Zicam Intense Sinus Relief

Description

ZICAM® is a nasal decongestant formulation containing 0.05% oxymetazoline hydrochloride. It is designed to provide maximum strength relief from sinus pressure associated with colds and allergies, offering up to 12 hours of relief. The product is presented as a 0.50 fluid ounce (15 mL) no-drip liquid nasal spray, enhanced with cooling menthol and eucalyptus for added comfort.

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, aids in clearing nasal passages, and reduces the swelling of nasal membranes.

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. This administration should not occur more frequently than every 10 to 12 hours, and 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 prior to use.

To properly use the nasal spray pump, the following steps should be followed:

1. To open the device, hold the actuator and squeeze while turning the cap.

2. Hold the bottle with the thumb at the bottom and the nozzle between the fingers.

3. Before the initial use, prime the pump by depressing it several times.

4. Position the tip of the nozzle just past the nasal opening, approximately 1/8 inch inside.

5. Administer 2 or 3 sprays in each nostril without tilting the head, and sniff deeply during administration.

6. After use, wipe the nozzle clean to maintain hygiene.

7. To close the device, turn the cap until it clicks securely.

Contraindications

Use is contraindicated in the following situations:

• Do not use for more than 3 days, as frequent or prolonged use may lead to the recurrence or worsening of nasal congestion.

• Do not exceed the directed dosage.

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

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use 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.

It is crucial to adhere to the recommended dosage guidelines. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, sharing this medication among multiple users may pose a risk of spreading infection.

In the event of accidental ingestion, it is imperative to keep the medication out of reach of children. If swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and consult a healthcare provider if symptoms persist.

Side Effects

Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

If symptoms persist, patients are advised to stop use and consult a healthcare professional for further evaluation and guidance.

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 Zicam Intense Sinus Relief (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 potential for altered pharmacokinetics and pharmacodynamics in 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. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions are implemented in a timely manner.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed reports of temporary discomfort, including symptoms such as 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. 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 emphasize that patients must not exceed the directed dosage and should not use it for more than three days. 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, healthcare providers should caution patients that the use of this container by more than one person 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, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be retained for future reference regarding full labeling. It is essential to store the product at a temperature range of 15-29°C (59-84°F) to ensure its stability and efficacy. Additionally, the carton should be kept for future reference on labeling information. Special handling requirements are not specified; however, adherence to the recommended storage conditions is crucial for maintaining product integrity.

Additional Clinical Information

The route of administration for the medication is nasal. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)