Olidental Gargle

Description

No relevant information is available for SPL code 34089-3.

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 12 years of age and older should use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) 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. Additionally, patients should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal efficacy.

For children under 12 years of age, it is advised to consult a dentist or doctor prior to use. Caregivers should supervise children as necessary until they are capable of using the rinse without supervision.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Healthcare professionals should advise patients to discontinue use and consult a dentist if they experience any oral irritation or tooth sensitivity. This precaution is essential to prevent potential complications and ensure appropriate management of any adverse effects.

It is imperative to keep this product out of the reach of children. In the event that a child accidentally swallows more than the recommended amount for rinsing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt action is crucial to mitigate any potential risks associated with ingestion.

Side Effects

Patients should be advised to discontinue use and consult a dentist if they experience oral irritation or tooth sensitivity. These reactions warrant immediate attention to prevent further complications.

In clinical trials and postmarketing experiences, the occurrence of oral irritation and tooth sensitivity has been noted, emphasizing the importance of monitoring for these adverse reactions.

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 Olidental Gargle (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use the product twice daily after brushing their teeth with a toothpaste. For children under 12 years of age, it is recommended to consult a dentist or doctor prior to use. Additionally, caregivers should supervise younger children as necessary until they are capable of using the product without supervision.

Geriatric Use

There is no specific information regarding the use of OLIDENTAL GARGLE (sodium fluoride liquid) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, taking into account the individual patient's health status and any potential risks associated with its use. Monitoring for efficacy and safety is recommended, as with any medication administered to elderly patients.

Pregnancy

There are no specific statements regarding the use of OLIDENTAL GARGLE during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

Lactation

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

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.

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 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 patients closely for any signs or symptoms that may arise following an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response. Common manifestations may include altered mental status, cardiovascular instability, gastrointestinal disturbances, and respiratory complications.

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 hemodynamic stability. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. Continuous monitoring and supportive care remain the cornerstones of effective management in 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 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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects associated with accidental overdose.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should administer the rinse orally, using 10 mL (2 teaspoonfuls) twice daily after brushing their teeth. The rinse should be vigorously swished between the teeth for 1 minute before spitting it out. It is important not to swallow the rinse and to avoid eating or drinking for 30 minutes following the rinse.

Clinicians should advise patients to supervise children during use until they are capable of using the product without assistance. Patients are instructed to discontinue use and consult a dentist if they experience oral irritation or tooth sensitivity. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion beyond the recommended amount, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)