Meijer

Description

Oxymetazoline HCl is a pharmaceutical compound with a concentration of 0.05%. It is presented in a dosage form suitable for administration. The chemical name is oxymetazoline hydrochloride, and it is characterized by its specific empirical formula. The molecular weight and additional physical or organoleptic properties are not specified. Inactive ingredients are not detailed in the provided information.

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

For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, administered not more frequently than every 10 to 12 hours. It is important to note that the total number of doses should not exceed 2 in any 24-hour period.

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

To properly use the spray, the healthcare professional should instruct the patient to push firmly down on the cap and turn it counterclockwise to open. When administering the spray, the patient should squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use of this product is contraindicated in the following situations:

• Use is not recommended for more than 3 days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

• The product should not be used by more than one person, as this may facilitate the spread of infection.

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) without delay.

Patients should discontinue use and consult a physician if symptoms persist. Continuous monitoring of the patient's condition is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware that there are no specific side effects listed for this medication. However, it is important to monitor for any symptoms that may persist, in which case patients are advised to stop use and consult a doctor.

Before using this medication, patients with certain pre-existing conditions should seek medical advice. These conditions include heart disease, high blood pressure, diabetes, thyroid disease, and difficulty urinating due to an enlarged prostate gland.

There are no additional adverse reactions reported in clinical trials or postmarketing experiences.

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 Meijer (nasal). 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 for this age group during administration.

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 specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is essential to exercise caution when administering the drug to this population. Special monitoring of liver function tests is recommended to ensure patient safety and to assess the need for further dosage modifications. Regular evaluation of liver function will help in managing any risks associated with compromised liver function.

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 may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is critical. Recommended actions include:

1. Assessment and Monitoring: Conduct a thorough evaluation of the patient’s vital signs, level of consciousness, and any observable symptoms. Continuous monitoring may be necessary to detect any deterioration in the patient’s condition.

2. Supportive Care: Initiate supportive measures as required, which may include airway management, oxygen supplementation, intravenous fluids, and other interventions tailored to the patient’s needs.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies, including the use of antidotes if applicable.

4. Documentation: Ensure that all findings, interventions, and patient responses are meticulously documented in the medical record for ongoing care and legal purposes.

5. Patient Education: Following stabilization, it is advisable to educate the patient and their caregivers about the risks associated with the substance involved, including safe usage practices to prevent future incidents.

In summary, while specific overdosage information is not provided, healthcare professionals should be prepared to act swiftly and effectively in managing potential overdose situations, prioritizing patient safety and appropriate medical intervention.

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 relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data from animal pharmacology and toxicology studies.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: temporary discomfort, which may include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge.

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.

Additionally, patients should be encouraged to consult a doctor prior to use 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 a carton that should be retained for future reference regarding the complete labeling information. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

Additional Clinical Information

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

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

Drug Information (PDF)

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

View product document (PDF)