Sinus Severe Ultra Fine Mist

Description

Oxymetazoline HCl is presented in a concentration of 0.05%. The product is contained in a volume of 0.5 fluid ounces (15 mL).

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and other upper respiratory allergies. It is also indicated for alleviating sinus congestion and pressure.

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, administered no more frequently than every 10 to 12 hours. It is imperative 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 properly administer the medication, the following steps should be observed:

1. Remove the protective cap from the spray container.

2. Prior to the initial use, prime the pump by firmly depressing its rim several times until a fine mist is produced.

3. Hold the container with the thumb at the base and the nozzle positioned between the first and second fingers.

4. Insert the nozzle into the nostril without tilting the head.

5. Fully depress the rim with a firm, even stroke while inhaling deeply to ensure effective delivery of the medication.

Contraindications

Use of this product is contraindicated in patients with the following conditions:

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Difficulty in urination due to enlargement of the prostate gland, unless directed by a physician

These contraindications are based on the potential for adverse effects associated with the underlying conditions.

Warnings and Precautions

The recommended dosage should not be exceeded, and the product is intended for use for no longer than three days. It is crucial to adhere strictly to the directions provided, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

This product is contraindicated in individuals with certain medical conditions. Specifically, it should not be used by patients with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty in urination due to prostate gland enlargement, unless directed by a healthcare professional.

Users may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that sharing this product among multiple users may facilitate the spread of infection.

Patients should discontinue use and consult a physician 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 symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that this product is contraindicated in individuals with certain medical conditions, including heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, unless directed by a healthcare professional.

Additionally, frequent or prolonged use of this product may lead to a recurrence or worsening of nasal congestion. There is also a risk associated with the use of this container by more than one person, as it may facilitate the spread of infection.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Sinus Severe Ultra Fine Mist (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

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 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 studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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.

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 of this product.

Temporary discomfort may occur with the use of this product, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge.

No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed that the use of this product may be associated with temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to emphasize that patients should not exceed the recommended dosage and should not use the product for more than three days. Patients should be instructed to use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Providers should caution patients against using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate gland enlargement, unless directed by a healthcare professional.

Patients should be made aware that the product may cause temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is crucial to inform patients that sharing this container with others may lead to the spread of infection.

Finally, healthcare providers should instruct patients to stop using the product and consult a doctor if their symptoms persist.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sinus Severe Ultra Fine Mist, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)