Nasal Decongestant

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated as an original spray mist. This product is recognized as the #1 doctor-recommended adult nasal spray active ingredient. It provides fast and powerful relief from nasal congestion associated with colds and allergies, delivering maximum strength effects for up to 12 hours. The product is packaged 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 drug 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. Dosing should not occur 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, consultation with a physician is recommended prior to use.

To administer the medication, the user should push firmly down on the cap and turn it counterclockwise to open. While spraying, the user must squeeze the bottle quickly and firmly, ensuring that the head is not tilted backward during the administration. 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 consecutive days due to the risk of nasal congestion recurrence or worsening.

• Use is contraindicated if the product is intended for more than the directed dosage, as this may lead to adverse effects.

• The use of this product by multiple individuals is contraindicated due to the potential for infection transmission.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and require careful consideration before use.

When utilizing this product, it is imperative to adhere strictly to the recommended dosage. Users should not exceed the directed amount and should limit usage to no more than three consecutive days. Prolonged or frequent use may lead to a rebound effect, resulting in worsened nasal congestion. Additionally, users may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. It is also important to note that sharing this product among multiple individuals may facilitate the spread of infection.

Patients are advised to discontinue use and seek medical advice if symptoms persist despite treatment. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using this product may experience temporary discomfort, which can include sensations of burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

If symptoms persist, patients are advised to discontinue use and consult a healthcare professional for further evaluation and guidance.

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 Nasal Decongestant (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 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, consultation with a healthcare professional is advised prior to use.

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 considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers may use this medication to temporarily relieve nasal congestion associated with common cold, hay fever, and upper respiratory allergies, as well as to alleviate sinus congestion and pressure. However, the effects on breastfed infants have not been specifically studied. Therefore, healthcare professionals should weigh the benefits of treatment against potential risks when advising lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge, has been reported in postmarketing experience. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. These events were reported voluntarily or identified through surveillance programs.

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. It is important to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. Patients should be informed that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Providers should also discuss the possibility of temporary discomfort, which may include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. It is essential to inform patients that sharing this container with others may increase the risk of spreading infections.

Before initiating treatment, 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. This precaution is vital to ensure the safe and effective use of the product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, ensuring that all necessary details are readily accessible for proper handling and administration.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, it is recommended to use 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, with a maximum of 2 doses within a 24-hour period. For children under 6 years of age, consultation with a doctor is advised before 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 Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)