Equaline Nasal

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated to provide maximum strength relief from nasal and sinus congestion associated with colds and allergies. This product features a No Drip active ingredient, ensuring that it does not drip from the nose or down the throat, thereby enhancing user comfort. The formulation is delivered through an original pump mist, allowing for precise application. Each 1 FL OZ (30 mL) bottle is designed to provide up to 12 hours of relief, making it a preferred choice among healthcare professionals, as it is the #1 doctor-recommended active ingredient for adult nasal sprays.

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, 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 the total number of doses should not exceed 2 in any 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 for use, hold the white tabs, squeeze the grooved area of the cap firmly, 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 must be wiped clean, and the cap should be secured.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, it should not be used for more than three consecutive days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to consult a physician prior to use 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. These conditions may increase the risk of adverse effects and require careful consideration before initiating treatment.

When administering this product, it is crucial to adhere to the recommended dosage. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or worsening of 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 container with others may pose a risk of spreading infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Healthcare providers should instruct patients to discontinue use and seek medical advice if symptoms persist, as this may indicate the need for further evaluation and management.

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 dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Equaline Nasal (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may use the medication with adult supervision, receiving 2 or 3 sprays in each nostril 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 doctor 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 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 considered in these populations to ensure the safety of both the mother and the fetus or 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. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should weigh the potential benefits against any unknown risks when considering this treatment for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 available information.

Overdosage

In the event of an overdose, 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 of an overdose 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 recovery.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort may occur following the use of the product. Reported symptoms include burning, stinging, sneezing, and an increase in nasal discharge. These events have been documented through voluntary reports and 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. It is important to emphasize that while using this product, patients must not exceed the recommended dosage and should not use it for more than three consecutive 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 sharing this container with others 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, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

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

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, which may be necessary for proper usage and handling of the product. Special handling requirements should be observed to maintain the integrity of the product throughout its storage period.

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 prior to use.

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

Drug Information (PDF)

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

View product document (PDF)