Publix

Description

Oxymetazoline HCl is a pharmaceutical compound available in a concentration of 0.05%. It is provided 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 by shrinking 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 to not exceed 2 doses within a 24-hour period.

For children under 6 years of age, it is advised to consult a physician prior to administration.

Prior to use, the bottle must be shaken well. For first-time use, the protective cap should be removed by pressing and twisting it off. The lock tab should be rotated to align the arrow marks to unlock the pump. The metered pump must be primed by firmly depressing it several times.

To administer the spray, the bottle 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. The rim should be fully depressed with a firm, even stroke while the patient sniffs deeply. After use, the nozzle should be wiped clean. To secure the pump, ensure that the arrow marks are not aligned and replace the protective cap on the tip.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, do not use for more than 3 days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at (1-800-222-1222) for guidance.

Patients should discontinue use and consult a healthcare provider if symptoms persist. This precaution is essential to ensure appropriate evaluation and management of the patient's condition. Regular monitoring of symptoms is recommended to assess the need for further medical intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical practice, it is important to monitor for serious reactions, particularly in individuals with pre-existing conditions.

Patients are advised to stop use and consult a doctor if symptoms persist. Additionally, it is recommended that patients seek medical advice before using this medication if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

These precautions are essential to ensure the safe use of the medication and to mitigate any risks associated with underlying health conditions.

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 necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Publix (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. 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 no specific data available regarding the excretion of this medication in 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 may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating potential dosage adjustments. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with compromised liver function, as their response to treatment may differ from that of patients with normal liver function. Regular assessment of liver parameters is recommended to guide therapy and mitigate risks associated with hepatic impairment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient's characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

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 an increase in nasal discharge. No specific information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no detailed data provided on animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no reported adverse events or case reports to summarize at this time.

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

Before initiating use, patients should be encouraged to consult with their healthcare provider 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its efficacy and integrity. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The route of administration for the medication is nasal. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)