Serynth Fast Relief Nasal

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

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

Healthcare professionals should ensure that administration is conducted under adult supervision for children in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

• Exceeding the recommended dosage is prohibited, as it may lead to adverse effects.

• The product should not be used for more than 3 days. Prolonged or frequent use may result in the recurrence or worsening of nasal congestion.

• This product is contraindicated in children under 2 years of age due to safety concerns.

If symptoms persist, discontinue use and consult a healthcare professional.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and require careful consideration before initiating treatment.

In the event that symptoms persist despite use, patients are advised to discontinue the medication and seek medical advice promptly. Persistent symptoms may indicate a need for reevaluation of the treatment plan.

If the product is ingested, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Timely intervention is crucial in such cases to mitigate potential health risks.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a healthcare professional prior to use if there is a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. Additionally, it is recommended that individuals who are pregnant or breastfeeding consult a healthcare professional before using this medication. Special caution is advised for children aged 2 to under 6 years, and parents or guardians should seek guidance from a healthcare provider regarding the use of this product in this age group.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Serynth Fast Relief Nasal (naphazoline hcl 0.05% fast relief nasal). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 to under 6 years, the use of this medication is advised with caution.

In patients 6 years and older, 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 required 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 potential adverse effects or changes in efficacy, 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 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 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

Overdosage may lead to significant adverse effects that require prompt intervention. Healthcare professionals should be vigilant for symptoms indicative of overdosage, which may include severe headache, rapid heartbeat, and increased blood pressure.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Timely management is crucial to mitigate potential complications associated with excessive dosing.

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 these contexts.

Postmarketing Experience

Postmarketing experience has not been detailed in the provided text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to emphasize the necessity of adhering to the recommended dosage and to inform patients that they should not use the product for more than three days. Patients should be instructed to use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or increased nasal discharge. Healthcare providers should caution patients that using this container by more than one person may increase the risk of spreading infection.

Additionally, it is crucial to inform patients that the product is not suitable for children under the age of 2 years. Patients should be advised to discontinue use and consult a doctor if their symptoms persist. For those who are pregnant or breastfeeding, it is recommended to seek guidance from a health professional before using the product.

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 a temperature not exceeding 25°C to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 years and older, with adult supervision, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours, and should not exceed 2 doses within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)