Equaline Nasal

Description

Oxymetazoline hydrochloride is a nasal decongestant formulated at a concentration of 0.05%. This medication provides up to 12 hours of relief from nasal congestion. It is available in a dosage form of 1 fluid ounce (30 mL).

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 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 healthcare professional should instruct the patient to push firmly down on the cap and turn it counterclockwise to open. When ready to spray, the patient should squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward during administration. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

The product should not be used in the following situations:

• Use is contraindicated for more than 3 consecutive days due to the risk of nasal congestion recurrence or worsening.

• Use should not exceed the directed dosage to prevent potential adverse effects.

• The product should not be shared among individuals, as this may facilitate the spread of infection.

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. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this container with others may facilitate the spread of 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 consult a physician if symptoms persist, as this may indicate the need for further evaluation or alternative treatment options.

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 identified for the product. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Equaline 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 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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 safe use during pregnancy and lactation.

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 advising lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and the substance's pharmacological profile.

Healthcare providers are encouraged to monitor the patient closely and provide supportive care as necessary. It is imperative to follow established protocols for the management of overdosage, which may include decontamination, symptomatic treatment, and specific antidotes if applicable.

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 elucidate these aspects of nonclinical toxicology.

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 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.

Patients may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. Healthcare providers should emphasize that the use of this container by more than one person may increase the risk of spreading infection.

Additionally, patients should be encouraged to consult with their healthcare provider before using the 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. This precaution is essential 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 ensure its stability and efficacy.

Healthcare professionals are advised to retain the carton for future reference, as it contains important information regarding the full labeling of the product. Proper handling and storage conditions are crucial for maintaining the integrity of the product throughout its shelf life.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered 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, it is advised to consult a doctor before use.

Clinicians should counsel patients on important safety information, including the need to seek medical help or contact a Poison Control Center immediately if the medication is swallowed (1-800-222-1222). It is also important to inform patients that sharing the container with others may lead to the spread of infection. Patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate should consult a healthcare professional prior to use.

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)