Quality Choice

Description

Oxymetazoline hydrochloride is a nasal solution formulated at a concentration of 0.05%. This product is presented in a 1 fluid ounce (30 mL) container.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and upper respiratory allergies. It also provides temporary relief from sinus congestion and pressure. Additionally, this medication acts to shrink swollen nasal membranes, facilitating easier breathing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, may receive 2 or 3 sprays in each nostril. This dosage should not be repeated more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period.

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

To prepare the device for use, the cap should be pushed firmly down and turned counterclockwise. When administering the spray, the bottle should be squeezed quickly and firmly, ensuring that the head is not tilted backward during the process. After use, the nozzle should be wiped clean, and the cap should be securely replaced to maintain the integrity of the product.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to adhere to the following usage guidelines to prevent potential complications.

The product should not be used in excess of the directed dosage. Additionally, it is contraindicated for use beyond a duration of three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients should discontinue use and consult a physician if symptoms persist. It is essential to monitor the patient's condition closely and evaluate the need for further medical intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical practice, it is important to monitor for serious reactions, particularly in individuals with pre-existing conditions.

Patients are advised to stop use and consult a doctor if symptoms persist. Additionally, it is recommended that patients seek medical advice before using this medication if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

These precautions are essential to ensure the safe use of the medication and to mitigate any risks associated with underlying health conditions.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Quality Choice (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period. Adult supervision is advised for this age group during administration.

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

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 necessitate 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 require more careful management. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in patients with pre-existing liver conditions to ensure safety and efficacy. Special precautions should be taken when administering the drug to this population to mitigate potential risks associated with altered drug metabolism and clearance.

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, as the lack of detailed data does not preclude the possibility of adverse effects. Symptoms of overdose 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 further management and intervention strategies. Documentation of the incident and any interventions performed is crucial for ongoing patient care and for informing future treatment protocols.

Overall, while specific overdosage information is not provided, vigilance and prompt action are paramount in managing potential overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, may occur following the use of the product. Additionally, it has been reported that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be instructed to stop using the product and consult a doctor if symptoms persist.

When discussing the use of this product, healthcare providers should emphasize the importance of adhering to the recommended dosage. Patients should be informed not to exceed the directed amount and to limit use to no more than three days. It is crucial to highlight that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge while using the product. Healthcare providers should also caution that sharing this container with others may increase the risk of spreading infection.

Before initiating use, healthcare providers should encourage patients to consult with a doctor if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a carton that should be retained for future reference regarding the complete labeling information. It is essential to store the product at room temperature to maintain its integrity and efficacy.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours, with a maximum of 2 doses in any 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek medical advice before use if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or urinary issues related to an enlarged prostate. Pregnant or breastfeeding individuals should also consult a healthcare professional before use. Patients are advised to discontinue use and consult a doctor if symptoms persist, and to be aware that sharing the container may lead to the spread of infection.

Drug Information (PDF)

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

View product document (PDF)