Afrin Original

Description

Oxymetazoline HCl Nasal Solution is a nasal decongestant formulated as a nasal spray. It is marketed under the brand name Afrin® Original. Each unit contains 1/5 fluid ounce (6 mL) of the solution, designed for intranasal administration.

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

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 while keeping the head upright; tilting the head backward during administration is not recommended. 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 one person, as this may facilitate the spread of infection.

• Do not exceed the directed dosage, as this may lead to adverse effects.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to consult a physician prior to use in individuals with a history of heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland.

Adherence to dosage guidelines is crucial; patients should not exceed the recommended dosage or duration of use, which is limited to a maximum of three days. Prolonged or excessive use may lead to a rebound effect, resulting in worsened nasal congestion. Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users may facilitate the spread of infection.

Healthcare providers should instruct patients to discontinue use and seek medical advice if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

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

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

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Afrin Original (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 during administration for this age group.

Geriatric Use

There is no specific information available 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, 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 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 have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of data limits the ability to make informed decisions regarding its use in this population. Regular monitoring of renal function may be warranted 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

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. They should use the product only as directed, as 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 the use of this container by more than one person may increase the risk of spreading infection.

Additionally, healthcare providers should 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 a controlled temperature between 20° to 25°C (68° to 77°F) to ensure its efficacy and safety.

Healthcare professionals are advised to retain the card provided with the product for future reference regarding the full labeling and any additional information pertinent to the product's use and handling.

Additional Clinical Information

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, with a maximum of 2 doses in a 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 advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to inform patients that sharing the container with others may increase the risk of spreading infection. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)