a dentist or physician prior to use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. Ensure that the product is kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended dosage is swallowed, immediate medical attention should be sought, or the local Poison Control Center should be contacted without delay.

This product contains shellfish derivatives; therefore, it is contraindicated for use in pets. Healthcare professionals should advise patients accordingly to avoid any adverse reactions.

Additionally, the product should not be used if the safety seal is broken or missing, as this may indicate potential tampering or contamination. It is essential to ensure the integrity of the product prior to use to maintain safety and efficacy.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of reach of children to prevent accidental ingestion. In the event that more than the indicated amount is swallowed, patients are advised to seek medical attention or contact a Poison Control Center immediately.

The product contains shellfish derivatives, which may pose a risk for individuals with shellfish allergies. Additionally, it is not intended for use by pets, and patients should 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

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

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 aged 6 years and older are advised to use the rinse once daily after brushing their teeth with toothpaste. The recommended administration involves vigorously swishing 10 milliliters (2 teaspoons) of the rinse between the teeth for 1 minute before spitting it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following 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 may be required until the child is capable of using the product independently. For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information available 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.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of Synedent FLX in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 a Poison Control Center without delay if an excessive amount of the medication has been ingested.

Symptoms of overdosage may vary depending on the specific medication involved; however, it is crucial to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance involved. Continuous monitoring and assessment of the patient's condition are essential to address any complications that may arise.

In summary, swift action is necessary in cases of overdosage, with an emphasis on contacting medical professionals and Poison Control Centers for guidance on appropriate 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 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 necessity of proper storage to ensure the safety of young individuals.

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

Patients should be instructed on the proper oral administration of the rinse. For adults and children aged 6 years and older, the rinse should be used once daily after brushing teeth with toothpaste. Patients should vigorously swish 10 milliliters (2 teaspoons) of the rinse between their teeth for 1 minute before spitting it out, ensuring not to swallow the rinse. It is advised not to eat or drink for 30 minutes following the rinse. Children under 12 years should be guided in good rinsing habits to minimize swallowing, and supervision is recommended until they can use the product independently. For children under 6 years of age, consultation with a dentist or doctor is necessary.

Clinicians should counsel patients to keep the product out of reach of children and to seek medical attention or contact a Poison Control Center immediately if more than the indicated amount is swallowed. The rinse contains shellfish derivatives and is not intended for use by pets. Patients should also be advised not to use the product if the safety seal is broken or missing.

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)