Equate

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Before administration, the protective cap must be removed. For first-time use, the pump should be primed by firmly depressing its rim several times. The container 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 inhaling deeply.

For adults and children aged 6 years and older, with adult supervision, the recommended dosage is 2 to 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period. For children aged 2 to under 6 years, consultation with a physician is advised prior to use. The product is contraindicated for children under 2 years of age.

Contraindications

The product should not be used in the following situations:

• Exceeding the recommended dosage is contraindicated due to the potential for adverse effects.

• Prolonged use beyond 3 days is contraindicated, as it may lead to the recurrence or worsening of nasal congestion.

• The use of this product by multiple individuals is contraindicated to prevent the spread of infection.

Warnings and Precautions

For external use only; contact with eyes should be avoided. This product must not be ingested, applied in the nostrils, used on wounds or damaged skin, or covered with tight bandages.

Healthcare professionals should advise patients 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.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients are instructed to discontinue use and consult a healthcare provider if symptoms persist.

Side Effects

Patients using this product may experience temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge. These reactions are generally mild and transient.

Serious warnings are associated with the use of this product. It is intended for external use only and should not come into contact with the eyes. Patients are advised against using the product by mouth, in nostrils, on wounds or damaged skin, or with tight bandages. Exceeding the recommended dosage or using the product for more than three days is not advised, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. Additionally, if symptoms persist, it is recommended that patients stop use and consult a healthcare professional. It is important to note that the use of this container by more than one person may increase the risk of spreading infection.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years and older 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 aged 2 to under 6 years, it is advised to consult a physician before use. The product is contraindicated in children under 2 years of age.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 drug insert 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 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.

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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or increased nasal discharge. No additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology has been identified.

Postmarketing Experience

Postmarketing experience has indicated that the use of this product may be associated with temporary discomfort, including symptoms such as burning, stinging, sneezing, or increased nasal discharge. Additionally, it has been observed that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

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.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. It is important to emphasize that they should not exceed the recommended dosage while using this product. Additionally, patients should be cautioned against using the product for more than three days, 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 increased nasal discharge. It is crucial to inform them that using this container by more than one person may increase the risk of spreading infection.

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, thyroid disease, diabetes, or trouble 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 temperature not exceeding 25°C to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)