Dristan

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion due to colds, hay fever, or other upper respiratory allergies. It effectively shrinks swollen membranes and restores freer breathing through the nose. Additionally, it provides relief from sinus congestion and pressure, alleviating discomfort associated with these conditions.

The drug is specifically designed to relieve nasal congestion resulting from colds and allergies, as well as to reduce swelling of the nasal passages.

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, are recommended to receive 2 to 3 sprays in each nostril. This should not occur more frequently than every 10 to 12 hours, and the total dosage must not exceed 2 doses within a 24-hour period.

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

To properly administer the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly. It is important to avoid tilting the head backward during the spraying process. After use, the nozzle should be wiped clean, and the cap must be replaced tightly to ensure the child-resistant closure is maintained.

Contraindications

The product should not be used in the following situations:

• Use is contraindicated if the dosage exceeds the directed amount.

• Use is contraindicated for durations longer than 3 days.

• The use of this container by more than one person is contraindicated due to the risk of spreading infection.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to advise patients to consult a physician 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.

When utilizing this product, adherence to the following precautions is essential to ensure safe use. Patients should not exceed the recommended dosage and should refrain from using the product for more than three consecutive days. It is crucial to use the product strictly as directed, as 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. Additionally, it is important to note that sharing this container with others may facilitate the spread of infection.

Healthcare providers should instruct patients to discontinue use and seek medical advice if symptoms persist. Furthermore, it is vital to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Frequent or prolonged use of this product may lead to a recurrence or worsening of nasal congestion. Patients may also experience temporary discomfort, which can include sensations of burning, stinging, sneezing, or an increase in nasal discharge.

It is advised that patients discontinue use and consult a healthcare professional if symptoms persist.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Dristan (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 to 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

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 the safety of both the mother and the developing fetus or nursing infant.

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 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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage any clinical manifestations that arise.

In summary, the key steps in managing an overdosage include securing the product away from children, seeking immediate medical help, and contacting a Poison Control Center for guidance on further actions.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: burning, stinging, sneezing, and an increase in nasal discharge. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

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

Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to adhere to the following guidelines: do not exceed the recommended dosage, do not use the product for more than three days, and use it only as directed. Patients should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Additionally, they may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should also encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a container that is filled to the proper level to ensure correct spray action. It should be stored at a temperature range of 20-25°C (68-77°F). Healthcare professionals are advised to retain the carton for full labeling and additional information.

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 to 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.

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 Dristan, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)