Vita-P Oral and Nasal

Description

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

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with mucosal damage, the common cold, rhinitis, respiratory tract infections, oral ulcers, hay fever, and respiratory allergies.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product is administered via oral inhalation using a 2 ml nano-aerosol formulation composed of menthol and dihydroquercetin. It is important to note that this is a non-sterile product.

To prepare for administration, the healthcare professional should follow these steps:

1. Open the bottle cap.

2. Remove the silicone nail from the inhaler.

For inhalation, the patient should place the inhaler in their mouth and inhale for a duration of 3 seconds. The thermal sensation will be automatically atomized, allowing for immediate inhalation upon mouth contact.

The recommended dosing frequency is 3 to 5 times per day, ideally distributed across morning, afternoon, and evening sessions.

Contraindications

Use of this product is contraindicated in the following situations:

Discontinue use and seek medical attention if discomfort occurs during application. Caution is advised when administering this product to minors and individuals over 65 years of age, as well as to patients with asthma, heart disease, or those who are pregnant. The product is not recommended for use in disabled individuals under the age of 12. This product is intended for single-person use only; sharing may lead to the spread of infection.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a health professional prior to use if they are pregnant or breastfeeding. This precaution is essential to ensure the safety of both the patient and the fetus or infant.

In the event of accidental ingestion, immediate medical assistance should be sought, or the nearest medical center should be contacted without delay. Prompt action is critical to mitigate potential adverse effects.

Patients are advised to discontinue use and seek medical treatment if they experience any discomfort during application. This recommendation is particularly important for vulnerable populations, including individuals over 65 years of age, those with asthma, patients with heart disease, and pregnant women, who should exercise caution when using this product.

The product is contraindicated for use in individuals under the age of 12. Additionally, it is intended for single-person use only; cross-use of this product is strictly prohibited. Sharing the container may lead to the transmission of infections, thereby posing a significant health risk.

Healthcare professionals should monitor patients for any adverse reactions and ensure that they are aware of these critical warnings and precautions to promote safe usage.

Side Effects

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using this medication. This precaution is essential to ensure the safety of both the patient and the developing fetus or nursing infant.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is important for healthcare providers to monitor patients for any unexpected reactions and to report them as necessary.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Vita-P Oral and Nasal (menthol 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be treated with caution, particularly those under the age of 12. The product is not recommended for use in this population due to safety concerns. Additionally, it is important to keep the product out of reach of children to prevent accidental ingestion or misuse.

Geriatric Use

Elderly patients, particularly those aged 65 years and older, should be treated with caution when considering the use of this medication. The pharmacokinetics and pharmacodynamics may differ in this population, necessitating careful monitoring and potential dose adjustments based on individual patient response and tolerance.

Additionally, caution is advised for geriatric patients with pre-existing conditions such as asthma and heart disease. These conditions may exacerbate the risks associated with the medication, and healthcare providers should closely monitor these patients for any adverse effects or complications that may arise during treatment.

Overall, a thorough assessment of the patient's health status and ongoing evaluation throughout the course of therapy are essential to ensure safety and efficacy in elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function is advisable to ensure safe and effective use of the medication in this 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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, healthcare professionals should consider contacting a poison control center for guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, individuals are advised to consult a health professional prior to use. Caution is recommended when administering this product to minors, as well as to individuals over 65 years of age, those with asthma, patients with heart disease, and pregnant women.

No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a medical center if the product is swallowed. It is important to instruct patients to discontinue use and seek medical treatment if they experience any discomfort during application.

Providers should emphasize the need for caution when using this product in minors, as well as in individuals over 65 years of age, those with asthma, patients with heart disease, and pregnant women. Additionally, it is crucial to inform patients that the product is not recommended for use in individuals under the age of 12.

Patients should be made aware that this product is intended for single-person use only and should not be shared. Providers should stress that using this container by more than one person may increase the risk of spreading infection.

Storage and Handling

The product is supplied in packaging that must be inspected for damage prior to use; if the packaging is found to be damaged, it should not be utilized.

Storage conditions require that the product be maintained at room temperature. It is essential to protect the product from light exposure to ensure its integrity. Additionally, the product must not be frozen, as this could compromise its quality and effectiveness.

Additional Clinical Information

The product is administered topically, with the recommended method involving the opening of the bottle cap, removal of the silicone nail, and oral inhalation for a duration of three seconds. It is advised that patients perform this inhalation 3-5 times daily, distributed across morning, afternoon, and evening.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Caution is advised for use in minors, individuals over 65 years old, asthma patients, those with heart disease, and pregnant women. Patients should discontinue use and seek medical attention if they experience discomfort during administration. Additionally, the product is intended for single-person use only; sharing the container may lead to the spread of infection.

Drug Information (PDF)

This file contains official product information for Vita-P Oral and Nasal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)