Perioe Pop Complete Protection Prebiotic

Description

PERIOE is a prebiotic toothpaste formulated to provide complete protection for oral health. It is available in a Mint Blast flavor and contains fluoride to enhance its efficacy. The product is packaged in a 120g (4.2 oz) tube, ensuring a sufficient supply for regular use.

Uses and Indications

This drug is indicated for the protection against cavities.

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. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of teeth in children until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is not advised. In the event of accidental ingestion beyond the amount used for brushing, seek professional assistance or contact a Poison Control Center immediately.

Discontinue use if an allergic reaction occurs.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

General Precautions This product should be kept out of reach of children under 6 years of age. It is crucial to avoid swallowing the product. In the event of accidental ingestion of an amount exceeding that used for brushing, immediate professional assistance should be sought, or the local Poison Control Center should be contacted without delay.

Allergic Reactions Users must discontinue use immediately and contact a healthcare professional if any signs of an allergic reaction occur.

Emergency Medical Assistance In cases of accidental ingestion beyond the recommended amount, it is essential to seek emergency medical help promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions were noted with varying frequencies and should be communicated to patients to ensure they are adequately informed about potential risks.

In addition to the common and serious adverse reactions, there are additional adverse reactions that have been documented through postmarketing experiences. These reactions may not have been fully characterized in clinical trials but are important for healthcare providers to consider when prescribing this medication.

Healthcare professionals are encouraged to report any adverse reactions to enhance the understanding of the safety profile of this medication and to contribute to ongoing safety monitoring efforts.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Perioe Pop Complete Protection Prebiotic (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. It is advised that children under 2 years consult a dentist before use. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6. Parents and caregivers should supervise children's brushing until good oral hygiene habits are established. In the event of accidental swallowing of more than the amount used for brushing, professional assistance or contact with a Poison Control Center should be sought immediately.

Geriatric Use

There is no specific information 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

There is no specific information regarding the use of PERIOE POP Complete Protection Prebiotic Toothpaste Mint Blast during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for PERIOE POP Complete Protection Prebiotic Mint Blast toothpaste. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their creatinine clearance levels. It is essential for healthcare professionals to monitor renal function regularly in these patients. Special consideration should be given to those with severe renal impairment, as they may be at increased risk for adverse effects. Renal function tests should be conducted prior to initiating therapy and periodically thereafter to ensure appropriate dosing and safety.

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 the drug 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 supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for appropriate treatment and follow-up care.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion.

Patients should be informed not to swallow the product. In the event that they accidentally swallow more than the amount used for brushing, they should seek professional assistance or contact a Poison Control Center immediately.

Additionally, healthcare providers should instruct patients to discontinue use immediately if any allergic reaction develops. It is important for patients to be aware of the signs of an allergic reaction and to seek medical attention if they experience any concerning symptoms.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within the specified time frame.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age and to avoid swallowing. In the event of accidental ingestion of more than the amount used for brushing, patients should seek professional assistance or contact a Poison Control Center immediately. If an allergic reaction occurs, use should be discontinued right away. For children under 6, it is recommended to use a pea-sized amount to minimize swallowing, and parents should supervise brushing until proper habits are established. Additionally, for children under 2 years of age, consultation with a dentist is advised.

Drug Information (PDF)

This file contains official product information for Perioe Pop Complete Protection Prebiotic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)