Quality Choice

Description

Oxymetazoline HCl 0.05% is the active ingredient in the nasal spray. The dosage form is a nasal spray, with a strength of 0.05%, which is equivalent to 0.5 mg/mL.

Uses and Indications

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

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

Dosage and Administration

For adults and 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.

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

To properly administer the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly. It is essential that the patient does not tilt their head backward while spraying. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in the following situations:

• Use is not recommended for more than 3 days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

• The product should not be used by more than one person, as this may facilitate the spread of infection.

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 be closely monitored for symptom persistence. If symptoms continue despite treatment, it is imperative to discontinue use and consult a healthcare provider for further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In the event that symptoms persist, it is advised to stop use and consult a healthcare professional.

Before initiating treatment, patients with certain pre-existing conditions should seek medical advice. Specifically, individuals with heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland should consult a doctor prior to use. This precaution is essential to ensure the safe and effective use of the medication.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted 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 adverse effects or changes in therapeutic response, 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels, with special consideration given to those with severe renal impairment. Renal function tests are recommended prior to initiating therapy and should be performed periodically thereafter to ensure appropriate management of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments. It is essential to monitor liver function tests in individuals with pre-existing liver conditions to ensure safety and efficacy. Special precautions should be taken when administering the drug to this population, as compromised liver function may influence therapeutic outcomes and increase the risk of adverse effects.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and perform a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document all findings and interventions thoroughly and to report any adverse events related to overdosage to the appropriate regulatory authorities.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided from animal pharmacology and toxicology studies.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, has been reported. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. It is important to emphasize that when using this product, patients must not exceed the directed dosage and should not use it for more than three days. 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. Additionally, inform patients that the use of this container by more than one person may increase the risk of spreading infection.

Healthcare providers should also encourage patients to consult a doctor before using this product 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its efficacy and integrity. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 to under 12 years, it is recommended to administer 2 or 3 sprays in each nostril, not 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.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)