Oxymetazoline hydrochloride

Description

The product is identified by the National Drug Code (NDC) 63868-607-01. Further details regarding its chemical composition, dosage form, and inactive ingredients are not provided in the extracted facts.

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 functions by shrinking swollen nasal membranes, thereby facilitating easier breathing.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and 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.

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

Prior to use, the bottle should be shaken well. To administer the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward. After use, the nozzle should be wiped clean to maintain hygiene and prevent blockage.

Contraindications

The product should not be used in the following situations:

• Use is contraindicated for more than 3 consecutive days due to the risk of nasal congestion recurrence or worsening.

• The product should not be used in excess of the directed dosage to avoid potential adverse effects.

• Use of this container by multiple individuals is contraindicated as it may facilitate the spread of infection.

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 essential to consult a physician if the patient has a history of heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

When administering this product, it is critical to adhere to the following precautions: the dosage should not exceed the recommended amount, and the product should not be used for more than three consecutive days. Prolonged or frequent 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, it is important to note that sharing this container among multiple users may facilitate the spread of infection.

In the event of accidental ingestion, the product should be kept out of reach of children. Immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if symptoms persist. Furthermore, it is recommended that pregnant or breastfeeding individuals seek guidance from a healthcare professional before using this product.

Side Effects

Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

Frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. It is advised that the product not be used by more than one person to prevent the potential spread of infection.

Patients should discontinue use and consult a healthcare professional if symptoms persist. Additionally, individuals who are pregnant or breastfeeding should seek advice from a health professional prior to using the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of 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, and adult supervision is advised during administration.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a health professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

When discussing the use of this product, healthcare providers should emphasize the importance of adhering to the recommended dosage. Patients should be informed not to use more than directed and to limit use to no 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. It is also important to inform patients that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should counsel patients to stop using the product and consult a doctor if symptoms persist. Additionally, patients who are pregnant or breastfeeding should be advised to consult a health professional before using the product.

Providers should also recommend that patients seek medical advice prior to use if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a carton that should be retained for future reference on the full labeling. It is essential to store the product at a temperature range of 20˚C to 25˚C (68˚F to 77˚F) to ensure its stability and efficacy. Proper storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 to under 12 years, it is recommended to administer 2 or 3 sprays in each nostril, not more frequently than every 10-12 hours, with a maximum of 2 doses in any 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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