No Drip Severe Anefrin Nasal

Description

Walgreens NDC 0363-2350-52 is a severe congestion no drip nasal spray formulation containing oxymetazoline hydrochloride at a concentration of 0.05%. The product is presented in a dosage form of a nasal spray, with a total volume of 0.5 fluid ounces (15 milliliters).

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 of sinus congestion and pressure. The formulation works by shrinking swollen membranes, facilitating easier breathing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Before the initial use, the protective cap must be removed from the tip, and the pump should be primed by firmly depressing it several times.

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 and even stroke while the patient sniffs deeply.

After each use, the nozzle should be wiped clean to maintain hygiene.

For adults and children aged 6 to under 12 years (with adult supervision), the recommended dosage is 2 to 3 sprays in each nostril, not to exceed 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.

Contraindications

Use is contraindicated in the following situations:

• Use is not recommended for more than the directed dosage.

• Prolonged use beyond three days is contraindicated due to the risk of nasal congestion recurrence or worsening.

• The use of this product by multiple individuals is contraindicated as it may facilitate the spread of infection.

Warnings and Precautions

In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if symptoms persist. This precaution is essential to ensure patient safety and to facilitate appropriate medical evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical trials and postmarketing experiences, various adverse reactions have been reported, necessitating careful monitoring and consideration.

Serious adverse reactions may include those that require immediate medical attention. Patients are advised to stop use and consult a healthcare professional if symptoms persist. Additionally, individuals who are pregnant or breastfeeding should seek guidance from a health professional before using this medication to ensure safety for both the mother and child.

It is also important for patients 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. These precautions are essential to mitigate the risk of exacerbating existing health issues.

Overall, patients should remain vigilant regarding their health status while using this medication and report any concerning symptoms to their healthcare provider promptly.

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 No Drip Severe Anefrin Nasal (0.05% oxymetazoline hcl). 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 than every 10 to 12 hours. It is important to note that the total dosage should not 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

There is no specific information 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. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are breastfeeding. 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 considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if symptoms persist. It is important to emphasize that patients should not exceed the recommended dosage and should not use the product for more than three consecutive days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Healthcare providers should inform patients that sharing this container with others may increase the risk of spreading infection.

Before initiating use, patients should be encouraged to consult a doctor 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 on the full labeling. It is essential to store the product at a temperature range of 20° to 25°C (68° 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

No further data are available.

Drug Information (PDF)

This file contains official product information for No Drip Severe Anefrin Nasal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)