Equate Nasal

Description

equate™ is a nasal spray formulation that contains Phenylephrine Hydrochloride 1% as its active ingredient, serving as a nasal decongestant. This product is designed to provide fast relief from nasal congestion, swollen nasal membranes, sinus congestion, and sinus pressure. The formulation is characterized by its moisturizing properties and a no-drip feature, enhancing user comfort during application. Each bottle contains 1 fluid ounce (30 mL) of the solution, ensuring a convenient dosage form for effective use.

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 12 years and over are advised to administer 2 or 3 sprays in each nostril, not to exceed every 4 hours. For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

To ensure proper administration, the following steps should be followed:

1. Shake the bottle well before use.

2. Hold the white tabs and firmly squeeze the grooved area of the cap while turning it counterclockwise.

3. Prior to the initial use, prime the metered pump by firmly depressing the pump several times.

4. To spray, hold the bottle with the thumb at the base and the nozzle positioned between the first and second fingers.

5. Without tilting the head, insert the nozzle into the nostril.

6. Fully depress the rim with a firm, even stroke while sniffing deeply.

7. After use, wipe the nozzle clean and securely replace the cap.

Contraindications

Use is contraindicated in patients who exceed the directed dosage or utilize the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. Prior to use, it is imperative to consult a physician if the patient has a history of heart disease, high blood pressure, thyroid disease, diabetes, or experiences difficulty urinating due to an enlarged prostate gland.

It is essential to adhere strictly to the recommended dosage guidelines. 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. Temporary side effects, including burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, sharing this product among multiple users is discouraged, as it may facilitate the spread of infection.

Patients should be advised to discontinue use and consult a healthcare provider if symptoms persist. 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.

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 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 Equate Nasal (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 4 hours.

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 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 the safety of both the mother and the developing fetus.

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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment and monitoring.

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, 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 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, may occur following use. Additionally, it has been reported that the use of this container by more than one person may facilitate the spread of infection.

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. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. They should be cautioned that 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.

Healthcare providers should also 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 a doctor 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.

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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)