Sanatos

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sore throat, headache, nasal congestion, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

To prepare the solution, one packet should be dissolved in an 8 fl oz glass of hot water. If utilizing a microwave for heating, the packet's contents should first be added to a glass of cool water, followed by brisk stirring before and after heating. Care should be taken to avoid overheating the mixture.

The prepared drink should be sipped while hot, and it is recommended that the entire contents be consumed within 10 to 15 minutes.

For adults and children aged 12 years and older, the recommended dosage is one (1) packet every 4 hours, with a maximum limit of 6 packets within a 24-hour period. The use of this product is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 6 packets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Patients should be instructed to discontinue use immediately and seek medical assistance if any of these symptoms occur.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. It is recommended that individuals consult a healthcare provider prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, a persistent or chronic cough (as seen in smoking, asthma, chronic bronchitis, or emphysema), or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In the event of an accidental overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain or nasal congestion worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; or if any new symptoms arise.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 packets within 24 hours, use other drugs containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Patients should stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain or nasal congestion worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; or if any new symptoms arise.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough accompanied by excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), or difficulty urinating due to an enlarged prostate gland should seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

In cases of accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Sanatos (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is one (1) packet every 4 hours, with a maximum of 6 packets in a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to avoid potential overdose.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease.

This product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be particularly cautious and adhere to the following guidelines to minimize the risk of hepatotoxicity:

• The maximum daily dosage should not exceed 6 packets within a 24-hour period.

• Patients should avoid concurrent use with other medications that contain acetaminophen.

• Consumption of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of liver damage.

Close monitoring of liver function is advised for patients with hepatic impairment who are prescribed this product.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and timely action are essential in managing such situations effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health care professional before 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an accidental overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate potential health complications associated with overdose.

Storage and Handling

The product is supplied in packets that must be stored at room temperature, specifically within the range of 68-77°F (20-25°C). It is imperative that the integrity of the packets is maintained; therefore, the product should not be used if any packets are found to be punctured or torn.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being one packet every four hours, not to exceed six packets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)