Care One Nasal

Description

Oxymetazoline hydrochloride is a nasal decongestant formulated at a concentration of 0.05%. This product is presented in a dosage form of a nasal solution, with a total volume of 1 fluid ounce (30 mL). It is formulated to be gluten-free, ensuring suitability for individuals with gluten sensitivities.

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 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 to maintain the integrity of the product.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following usage guidelines:

• Do not exceed the recommended dosage.

• Do not use for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

These precautions are critical to ensure safe and effective use of the product.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to consult a physician prior to use in individuals with a history of heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland.

Patients should adhere strictly to the recommended dosage and duration of use. The product should not be used for more than three consecutive days, as exceeding this duration 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 product among multiple users may facilitate the spread of infection.

If symptoms persist despite use, patients are advised to discontinue use and consult a healthcare provider for further evaluation.

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 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 Care One 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

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers may use this medication to temporarily relieve nasal congestion associated with common cold, hay fever, and upper respiratory allergies. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the potential benefits and risks when recommending this treatment to 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 degree of impairment.

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 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 resolution of any complications arising from the overdosage.

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 these contexts.

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 when using this product, patients must not exceed the directed dosage and should not use it for more than three 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 the use of this container by more than one person 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, diabetes, thyroid disease, 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 integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information. Proper handling and storage conditions are crucial for maintaining the quality of the product.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be used more frequently than every 10 to 12 hours, with a maximum of 2 doses in a 24-hour period. For children under 6 years of age, consultation with a doctor is advised before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to note that sharing this container with others may lead to the spread of infection. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)