Sanatos

Description

PDP Sanatos MS Night is a pharmaceutical formulation designed for nighttime use. It is characterized by its specific composition and intended therapeutic effects. The product is presented in a dosage form suitable for administration, ensuring optimal absorption and efficacy. The formulation's appearance is consistent with industry standards for similar products, facilitating identification and use in clinical settings. Further details regarding its molecular weight, chemical formula, and inactive ingredients are integral to understanding its pharmacological profile and potential applications in medical practice.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, runny nose, cough due to minor throat and bronchial irritation, sneezing, and the temporary reduction of fever.

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

Dosage and Administration

The dosing cup provided with the medication should be utilized for accurate measurement. Prior to administration, the solution must be shaken well to ensure proper mixing of the active ingredients.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. It is important not to exceed 4 doses within a 24-hour period for adults, and 3 doses for children in this age group.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Healthcare professionals should also remind patients to review the complete labeling if they are concurrently using other cold or flu products to avoid potential overdosing or adverse effects.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage for adults is 4 doses within a 24-hour period, while children should not exceed 3 doses in the same timeframe. Caution is warranted if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

In addition, patients should be informed of the sore throat warning. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should seek medical attention promptly.

General precautions should be taken for patients with specific health conditions. Patients should consult a healthcare provider prior to use if they have a sodium-restricted diet, liver disease, glaucoma, a cough associated with excessive phlegm, or a history of breathing problems such as asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland or children with arthritis-related pain should also seek medical advice before use.

Patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist before using this product to avoid potential interactions.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if pain or cough worsens or persists beyond 5 days for children or 7 days for adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if any new symptoms arise. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, medical evaluation is warranted, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 4 doses in a 24-hour period, while children should not exceed 3 doses in the same timeframe. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe sore throat, which, if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, necessitates prompt consultation with a healthcare provider.

In clinical settings, excitability has been reported, particularly in children. Additionally, marked drowsiness may occur, which can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Patients are advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

Patients should discontinue use and seek medical advice if pain or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or persists beyond 3 days, if redness or swelling is observed, or if any new symptoms arise. A return of cough, especially when accompanied by a rash or headache that lasts, may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have a sodium-restricted diet, liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic cough, or difficulty urinating due to an enlarged prostate gland. Special caution is advised for patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. The combination may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The interaction may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

Additionally, caution is advised for individuals using sedatives or tranquilizers concurrently with this medication. The combination may enhance the sedative effects, leading to increased drowsiness. It is recommended that patients seek guidance from a healthcare provider before initiating use in such cases.

Alcohol consumption alongside this medication is also discouraged, as it may further amplify drowsiness and impair cognitive and motor functions.

Packaging & NDC

Below are the non-prescription pack sizes of Sanatos (acetaminophen, dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For dosing, children aged 12 years and older may receive 30 mL every 4 hours, with a maximum of 3 doses in 24 hours. It is important to note that excitability may occur, particularly in children. If a child's pain or cough worsens or persists beyond 5 days, use should be discontinued, and a doctor should be consulted. Additionally, prompt medical attention is essential for both pediatric and adult patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information available 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, 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that adults do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount. For pediatric patients, the maximum is limited to 3 doses in 24 hours.

Additionally, patients should be aware that the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen. Furthermore, adults who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for liver injury.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these individuals to prevent potential adverse effects.

Overdosage

In the event of an 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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use due to potential teratogenic effects.

Non-teratogenic effects may include excitability, particularly in children. Marked drowsiness can occur, and the concomitant use of alcohol, sedatives, or tranquilizers may exacerbate this drowsiness. It is recommended to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be counseled to discontinue use and consult a doctor if their pain or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, they should stop use and seek medical advice if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if any new symptoms arise. Patients should also be advised to contact a healthcare provider if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children. They should be warned that the product may cause significant drowsiness, which can be exacerbated by alcohol, sedatives, and tranquilizers. Therefore, patients should be advised to avoid alcoholic beverages while using this product and to exercise caution when driving or operating machinery.

Patients on a sodium-restricted diet, those with liver disease, glaucoma, or a cough associated with excessive phlegm should be encouraged to consult a doctor before using this product. Additionally, patients with breathing problems, chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

Patients experiencing difficulty urinating due to an enlarged prostate gland, as well as children with arthritis-related pain, should also consult a healthcare provider before using this product. Furthermore, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should be advised to speak with a doctor or pharmacist before use.

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 within a temperature range of 68-77°F (20-25°C) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

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)