Nasal

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated for intranasal administration. This product is presented as a nasal spray, containing a maximum strength formulation enhanced with menthol to provide additional relief. The product is designed to minimize post-nasal drip, ensuring a more comfortable user experience. Each bottle contains 1 fluid ounce (30 mL) of the solution.

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 mentioned in the available data.

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, 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 physician is recommended prior to use.

Prior to administration, the product must be shaken well. To prepare the device, hold the white tabs, firmly squeeze the grooved area of the cap, and turn it counterclockwise. Before the initial use, the metered pump should be primed by firmly depressing the pump several times. For application, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. A firm, even stroke should be used to fully depress the rim while simultaneously sniffing deeply. After use, the nozzle should be wiped clean, and the cap secured.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, do not use for more than 3 days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

When utilizing this product, it is imperative to adhere strictly to the recommended dosage. Users should not exceed the directed amount and should refrain from using the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, sharing this container with others may pose a risk of spreading infection.

If symptoms persist despite use, it is essential to discontinue use and consult a healthcare professional for further evaluation.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

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

It is important for patients to stop using the product and consult a healthcare professional if symptoms persist. Additionally, patients should seek medical advice before using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Patients are advised not to exceed the recommended dosage or duration of use, which should not exceed three days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Furthermore, the use of this product by more than one person may increase the risk of spreading infection.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Nasal (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 to note that the total dosage should not 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

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 any potential risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 these contexts.

Postmarketing Experience

Temporary discomfort, including symptoms such as 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 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. When using this product, it is essential to emphasize that 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. It is also important to inform patients that sharing this container with others may increase the risk of spreading infection.

Before using this product, patients should be encouraged to consult a doctor if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in packaging that includes the relevant NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information. Special handling requirements are not specified; however, standard precautions should be taken to maintain the integrity of the product during storage.

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 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)