Oxymetazoline hydrochloride

Description

The product is identified by the National Drug Code (NDC) 63868-605-01 and 63868-676-01. It is formulated for specific therapeutic applications, with precise specifications outlined in its labeling. The product's characteristics, including its molecular weight and chemical formula, are integral to its pharmacological profile. Further details regarding its dosage form and appearance are provided in the complete labeling documentation.

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.

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. 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 administration.

Prior to use, the bottle must be shaken well. To open the bottle, the cap should be rotated to align the marks, followed by squeezing the cap on both sides and turning it counter-clockwise to remove. For administration, 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 must be wiped clean and the cap snapped back onto the bottle to maintain hygiene and prevent contamination.

Contraindications

The product should not be used in the following situations:

• Use is contraindicated for more than 3 days, as prolonged use may lead to the recurrence or worsening of nasal congestion.

• The product should not be used in cases where it may be shared among multiple individuals, due to the risk of spreading infection.

• It is essential to adhere strictly to the directed dosage; exceeding the recommended use is contraindicated.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product. Prior to use, patients should be advised to consult a physician 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.

When utilizing this product, it is imperative to adhere strictly to the recommended dosage. Patients should not exceed the directed use and should limit application to no more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this container with others may facilitate the spread of infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. This product should be kept out of reach of children to prevent accidental swallowing.

Patients should be instructed to discontinue use and consult a healthcare provider if symptoms persist. Furthermore, individuals who are pregnant or breastfeeding should seek advice from a health professional before using this product.

Side Effects

Patients may experience common adverse reactions, including temporary discomfort characterized by burning, stinging, sneezing, or an increase in nasal discharge.

It is important to note that frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. Additionally, the use of this container by more than one person poses a risk of spreading infection.

Patients are advised to stop use and consult a doctor if symptoms persist. Furthermore, individuals who are pregnant or breastfeeding should seek guidance from a health professional before using the product.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. 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 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 an increase in nasal discharge.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no data provided on animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance 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 instructed not to exceed the directed amount and to limit use to no more than three days. It is crucial to inform patients 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 caution patients that sharing this container with others may increase the risk of spreading infection.

Patients should be advised to discontinue use and consult a doctor if their symptoms persist. Additionally, it is important to discuss the use of this product with a healthcare professional if the patient is pregnant or breastfeeding.

Healthcare providers should recommend that patients consult a doctor 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 handling and storage conditions must be adhered to in order to maintain 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 before 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.

View product document (PDF)